Trial Outcomes & Findings for Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder (NCT NCT00887224)
NCT ID: NCT00887224
Last Updated: 2014-11-21
Results Overview
Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
874 participants
Primary outcome timeframe
Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)
Results posted on
2014-11-21
Participant Flow
1072 participants were screened, 874 were enrolled into Desvenlafaxine succinate sustained release (DVS SR) open-label 8-week response phase; 659 entered into 12-week open label stability phase. After 20 weeks of open-label treatment 548 subjects were randomized to the 6-month double-blind phase to receive either placebo or to continue with DVS SR.
Participant milestones
| Measure |
DVS SR 50 mg (Open-label Phase)
Desvenlafaxine succinate sustained release (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
|
Placebo (Double-blind Phase)
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population).
|
DVS SR 50 mg (Double-blind Phase)
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).
|
|---|---|---|---|
|
Open-label Response (OLR) Phase
STARTED
|
874
|
0
|
0
|
|
Open-label Response (OLR) Phase
COMPLETED
|
752
|
0
|
0
|
|
Open-label Response (OLR) Phase
NOT COMPLETED
|
122
|
0
|
0
|
|
Between OLR and OLS Phases
STARTED
|
752
|
0
|
0
|
|
Between OLR and OLS Phases
COMPLETED
|
659
|
0
|
0
|
|
Between OLR and OLS Phases
NOT COMPLETED
|
93
|
0
|
0
|
|
Open-label Stability (OLS) Phase
STARTED
|
659
|
0
|
0
|
|
Open-label Stability (OLS) Phase
COMPLETED
|
576
|
0
|
0
|
|
Open-label Stability (OLS) Phase
NOT COMPLETED
|
83
|
0
|
0
|
|
Between OLS and DB Phases
STARTED
|
576
|
0
|
0
|
|
Between OLS and DB Phases
COMPLETED
|
548
|
0
|
0
|
|
Between OLS and DB Phases
NOT COMPLETED
|
28
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
STARTED
|
307
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
Discontinued Open-label Taper
|
144
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
COMPLETED
|
163
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
NOT COMPLETED
|
144
|
0
|
0
|
|
Double-blind (DB) Phase
STARTED
|
0
|
276
|
272
|
|
Double-blind (DB) Phase
COMPLETED
|
0
|
176
|
210
|
|
Double-blind (DB) Phase
NOT COMPLETED
|
0
|
100
|
62
|
|
DB Taper Phase / Post Study Follow Up
STARTED
|
0
|
267
|
265
|
|
DB Taper Phase / Post Study Follow Up
Did Not Enter DB Taper
|
0
|
9
|
7
|
|
DB Taper Phase / Post Study Follow Up
Discontinued DB Taper
|
0
|
41
|
30
|
|
DB Taper Phase / Post Study Follow Up
COMPLETED
|
0
|
226
|
235
|
|
DB Taper Phase / Post Study Follow Up
NOT COMPLETED
|
0
|
41
|
30
|
Reasons for withdrawal
| Measure |
DVS SR 50 mg (Open-label Phase)
Desvenlafaxine succinate sustained release (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
|
Placebo (Double-blind Phase)
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population).
|
DVS SR 50 mg (Double-blind Phase)
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).
