Trial Outcomes & Findings for Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. (NCT NCT01574703)
NCT ID: NCT01574703
Last Updated: 2016-12-29
Results Overview
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
4595 participants
Primary outcome timeframe
Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Results posted on
2016-12-29
Participant Flow
Of the 6293 participants who completed the parent study NCT01456936 as per protocol, a total of 4595 participants enrolled into this study NCT01574703 from 132 centers in 16 countries.
This is a non-treatment extension study of parent study NCT01456936. No study drug was provided in this extension phase. However, cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline(N=2016), bupropion(N=2006),NRT(N=2022), or placebo(N=2014) in a triple-dummy design were analyzed in this study.
Participant milestones
| Measure |
Varenicline
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
Nicotine Replacement Therapy (NRT) Patch
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1192
|
1166
|
1116
|
1121
|
|
Overall Study
COMPLETED
|
1067
|
1054
|
1011
|
1007
|
|
Overall Study
NOT COMPLETED
|
125
|
112
|
105
|
114
|
Reasons for withdrawal
| Measure |
Varenicline
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
Nicotine Replacement Therapy (NRT) Patch
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Unspecified Reason
|
27
|
15
|
20
|
16
|
|
Overall Study
Withdrawal by Subject
|
53
|
52
|
36
|
61
|
|
Overall Study
Met Withdrawal Criteria
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
43
|
41
|
46
|
35
|
|
Overall Study
Death
|
2
|
1
|
1
|
0
|
Baseline Characteristics
Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
Baseline characteristics by cohort
| Measure |
Varenicline
n=1192 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=1166 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=1116 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=1121 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
Total
n=4595 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.1 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
47.7 Years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
48.3 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
47.5 Years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
47.9 Years
STANDARD_DEVIATION 12.2 • n=21 Participants
|
|
Gender
Female
|
659 Participants
n=5 Participants
|
648 Participants
n=7 Participants
|
623 Participants
n=5 Participants
|
621 Participants
n=4 Participants
|
2551 Participants
n=21 Participants
|
|
Gender
Male
|
533 Participants
n=5 Participants
|
518 Participants
n=7 Participants
|
493 Participants
n=5 Participants
|
500 Participants
n=4 Participants
|
2044 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.
Outcome measures
| Measure |
Varenicline
n=2016 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=2006 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=2022 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=2014 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
|
0.29 Unitless
Interval 0.05 to 1.68
|
0.50 Unitless
Interval 0.1 to 2.5
|
0.29 Unitless
Interval 0.05 to 1.7
|
NA Unitless
Hazard ratio relative to Placebo.
|
SECONDARY outcome
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.
Outcome measures
| Measure |
Varenicline
n=2016 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=2006 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=2022 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=2014 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
|
0.29 Unitless
Interval 0.05 to 1.7
|
0.51 Unitless
Interval 0.1 to 2.51
|
0.50 Unitless
Interval 0.1 to 2.48
|
NA Unitless
Hazard ratio relative to Placebo.
|
SECONDARY outcome
Timeframe: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.
Outcome measures
| Measure |
Varenicline
n=2016 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=2006 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=2022 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=2014 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Time to MACE Until the End of Study NCT01574703.
|
0.39 Unitless
Interval 0.12 to 1.27
|
1.09 Unitless
Interval 0.42 to 2.83
|
0.75 Unitless
Interval 0.26 to 2.13
|
NA Unitless
Hazard ratio relative to Placebo.
|
SECONDARY outcome
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).
Outcome measures
| Measure |
Varenicline
n=2016 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=2006 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=2022 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=2014 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
|
0.05 percentage of participants
|
0.10 percentage of participants
|
0.05 percentage of participants
|
0.20 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.
Outcome measures
| Measure |
Varenicline
n=2016 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=2006 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=2022 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=2014 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
|
0.25 percentage of participants
|
0.20 percentage of participants
|
0.10 percentage of participants
|
0.25 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.
Outcome measures
| Measure |
Varenicline
n=2016 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=2006 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=2022 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=2014 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
|
0.05 percentage of participants
|
0.10 percentage of participants
|
0.10 percentage of participants
|
0.20 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.
Outcome measures
| Measure |
Varenicline
n=2016 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=2006 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=2022 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=2014 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
|
0.25 percentage of participants
|
0.20 percentage of participants
|
0.15 percentage of participants
|
0.35 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.
Outcome measures
| Measure |
Varenicline
n=2016 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=2006 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=2022 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=2014 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Incidence of MACE Assessed Until End of Study NCT01574703.
|
0.15 percentage of participants
|
0.45 percentage of participants
|
0.30 percentage of participants
|
0.40 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.
Outcome measures
| Measure |
Varenicline
n=2016 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=2006 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=2022 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=2014 Participants
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Incidence of MACE+ Assessed Until End of Study NCT01574703.
|
0.50 percentage of participants
|
0.75 percentage of participants
|
0.49 percentage of participants
|
0.60 percentage of participants
|
Adverse Events
Varenicline
Serious events: 34 serious events
Other events: 165 other events
Deaths: 0 deaths
Bupropion
Serious events: 39 serious events
Other events: 160 other events
Deaths: 0 deaths
NRT Patch
Serious events: 43 serious events
Other events: 116 other events
Deaths: 0 deaths
Placebo
Serious events: 41 serious events
Other events: 143 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=1192 participants at risk
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=1166 participants at risk
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=1116 participants at risk
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=1121 participants at risk
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.34%
4/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.18%
2/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
General disorders
Chest pain
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.18%
2/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.18%
2/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Coronary artery disease
|
0.17%
2/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Myocardial infarction
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.17%
2/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Endocrine disorders
Goitre
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Eye disorders
Chalazion
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Eye disorders
Endocrine ophthalmopathy
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Enteritis
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
General disorders
Death
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Hepatobiliary disorders
Cholangitis
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.18%
2/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.18%
2/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Erysipelas
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Haemorrhagic fever with renal syndrome
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Meningitis viral
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Necrotising fasciitis
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Pneumonia
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.27%
3/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Post procedural infection
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Pyelonephritis
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatosplenic T-cell lymphoma
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage II
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Nervous system disorders
Morton's neuralgia
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Nervous system disorders
Syncope
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.18%
2/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Psychiatric disorders
Major depression
|
0.17%
2/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.18%
2/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.17%
2/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.18%
2/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
1/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.18%
2/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Surgical and medical procedures
Drug detoxification
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Vascular disorders
Embolism
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.09%
1/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
0.00%
0/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
Other adverse events
| Measure |
Varenicline
n=1192 participants at risk
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
|
Bupropion
n=1166 participants at risk
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
|
NRT Patch
n=1116 participants at risk
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
|
Placebo
n=1121 participants at risk
This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.6%
103/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
6.7%
78/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
6.2%
69/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
7.2%
81/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
63/1192 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
7.2%
84/1166 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
4.3%
48/1116 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
5.6%
63/1121 • Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER