Trial Outcomes & Findings for Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder (NCT NCT00669110)
NCT ID: NCT00669110
Last Updated: 2021-08-19
Results Overview
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Baseline (Extension study) up to Extension study Week 29 Follow up visit
Results posted on
2021-08-19
Participant Flow
Eligible participants transitioned from preceding Core study NCT00619619 (3151A6-2000 \[B2061012\]) on Day 56 to this Extension study NCT00669110 (3151A6-2001 \[B2061013\]) to continue treatment on a flexible dose schedule. A total of 8 participants (Children n=2 and Adolescent n=6) discontinued during Taper/post-study or Follow-up phase of Core study.
Baseline (Day-1) in the Extension study = Week 8 (Day 56) in the Core study. However, Baseline for the Clinical Global Impressions Scale - Improvement (CGI-I) = Inpatient Day 1 through 4 in the Core study and Baseline for the Columbia Suicide-Severity Rating Scale (C-SSRS) = Day-1 in the Core study.
Participant milestones
| Measure |
DVS SR - Children
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
Reasons for withdrawal
| Measure |
DVS SR - Children
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Caregiver request
|
3
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.65 years
STANDARD_DEVIATION 1.31 • n=5 Participants
|
13.55 years
STANDARD_DEVIATION 1.64 • n=7 Participants
|
11.60 years
STANDARD_DEVIATION 2.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Females
Breasts Stage 1
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Females
Breasts Stage 2
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Females
Breasts Stage 3
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Females
Breasts Stage 4
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Females
Breasts Stage 5
|
0 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Females
Pubic hair Stage 1
|
6 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Females
Pubic hair Stage 2
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Females
Pubic hair Stage 3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Females
Pubic hair Stage 4
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Females
Pubic hair Stage 5
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Penis Stage 1
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Penis Stage 2
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Penis Stage 3
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Penis Stage 4
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Penis Stage 5
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Pubic hair Stage 1
|
6 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Pubic hair Stage 2
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Pubic hair Stage 3
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Pubic hair Stage 4
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Pubic hair Stage 5
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Testes Stage 1
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Testes Stage 2
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Testes Stage 3
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Testes Stage 4
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Number of participants for Tanner Assessment: Males
Testes Stage 5
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Extension study) up to Extension study Week 29 Follow up visitPopulation: Safety population (Baseline=Extension study) includes all treatment assigned participants with at least 1 dose of study treatment during Extension study NCT00669110.
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
Adverse events
|
13 participants
|
15 participants
|
|
Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
Serious adverse events
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study)Population: Safety population (Baseline=Core study) includes all treatment assigned participants with at least 1 dose of study treatment during Core study NCT00619619 and Extension study NCT00669110.
C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Completed suicide: No
|
20 participants
|
20 participants
|
|
Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Suicide attempt: No
|
20 participants
|
20 participants
|
|
Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Preparatory acts - imminent suicidal behavior: No
|
20 participants
|
20 participants
|
|
Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Suicidal ideation: Yes
|
0 participants
|
3 participants
|
|
Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Suicidal ideation: No
|
20 participants
|
17 participants
|
|
Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Any suicidal behavior and/or ideation: Yes
|
0 participants
|
3 participants
|
|
Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Any suicidal behavior and/or ideation: No
|
20 participants
|
17 participants
|
|
Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Self-injurious behavior, no suicidal intent: No
|
20 participants
|
20 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination)Population: Intent to Treat population (ITT): all treatment assigned participants with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after first dose in Extension study NCT00669110. Last observation carried forward (LOCF).
CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Change From Baseline (Bsl) in Children's Depression Rating Scale - Revised (CDRS-R) Total Score at Final On-therapy Visit
Baseline mean
|
32.40 scores on a scale
Standard Deviation 7.61
|
33.70 scores on a scale
Standard Deviation 6.34
|
|
Change From Baseline (Bsl) in Children's Depression Rating Scale - Revised (CDRS-R) Total Score at Final On-therapy Visit
Change from Bsl Outpatient Week 26
|
-1.85 scores on a scale
Standard Deviation 5.51
|
-1.95 scores on a scale
Standard Deviation 6.85
|
|
Change From Baseline (Bsl) in Children's Depression Rating Scale - Revised (CDRS-R) Total Score at Final On-therapy Visit
Change from Bsl Outpatient Week >26
|
-1.85 scores on a scale
Standard Deviation 5.51
|
-1.70 scores on a scale
Standard Deviation 6.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)Population: ITT population; LOCF.
CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission defined as a CDRS-R total score ≤28 (coded value of 1).
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
Outpatient Week 1
|
26.7 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
Outpatient Week 2
|
30 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
Outpatient Week 4
|
30 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
Outpatient Week 6
|
25 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
Outpatient Week 10
|
45 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
Outpatient Week 14
|
25 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
Outpatient Week 18
|
35 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
Outpatient Week 22
|
30 percentage of participants
|
35 percentage of participants
|
|
Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
Outpatient Week 26
|
30 percentage of participants
|
30 percentage of participants
|
|
Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
Outpatient Week >26
|
30 percentage of participants
|
25 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)Population: ITT population; LOCF.
HAM-D17 is a clinician-rated interview to measure presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Change from Bsl Outpatient Week 10
|
-1.30 scores on a scale
Standard Deviation 3.06
|
-1.40 scores on a scale
Standard Deviation 2.66
|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Baseline mean
|
5.15 scores on a scale
Standard Deviation 3.01
|
7.45 scores on a scale
Standard Deviation 4.10
|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Change from Bsl Outpatient Week 1
|
0.53 scores on a scale
Standard Deviation 2.72
|
1.79 scores on a scale
Standard Deviation 2.97
|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Change from Bsl Outpatient Week 2
|
-0.50 scores on a scale
Standard Deviation 2.80
|
0.70 scores on a scale
Standard Deviation 3.01
|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Change from Bsl Outpatient Week 4
|
-0.40 scores on a scale
Standard Deviation 2.28
|
-0.95 scores on a scale
Standard Deviation 2.24
|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Change from Bsl Outpatient Week 6
|
-0.45 scores on a scale
Standard Deviation 2.31
|
-0.70 scores on a scale
Standard Deviation 2.68
|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Change from Bsl Outpatient Week 14
|
-0.45 scores on a scale
Standard Deviation 2.58
|
-1.65 scores on a scale
Standard Deviation 3.08
|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Change from Bsl Outpatient Week 18
|
-1.65 scores on a scale
Standard Deviation 2.48
|
-2.45 scores on a scale
Standard Deviation 3.10
|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Change from Bsl Outpatient Week 22
|
-1.05 scores on a scale
Standard Deviation 2.26
|
-2.15 scores on a scale
Standard Deviation 3.22
|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Change from Bsl Outpatient Week 26
|
-1.65 scores on a scale
Standard Deviation 2.94
|
-2.35 scores on a scale
Standard Deviation 3.39
|
|
Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Change from Bsl Outpatient Week >26
|
-1.65 scores on a scale
Standard Deviation 2.94
|
-2.10 scores on a scale
Standard Deviation 3.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)Population: ITT population; LOCF. No participants had a CGI-S score of 5, 6 or 7 (markedly, severely, or extremely ill), therefore only scores 1 through 4 (normal to moderately ill) are reported.