|
|---|---|---|---|
|
Open-label Response (OLR) Phase
Adverse Event
|
46
|
0
|
0
|
|
Open-label Response (OLR) Phase
Failed to return
|
6
|
0
|
0
|
|
Open-label Response (OLR) Phase
Lack of Efficacy
|
26
|
0
|
0
|
|
Open-label Response (OLR) Phase
Lost to Follow-up
|
16
|
0
|
0
|
|
Open-label Response (OLR) Phase
Other
|
1
|
0
|
0
|
|
Open-label Response (OLR) Phase
Protocol Violation
|
12
|
0
|
0
|
|
Open-label Response (OLR) Phase
Withdrawal by Subject
|
15
|
0
|
0
|
|
Open-label Stability (OLS) Phase
Adverse Event
|
22
|
0
|
0
|
|
Open-label Stability (OLS) Phase
Failed to return
|
3
|
0
|
0
|
|
Open-label Stability (OLS) Phase
Lack of Efficacy
|
16
|
0
|
0
|
|
Open-label Stability (OLS) Phase
Lost to Follow-up
|
9
|
0
|
0
|
|
Open-label Stability (OLS) Phase
Other
|
1
|
0
|
0
|
|
Open-label Stability (OLS) Phase
Protocol Violation
|
13
|
0
|
0
|
|
Open-label Stability (OLS) Phase
Withdrawal by Subject
|
19
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
Adverse Event
|
28
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
Failed to return
|
17
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
Physician Decision
|
10
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
Lost to Follow-up
|
8
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
Other
|
30
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
Protocol Violation
|
3
|
0
|
0
|
|
OL Taper Phase / OL Follow Up
Withdrawal by Subject
|
48
|
0
|
0
|
|
Double-blind (DB) Phase
Adverse Event
|
0
|
7
|
2
|
|
Double-blind (DB) Phase
Failed to return
|
0
|
2
|
2
|
|
Double-blind (DB) Phase
Lack of Efficacy
|
0
|
67
|
33
|
|
Double-blind (DB) Phase
Lost to Follow-up
|
0
|
8
|
8
|
|
Double-blind (DB) Phase
Other
|
0
|
2
|
0
|
|
Double-blind (DB) Phase
Protocol Violation
|
0
|
8
|
5
|
|
Double-blind (DB) Phase
Withdrawal by Subject
|
0
|
6
|
12
|
|
DB Taper Phase / Post Study Follow Up
Adverse Event
|
0
|
5
|
0
|
|
DB Taper Phase / Post Study Follow Up
Failed to return
|
0
|
5
|
4
|
|
DB Taper Phase / Post Study Follow Up
Physician Decision
|
0
|
6
|
0
|
|
DB Taper Phase / Post Study Follow Up
Lost to Follow-up
|
0
|
2
|
2
|
|
DB Taper Phase / Post Study Follow Up
Other
|
0
|
11
|
12
|
|
DB Taper Phase / Post Study Follow Up
Protocol Violation
|
0
|
4
|
1
|
|
DB Taper Phase / Post Study Follow Up
Withdrawal by Subject
|
0
|
8
|
11
|
Baseline Characteristics
Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
DVS SR 50 mg (Open-label Phase)
n=874 Participants
DVS SR 50 mg PO QD for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
|
Placebo (Double-blind Phase)
n=276 Participants
Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population).
|
DVS SR 50 mg (Double-blind Phase)
n=272 Participants
Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).
|
Total
n=1422 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.98 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
44.98 years
STANDARD_DEVIATION 13.25 • n=4 Participants
|
|
Gender
Female
|
608 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
608 participants
n=4 Participants
|
|
Gender
Male
|
266 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
266 participants
n=4 Participants
|
|
Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale
1=very much improved
|
0 participants
n=5 Participants
|
239 participants
n=7 Participants
|
223 participants
n=5 Participants
|
462 participants
n=4 Participants
|
|
Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale
2=much improved
|
0 participants
n=5 Participants
|
36 participants
n=7 Participants
|
49 participants
n=5 Participants
|
85 participants
n=4 Participants
|
|
Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale
3=minimally improved
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale
4=no change
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale
5=minimally worse
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale
6=much worse
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale
7=very much worse
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Total Score
|
NA scores on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
4.58 scores on a scale
STANDARD_DEVIATION 3.02 • n=7 Participants
|
4.69 scores on a scale
STANDARD_DEVIATION 2.97 • n=5 Participants
|
4.64 scores on a scale
STANDARD_DEVIATION 2.99 • n=4 Participants
|
|
Number of participants with remission based on HAM-D17 score
Remission=No
|
0 participants
n=5 Participants
|
46 participants
n=7 Participants
|
52 participants
n=5 Participants
|
98 participants
n=4 Participants
|
|
Number of participants with remission based on HAM-D17 score
Remission=Yes
|
0 participants
n=5 Participants
|
230 participants
n=7 Participants
|
220 participants
n=5 Participants
|
450 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)Population: All Randomized population: all participants randomly assigned to the Double-blind treatment phase of the study.
Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).
Outcome measures
| Measure |
Placebo
n=276 Participants
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
|
DVS SR 50 mg
n=272 Participants
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
|
|---|---|---|
|
Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185
|
30.2 percent estimated probability
|
14.3 percent estimated probability
|
SECONDARY outcome
Timeframe: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)Population: All Randomized population. N=number of participants with analyzable data at observation (Observed Cases).
CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Outcome measures
| Measure |
Placebo
n=267 Participants
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
|
DVS SR 50 mg
n=261 Participants
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
|
|---|---|---|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 1: 1=very much improved
|
9 participants
|
3 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 1: 3=minimally improved
|
12 participants
|
19 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 1: 4=no change
|
227 participants
|
212 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 1: 6=much worse
|
2 participants
|
3 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 4: 3=minimally improved
|
20 participants
|
28 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 4: 4=no change
|
169 participants
|
181 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 6: 2=much improved
|
5 participants
|
11 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 6: 3=minimally improved
|
20 participants
|
31 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 6: 4=no change
|
153 participants
|
174 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 6: 5=minimally worse
|
40 participants
|
16 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 6: 6=much worse
|
14 participants
|
6 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 14: 4=no change
|
124 participants
|
159 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 14: 5=minimally worse
|
49 participants
|
25 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 14: 6=much worse
|
10 participants
|
3 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 18: 4=no change
|
117 participants
|
151 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 26: 7=very much worse
|
1 participants
|
0 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 26: 6=much worse
|
10 participants
|
5 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 1: 2=much improved
|
1 participants
|
3 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 1: 5=minimally worse
|
16 participants
|
20 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 1: 7=very much worse
|
0 participants
|
1 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 2: 1=very much improved
|
7 participants
|
3 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 2: 2=much improved
|
5 participants
|
6 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 2: 3=minimally improved
|
15 participants
|
24 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 2: 4=no change
|
183 participants
|
197 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 2: 5=minimally worse
|
32 participants
|
25 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 2: 6=much worse
|
15 participants
|
4 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 2: 7=very much worse
|
0 participants
|
0 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 3: 1=very much improved
|
5 participants
|
6 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 3: 2=much improved
|
5 participants
|
8 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 3: 3=minimally improved
|
17 participants
|
27 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 3: 4=no change
|
169 participants
|
185 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 3: 5=minimally worse
|
45 participants
|
24 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 3: 6=much worse
|
6 participants
|
2 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 3: 7=very much worse
|
0 participants
|
0 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 4: 1=very much improved
|
5 participants
|
8 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 4: 2=much improved
|
6 participants
|
7 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 4: 5=minimally worse
|
39 participants
|
20 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 4: 6=much worse
|
6 participants
|
2 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 4: 7=very much worse
|
1 participants
|
1 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 6: 1=very much improved
|
6 participants
|
9 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 6: 7=very much worse
|
0 participants
|
0 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 10: 1=very much improved
|
3 participants
|
7 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 10: 2=much improved
|
4 participants
|
9 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 10: 3=minimally improved
|
19 participants
|
28 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 10: 4=no change
|
140 participants
|
161 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 10: 5=minimally worse
|
46 participants
|
28 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 10: 6=much worse
|
9 participants
|
8 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 10: 7=very much worse
|
1 participants
|
1 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 14: 1=very much improved
|
3 participants
|
4 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 26: 1=very much improved
|
7 participants
|
9 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 14: 2=much improved
|
5 participants
|
10 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 14: 3=minimally improved
|
16 participants
|
29 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 14: 7=very much worse
|
0 participants
|
0 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 18: 1=very much improved
|
6 participants
|
7 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 18: 2=much improved
|
6 participants
|
6 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 18: 3=minimally improved
|
12 participants
|
28 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 18: 5=minimally worse
|
39 participants
|
24 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 18: 6=much worse
|
12 participants
|
6 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 18: 7=very much worse
|
0 participants
|
1 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 22: 1=very much improved
|
7 participants
|
8 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 22: 2=much improved
|
4 participants
|
6 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 22: 3=minimally improved
|
13 participants
|
29 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 22: 4=no change
|
116 participants
|
139 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 22: 5=minimally worse
|
30 participants
|
28 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 22: 6=much worse
|
13 participants
|
5 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 22: 7=very much worse
|
1 participants
|
0 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 26: 2=much improved
|
7 participants
|
10 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 26: 3=minimally improved
|
13 participants
|
29 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 26: 4=no change
|
105 participants
|
135 participants
|
|
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
DB Week 26: 5=minimally worse
|
31 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)Population: All Randomized population. N=number of participants with analyzable data at observation.
CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM).
Outcome measures
| Measure |
Placebo
n=267 Participants
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
|
DVS SR 50 mg
n=261 Participants
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Change from Baseline at DB Week 1
|
0.03 scores on a scale
Standard Error 0.03
|
0.03 scores on a scale
Standard Error 0.03
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Change from Baseline at DB Week 2
|
0.18 scores on a scale
Standard Error 0.04
|
0.09 scores on a scale
Standard Error 0.04
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Change from Baseline at DB Week 3
|
0.21 scores on a scale
Standard Error 0.04
|
0.07 scores on a scale
Standard Error 0.04
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Change from Baseline at DB Week 4
|
0.23 scores on a scale
Standard Error 0.05
|
0.06 scores on a scale
Standard Error 0.05
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Change from Baseline at DB Week 6
|
0.32 scores on a scale
Standard Error 0.05
|
0.06 scores on a scale
Standard Error 0.05
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Change from Baseline at DB Week 10
|
0.39 scores on a scale
Standard Error 0.06
|
0.11 scores on a scale
Standard Error 0.06
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Change from Baseline at DB Week 14
|
0.38 scores on a scale
Standard Error 0.05
|
0.05 scores on a scale
Standard Error 0.05
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Change from Baseline at DB Week 18
|
0.42 scores on a scale
Standard Error 0.06
|
0.09 scores on a scale
Standard Error 0.06
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Change from Baseline at DB Week 22
|
0.56 scores on a scale
Standard Error 0.07
|
0.13 scores on a scale
Standard Error 0.07
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Change from Baseline at DB Week 26
|
0.53 scores on a scale
Standard Error 0.06
|
0.09 scores on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)Population: All Randomized population. N=number of participants with analyzable data at observation.
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.
Outcome measures
| Measure |
Placebo
n=267 Participants
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
|
DVS SR 50 mg
n=261 Participants
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
|
|---|---|---|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Change from Baseline at DB Week 1
|
0.28 scores on a scale
Standard Error 0.17
|
0.25 scores on a scale
Standard Error 0.17
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Change from Baseline at DB Week 2
|
1.40 scores on a scale
Standard Error 0.24
|
0.53 scores on a scale
Standard Error 0.24
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Change from Baseline at DB Week 3
|
1.32 scores on a scale
Standard Error 0.22
|
0.45 scores on a scale
Standard Error 0.23
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Change from Baseline at DB Week 4
|
1.50 scores on a scale
Standard Error 0.24
|
0.11 scores on a scale
Standard Error 0.24
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Change from Baseline at DB Week 6
|
1.94 scores on a scale
Standard Error 0.28
|
0.31 scores on a scale
Standard Error 0.28
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Change from Baseline at DB Week 10
|
2.37 scores on a scale
Standard Error 0.32
|
0.69 scores on a scale
Standard Error 0.31
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Change from Baseline at DB Week 14
|
2.66 scores on a scale
Standard Error 0.30
|
0.62 scores on a scale
Standard Error 0.30
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Change from Baseline at DB Week 18
|
2.51 scores on a scale
Standard Error 0.33
|
0.56 scores on a scale
Standard Error 0.32
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Change from Baseline at DB Week 22
|
3.22 scores on a scale
Standard Error 0.37
|
0.92 scores on a scale
Standard Error 0.36
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Change from Baseline at DB Week 26
|
3.12 scores on a scale
Standard Error 0.36
|
0.77 scores on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)Population: All Randomized population. N=number of participants with analyzable data at observation.
HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.
Outcome measures
| Measure |
Placebo
n=267 Participants
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
|
DVS SR 50 mg
n=261 Participants
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
|
|---|---|---|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Change from baseline at DB Week 4
|
0.92 scores on a scale
Standard Error 0.15
|
0.03 scores on a scale
Standard Error 0.15
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Change from baseline at DB Week1
|
0.03 scores on a scale
Standard Error 0.10
|
0.01 scores on a scale
Standard Error 0.10
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Change from baseline at DB Week 2
|
0.66 scores on a scale
Standard Error 0.14
|
0.13 scores on a scale
Standard Error 0.14
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Change from baseline at DB Week 3
|
0.72 scores on a scale
Standard Error 0.14
|
0.14 scores on a scale
Standard Error 0.14
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Change from baseline at DB Week 6
|
1.04 scores on a scale
Standard Error 0.17
|
0.16 scores on a scale
Standard Error 0.16
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Change from baseline at DB Week 10
|
1.41 scores on a scale
Standard Error 0.19
|
0.33 scores on a scale
Standard Error 0.18
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Change from baseline at DB Week 14
|
1.47 scores on a scale
Standard Error 0.17
|
0.34 scores on a scale
Standard Error 0.17
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Change from baseline at DB Week 18
|
1.51 scores on a scale
Standard Error 0.20
|
0.21 scores on a scale
Standard Error 0.19
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Change from baseline at DB Week 22
|
1.68 scores on a scale
Standard Error 0.20
|
0.45 scores on a scale
Standard Error 0.19
|
|
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Change from baseline at DB Week 26
|
1.53 scores on a scale
Standard Error 0.20
|
0.26 scores on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Double-blind phase Week 26 (Study Day 322)Population: All Randomized population. N=number of participants with analyzable data at observation based on Last Observation Carried Forward (LOCF).
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7.
Outcome measures
| Measure |
Placebo
n=273 Participants
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
|
DVS SR 50 mg
n=270 Participants
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
|
|---|---|---|
|
Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26
|
148 participants
|
201 participants
|
SECONDARY outcome
Timeframe: Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)Population: All Randomized population. N=number of participants with analyzable data at observation.
WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.
Outcome measures
| Measure |
Placebo
n=265 Participants
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
|
DVS SR 50 mg
n=261 Participants
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
|
|---|---|---|
|
Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index
Change from baseline at DB Week 14
|
-2.51 scores on a scale
Standard Error 0.35
|
-0.38 scores on a scale
Standard Error 2.36
|
|
Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index
Change from baseline at DB Week 26
|
-2.36 scores on a scale
Standard Error 0.38
|
-0.04 scores on a scale
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)Population: All Randomized population. Change from baseline (Bsl) mean=adjusted mean change calculated using MMRM.
WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.
Outcome measures
| Measure |
Placebo
n=265 Participants
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
|
DVS SR 50 mg
n=261 Participants
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
|
|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
Change from Bsl at DB Week 14: Presenteeism
|
9.35 scores on a scale
Standard Error 2.30
|
2.44 scores on a scale
Standard Error 2.55
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
Change from Bsl at DB Week 14: Absenteeism
|
1.64 scores on a scale
Standard Error 1.72
|
0.62 scores on a scale
Standard Error 1.87
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
Change from Bsl DB Week 14: Work productivity loss
|
9.66 scores on a scale
Standard Error 2.48
|
2.19 scores on a scale
Standard Error 2.75
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
Change from Bsl at DB Week 14: Activity impairment
|
11.02 scores on a scale
Standard Error 1.62
|
3.45 scores on a scale
Standard Error 1.66
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
Change from Bsl at DB Week 26: Absenteeism
|
0.43 scores on a scale
Standard Error 2.05
|
0.77 scores on a scale
Standard Error 2.08
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
Change from Bsl at DB Week 26: Presenteeism
|
7.75 scores on a scale
Standard Error 2.35
|
-0.49 scores on a scale
Standard Error 2.41
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
Change from Bsl DB Week 26: Work productivity loss
|
8.47 scores on a scale
Standard Error 2.56
|
-0.00 scores on a scale
Standard Error 2.63
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
Change from Bsl at DB Week 26: Activity impairment
|
9.67 scores on a scale
Standard Error 1.75
|
2.05 scores on a scale
Standard Error 1.69
|
Adverse Events
DVS SR 50 mg (Open-label Response Phase)
Serious events: 9 serious events
Other events: 609 other events
Deaths: 0 deaths
DVS SR 50 mg (Open Label Stability Phase)
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo (Double-blind Phase)
Serious events: 7 serious events
Other events: 81 other events
Deaths: 0 deaths
DVS SR 50 mg (Double-blind Phase)
Serious events: 8 serious events
Other events: 55 other events
Deaths: 0 deaths
Placebo (DB Taper / DB Post Study Follow Up)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
DVS SR 50 mg (DB Taper / DB Post Study Follow Up)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DVS SR 50 mg (Open-label Response Phase)
n=874 participants at risk
DVS SR 50 mg PO QD for 8 weeks.
|
DVS SR 50 mg (Open Label Stability Phase)
n=659 participants at risk
DVS SR 50 mg PO QD; Responders at week 8 entered a 12-week stability phase.
|
DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up)
n=326 participants at risk
Participants who concluded DVS SR 50 mg open-label study or discontinued treatment at any time in OLR or OLS could have entered the taper phase and received DVS SR 25 mg PO QD for a 7-day period of taper treatment. N=number of participants with OL Taper or OL Post Study Follow Up emergent events who did not enter the DB Phase and concluded or discontinued with or without taper treatment.
|
Placebo (Double-blind Phase)
n=276 participants at risk
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
|
DVS SR 50 mg (Double-blind Phase)
n=272 participants at risk
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
|
Placebo (DB Taper / DB Post Study Follow Up)
n=276 participants at risk
Participants who concluded or discontinued placebo during the DB phase could have entered the taper phase and received placebo matching DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
|
DVS SR 50 mg (DB Taper / DB Post Study Follow Up)
n=272 participants at risk
Participants who concluded or discontinued DVS SR 50 mg during the DB phase could have entered the taper phase and received DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Abnormal behaviour
|
0.11%
1/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.23%
2/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.11%
1/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Infections and infestations
Subcutaneous abscess
|
0.11%
1/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Psychiatric disorders
Aggression
|
0.11%
1/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Psychiatric disorders
Depressive symptom
|
0.11%
1/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Psychiatric disorders
Suicidal ideation
|
0.23%
2/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.30%
2/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.31%
1/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Psychiatric disorders
Suicide attempt
|
0.23%
2/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.11%
1/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Infections and infestations
Viral infection
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Psychiatric disorders
Depression
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.31%
1/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Psychiatric disorders
Self injurious behaviour
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.15%
1/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
General disorders
Pyrexia
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Infections and infestations
Genital infection bacterial
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.37%
1/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.31%
1/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Pregnancy, puerperium and perinatal conditions
Intrauterine death
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.31%
1/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.31%
1/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
Other adverse events
| Measure |
DVS SR 50 mg (Open-label Response Phase)
n=874 participants at risk
DVS SR 50 mg PO QD for 8 weeks.
|
DVS SR 50 mg (Open Label Stability Phase)
n=659 participants at risk
DVS SR 50 mg PO QD; Responders at week 8 entered a 12-week stability phase.
|
DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up)
n=326 participants at risk
Participants who concluded DVS SR 50 mg open-label study or discontinued treatment at any time in OLR or OLS could have entered the taper phase and received DVS SR 25 mg PO QD for a 7-day period of taper treatment. N=number of participants with OL Taper or OL Post Study Follow Up emergent events who did not enter the DB Phase and concluded or discontinued with or without taper treatment.
|
Placebo (Double-blind Phase)
n=276 participants at risk
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
|
DVS SR 50 mg (Double-blind Phase)
n=272 participants at risk
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
|
Placebo (DB Taper / DB Post Study Follow Up)
n=276 participants at risk
Participants who concluded or discontinued placebo during the DB phase could have entered the taper phase and received placebo matching DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
|
DVS SR 50 mg (DB Taper / DB Post Study Follow Up)
n=272 participants at risk
Participants who concluded or discontinued DVS SR 50 mg during the DB phase could have entered the taper phase and received DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.8%
51/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
44/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Gastrointestinal disorders
Dry mouth
|
11.9%
104/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Gastrointestinal disorders
Nausea
|
21.1%
184/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
2.6%
7/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Nervous system disorders
Dizziness
|
7.1%
62/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
10.5%
29/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
4.8%
13/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.36%
1/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
4.8%
13/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Nervous system disorders
Headache
|
18.3%
160/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
5.5%
36/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
2.5%
8/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
12.7%
35/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
12.5%
34/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
1.4%
4/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
2.6%
7/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Nervous system disorders
Somnolence
|
5.1%
45/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Psychiatric disorders
Insomnia
|
5.0%
44/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.7%
50/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
|
Psychiatric disorders
Depression
|
0.00%
0/874 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/659 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
0.00%
0/326 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
6.2%
17/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
2.9%
8/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
3.3%
9/276 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
1.1%
3/272 • Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
|
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