Trial Outcomes & Findings for Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder (NCT NCT00619619)
NCT ID: NCT00619619
Last Updated: 2011-02-23
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
59 participants
Primary outcome timeframe
Baseline to Follow-up (up to Day 77)
Results posted on
2011-02-23
Participant Flow
Treatment to be given at only 1 dose level at a time for at least the first 6 subjects per dose group. Approximately 6 to 8 subjects were to be enrolled in each of the dose cohorts; 4 dose levels were to be evaluated per age stratum in sequential manner and ascending order (10 to 100 milligrams (mg) for children; 25 to 200 mg for adolescents).
Screening period 6 to 14 days followed by treatment period (up to 3.5 day inpatient and up to 7.5 week outpatient phase). Participants who enter outpatient period but do not continue into 6-month open-label extension study (NCT00669110) will participate in taper period of 0 to 2 weeks depending on dose of study treatment to which they are assigned.
Participant milestones
| Measure |
Desvenlafaxine 10 mg Children
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
9
|
7
|
7
|
7
|
8
|
8
|
|
Overall Study
Entered the Extension Study
|
6
|
5
|
8
|
3
|
7
|
6
|
6
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
8
|
6
|
5
|
7
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
2
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
Desvenlafaxine 10 mg Children
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
2
|
Baseline Characteristics
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Desvenlafaxine 10 mg Children
n=6 Participants
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
8.83 years
STANDARD_DEVIATION 1.33 • n=39 Participants
|
9.57 years
STANDARD_DEVIATION 1.13 • n=41 Participants
|
9.89 years
STANDARD_DEVIATION 1.27 • n=35 Participants
|
9.71 years
STANDARD_DEVIATION 0.95 • n=31 Participants
|
15.00 years
STANDARD_DEVIATION 1.83 • n=146 Participants
|
13.14 years
STANDARD_DEVIATION 1.46 • n=19 Participants
|
14.25 years
STANDARD_DEVIATION 1.67 • n=147 Participants
|
14.00 years
STANDARD_DEVIATION 1.60 • n=193 Participants
|
11.86 years
STANDARD_DEVIATION 2.71
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
3 Participants
n=147 Participants
|
5 Participants
n=193 Participants
|
29 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
5 Participants
n=147 Participants
|
3 Participants
n=193 Participants
|
30 Participants
|
|
Children's Depression Ratings Scale-Revised (CDRS-R) total score
|
57.50 scores on a scale
STANDARD_DEVIATION 4.89 • n=39 Participants
|
52.43 scores on a scale
STANDARD_DEVIATION 5.13 • n=41 Participants
|
49.89 scores on a scale
STANDARD_DEVIATION 7.30 • n=35 Participants
|
46.43 scores on a scale
STANDARD_DEVIATION 4.35 • n=31 Participants
|
64.86 scores on a scale
STANDARD_DEVIATION 11.87 • n=146 Participants
|
57.71 scores on a scale
STANDARD_DEVIATION 1.98 • n=19 Participants
|
57.88 scores on a scale
STANDARD_DEVIATION 9.19 • n=147 Participants
|
48.63 scores on a scale
STANDARD_DEVIATION 6.25 • n=193 Participants
|
54.17 scores on a scale
STANDARD_DEVIATION 8.78
|
PRIMARY outcome
Timeframe: Baseline to Follow-up (up to Day 77)Population: Safety population includes all treatment-assigned participants who have taken at least 1 dose of study treatment.
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 |
Desvenlafaxine 10 mg Children
n=6 Participants
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
Non-serious Adverse Events
|
1 participants
|
3 participants
|
3 participants
|
7 participants
|
4 participants
|
2 participants
|
7 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56Population: PK population: all participants in the Safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.
Noncompartmental pharmacokinetic (PK) parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL).
Outcome measures
| Measure |
Desvenlafaxine 10 mg Children
n=6 Participants
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
33.9 ng/mL
Standard Deviation 12.1
|
98 ng/mL
Standard Deviation 60.5
|
108 ng/mL
Standard Deviation 27
|
263 ng/mL
Standard Deviation 66
|
46.1 ng/mL
Standard Deviation 15.9
|
93.9 ng/mL
Standard Deviation 15.5
|
202 ng/mL
Standard Deviation 92
|
449 ng/mL
Standard Deviation 126
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56Population: PK population
Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).
Outcome measures
| Measure |
Desvenlafaxine 10 mg Children
n=6 Participants
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
4.7 hr
Standard Deviation 2.1
|
4.3 hr
Standard Deviation 1.4
|
5.1 hr
Standard Deviation 3
|
5.0 hr
Standard Deviation 2.0
|
4.3 hr
Standard Deviation 0.7
|
8.7 hr
Standard Deviation 7.1
|
7.6 hr
Standard Deviation 3.4
|
7.5 hr
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56Population: PK population
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).
Outcome measures
| Measure |
Desvenlafaxine 10 mg Children
n=6 Participants
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2)
|
7.8 hr
Standard Deviation 1.4
|
8.6 hr
Standard Deviation 1.6
|
9.4 hr
Standard Deviation 2.7
|
9.0 hr
Standard Deviation 2.0
|
12 hr
Standard Deviation 3
|
10.2 hr
Standard Deviation 3.7
|
9.6 hr
Standard Deviation 2.0
|
9.8 hr
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56Population: PK population
AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to infinity. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms multiplied by hours divided by milliliters (ng\*hr/mL).
Outcome measures
| Measure |
Desvenlafaxine 10 mg Children
n=6 Participants
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=8 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Infinity (AUC0-∞)
|
628 ng*hr/mL
Standard Deviation 346
|
1704 ng*hr/mL
Standard Deviation 553
|
2414 ng*hr/mL
Standard Deviation 924
|
6732 ng*hr/mL
Standard Deviation 3031
|
1123 ng*hr/mL
Standard Deviation 361
|
2281 ng*hr/mL
Standard Deviation 689
|
5290 ng*hr/mL
Standard Deviation 2188
|
11730 ng*hr/mL
Standard Deviation 3113
|
SECONDARY outcome
Timeframe: Day 1, Day 28, and Day 56Population: PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.
Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A\*W\^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose \[(ng\*hr/mL)/mg of dose\].
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Day 28, and Day 56Population: PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.
Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A\*W\^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose \[(ng\*hr/mL)/mg of dose\].
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)Population: ITT: all treatment-assigned subjects with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after the first dose of study treatment.
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 or 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 |
Desvenlafaxine 10 mg Children
n=6 Participants
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
Outpatient Week 3
|
-19.67 scores on a scale
Standard Deviation 6.77
|
-18.57 scores on a scale
Standard Deviation 7.93
|
-16.89 scores on a scale
Standard Deviation 13.49
|
-10.43 scores on a scale
Standard Deviation 9.11
|
-11.71 scores on a scale
Standard Deviation 13.23
|
-14.57 scores on a scale
Standard Deviation 6.19
|
-21.25 scores on a scale
Standard Deviation 10.99
|
-13.13 scores on a scale
Standard Deviation 11.47
|
|
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
Outpatient Week 4
|
-19.50 scores on a scale
Standard Deviation 6.50
|
-20.86 scores on a scale
Standard Deviation 10.98
|
-17.56 scores on a scale
Standard Deviation 15.99
|
-10.00 scores on a scale
Standard Deviation 4.69
|
-14.57 scores on a scale
Standard Deviation 14.06
|
-19.43 scores on a scale
Standard Deviation 9.43
|
-23.50 scores on a scale
Standard Deviation 10.69
|
-12.50 scores on a scale
Standard Deviation 9.41
|
|
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
Outpatient Week 5
|
-19.50 scores on a scale
Standard Deviation 6.50
|
-23.00 scores on a scale
Standard Deviation 8.56
|
-19.56 scores on a scale
Standard Deviation 13.46
|
-10.29 scores on a scale
Standard Deviation 4.39
|
-14.57 scores on a scale
Standard Deviation 14.06
|
-19.43 scores on a scale
Standard Deviation 9.43
|
-23.88 scores on a scale
Standard Deviation 10.36
|
-12.50 scores on a scale
Standard Deviation 9.41
|
|
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
Outpatient Week 6
|
-21.83 scores on a scale
Standard Deviation 6.77
|
-19.86 scores on a scale
Standard Deviation 9.94
|
-18.44 scores on a scale
Standard Deviation 13.79
|
-12.00 scores on a scale
Standard Deviation 5.48
|
-20.57 scores on a scale
Standard Deviation 18.98
|
-17.14 scores on a scale
Standard Deviation 6.20
|
-24.63 scores on a scale
Standard Deviation 8.99
|
-14.38 scores on a scale
Standard Deviation 9.93
|
|
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
Outpatient Week 7
|
-21.83 scores on a scale
Standard Deviation 6.77
|
-20.43 scores on a scale
Standard Deviation 10.06
|
-19.11 scores on a scale
Standard Deviation 13.20
|
-12.00 scores on a scale
Standard Deviation 5.48
|
-20.57 scores on a scale
Standard Deviation 18.98
|
-17.14 scores on a scale
Standard Deviation 6.20
|
-25.38 scores on a scale
Standard Deviation 7.87
|
-14.50 scores on a scale
Standard Deviation 9.89
|
|
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
Outpatient Week 8
|
-22.00 scores on a scale
Standard Deviation 7.01
|
-20.29 scores on a scale
Standard Deviation 7.18
|
-19.78 scores on a scale
Standard Deviation 14.49
|
-14.14 scores on a scale
Standard Deviation 6.52
|
-21.43 scores on a scale
Standard Deviation 19.86
|
-22.29 scores on a scale
Standard Deviation 3.09
|
-27.25 scores on a scale
Standard Deviation 6.78
|
-15.38 scores on a scale
Standard Deviation 8.65
|
|
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
Outpatient Week >8
|
-22.00 scores on a scale
Standard Deviation 7.01
|
-20.00 scores on a scale
Standard Deviation 7.05
|
-19.89 scores on a scale
Standard Deviation 14.51
|
-14.14 scores on a scale
Standard Deviation 6.52
|
-21.43 scores on a scale
Standard Deviation 19.86
|
-22.29 scores on a scale
Standard Deviation 3.09
|
-26.75 scores on a scale
Standard Deviation 7.42
|
-15.38 scores on a scale
Standard Deviation 8.65
|
|
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
Inpatient Days 1 to 4
|
-6.83 scores on a scale
Standard Deviation 6.15
|
-9.86 scores on a scale
Standard Deviation 5.40
|
-2.78 scores on a scale
Standard Deviation 3.07
|
-6.43 scores on a scale
Standard Deviation 10.00
|
-7.00 scores on a scale
Standard Deviation 18.18
|
-4.57 scores on a scale
Standard Deviation 2.99
|
-8.25 scores on a scale
Standard Deviation 4.33
|
-10.38 scores on a scale
Standard Deviation 13.45
|
|
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
Outpatient Days 5 to 7
|
-10.67 scores on a scale
Standard Deviation 6.44
|
-13.86 scores on a scale
Standard Deviation 8.51
|
-10.44 scores on a scale
Standard Deviation 10.79
|
-7.86 scores on a scale
Standard Deviation 8.28
|
-8.00 scores on a scale
Standard Deviation 13.88
|
-8.29 scores on a scale
Standard Deviation 4.27
|
-9.50 scores on a scale
Standard Deviation 8.11
|
-11.25 scores on a scale
Standard Deviation 14.00
|
|
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
Outpatient Week 2
|
-17.67 scores on a scale
Standard Deviation 6.92
|
-18.86 scores on a scale
Standard Deviation 10.51
|
-14.44 scores on a scale
Standard Deviation 12.68
|
-9.57 scores on a scale
Standard Deviation 10.83
|
-8.29 scores on a scale
Standard Deviation 13.46
|
-11.29 scores on a scale
Standard Deviation 5.53
|
-18.13 scores on a scale
Standard Deviation 11.12
|
-13.13 scores on a scale
Standard Deviation 14.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)Population: ITT
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \& weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.
Outcome measures
| Measure |
Desvenlafaxine 10 mg Children
n=6 Participants
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
Inpatient Days 1 to 4
|
-6.00 Score on a scale
Standard Deviation 5.73
|
-5.43 Score on a scale
Standard Deviation 4.31
|
-0.33 Score on a scale
Standard Deviation 1.94
|
-2.43 Score on a scale
Standard Deviation 6.92
|
-2.29 Score on a scale
Standard Deviation 7.45
|
-0.57 Score on a scale
Standard Deviation 1.13
|
-1.50 Score on a scale
Standard Deviation 4.54
|
-5.63 Score on a scale
Standard Deviation 7.42
|
|
Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
Outpatient Week 2
|
-9.33 Score on a scale
Standard Deviation 7.00
|
-10.71 Score on a scale
Standard Deviation 4.61
|
-6.11 Score on a scale
Standard Deviation 2.67
|
-5.57 Score on a scale
Standard Deviation 4.20
|
-2.71 Score on a scale
Standard Deviation 4.27
|
-5.71 Score on a scale
Standard Deviation 3.40
|
-8.13 Score on a scale
Standard Deviation 4.91
|
-9.38 Score on a scale
Standard Deviation 7.41
|
|
Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
Outpatient Week 3
|
-9.33 Score on a scale
Standard Deviation 7.00
|
-10.29 Score on a scale
Standard Deviation 5.41
|
-6.11 Score on a scale
Standard Deviation 2.67
|
-5.57 Score on a scale
Standard Deviation 4.20
|
-2.71 Score on a scale
Standard Deviation 4.27
|
-5.71 Score on a scale
Standard Deviation 3.40
|
-8.13 Score on a scale
Standard Deviation 4.91
|
-8.88 Score on a scale
Standard Deviation 6.33
|
|
Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
Outpatient Week 4
|
-11.00 Score on a scale
Standard Deviation 5.62
|
-13.00 Score on a scale
Standard Deviation 6.30
|
-7.22 Score on a scale
Standard Deviation 5.61
|
-7.57 Score on a scale
Standard Deviation 3.05
|
-7.29 Score on a scale
Standard Deviation 5.19
|
-7.57 Score on a scale
Standard Deviation 2.99
|
-12.13 Score on a scale
Standard Deviation 5.69
|
-9.00 Score on a scale
Standard Deviation 5.24
|
|
Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
Outpatient Week 5
|
-11.00 Score on a scale
Standard Deviation 5.62
|
-14.14 Score on a scale
Standard Deviation 4.10
|
-7.56 Score on a scale
Standard Deviation 5.64
|
-9.00 Score on a scale
Standard Deviation 1.91
|
-7.29 Score on a scale
Standard Deviation 5.19
|
-7.57 Score on a scale
Standard Deviation 2.99
|
-12.25 Score on a scale
Standard Deviation 5.73
|
-9.00 Score on a scale
Standard Deviation 5.24
|
|
Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
Outpatient Week 8
|
-12.17 Score on a scale
Standard Deviation 6.01
|
-14.00 Score on a scale
Standard Deviation 4.62
|
-8.44 Score on a scale
Standard Deviation 6.88
|
-11.14 Score on a scale
Standard Deviation 4.14
|
-11.14 Score on a scale
Standard Deviation 9.56
|
-9.86 Score on a scale
Standard Deviation 3.93
|
-14.25 Score on a scale
Standard Deviation 3.96
|
-11.63 Score on a scale
Standard Deviation 5.40
|
|
Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
Outpatient Week >8
|
-12.17 Score on a scale
Standard Deviation 6.01
|
-13.86 Score on a scale
Standard Deviation 4.81
|
-9.11 Score on a scale
Standard Deviation 6.68
|
-11.14 Score on a scale
Standard Deviation 4.14
|
-11.14 Score on a scale
Standard Deviation 9.56
|
-9.86 Score on a scale
Standard Deviation 3.93
|
-13.00 Score on a scale
Standard Deviation 5.37
|
-11.63 Score on a scale
Standard Deviation 5.40
|
|
Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
Outpatient Days 5 to 7
|
-6.00 Score on a scale
Standard Deviation 5.73
|
-5.43 Score on a scale
Standard Deviation 4.31
|
-0.33 Score on a scale
Standard Deviation 1.94
|
-2.43 Score on a scale
Standard Deviation 6.92
|
-2.00 Score on a scale
Standard Deviation 7.59
|
-0.57 Score on a scale
Standard Deviation 1.13
|
-1.50 Score on a scale
Standard Deviation 4.54
|
-5.63 Score on a scale
Standard Deviation 7.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)Population: ITT; no participants had a CGI-S score of 6 or 7, therefore only scores 1 through 5 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 |
Desvenlafaxine 10 mg Children
n=6 Participants
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 4: markedly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 5: mildly ill
|
66.7 percentage of participants
|
28.6 percentage of participants
|
55.6 percentage of participants
|
14.3 percentage of participants
|
28.6 percentage of participants
|
85.7 percentage of participants
|
12.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 5: moderately ill
|
16.7 percentage of participants
|
0.0 percentage of participants
|
22.2 percentage of participants
|
85.7 percentage of participants
|
71.4 percentage of participants
|
14.3 percentage of participants
|
37.5 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 5: markedly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 5: not ill at all
|
0.0 percentage of participants
|
14.3 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 5: borderline ill
|
16.7 percentage of participants
|
57.1 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
50 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Inpatient Days 1 to 4: mildly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Inpatient Days 1 to 4: moderately ill
|
100 percentage of participants
|
100 percentage of participants
|
88.9 percentage of participants
|
85.7 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Inpatient Days 1 to 4: markedly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Days 5 to 7: not ill at all
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Days 5 to 7: borderline ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Days 5 to 7: mildly ill
|
0.0 percentage of participants
|
42.9 percentage of participants
|
44.4 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Days 5 to 7: moderately ill
|
100 percentage of participants
|
57.1 percentage of participants
|
55.6 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
85.7 percentage of participants
|
100 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Days 5 to 7: markedly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 2: not ill at all
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 2: borderline ill
|
0.0 percentage of participants
|
14.3 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 2: moderately ill
|
33.3 percentage of participants
|
28.6 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
71.4 percentage of participants
|
50 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 6: not ill at all
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week >8: markedly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 7: borderline ill
|
50 percentage of participants
|
42.9 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
62.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 7: mildly ill
|
50 percentage of participants
|
57.1 percentage of participants
|
77.8 percentage of participants
|
28.6 percentage of participants
|
57.1 percentage of participants
|
57.1 percentage of participants
|
25 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 7: moderately ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
71.4 percentage of participants
|
42.9 percentage of participants
|
28.6 percentage of participants
|
12.5 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 7: markedly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 8: not ill at all
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 8: borderline ill
|
66.7 percentage of participants
|
42.9 percentage of participants
|
22.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
28.6 percentage of participants
|
50 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 8: mildly ill
|
33.3 percentage of participants
|
57.1 percentage of participants
|
66.7 percentage of participants
|
71.4 percentage of participants
|
57.1 percentage of participants
|
71.4 percentage of participants
|
25 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 8: moderately ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
28.6 percentage of participants
|
42.9 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 8: markedly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week >8: not ill at all
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week >8: borderline ill
|
66.7 percentage of participants
|
57.1 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
28.6 percentage of participants
|
50 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week >8: mildly ill
|
33.3 percentage of participants
|
42.9 percentage of participants
|
55.6 percentage of participants
|
71.4 percentage of participants
|
57.1 percentage of participants
|
71.4 percentage of participants
|
25 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week >8: moderately ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
28.6 percentage of participants
|
42.9 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Inpatient Days 1 to 4: not ill at all
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Inpatient Days 1 to 4: borderline ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 2: mildly ill
|
66.7 percentage of participants
|
57.1 percentage of participants
|
55.6 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
28.6 percentage of participants
|
50 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 2: markedly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 3: not ill at all
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 3: borderline ill
|
0.0 percentage of participants
|
57.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
25 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 3: mildly ill
|
66.7 percentage of participants
|
42.9 percentage of participants
|
88.9 percentage of participants
|
0.0 percentage of participants
|
28.6 percentage of participants
|
57.1 percentage of participants
|
37.5 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 3: moderately ill
|
33.3 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
100 percentage of participants
|
71.4 percentage of participants
|
42.9 percentage of participants
|
37.5 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 3: markedly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 4: not ill at all
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 4: borderline ill
|
16.7 percentage of participants
|
57.1 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
50 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 4: mildly ill
|
66.7 percentage of participants
|
28.6 percentage of participants
|
66.7 percentage of participants
|
14.3 percentage of participants
|
28.6 percentage of participants
|
85.7 percentage of participants
|
12.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 4: moderately ill
|
16.7 percentage of participants
|
0.0 percentage of participants
|
22.2 percentage of participants
|
85.7 percentage of participants
|
71.4 percentage of participants
|
14.3 percentage of participants
|
37.5 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 6: borderline ill
|
50 percentage of participants
|
57.1 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
62.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 6: mildly ill
|
50 percentage of participants
|
42.9 percentage of participants
|
66.7 percentage of participants
|
28.6 percentage of participants
|
57.1 percentage of participants
|
57.1 percentage of participants
|
12.5 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 6: moderately ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
71.4 percentage of participants
|
42.9 percentage of participants
|
28.6 percentage of participants
|
25 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 6: markedly ill
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
Outpatient Week 7: not ill at all
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)Population: ITT; no participants had a CGI-I score of 6 or 7, therefore only scores 1 through 5 are reported.
