Trial Outcomes & Findings for Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use (NCT NCT00856583)
NCT ID: NCT00856583
Last Updated: 2011-08-19
Results Overview
The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
9809 participants
Primary outcome timeframe
As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
Results posted on
2011-08-19
Participant Flow
593 centres in 38 countries (Europe and Asia). First patient first visit: 11 July 2002. Last patient last visit: 22 February 2008.
Participant milestones
| Measure |
Sertindole
Normally in the range of 4 to 20 mg/day
|
Risperidone
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
4905
|
4904
|
|
Overall Study
COMPLETED
|
1768
|
2307
|
|
Overall Study
NOT COMPLETED
|
3137
|
2597
|
Reasons for withdrawal
| Measure |
Sertindole
Normally in the range of 4 to 20 mg/day
|
Risperidone
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
389
|
377
|
|
Overall Study
Serious Adverse Event (SAE)
|
99
|
65
|
|
Overall Study
Non-SAE: Mostly Asymptomatic ECGs
|
393
|
179
|
|
Overall Study
Non-compliance
|
305
|
262
|
|
Overall Study
Withdrawal by Subject
|
1092
|
919
|
|
Overall Study
Physician Decision
|
59
|
82
|
|
Overall Study
Pregnancy
|
14
|
5
|
|
Overall Study
Other
|
92
|
104
|
|
Overall Study
Non-evaluable: Patient on Polytherapy
|
694
|
604
|
Baseline Characteristics
Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use
Baseline characteristics by cohort
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
Total
n=9809 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
38.4 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
38.3 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
38.3 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
Age, Customized
18 to 65 years
|
4806 participants
n=99 Participants
|
4820 participants
n=107 Participants
|
9626 participants
n=206 Participants
|
|
Age, Customized
> 65 years
|
99 participants
n=99 Participants
|
84 participants
n=107 Participants
|
183 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2195 Participants
n=99 Participants
|
2188 Participants
n=107 Participants
|
4383 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2710 Participants
n=99 Participants
|
2716 Participants
n=107 Participants
|
5426 Participants
n=206 Participants
|
|
Duration of schizophrenia
Unknown
|
125 participants
n=99 Participants
|
87 participants
n=107 Participants
|
212 participants
n=206 Participants
|
|
Duration of schizophrenia
< 5 years
|
1450 participants
n=99 Participants
|
1468 participants
n=107 Participants
|
2918 participants
n=206 Participants
|
|
Duration of schizophrenia
5 to 10 years
|
1254 participants
n=99 Participants
|
1278 participants
n=107 Participants
|
2532 participants
n=206 Participants
|
|
Duration of schizophrenia
> 10 years
|
2076 participants
n=99 Participants
|
2071 participants
n=107 Participants
|
4147 participants
n=206 Participants
|
|
Reasons for prescription of study drug
Adverse drug reaction
|
1121 participants
n=99 Participants
|
1072 participants
n=107 Participants
|
2193 participants
n=206 Participants
|
|
Reasons for prescription of study drug
Lack of efficacy
|
2542 participants
n=99 Participants
|
2580 participants
n=107 Participants
|
5122 participants
n=206 Participants
|
|
Reasons for prescription of study drug
None or poor compliance
|
161 participants
n=99 Participants
|
169 participants
n=107 Participants
|
330 participants
n=206 Participants
|
|
Reasons for prescription of study drug
Patient's choice
|
992 participants
n=99 Participants
|
979 participants
n=107 Participants
|
1971 participants
n=206 Participants
|
|
Reasons for prescription of study drug
Other
|
89 participants
n=99 Participants
|
104 participants
n=107 Participants
|
193 participants
n=206 Participants
|
|
Number of previous suicide attempts
Unknown
|
17 participants
n=99 Participants
|
11 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Number of previous suicide attempts
0 previous suicide attempts
|
4281 participants
n=99 Participants
|
4288 participants
n=107 Participants
|
8569 participants
n=206 Participants
|
|
Number of previous suicide attempts
1 previous suicide attempt
|
378 participants
n=99 Participants
|
377 participants
n=107 Participants
|
755 participants
n=206 Participants
|
|
Number of previous suicide attempts
2 previous suicide attempts
|
125 participants
n=99 Participants
|
126 participants
n=107 Participants
|
251 participants
n=206 Participants
|
|
Number of previous suicide attempts
3 previous suicide attempts
|
52 participants
n=99 Participants
|
53 participants
n=107 Participants
|
105 participants
n=206 Participants
|
|
Number of previous suicide attempts
4 previous suicide attempts
|
18 participants
n=99 Participants
|
13 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Number of previous suicide attempts
>= 5 previous suicide attempts
|
34 participants
n=99 Participants
|
36 participants
n=107 Participants
|
70 participants
n=206 Participants
|
|
Time since last suicide attempt
No previous suicide attempt or unknown
|
4298 participants
n=99 Participants
|
4301 participants
n=107 Participants
|
8599 participants
n=206 Participants
|
|
Time since last suicide attempt
< 1 year
|
122 participants
n=99 Participants
|
117 participants
n=107 Participants
|
239 participants
n=206 Participants
|
|
Time since last suicide attempt
1 to 5 years
|
226 participants
n=99 Participants
|
218 participants
n=107 Participants
|
444 participants
n=206 Participants
|
|
Time since last suicide attempt
> 5 years
|
259 participants
n=99 Participants
|
268 participants
n=107 Participants
|
527 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsPopulation: The analysis population included all patients who took at least one dose of study drug.
The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Number of Participants With All-cause Mortality
Number of deaths (WRT+30 days)
|
64 participants
|
61 participants
|
|
Number of Participants With All-cause Mortality
Number of deaths (ORT)
|
40 participants
|
44 participants
|
PRIMARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsPopulation: The analysis population included all patients who took at least one dose of study drug.
Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation
|
10 participants
|
6 participants
|
SECONDARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsPopulation: The analysis population included all patients who took at least one dose of study drug.
The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide.
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC
|
31 participants
|
12 participants
|
SECONDARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsThe analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide.
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Cause-specific Mortality: Number of Participants With Completed Suicides - ISC
|
14 participants
|
21 participants
|
SECONDARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsThe analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide.
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC
|
19 participants
|
28 participants
|
SECONDARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsThe analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA
|
17 participants
|
8 participants
|
SECONDARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsThe analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA
|
13 participants
|
21 participants
|
SECONDARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsThe analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA
|
34 participants
|
32 participants
|
SECONDARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsPopulation: The analysis population included all patients who took at least one dose of study drug.
The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide.
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC
|
68 participants
|
76 participants
|
SECONDARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsThe analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA
|
43 participants
|
65 participants
|
SECONDARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsPopulation: The analysis population included all patients who took at least one dose of study drug.
The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease
|
174 participants
|
149 participants
|
SECONDARY outcome
Timeframe: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 monthsPopulation: The analysis population included all patients who took at least one dose of study drug.
The analysis was based on time from start of study drug until stop of study drug for any reason other than sponsor closure of the study