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 1: not ill at all
|
13.3 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 1: borderline ill
|
53.3 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 1: mildly ill
|
26.7 percentage of participants
|
57.9 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 1: moderately ill
|
6.7 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 2: not ill at all
|
10 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 2: borderline ill
|
40 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 2: mildly ill
|
45 percentage of participants
|
45 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 2: moderately ill
|
5 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 4: not ill at all
|
10 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 4: borderline ill
|
50 percentage of participants
|
30 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 4: mildly ill
|
30 percentage of participants
|
35 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 4: moderately ill
|
10 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 6: not ill at all
|
10 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 6: borderline ill
|
40 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 6: mildly ill
|
45 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 6: moderately ill
|
5 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 10: not ill at all
|
15 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 10: borderline ill
|
45 percentage of participants
|
35 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 10: mildly ill
|
35 percentage of participants
|
45 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 10: moderately ill
|
5 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 14: not ill at all
|
5 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 14: borderline ill
|
55 percentage of participants
|
55 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 14: mildly ill
|
35 percentage of participants
|
30 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 14: moderately ill
|
5 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 18: not ill at all
|
5 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 18: borderline ill
|
70 percentage of participants
|
55 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 18: mildly ill
|
20 percentage of participants
|
35 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 18: moderately ill
|
5 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 22: not ill at all
|
5 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 22: borderline ill
|
60 percentage of participants
|
55 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 22: mildly ill
|
30 percentage of participants
|
35 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 22: moderately ill
|
5 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 26: not ill at all
|
5 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 26: borderline ill
|
75 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 26: mildly ill
|
15 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week 26: moderately ill
|
5 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week >26: not ill at all
|
5 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week >26: borderline ill
|
75 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week >26: mildly ill
|
15 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Outpatient Week >26: moderately ill
|
5 percentage of participants
|
5 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)Population: ITT population; LOCF. No participants had a CGI-I score of 6 or 7 (much worse, very much worse), therefore only scores 1 through 5 (very much improved to minimally worse) are reported. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 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. Scores above 4 reflect worsening of illness state as compared to baseline.
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 1: very much improved
|
25 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 1: much improved
|
55 percentage of participants
|
45 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 1: minimally improved
|
20 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 1: minimally worse
|
0.0 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 2: very much improved
|
25 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 2: much improved
|
55 percentage of participants
|
55 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 2: minimally improved
|
15 percentage of participants
|
30 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 4: very much improved
|
35 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 4: much improved
|
45 percentage of participants
|
55 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 4: minimally improved
|
15 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 4: minimally worse
|
5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 6: very much improved
|
35 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 6: much improved
|
35 percentage of participants
|
65 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 6: minimally improved
|
30 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 10: very much improved
|
30 percentage of participants
|
30 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 10: much improved
|
40 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 10: minimally improved
|
30 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 10: no change
|
0.0 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 14: very much improved
|
25 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 14: much improved
|
50 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 14: minimally improved
|
20 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 14: no change
|
5 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 18: very much improved
|
30 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 18: much improved
|
55 percentage of participants
|
45 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 18: minimally improved
|
15 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 22: very much improved
|
30 percentage of participants
|
45 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 22: much improved
|
50 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 22: minimally improved
|
20 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 26: very much improved
|
40 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 26: much improved
|
45 percentage of participants
|
45 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 26: minimally improved
|
15 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week >26: very much improved
|
40 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week >26: much improved
|
45 percentage of participants
|
45 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week >26: minimally improved
|
15 percentage of participants
|
15 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)Population: ITT population; LOCF. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Participant with response is defined as having a score of 1 (very much improved) or 2 (much improved).
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 1
|
80 percentage of participants
|
55 percentage of participants
|
|
Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 2
|
80 percentage of participants
|
70 percentage of participants
|
|
Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 4
|
80 percentage of participants
|
75 percentage of participants
|
|
Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 6
|
70 percentage of participants
|
85 percentage of participants
|
|
Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 10
|
70 percentage of participants
|
80 percentage of participants
|
|
Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 14
|
75 percentage of participants
|
80 percentage of participants
|
|
Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 18
|
85 percentage of participants
|
85 percentage of participants
|
|
Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 22
|
80 percentage of participants
|
85 percentage of participants
|
|
Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week 26
|
85 percentage of participants
|
85 percentage of participants
|
|
Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
Outpatient Week >26
|
85 percentage of participants
|
85 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Extension study), Week 26 (Extension study)Population: Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.
Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.
Outcome measures
| Measure |
DVS SR - Children
n=7 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=3 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females
Breasts: 0=no stage change
|
5 participants
|
1 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females
Breasts: 1=change of 1 stage
|
1 participants
|
1 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females
Breasts: 2=change of 2 stages
|
1 participants
|
1 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females
Pubic hair: 0=no stage change
|
6 participants
|
2 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females
Pubic hair: 1=change of 1 stage
|
1 participants
|
0 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females
Pubic hair: 2=change of 2 stages
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Extension study), Week 26 (Extension study)Population: Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.
Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Male pubertal development staged by size of the genitalia and development of pubic hair (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.
Outcome measures
| Measure |
DVS SR - Children
n=5 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=4 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Penis: 0=no stage change
|
4 participants
|
3 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Penis: 1=change of 1 stage
|
1 participants
|
0 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Penis: 2=change of 2 stages
|
0 participants
|
1 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Pubic hair: 0=no stage change
|
2 participants
|
2 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Pubic hair: 1=change of 1 stage
|
3 participants
|
1 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Pubic hair: 2=change of 2 stages
|
0 participants
|
1 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Testes: 0=no stage change
|
3 participants
|
3 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Testes: 1=change of 1 stage
|
2 participants
|
0 participants
|
|
Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Testes: 2=change of 2 stages
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)Population: Safety population (Baseline=Extension study).
PCI criteria for females: systolic BP \[SBP\] ranges from \>110 and diastolic BP \[DBP\] \>73 (\>110/73) at age 6 up to BP \>124/81 at age 11; BP from \>121/79 at age 12 up to BP \>132/86 at age 17. Criteria for males: BP ranges from \>112/73 at age 6 up to BP \>123/82 at age 10; BP from \>119/79 at age 11 up to BP \>140/89 at age 17. Vitals signs meeting the criteria for PCI categorized as BP elevation for 3 consecutive visits or as postural change in BP (decrease in SBP ≥20 millimeters of mercury \[mmHg\] or in DBP ≥15 mmHg for the last supine to first standing BP \[supine to standing\]).
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)
Elevated supine SBP, 3 consecutive visits
|
4 participants
|
0 participants
|
|
Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)
Decrease SBP ≥20 mmHg supine to standing
|
2 participants
|
0 participants
|
|
Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)
Decrease DBP ≥15 mmHg supine to standing
|
0 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)Population: Safety population (Baseline=Extension study).
Vitals signs meeting the PCI criteria for weight categorized according to an increase of ≥7 percent or a decrease of ≥3.5 percent in body weight.
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight
Increase ≥7 percent in body weight
|
11 participants
|
4 participants
|
|
Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight
Decrease of ≥3.5 percent in body weight
|
1 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)Population: Safety population (Baseline=Extension study).
PCI criteria for females: supine pulse rate (beats per minute \[bpm\]) ranges from \<68 or \>126 at age 6 to pulse \<63 or \>121 at age 11; pulse from \<63 or \>121 at age 12 to \<54 or \>110 at age 17; pulse from \<50 or \>104 at age 18. Criteria for males: pulse ranges from \<68 or \>126 at age 6 to pulse \<63 or \>121 at age 11; pulse from \<58 or \>116 at age 12 to \<50 or \>104 at age 17; pulse from \<45 or \>99 at age 18. Vitals signs meeting criteria for PCI categorized as Low or as postural change in pulse (increase in pulse ≥20 bpm for last supine to first standing pulse \[supine to standing\]).
Outcome measures
| Measure |
DVS SR - Children
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate
Low supine pulse rate
|
1 participants
|
2 participants
|
|
Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate
Increase in pulse rate ≥20 mmHg supine to standing
|
14 participants
|
12 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)Population: Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data. Participants may be represented in \>1 category.
ECG results meeting the criteria for PCI categorized as PR interval ≥200 milliseconds (msec); QT interval ≥480msec; QRS interval ≥120 msec; corrected QT (QTc) ≥500 msec ); \>450 msec for males and \>470 msec for females or increase of ≥60 msec or ≥30 msec change from baseline QTcB=QT corrected using Bazett formula; QTcF=QT corrected using the Fridericia formula.
Outcome measures
| Measure |
DVS SR - Children
n=17 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=14 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)
PR interval ≥200 msec
|
0 participants
|
1 participants
|
|
Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)
QRS interval ≥120 msec
|
0 participants
|
1 participants
|
|
Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)
QTcF interval ≥30 msec change from baseline
|
5 participants
|
1 participants
|
|
Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)
QTcB interval ≥30 msec change from baseline
|
6 participants
|
1 participants
|
|
Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)
QTcB interval ≥60 msec change from baseline
|
1 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)
QTcB interval >470 or increase ≥60 msec (females)
|
1 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)Population: Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data.
PCI criteria for females: heart rate (bpm) ranges from \<68 and \>126 at age 6 to \<63 and \>121 at age 11; heart rate from \<63 and \>121 at age 12 to \<54 and \>110 at age 17; heart rate \<50 and \>104 at age 18. Criteria for males: heart rate ranges from \< 68 and \>126 at age 6 to \<63 and \>121 at age 11; heart rate \<58 and \>116 at age 12 up \<50 and \>104 at age 17; heart rate \<45 and \>99 at age 18. Heart rates meeting the criteria for PCI categorized as low (less than the lower limit specified for age).
Outcome measures
| Measure |
DVS SR - Children
n=17 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=14 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)
|
0 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Extension study) up to Week 26 (Extension study)Population: Safety population (Baseline=Extension study). N=number of participants with analyzable laboratory data. Participants may be represented in \>1 category.
Laboratory test results meeting the criteria for PCI categorized as bicarbonate increase or decrease from baseline of ≥4 millimoles per liter (mmol/L); hematocrit \<0.32 or \>0.50 (females) or \<0.37 or \>0.55 (males) liters per liter (L/L); high density lipoprotein (HDL) cholesterol (fasting or nonfasting / unknown) decrease \>0.21 mmol/L and test value ≥1.16 mmol/L; triglycerides (fasting or nonfasting / unknown) ≥2.258 mmol/L or increase ≥1.13 mmol/L and test value ≥3.39 mmol/L; urine specific gravity \<1.001 or \>1.035; and positive urinalysis result for protein (albumin), hemoglobin, or ketones.
Outcome measures
| Measure |
DVS SR - Children
n=17 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=14 Participants
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
Bicarbonate: increase
|
2 participants
|
0 participants
|
|
Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
Bicarbonate: decrease
|
0 participants
|
1 participants
|
|
Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
Hematocrit: low
|
4 participants
|
2 participants
|
|
Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
HDL cholesterol: decrease
|
2 participants
|
1 participants
|
|
Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
Triglycerides: high
|
4 participants
|
1 participants
|
|
Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
Urine specific gravity: high
|
3 participants
|
3 participants
|
|
Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
Urine protein albumin: positive result
|
9 participants
|
9 participants
|
|
Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
Urine ketones: positive result
|
0 participants
|
1 participants
|
|
Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
Urine hemoglobin: positive result
|
0 participants
|
1 participants
|
Adverse Events
DVS SR - Children
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
DVS SR - Adolescents
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DVS SR - Children
n=20 participants at risk
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 participants at risk
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Psychiatric disorders
Negativism (oppositional behavior)
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
DVS SR - Children
n=20 participants at risk
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
|
DVS SR - Adolescents
n=20 participants at risk
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
|
|---|---|---|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
4/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.0%
3/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Lip swelling
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
4/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Feeling jittery
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral infection
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Localised infection
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Lymph gland infection
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Heart rate increased
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Disturbance in attention
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
5/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
30.0%
6/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/11 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Aggression
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
2/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER