Trial Outcomes & Findings for A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features (NCT NCT03573297)
NCT ID: NCT03573297
Last Updated: 2023-09-28
Results Overview
Relapse was defined as the occurrence of any 1 of the following: * Young Mania Rating Score (YMRS) total score ≥ 17 (range 0-60; higher score indicates a worse outcome); * Montgomery Asberg Depression Rating Scale; (MADRS) total score ≥ 20 (range 0-60; higher score indicates more depressive symptoms); * Clinical Global Impression-Improvement scale (CGI-S) ≥ 4 (range from 1 \[normal, not at all ill\] to 7 \[extremely ill\]); * Initiation of additional psychiatric medication; * Psychiatric hospitalization; * Exacerbation of illness as judged by clinical impression of the Investigator. Time to first relapse (days) was calculated as the date of the first relapse - the date of randomization + 1. Participants who did not meet the relapse criteria were considered censored at the time of completion or discontinuation from the Double-Blind Treatment Period (DBTP) of the study. Percentiles (95% Confidence Intervals \[CI\]) are based on Kaplan-Meier estimates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
901 participants
Primary outcome timeframe
From Week 16 to Week 55
Results posted on
2023-09-28
Participant Flow
A total of 901 participants were enrolled; 5 participants did not enter the open label treatment period.
Participant milestones
| Measure |
Open Label Treatment Period
Participants started on cariprazine 1.5 mg once daily (QD), with a target dose of 3.0 mg QD, for up to 16 weeks.
|
Double-Blind Placebo QD
Partcipants randomized to receive placebo QD for up to 39 weeks.
|
Double-Blind Cariprazine 1.5 mg QD
Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
|
Double-Blind Cariprazine 3.0 mg QD
Participants randomized to receive cariprazine 3.0 mg QD for up to 39 weeks.
|
|---|---|---|---|---|
|
Open Label Treatment Period
STARTED
|
896
|
0
|
0
|
0
|
|
Open Label Treatment Period
COMPLETED
|
440
|
0
|
0
|
0
|
|
Open Label Treatment Period
NOT COMPLETED
|
456
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
STARTED
|
0
|
145
|
147
|
148
|
|
Double-Blind Treatment Period
Randomized and Treated in Double-Blind Treatment Period
|
0
|
145
|
144
|
147
|
|
Double-Blind Treatment Period
COMPLETED
|
0
|
79
|
82
|
84
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
0
|
66
|
65
|
64
|
Reasons for withdrawal
| Measure |
Open Label Treatment Period
Participants started on cariprazine 1.5 mg once daily (QD), with a target dose of 3.0 mg QD, for up to 16 weeks.
|
Double-Blind Placebo QD
Partcipants randomized to receive placebo QD for up to 39 weeks.
|
Double-Blind Cariprazine 1.5 mg QD
Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
|
Double-Blind Cariprazine 3.0 mg QD
Participants randomized to receive cariprazine 3.0 mg QD for up to 39 weeks.
|
|---|---|---|---|---|
|
Open Label Treatment Period
Adverse Event
|
67
|
0
|
0
|
0
|
|
Open Label Treatment Period
Lack of Efficacy
|
35
|
0
|
0
|
0
|
|
Open Label Treatment Period
Withdrawal by Subject
|
104
|
0
|
0
|
0
|
|
Open Label Treatment Period
Lost to Follow-up
|
55
|
0
|
0
|
0
|
|
Open Label Treatment Period
Pregnancy
|
1
|
0
|
0
|
0
|
|
Open Label Treatment Period
Protocol Violation
|
17
|
0
|
0
|
0
|
|
Open Label Treatment Period
Non-Compliance With Study Drug
|
25
|
0
|
0
|
0
|
|
Open Label Treatment Period
Study Terminated by Sponsor
|
2
|
0
|
0
|
0
|
|
Open Label Treatment Period
Failure to Meet Randomization Criteria
|
143
|
0
|
0
|
0
|
|
Open Label Treatment Period
Other, Not Specified
|
7
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
Relapse Event during Double-blind Treatment Period
|
0
|
29
|
25
|
26
|
|
Double-Blind Treatment Period
Adverse Event
|
0
|
1
|
5
|
1
|
|
Double-Blind Treatment Period
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Double-Blind Treatment Period
Withdrawal by Subject
|
0
|
23
|
11
|
14
|
|
Double-Blind Treatment Period
Lost to Follow-up
|
0
|
4
|
4
|
9
|
|
Double-Blind Treatment Period
Protocol Violation
|
0
|
3
|
8
|
4
|
|
Double-Blind Treatment Period
Non-Compliance With Study Drug
|
0
|
0
|
4
|
4
|
|
Double-Blind Treatment Period
Other, Not Specified
|
0
|
5
|
8
|
6
|
Baseline Characteristics
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
Baseline characteristics by cohort
| Measure |
Open Label Treatment Period
n=896 Participants
Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.
|
|---|---|
|
Age, Customized
< 45 years
|
539 Participants
n=99 Participants
|
|
Age, Customized
≥ 45 years
|
357 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
542 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
354 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
89 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
806 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
258 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
591 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From Week 16 to Week 55Population: Double-Blind Intent-to-Treat Population: All participants who took at least 1 dose of DB IP and had at least 1 post-randomization assessment of the YMRS, MADRS or CGI-S scores or relapsed during the 39-week DBTP of the study.
Relapse was defined as the occurrence of any 1 of the following: * Young Mania Rating Score (YMRS) total score ≥ 17 (range 0-60; higher score indicates a worse outcome); * Montgomery Asberg Depression Rating Scale; (MADRS) total score ≥ 20 (range 0-60; higher score indicates more depressive symptoms); * Clinical Global Impression-Improvement scale (CGI-S) ≥ 4 (range from 1 \[normal, not at all ill\] to 7 \[extremely ill\]); * Initiation of additional psychiatric medication; * Psychiatric hospitalization; * Exacerbation of illness as judged by clinical impression of the Investigator. Time to first relapse (days) was calculated as the date of the first relapse - the date of randomization + 1. Participants who did not meet the relapse criteria were considered censored at the time of completion or discontinuation from the Double-Blind Treatment Period (DBTP) of the study. Percentiles (95% Confidence Intervals \[CI\]) are based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Double-Blind Placebo QD
n=142 Participants
Participants randomized to receive placebo QD for up to 39 weeks.
|
Double-Blind Cariprazine 1.5 mg QD
n=143 Participants
Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
|
Double-Blind Cariprazine 3.0 mg QD
n=145 Participants
Participants randomized to receive cariprazine 3.0 mg QD for up to 39 weeks.
|
|---|---|---|---|
|
Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period
25% percentile
|
NA days
Interval 156.0 to
Not estimable because the 3 treatment curves did not pass through the 25% percentile mark.
|
NA days
Interval 220.0 to
Not estimable because the 3 treatment curves did not pass through the 25% percentile mark.
|
NA days
Interval 224.0 to
Not estimable because the 3 treatment curves did not pass through the 25% percentile mark.
|
|
Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period
50% percentile
|
NA days
Not estimable because the 3 treatment curves did not pass through the 50% percentile mark.
|
NA days
Not estimable because the 3 treatment curves did not pass through the 50% percentile mark.
|
NA days
Not estimable because the 3 treatment curves did not pass through the 50% percentile mark.
|
|
Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period
75% percentile
|
NA days
Not estimable because the 3 treatment curves did not pass through the 75% percentile mark.
|
NA days
Not estimable because the 3 treatment curves did not pass through the 75% percentile mark.
|
NA days
Not estimable because the 3 treatment curves did not pass through the 75% percentile mark.
|
Adverse Events
Open Label Treatment Period
Serious events: 19 serious events
Other events: 256 other events
Deaths: 1 deaths
Double-Blind Placebo QD
Serious events: 5 serious events
Other events: 27 other events
Deaths: 1 deaths
Double-Blind Cariprazine 1.5 mg QD
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
Double-Blind Cariprazine 3.0 mg QD
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label Treatment Period
n=896 participants at risk
Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.
|
Double-Blind Placebo QD
n=145 participants at risk
Participants randomized to receive placebo QD for up to 39 weeks.
|
Double-Blind Cariprazine 1.5 mg QD
n=144 participants at risk
Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
|
Double-Blind Cariprazine 3.0 mg QD
n=147 participants at risk
Participants randomized to receive cariprazine 3.0 mg QD for up to 39 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
PALPITATIONS
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Infections and infestations
APPENDICEAL ABSCESS
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/144 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/144 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Infections and infestations
CORONAVIRUS PNEUMONIA
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/144 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Infections and infestations
COVID-19
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Infections and infestations
SEPSIS
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/145 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/145 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/145 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/145 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Nervous system disorders
PARAESTHESIA
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Nervous system disorders
SACRAL RADICULOPATHY
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/144 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.33%
3/896 • Number of events 3 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/144 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.68%
1/147 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Psychiatric disorders
BIPOLAR I DISORDER
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
1.4%
2/145 • Number of events 2 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/144 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.68%
1/147 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Psychiatric disorders
DEPRESSION
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Psychiatric disorders
HALLUCINATION, AUDITORY
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/144 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Psychiatric disorders
MANIA
|
0.33%
3/896 • Number of events 3 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.56%
5/896 • Number of events 5 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.68%
1/147 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/896 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/144 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Skin and subcutaneous tissue disorders
STEVENS-JOHNSON SYNDROME
|
0.11%
1/896 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/145 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/144 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
Other adverse events
| Measure |
Open Label Treatment Period
n=896 participants at risk
Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.
|
Double-Blind Placebo QD
n=145 participants at risk
Participants randomized to receive placebo QD for up to 39 weeks.
|
Double-Blind Cariprazine 1.5 mg QD
n=144 participants at risk
Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
|
Double-Blind Cariprazine 3.0 mg QD
n=147 participants at risk
Participants randomized to receive cariprazine 3.0 mg QD for up to 39 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
6.9%
62/896 • Number of events 64 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.69%
1/145 • Number of events 1 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
1.4%
2/144 • Number of events 2 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
0.00%
0/147 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.89%
8/896 • Number of events 8 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
2.8%
4/145 • Number of events 6 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
2.1%
3/144 • Number of events 3 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
6.8%
10/147 • Number of events 10 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Investigations
WEIGHT INCREASED
|
4.5%
40/896 • Number of events 40 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
4.8%
7/145 • Number of events 7 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
7.6%
11/144 • Number of events 12 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
8.8%
13/147 • Number of events 17 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Nervous system disorders
AKATHISIA
|
11.7%
105/896 • Number of events 117 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
1.4%
2/145 • Number of events 2 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
4.2%
6/144 • Number of events 7 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
1.4%
2/147 • Number of events 2 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Nervous system disorders
HEADACHE
|
8.8%
79/896 • Number of events 90 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
10.3%
15/145 • Number of events 22 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
9.7%
14/144 • Number of events 23 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
6.8%
10/147 • Number of events 13 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
|
Psychiatric disorders
INSOMNIA
|
8.6%
77/896 • Number of events 85 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
3.4%
5/145 • Number of events 7 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
6.2%
9/144 • Number of events 12 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
4.1%
6/147 • Number of events 7 • Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER