Trial Outcomes & Findings for A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD (NCT NCT01371708)
NCT ID: NCT01371708
Last Updated: 2017-07-27
Results Overview
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
283 participants
Primary outcome timeframe
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Results posted on
2017-07-27
Participant Flow
A total of 304 participants completed study B2061032, 283 of whom were enrolled in the current extension study, B2061030, and 281 received treatment.
Participant milestones
| Measure |
Placebo/DVS-SR
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
93
|
98
|
|
Overall Study
Received Treatment
|
91
|
93
|
97
|
|
Overall Study
COMPLETED
|
66
|
63
|
59
|
|
Overall Study
NOT COMPLETED
|
26
|
30
|
39
|
Reasons for withdrawal
| Measure |
Placebo/DVS-SR
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Overall Study
Insufficient clinical response
|
3
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
9
|
7
|
|
Overall Study
Protocol Violation
|
2
|
1
|
2
|
|
Overall Study
No longer willing to participate
|
7
|
7
|
13
|
|
Overall Study
Medication error/not related to AE
|
0
|
1
|
0
|
|
Overall Study
Other
|
3
|
2
|
4
|
|
Overall Study
Adverse Event
|
5
|
8
|
12
|
|
Overall Study
Started but did not receive treatment
|
1
|
0
|
1
|
Baseline Characteristics
A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
Baseline characteristics by cohort
| Measure |
Placebo/DVS-SR
n=91 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
n=93 Participants
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
n=97 Participants
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
7 to 11 years
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Age, Customized
12 to 17 years
|
63 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
62 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
187 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who received at least 1 dose of study drug in study B2061030
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Outcome measures
| Measure |
Placebo/DVS-SR
n=91 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
n=93 Participants
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
n=97 Participants
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
|
78.0 Percentage of participants
|
73.1 Percentage of participants
|
71.1 Percentage of participants
|
PRIMARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who received at least 1 dose of study drug in study B2061030
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Outcome measures
| Measure |
Placebo/DVS-SR
n=281 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
|
74.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Outcome measures
| Measure |
Placebo/DVS-SR
n=63 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
n=57 Participants
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
n=56 Participants
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
|
-6.79 Units on a scale
Standard Deviation 12.05
|
-10.72 Units on a scale
Standard Deviation 10.80
|
-8.57 Units on a scale
Standard Deviation 13.01
|
SECONDARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Outcome measures
| Measure |
Placebo/DVS-SR
n=176 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)
|
-8.63 Units on a scale
Standard Deviation 12.03
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Outcome measures
| Measure |
Placebo/DVS-SR
n=63 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
n=57 Participants
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
n=56 Participants
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
|
-1.02 Units on a scale
Standard Deviation 1.18
|
-1.44 Units on a scale
Standard Deviation 1.12
|
-0.70 Units on a scale
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Outcome measures
| Measure |
Placebo/DVS-SR
n=176 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
|
-1.05 Units on a scale
Standard Deviation 1.26
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Outcome measures
| Measure |
Placebo/DVS-SR
n=63 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
n=57 Participants
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
n=56 Participants
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases
|
87.3 Percentage of participants
|
94.7 Percentage of participants
|
89.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Outcome measures
| Measure |
Placebo/DVS-SR
n=176 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)
|
90.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Outcome measures
| Measure |
Placebo/DVS-SR
n=63 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
n=57 Participants
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
n=56 Participants
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Week 26: Very much improved
|
54.0 Percentage of participants
|
73.7 Percentage of participants
|
53.6 Percentage of participants
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Week 26: Much improved
|
33.3 Percentage of participants
|
21.1 Percentage of participants
|
35.7 Percentage of participants
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Week 26: Minimally improved
|
9.5 Percentage of participants
|
5.3 Percentage of participants
|
10.7 Percentage of participants
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Week 26: No change
|
1.6 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Week 26: Minimally worse
|
1.6 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Week 26: Much worse
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Week 26: Very much worse
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Outcome measures
| Measure |
Placebo/DVS-SR
n=176 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Week 26: Very much improved
|
60.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Week 26: Much improved
|
30.1 Percentage of participants
|
—
|
—
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Week 26: Minimally improved
|
8.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Week 26: No change
|
0.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Week 26: Minimally worse
|
0.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Week 26: Much worse
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Week 26: Very much worse
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Outcome measures
| Measure |
Placebo/DVS-SR
n=63 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
n=57 Participants
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
n=56 Participants
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases
|
73.0 Percentage of participants
|
89.5 Percentage of participants
|
75.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030Population: All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Outcome measures
| Measure |
Placebo/DVS-SR
n=176 Participants
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|
|
Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)
|
79.0 Percentage of participants
|
—
|
—
|
Adverse Events
Placebo/DVS-SR
Serious events: 4 serious events
Other events: 60 other events
Deaths: 0 deaths
DVS-SR, Low Dose/DVS-SR
Serious events: 6 serious events
Other events: 57 other events
Deaths: 0 deaths
DVS-SR, High Dose/DVS-SR
Serious events: 3 serious events
Other events: 58 other events
Deaths: 0 deaths
Combination Group
Serious events: 13 serious events
Other events: 175 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/DVS-SR
n=91 participants at risk
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
n=93 participants at risk
Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
n=97 participants at risk
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
Combination Group
n=281 participants at risk
Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.2%
2/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.0%
1/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
3/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Suicide threat
|
1.1%
1/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.36%
1/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.36%
1/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.0%
1/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.36%
1/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.36%
1/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.36%
1/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Aggression
|
1.1%
1/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.36%
1/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Agitation
|
1.1%
1/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.71%
2/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.36%
1/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.36%
1/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Major depression
|
1.1%
1/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.36%
1/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Pyromania
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.36%
1/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Suicidal ideation
|
2.2%
2/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.1%
2/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.8%
5/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
Other adverse events
| Measure |
Placebo/DVS-SR
n=91 participants at risk
Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, Low Dose/DVS-SR
n=93 participants at risk
Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
DVS-SR, High Dose/DVS-SR
n=97 participants at risk
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
Combination Group
n=281 participants at risk
Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|---|---|---|---|---|
|
Infections and infestations
Otitis media
|
3.3%
3/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.0%
1/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.8%
5/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.1%
1/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.1%
3/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.8%
5/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.4%
4/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
8.2%
8/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
4.6%
13/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.1%
3/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
3/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
2/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
5.2%
5/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.8%
8/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Gastrointestinal disorders
Nausea
|
4.4%
4/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
11.8%
11/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
6.2%
6/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
7.5%
21/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
6/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.2%
2/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
4.1%
4/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
4.3%
12/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
General disorders
Fatigue
|
3.3%
3/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.1%
3/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.1%
6/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Infections and infestations
Gastroenteritis
|
3.3%
3/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.2%
2/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.0%
1/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.1%
6/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Infections and infestations
Gastroenteritis viral
|
7.7%
7/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.2%
3/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
6.2%
6/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
5.7%
16/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Infections and infestations
Nasopharyngitis
|
9.9%
9/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
4.3%
4/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
8.2%
8/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
7.5%
21/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Infections and infestations
Sinusitis
|
1.1%
1/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.2%
2/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
5.2%
5/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.8%
8/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
4/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
10.8%
10/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.1%
2/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
5.7%
16/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
8.8%
8/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
4.3%
4/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
8.2%
8/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
7.1%
20/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.3%
3/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
3/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Investigations
Weight increased
|
5.5%
5/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
4.3%
4/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
5.2%
5/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
5.0%
14/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.4%
4/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.2%
2/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.0%
1/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.5%
7/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.2%
3/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.0%
1/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.4%
4/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
3/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.2%
2/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.1%
2/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.5%
7/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Nervous system disorders
Dizziness
|
4.4%
4/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
6.5%
6/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
5.2%
5/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
5.3%
15/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Nervous system disorders
Headache
|
13.2%
12/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
17.2%
16/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
17.5%
17/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
16.0%
45/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Nervous system disorders
Psychomotor hyperactivity
|
3.3%
3/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.4%
4/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Nervous system disorders
Somnolence
|
11.0%
10/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.2%
3/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.0%
1/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
5.0%
14/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Agitation
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.2%
2/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.1%
3/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.8%
5/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
3.3%
3/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.1%
1/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.1%
2/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.1%
6/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Depression
|
1.1%
1/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.2%
3/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
4.1%
4/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.8%
8/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Initial insomnia
|
5.5%
5/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.0%
1/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
2.1%
6/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Insomnia
|
7.7%
7/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
6.5%
6/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
4.1%
4/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
6.0%
17/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Irritability
|
3.3%
3/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
4.3%
4/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
7.2%
7/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
5.0%
14/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Psychiatric disorders
Self injurious behaviour
|
0.00%
0/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.2%
3/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.0%
1/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.4%
4/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.1%
1/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.1%
3/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.4%
4/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
2/91 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
3.2%
3/93 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
0.00%
0/97 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
1.8%
5/281 • From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,
|
Additional Information
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
Phone: 1-800-718-1021
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