Outcome measures
| Measure |
Sertindole
n=4905 Participants
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 Participants
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure
|
3136 participants
430 PET?
|
2597 participants
433
|
Adverse Events
Sertindole
Serious events: 266 serious events
Other events: 397 other events
Deaths: 0 deaths
Risperidone
Serious events: 217 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sertindole
n=4905 participants at risk
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 participants at risk
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Arrhythmia
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Atrial flutter
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Cardiac arrest
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Cardiac failure
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Cardiac failure acute
|
0.08%
4/4905 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Cardiomyopathy
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Conduction disorder
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Myocardial infarction
|
0.08%
4/4905 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.08%
4/4905 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Palpitations
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Torsade de pointes
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Eye disorders
Eyelid disorder
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Eye disorders
Meibomianitis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Eye disorders
Retinal detachment
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Anal fistula
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Ascites
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.08%
4/4904 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Haematemesis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Nausea
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
General disorders
Asthenia
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
General disorders
Chest pain
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
General disorders
Condition aggravated
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
General disorders
Death
|
0.24%
12/4905 • Number of events 12 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
General disorders
Drowning
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
General disorders
Generalised oedema
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
General disorders
Oedema peripheral
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
General disorders
Pyrexia
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
General disorders
Sudden death
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Hepatobiliary disorders
Hepatocellular damage
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Immune system disorders
Hypersensitivity
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Appendicitis
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Bronchitis
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Bronchopneumonia
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Gangrene
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Gastroenteritis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Infection
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Infection in an immunocompromised host
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Laryngitis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Meningitis tuberculous
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Obstructive chronic bronchitis with acute exacerbation
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Pneumonia
|
0.14%
7/4905 • Number of events 9 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.14%
7/4904 • Number of events 7 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Pneumonia chlamydial
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Postoperative wound infection
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.08%
4/4905 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Pyelonephritis acute
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Sepsis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Urinary tract infection
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Infections and infestations
Vaginal candidiasis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.12%
6/4904 • Number of events 6 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Fall
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.43%
21/4905 • Number of events 23 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.29%
14/4904 • Number of events 16 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.02%
1/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Multiple drug overdose intentional
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.31%
15/4905 • Number of events 16 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.16%
8/4904 • Number of events 8 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.08%
4/4905 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Self mutilation
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Investigations
Alanine aminotransferase increased
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Investigations
Aspartate aminotransferase increased
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Investigations
Blood triglycerides increased
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.35%
17/4905 • Number of events 18 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Investigations
Hepatic enzyme increased
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Investigations
Medical observation
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Investigations
Weight increased
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.08%
4/4905 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Metabolism and nutrition disorders
Type 2 diabetis mellitus
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis postmenopausal
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal carcinoma
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of testis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gammopathy
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Scrotal cancer
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Brain damage
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Coma
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Convulsion
|
0.08%
4/4905 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.10%
5/4904 • Number of events 6 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Diabetic coma
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Dizziness
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Epilepsy
|
0.10%
5/4905 • Number of events 5 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Grand mal convulsion
|
0.10%
5/4905 • Number of events 5 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Headache
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Loss of consciousness
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Status epilepticus
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Syncope
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Completed suicide
|
0.27%
13/4905 • Number of events 13 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.43%
21/4904 • Number of events 21 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Delirium
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Depression
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Intentional self-injury
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Mania
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Psychotic disorder
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Suicidal ideation
|
0.14%
7/4905 • Number of events 7 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.08%
4/4904 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Psychiatric disorders
Suicide attempt
|
0.59%
29/4905 • Number of events 30 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.92%
45/4904 • Number of events 49 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Renal and urinary disorders
Calculus urinary
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Renal and urinary disorders
Renal colic
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Renal and urinary disorders
Urge incontinence
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Reproductive system and breast disorders
Galactorrhoea
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Reproductive system and breast disorders
Haematosalpinx
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.08%
4/4905 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.06%
3/4905 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
3/4905 • Number of events 5 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
4/4905 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.06%
3/4904 • Number of events 3 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
4/4905 • Number of events 4 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Social circumstances
Alcohol use
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Social circumstances
Drug abuser
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Social circumstances
Physical assault
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Social circumstances
Social problem
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Social circumstances
Treatment noncompliance
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Surgical and medical procedures
Bunion operation
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Surgical and medical procedures
Plastic surgery
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Surgical and medical procedures
Varicose vein operation
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Vascular disorders
Deep vein thrombosis
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Vascular disorders
Hypertension
|
0.04%
2/4905 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Vascular disorders
Hypertensive crisis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Vascular disorders
Labile hypertension
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Vascular disorders
Orthostatic hypotension
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.04%
2/4904 • Number of events 2 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Vascular disorders
Phlebitis
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.02%
1/4904 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
|
Vascular disorders
Shock
|
0.02%
1/4905 • Number of events 1 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.00%
0/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
Other adverse events
| Measure |
Sertindole
n=4905 participants at risk
Normally in the range of 4 to 20 mg/day
|
Risperidone
n=4904 participants at risk
Normally in the range of 2 to 8 mg/day
|
|---|---|---|
|
Investigations
Electrocardiogram QT prolonged
|
8.1%
397/4905 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
0.22%
11/4904 • As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the results by the investigator will be subject to mutual agreement between the investigator and H. Lundbeck A/S.
- Publication restrictions are in place
Restriction type: OTHER