Trial Outcomes & Findings for Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women (NCT NCT00369343)
NCT ID: NCT00369343
Last Updated: 2012-05-07
Results Overview
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17
COMPLETED
PHASE3
381 participants
Baseline to 8 weeks
2012-05-07
Participant Flow
Patients were recruited in the United States from September 2006 to September 2007.
Patients were screened over 4 weeks.
Participant milestones
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
|---|---|---|
|
Double-blind Phase
STARTED
|
256
|
125
|
|
Double-blind Phase
COMPLETED
|
212
|
109
|
|
Double-blind Phase
NOT COMPLETED
|
44
|
16
|
|
Open-label Phase
STARTED
|
212
|
109
|
|
Open-label Phase
COMPLETED
|
155
|
79
|
|
Open-label Phase
NOT COMPLETED
|
57
|
30
|
Reasons for withdrawal
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
|---|---|---|
|
Double-blind Phase
Adverse Event
|
19
|
4
|
|
Double-blind Phase
Failed to return
|
2
|
0
|
|
Double-blind Phase
Lost to Follow-up
|
9
|
2
|
|
Double-blind Phase
Protocol Violation
|
2
|
0
|
|
Double-blind Phase
Withdrawal by Subject
|
8
|
6
|
|
Double-blind Phase
Lack of Efficacy
|
0
|
4
|
|
Double-blind Phase
Protocol deviation
|
4
|
0
|
|
Open-label Phase
Adverse Event
|
19
|
7
|
|
Open-label Phase
Failed to return
|
4
|
0
|
|
Open-label Phase
Physician Decision
|
2
|
0
|
|
Open-label Phase
Lost to Follow-up
|
5
|
3
|
|
Open-label Phase
inadvertently reported study completers
|
3
|
2
|
|
Open-label Phase
Protocol Violation
|
1
|
3
|
|
Open-label Phase
Withdrawal by Subject
|
15
|
6
|
|
Open-label Phase
Lack of Efficacy
|
4
|
3
|
|
Open-label Phase
Lack of continuance tolerability
|
3
|
4
|
|
Open-label Phase
did not take study drug
|
1
|
2
|
Baseline Characteristics
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=256 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=125 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Total
n=381 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
52.01 years
STANDARD_DEVIATION 6.50 • n=5 Participants
|
52.56 years
STANDARD_DEVIATION 7.17 • n=7 Participants
|
52.19 years
STANDARD_DEVIATION 6.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
256 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
381 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, who took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=157 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=81 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.
|
-12.64 units on scale
Standard Error 0.53
|
-8.33 units on scale
Standard Error 0.74
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=186 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=97 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
1 (very much improved)
|
42.5 percentage of patients
|
22.7 percentage of patients
|
—
|
|
Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
2 (much improved)
|
25.3 percentage of patients
|
18.6 percentage of patients
|
—
|
|
Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
3 (minimally improved)
|
16.7 percentage of patients
|
17.5 percentage of patients
|
—
|
|
Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
4 (no change)
|
13.4 percentage of patients
|
32.0 percentage of patients
|
—
|
|
Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
5 (minimally worse)
|
1.1 percentage of patients
|
7.2 percentage of patients
|
—
|
|
Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
6 (much worse)
|
0.5 percentage of patients
|
2.1 percentage of patients
|
—
|
|
Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
7 (very much worse)
|
0.5 percentage of patients
|
0.0 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=186 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=98 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Percentage of Patients Achieving Remission
|
38.2 percentage of patients
|
22.4 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).
A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=186 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=98 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Percentage of Patients Achieving Response to Treatment
|
58.6 percentage of patients
|
31.6 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.
The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=158 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=81 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8
|
-8.62 units on scale
Standard Error 0.44
|
-5.89 units on scale
Standard Error 0.62
|
—
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation.
EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=158 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=81 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
|
0.18 units on scale
Standard Error 0.02
|
0.06 units on scale
Standard Error 0.02
|
—
|
SECONDARY outcome
Timeframe: open label baseline and 6 monthsPopulation: Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=207 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=103 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months
|
-12.52 units on scale
Standard Deviation 7.17
|
-12.45 units on scale
Standard Deviation 6.85
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase.
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=208 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=103 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Clinical Global Impression Improvement (CGI-I) Score
|
1.55 units on scale
Standard Deviation 1.00
|
1.56 units on scale
Standard Deviation 0.99
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=207 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=103 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Percentage of Patients Achieving Remission
|
55.6 percentage of patients
|
48.5 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.
A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=207 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=103 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Percentage of Patients Achieving a Response to Treatment
|
70.5 percentage of patients responding
|
66.0 percentage of patients responding
|
—
|
SECONDARY outcome
Timeframe: open label baseline to 6 monthsPopulation: Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.
The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=207 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=103 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months
|
-10.95 units on scale
Standard Deviation 6.90
|
-10.38 units on scale
Standard Deviation 5.64
|
—
|
SECONDARY outcome
Timeframe: open label baseline to 6 monthsPopulation: Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.
EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=208 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=102 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months
|
0.19 units on scale
Standard Deviation 0.26
|
0.22 units on scale
Standard Deviation 0.31
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Open-label (OL) safety population: Patients completed double-blind and continued in OL with ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with \<4 wks therapy. Patients analyzed varied by time (0mg, 100mg, 200mg): Early Termination (n=9,98,207); Taper week 1 (n=4,76,193); Taper week 2 (n=5,75,195); Post-taper (n=5,71,192)
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom," "absent," or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-Release (DVS SR)
n=9 Participants
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
Placebo
n=98 Participants
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
|
200 mg
n=207 Participants
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
|
|---|---|---|---|
|
Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
End of 8 week DB / OL phase or early termination
|
4.00 units on scale
Standard Deviation 5.05
|
2.07 units on scale
Standard Deviation 4.03
|
1.27 units on scale
Standard Deviation 3.40
|
|
Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
Taper week 1
|
2.00 units on scale
Standard Deviation 2.16
|
3.32 units on scale
Standard Deviation 4.35
|
2.47 units on scale
Standard Deviation 3.61
|
|
Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
Taper week 2
|
1.40 units on scale
Standard Deviation 3.13
|
5.29 units on scale
Standard Deviation 5.96
|
3.76 units on scale
Standard Deviation 4.71
|
|
Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
Post-taper
|
0.60 units on scale
Standard Deviation 0.89
|
1.41 units on scale
Standard Deviation 2.18
|
2.46 units on scale
Standard Deviation 3.97
|
Adverse Events
Double-blind DVS SR
Double-blind Placebo
Open-label DVS SR/ DVS SR
Open-label Placebo/DVS SR
Serious adverse events
| Measure |
Double-blind DVS SR
Days 1 to 7:
Patients will be instructed to take 1-50mg tablet per day
Days 8 to 14:
Patients will be instructed to take 1-100mg tablet per day
Days 15 to 56:
At the discretion of the investigator, patients may be assigned to 100mg or 200mg tablets per day
|
Double-blind Placebo
Placebo administered daily for 8 weeks
|
Open-label DVS SR/ DVS SR
Patients were in the DVS SR arm during both the double-blind and open-label phase.
|
Open-label Placebo/DVS SR
Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
|
|---|---|---|---|---|
|
Cardiac disorders
Hypertension
|
0.39%
1/256
|
0.00%
0/125
|
0.00%
0/208
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Skin carcinoma
|
0.00%
0/256
|
0.80%
1/125
|
0.00%
0/208
|
0.00%
0/103
|
|
Nervous system disorders
Psychotic depression
|
0.39%
1/256
|
0.00%
0/125
|
0.00%
0/208
|
0.00%
0/103
|
|
General disorders
Infection
|
0.39%
1/256
|
0.00%
0/125
|
0.00%
0/208
|
0.00%
0/103
|
|
Cardiac disorders
Cerebrovascular disorder
|
0.00%
0/256
|
0.80%
1/125
|
0.00%
0/208
|
0.00%
0/103
|
|
General disorders
Medication error
|
0.39%
1/256
|
0.00%
0/125
|
0.00%
0/208
|
0.00%
0/103
|
|
General disorders
Chest pain
|
0.39%
1/256
|
0.00%
0/125
|
0.00%
0/208
|
0.97%
1/103
|
|
Reproductive system and breast disorders
Uterine fibroids enlarged
|
0.00%
0/256
|
0.00%
0/125
|
0.00%
0/208
|
0.97%
1/103
|
|
General disorders
Accidental overdose
|
0.00%
0/256
|
0.00%
0/125
|
1.4%
3/208
|
0.00%
0/103
|
|
General disorders
Overdose
|
0.00%
0/256
|
0.00%
0/125
|
0.96%
2/208
|
0.00%
0/103
|
|
General disorders
Allergic reaction
|
0.00%
0/256
|
0.00%
0/125
|
0.48%
1/208
|
0.00%
0/103
|
|
Vascular disorders
Cerebral ischemia
|
0.00%
0/256
|
0.00%
0/125
|
0.48%
1/208
|
0.00%
0/103
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/256
|
0.00%
0/125
|
0.48%
1/208
|
0.00%
0/103
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/256
|
0.00%
0/125
|
0.48%
1/208
|
0.00%
0/103
|
|
Blood and lymphatic system disorders
Coagulation disorder
|
0.00%
0/256
|
0.00%
0/125
|
0.48%
1/208
|
0.00%
0/103
|
|
Nervous system disorders
Psychosis
|
0.00%
0/256
|
0.00%
0/125
|
0.48%
1/208
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Skin melanoma
|
0.00%
0/256
|
0.00%
0/125
|
0.48%
1/208
|
0.00%
0/103
|
|
Reproductive system and breast disorders
Endometrial carcinoma
|
0.00%
0/256
|
0.00%
0/125
|
0.48%
1/208
|
0.00%
0/103
|
|
Reproductive system and breast disorders
Breast carcinoma
|
0.00%
0/256
|
0.00%
0/125
|
0.48%
1/208
|
0.00%
0/103
|
Other adverse events
| Measure |
Double-blind DVS SR
Days 1 to 7:
Patients will be instructed to take 1-50mg tablet per day
Days 8 to 14:
Patients will be instructed to take 1-100mg tablet per day
Days 15 to 56:
At the discretion of the investigator, patients may be assigned to 100mg or 200mg tablets per day
|
Double-blind Placebo
Placebo administered daily for 8 weeks
|
Open-label DVS SR/ DVS SR
Patients were in the DVS SR arm during both the double-blind and open-label phase.
|
Open-label Placebo/DVS SR
Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
|
|---|---|---|---|---|
|
General disorders
Abdominal pain
|
4.3%
11/256
|
6.4%
8/125
|
10.1%
21/208
|
7.8%
8/103
|
|
General disorders
Asthenia
|
6.6%
17/256
|
8.0%
10/125
|
10.1%
21/208
|
10.7%
11/103
|
|
General disorders
Headache
|
26.6%
68/256
|
20.8%
26/125
|
39.4%
82/208
|
41.7%
43/103
|
|
General disorders
Infection
|
6.2%
16/256
|
8.0%
10/125
|
19.2%
40/208
|
17.5%
18/103
|
|
General disorders
Pain
|
3.1%
8/256
|
5.6%
7/125
|
9.6%
20/208
|
11.7%
12/103
|
|
Vascular disorders
Hypertension
|
6.6%
17/256
|
1.6%
2/125
|
10.1%
21/208
|
3.9%
4/103
|
|
Vascular disorders
Vasodilatation
|
5.9%
15/256
|
4.0%
5/125
|
8.7%
18/208
|
6.8%
7/103
|
|
Gastrointestinal disorders
Anorexia
|
5.9%
15/256
|
0.80%
1/125
|
5.8%
12/208
|
5.8%
6/103
|
|
Gastrointestinal disorders
Constipation
|
14.1%
36/256
|
6.4%
8/125
|
17.8%
37/208
|
21.4%
22/103
|
|
Gastrointestinal disorders
Diarrhea
|
8.6%
22/256
|
10.4%
13/125
|
15.9%
33/208
|
14.6%
15/103
|
|
Gastrointestinal disorders
Dry mouth
|
23.8%
61/256
|
9.6%
12/125
|
26.9%
56/208
|
22.3%
23/103
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
16/256
|
1.6%
2/125
|
9.6%
20/208
|
3.9%
4/103
|
|
Gastrointestinal disorders
Nausea
|
16.8%
43/256
|
12.0%
15/125
|
25.0%
52/208
|
31.1%
32/103
|
|
Nervous system disorders
Dizziness
|
11.3%
29/256
|
7.2%
9/125
|
2.9%
6/208
|
5.8%
6/103
|
|
Nervous system disorders
Insomnia
|
11.3%
29/256
|
6.4%
8/125
|
15.4%
32/208
|
15.5%
16/103
|
|
Nervous system disorders
Nervousness
|
5.1%
13/256
|
3.2%
4/125
|
6.7%
14/208
|
6.8%
7/103
|
|
Nervous system disorders
Somnolence
|
14.5%
37/256
|
7.2%
9/125
|
13.0%
27/208
|
14.6%
15/103
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.6%
17/256
|
2.4%
3/125
|
9.6%
20/208
|
11.7%
12/103
|
|
General disorders
Accidental injury
|
0.00%
0/256
|
0.00%
0/125
|
16.8%
35/208
|
11.7%
12/103
|
|
General disorders
Back pain
|
0.00%
0/256
|
0.00%
0/125
|
6.2%
13/208
|
5.8%
6/103
|
|
General disorders
Flu syndrome
|
0.00%
0/256
|
0.00%
0/125
|
5.3%
11/208
|
4.9%
5/103
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/256
|
0.00%
0/125
|
3.4%
7/208
|
8.7%
9/103
|
|
Metabolism and nutrition disorders
Weight gain
|
0.00%
0/256
|
0.00%
0/125
|
8.2%
17/208
|
8.7%
9/103
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/256
|
0.00%
0/125
|
8.7%
18/208
|
5.8%
6/103
|
|
Nervous system disorders
Abnormal dreams
|
0.00%
0/256
|
0.00%
0/125
|
7.2%
15/208
|
0.97%
1/103
|
|
Nervous system disorders
Anxiety
|
0.00%
0/256
|
0.00%
0/125
|
2.9%
6/208
|
5.8%
6/103
|
|
Nervous system disorders
Hostility
|
0.00%
0/256
|
0.00%
0/125
|
1.4%
3/208
|
6.8%
7/103
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/256
|
0.00%
0/125
|
5.8%
12/208
|
9.7%
10/103
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/256
|
0.00%
0/125
|
6.7%
14/208
|
6.8%
7/103
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/256
|
0.00%
0/125
|
11.1%
23/208
|
10.7%
11/103
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/256
|
0.00%
0/125
|
9.1%
19/208
|
8.7%
9/103
|
|
Eye disorders
Abnormal vision
|
0.00%
0/256
|
0.00%
0/125
|
6.2%
13/208
|
4.9%
5/103
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/256
|
0.00%
0/125
|
7.2%
15/208
|
1.9%
2/103
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER