Trial Outcomes & Findings for A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD (NCT NCT01371721)
NCT ID: NCT01371721
Last Updated: 2017-02-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
269 participants
Primary outcome timeframe
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Results posted on
2017-02-08
Participant Flow
Participants who completed the 8-week, double-blind treatment phase of Desvenlafaxine Succinate Sustained Release (DVS SR B2061014 NCT01372150) and completed the 1-week transition phase (week 9) of the short-term study were eligible to participate in this study (DVS SR B2061031).
Participant milestones
| Measure |
Placebo / DVS SR
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
|---|---|---|---|
|
Overall Study
STARTED
|
88
|
89
|
92
|
|
Overall Study
Treated
|
87
|
89
|
92
|
|
Overall Study
COMPLETED
|
59
|
65
|
62
|
|
Overall Study
NOT COMPLETED
|
29
|
24
|
30
|
Reasons for withdrawal
| Measure |
Placebo / DVS SR
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
5
|
|
Overall Study
Protocol Violation
|
6
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
8
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
11
|
|
Overall Study
Other
|
2
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
3
|
|
Overall Study
Randomized but not treated
|
1
|
0
|
0
|
Baseline Characteristics
A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD
Baseline characteristics by cohort
| Measure |
Placebo / DVS SR
n=87 Participants
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
n=89 Participants
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
n=92 Participants
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Total
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.5 Years
STANDARD_DEVIATION 2.90 • n=5 Participants
|
12.4 Years
STANDARD_DEVIATION 3.01 • n=7 Participants
|
12.8 Years
STANDARD_DEVIATION 3.14 • n=5 Participants
|
12.6 Years
STANDARD_DEVIATION 3.01 • n=4 Participants
|
|
Gender
Female
|
47 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Gender
Male
|
40 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 StudyPopulation: Safety Population-includes all treatment-assigned participants who took at least one dose of investigational product in the period of study B2061031.
Outcome measures
| Measure |
Placebo / DVS SR
n=87 Participants
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
n=89 Participants
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
n=92 Participants
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Combination
n=268 Participants
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing a Treatment Emergent Adverse Event
|
70.1 Percentage of Participants
|
75.3 Percentage of Participants
|
73.9 Percentage of Participants
|
73.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 StudyPopulation: ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Outcome measures
| Measure |
Placebo / DVS SR
n=55 Participants
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
n=61 Participants
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
n=56 Participants
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Combination
n=172 Participants
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
|---|---|---|---|---|
|
Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases
|
-5.55 Score on a Scale
Standard Deviation 10.80
|
-6.41 Score on a Scale
Standard Deviation 11.50
|
-5.32 Score on a Scale
Standard Deviation 7.29
|
-5.78 Score on a Scale
Standard Deviation 10.03
|
SECONDARY outcome
Timeframe: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 StudyPopulation: ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.
A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
Outcome measures
| Measure |
Placebo / DVS SR
n=55 Participants
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
n=61 Participants
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
n=56 Participants
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Combination
n=172 Participants
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
|---|---|---|---|---|
|
Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases
|
-0.78 Score on a Scale
Standard Deviation 1.23
|
-0.77 Score on a Scale
Standard Deviation 1.16
|
-0.82 Score on a Scale
Standard Deviation 0.92
|
-0.79 Score on a Scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 StudyPopulation: ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Outcome measures
| Measure |
Placebo / DVS SR
n=55 Participants
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
n=61 Participants
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
n=56 Participants
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Combination
n=172 Participants
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
|---|---|---|---|---|
|
Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26
|
90.9 Percentage of Participants
|
93.4 Percentage of Participants
|
92.9 Percentage of Participants
|
92.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 StudyPopulation: ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Outcome measures
| Measure |
Placebo / DVS SR
n=55 Participants
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
n=61 Participants
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
n=56 Participants
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Combination
n=172 Participants
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
|---|---|---|---|---|
|
Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases
|
74.5 Percentage of Participants
|
78.7 Percentage of Participants
|
73.2 Percentage of Participants
|
75.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 StudyPopulation: ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Outcome measures
| Measure |
Placebo / DVS SR
n=55 Participants
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
n=61 Participants
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
n=56 Participants
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Combination
n=172 Participants
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
|---|---|---|---|---|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
Very Much Worse
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
Very Much Improved
|
63.6 Percentage of Participants
|
63.9 Percentage of Participants
|
57.1 Percentage of Participants
|
61.6 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
Much Improved
|
27.3 Percentage of Participants
|
29.5 Percentage of Participants
|
35.7 Percentage of Participants
|
30.8 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
Minimally Improved
|
3.6 Percentage of Participants
|
3.3 Percentage of Participants
|
5.4 Percentage of Participants
|
4.1 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
No Change
|
3.6 Percentage of Participants
|
1.6 Percentage of Participants
|
1.8 Percentage of Participants
|
2.3 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
Minimally Worse
|
0.0 Percentage of Participants
|
1.6 Percentage of Participants
|
0.0 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
Much Worse
|
1.8 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.6 Percentage of Participants
|
Adverse Events
Placebo / DVS SR
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
Fluoxetine / DVS SR
Serious events: 2 serious events
Other events: 61 other events
Deaths: 0 deaths
Desvenlafaxine Succinate Sustained Release / DVS SR
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
Combination
Serious events: 10 serious events
Other events: 170 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo / DVS SR
n=87 participants at risk
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
n=89 participants at risk
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
n=92 participants at risk
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Combination
n=268 participants at risk
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.37%
1/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Psychiatric disorders
Aggression
|
1.1%
1/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.37%
1/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Psychiatric disorders
Frustration
|
1.1%
1/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.37%
1/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Psychiatric disorders
Hallucination, auditory
|
1.1%
1/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.37%
1/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Psychiatric disorders
Irritability
|
1.1%
1/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.37%
1/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Psychiatric disorders
Self injurious behaviour
|
1.1%
1/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.37%
1/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Psychiatric disorders
Suicide attempt
|
3.4%
3/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.9%
5/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.37%
1/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.37%
1/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
Other adverse events
| Measure |
Placebo / DVS SR
n=87 participants at risk
Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Fluoxetine / DVS SR
n=89 participants at risk
Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Desvenlafaxine Succinate Sustained Release / DVS SR
n=92 participants at risk
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
Combination
n=268 participants at risk
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.4%
3/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
9/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
7/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
9.0%
8/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
7.6%
7/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
8.2%
22/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
2.3%
2/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
6/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
3/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
5.6%
5/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.7%
10/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
2/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.9%
5/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.5%
4/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
10.3%
9/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
15.7%
14/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
8.7%
8/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
11.6%
31/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
5/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
10.1%
9/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
6.5%
6/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
7.5%
20/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
General disorders
Fatigue
|
2.3%
2/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.0%
8/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Infections and infestations
Bronchitis
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
4.3%
4/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.9%
5/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
2.3%
2/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.6%
7/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis viral
|
4.6%
4/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
5.4%
5/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
4.5%
12/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Infections and infestations
Influenza
|
5.7%
5/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.6%
7/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
12.6%
11/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
4.5%
4/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
6.5%
6/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
7.8%
21/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Infections and infestations
Pharyngitis
|
1.1%
1/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
4.3%
4/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.6%
7/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.3%
2/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.6%
7/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Infections and infestations
Sinusitis
|
2.3%
2/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.0%
8/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
7/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
10.1%
9/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
8.7%
8/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
9.0%
24/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Infections and infestations
Viral infection
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.5%
4/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.9%
5/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.9%
5/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.9%
5/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Investigations
Blood pressure increased
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
6/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Investigations
Weight increased
|
8.0%
7/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
12.4%
11/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
13.0%
12/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
11.2%
30/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.4%
3/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.9%
5/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.1%
1/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
6/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
2/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.6%
7/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.6%
4/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
6/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Nervous system disorders
Dizziness
|
5.7%
5/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
5.6%
5/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
8.7%
8/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
6.7%
18/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
13.8%
12/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
18.0%
16/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
20.7%
19/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
17.5%
47/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Psychiatric disorders
Insomnia
|
2.3%
2/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
5.6%
5/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.6%
7/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Psychiatric disorders
Irritability
|
3.4%
3/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
2/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.0%
8/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.1%
1/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
5.4%
5/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
2.2%
6/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
6/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
4.3%
4/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
4.1%
11/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.9%
5/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.9%
6/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.4%
3/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
1/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.7%
10/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/87 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
0.00%
0/89 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
3.3%
3/92 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
1.1%
3/268 • Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI must remove any previously undisclosed Confidential Information (other than the Study results themselves) before public release.
- Publication restrictions are in place
Restriction type: OTHER