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 |
Desvenlafaxine 10 mg Children
n=6 Participants
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 Participants
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 Participants
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 2: very much improved
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Days 5 to 7: minimally improved
|
50 percentage of participants
|
14.3 percentage of participants
|
55.6 percentage of participants
|
42.9 percentage of participants
|
42.9 percentage of participants
|
57.1 percentage of participants
|
25 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Days 5 to 7: no change
|
50 percentage of participants
|
71.4 percentage of participants
|
33.3 percentage of participants
|
57.1 percentage of participants
|
57.1 percentage of participants
|
42.9 percentage of participants
|
75 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Days 5 to 7: minimally worse
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 2: much improved
|
33.3 percentage of participants
|
28.6 percentage of participants
|
44.4 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 2: minimally improved
|
50 percentage of participants
|
42.9 percentage of participants
|
11.1 percentage of participants
|
42.9 percentage of participants
|
42.9 percentage of participants
|
57.1 percentage of participants
|
75 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 2: no change
|
16.7 percentage of participants
|
28.6 percentage of participants
|
33.3 percentage of participants
|
42.9 percentage of participants
|
57.1 percentage of participants
|
42.9 percentage of participants
|
25 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 2: minimally worse
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 3: very much improved
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 3: much improved
|
50 percentage of participants
|
85.7 percentage of participants
|
44.4 percentage of participants
|
14.3 percentage of participants
|
28.6 percentage of participants
|
0.0 percentage of participants
|
37.5 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 3: minimally improved
|
50 percentage of participants
|
14.3 percentage of participants
|
44.4 percentage of participants
|
57.1 percentage of participants
|
57.1 percentage of participants
|
71.4 percentage of participants
|
37.5 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 3: no change
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
28.6 percentage of participants
|
14.3 percentage of participants
|
28.6 percentage of participants
|
25 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 3: minimally worse
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 4: very much improved
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 4: much improved
|
50 percentage of participants
|
71.4 percentage of participants
|
55.6 percentage of participants
|
28.6 percentage of participants
|
28.6 percentage of participants
|
0.0 percentage of participants
|
50 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 4: minimally improved
|
50 percentage of participants
|
14.3 percentage of participants
|
22.2 percentage of participants
|
57.1 percentage of participants
|
57.1 percentage of participants
|
85.7 percentage of participants
|
37.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 4: no change
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 5: minimally worse
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Inpatient Days 1 to 4: very much improved
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Inpatient Days 1 to 4: much improved
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Inpatient Days 1 to 4: minimally improved
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.00 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Inpatient Days 1 to 4: no change
|
100 percentage of participants
|
100 percentage of participants
|
88.9 percentage of participants
|
85.7 percentage of participants
|
85.7 percentage of participants
|
100 percentage of participants
|
87.5 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Inpatient Days 1 to 4: minimally worse
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Days 5 to 7: very much improved
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Days 5 to 7: much improved
|
0.0 percentage of participants
|
14.3 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 4: minimally worse
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 5: very much improved
|
0.0 percentage of participants
|
14.3 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 5: much improved
|
50 percentage of participants
|
85.7 percentage of participants
|
55.6 percentage of participants
|
28.6 percentage of participants
|
28.6 percentage of participants
|
0.0 percentage of participants
|
50 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 5: minimally improved
|
50 percentage of participants
|
0.0 percentage of participants
|
22.2 percentage of participants
|
71.4 percentage of participants
|
57.1 percentage of participants
|
85.7 percentage of participants
|
37.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 5: no change
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 6: very much improved
|
0.0 percentage of participants
|
14.3 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 6: much improved
|
50 percentage of participants
|
57.1 percentage of participants
|
66.7 percentage of participants
|
28.6 percentage of participants
|
57.1 percentage of participants
|
71.4 percentage of participants
|
75 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 6: minimally improved
|
50 percentage of participants
|
28.6 percentage of participants
|
22.2 percentage of participants
|
71.4 percentage of participants
|
28.6 percentage of participants
|
28.6 percentage of participants
|
12.5 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 6: no change
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 6: minimally worse
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 7: very much improved
|
0.0 percentage of participants
|
14.3 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 7: much improved
|
50 percentage of participants
|
42.9 percentage of participants
|
55.6 percentage of participants
|
28.6 percentage of participants
|
57.1 percentage of participants
|
71.4 percentage of participants
|
75 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 7: minimally improved
|
50 percentage of participants
|
42.9 percentage of participants
|
33.3 percentage of participants
|
71.4 percentage of participants
|
28.6 percentage of participants
|
28.6 percentage of participants
|
12.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 7: no change
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 7: minimally worse
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 8: very much improved
|
0.0 percentage of participants
|
14.3 percentage of participants
|
22.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 8: much improved
|
83.3 percentage of participants
|
71.4 percentage of participants
|
22.2 percentage of participants
|
71.4 percentage of participants
|
57.1 percentage of participants
|
71.4 percentage of participants
|
75 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 8: minimally improved
|
16.7 percentage of participants
|
14.3 percentage of participants
|
55.6 percentage of participants
|
28.6 percentage of participants
|
28.6 percentage of participants
|
28.6 percentage of participants
|
0.0 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 8: no change
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week 8: minimally worse
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week >8: very much improved
|
0.0 percentage of participants
|
14.3 percentage of participants
|
22.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week >8: much improved
|
83.3 percentage of participants
|
71.4 percentage of participants
|
33.3 percentage of participants
|
71.4 percentage of participants
|
57.1 percentage of participants
|
71.4 percentage of participants
|
75 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week >8: minimally improved
|
16.7 percentage of participants
|
14.3 percentage of participants
|
44.4 percentage of participants
|
28.6 percentage of participants
|
28.6 percentage of participants
|
28.6 percentage of participants
|
0.0 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week >8: no change
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
Outpatient Week >8: minimally worse
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Desvenlafaxine 10 mg Children
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Desvenlafaxine 25 mg Children
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Desvenlafaxine 50 mg Children
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Desvenlafaxine 100 mg Children
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Desvenlafaxine 25 mg Adolescent
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Desvenlafaxine 50 mg Adolescent
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Desvenlafaxine 100 mg Adolescent
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Desvenlafaxine 200 mg Adolescent
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Desvenlafaxine 10 mg Children
n=6 participants at risk
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 participants at risk
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 participants at risk
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 participants at risk
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 participants at risk
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 participants at risk
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 participants at risk
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 participants at risk
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
Other adverse events
| Measure |
Desvenlafaxine 10 mg Children
n=6 participants at risk
Desvenlafaxine sustained release 10 milligram (mg) tablet
|
Desvenlafaxine 25 mg Children
n=7 participants at risk
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Children
n=9 participants at risk
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Children
n=7 participants at risk
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 25 mg Adolescent
n=7 participants at risk
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
|
Desvenlafaxine 50 mg Adolescent
n=7 participants at risk
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 100 mg Adolescent
n=8 participants at risk
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
|
Desvenlafaxine 200 mg Adolescent
n=8 participants at risk
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
|
|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
11.1%
1/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
22.2%
2/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
28.6%
2/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
28.6%
2/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
25.0%
2/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
11.1%
1/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
28.6%
2/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
62.5%
5/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
11.1%
1/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
28.6%
2/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
25.0%
2/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Application site irritation
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Asthenia
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Feeling jittery
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Investigations
Heart rate increased
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Headache
|
16.7%
1/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
11.1%
1/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
42.9%
3/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
25.0%
2/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
11.1%
1/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
28.6%
2/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
50.0%
4/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
25.0%
2/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
11.1%
1/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
28.6%
2/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
11.1%
1/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
28.6%
2/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
12.5%
1/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/9
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
14.3%
1/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/7
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
0.00%
0/8
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
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