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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00798707
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : June 6, 2011
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Drug: placebo
Enrollment 709

Recruitment Details  
Pre-assignment Details A total of 907 potential participants were screened for this study. 813 participants were enrolled and received single-blind placebo during the screening period prior to randomization.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) . Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET. DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Period Title: Overall Study
Started 235 237 237
Treated 231 232 236
Completed 209 204 215
Not Completed 26 33 22
Reason Not Completed
Adverse Event             6             8             8
Failed to return             2             2             0
Investigator             0             1             2
Lack of Efficacy             2             2             1
Lost to Follow-up             5             6             6
Other             0             1             0
Protocol Violation             4             0             2
Withdrawal by Subject             3             8             2
Randomized not treated             4             5             1
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg Total
Hide Arm/Group Description Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) . Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET. DVS SR 50 mg daily until Day 56 (Week 8) or ET. Total of all reporting groups
Overall Number of Baseline Participants 231 232 236 699
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 231 participants 232 participants 236 participants 699 participants
40.26  (12.32) 40.19  (11.88) 38.59  (12.08) 39.67  (12.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants 232 participants 236 participants 699 participants
Female
128
  55.4%
127
  54.7%
131
  55.5%
386
  55.2%
Male
103
  44.6%
105
  45.3%
105
  44.5%
313
  44.8%
Hamilton Psychiatric Scale for Depression-17 item (HAM-D17) total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 231 participants 232 participants 236 participants 699 participants
23.06  (2.59) 23.08  (2.93) 22.81  (2.61) 22.98  (2.71)
[1]
Measure Description: HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 231 participants 232 participants 236 participants 699 participants
4.39  (0.59) 4.35  (0.57) 4.33  (0.56) 4.36  (0.58)
[1]
Measure Description: CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Montgomery-Asberg Depression Rating Scale (MADRS) total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 231 participants 232 participants 236 participants 699 participants
28.19  (5.74) 28.08  (5.46) 28.21  (5.38) 28.16  (5.52)
[1]
Measure Description: MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
HAM-D6 total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 231 participants 232 participants 236 participants 699 participants
12.58  (1.79) 12.61  (1.77) 12.43  (1.75) 12.54  (1.77)
[1]
Measure Description: HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items associated with major depression and is a subset of the HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.
Sheehan Disability Scale (SDS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 231 participants 232 participants 236 participants 699 participants
16.31  (7.78) 17.02  (7.34) 16.39  (7.27) 16.57  (7.46)
[1]
Measure Description: SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities.Participant rates extent to which each of these domains are impaired by his/her symptoms using 10 point visual analog scale:(0=not at all impaired,10=extremely impaired) for total maximum score of 30.
World Health Organization 5-Item Well-Being Index (WHO-5)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 231 participants 232 participants 236 participants 699 participants
7.21  (4.47) 6.89  (3.99) 7.18  (4.34) 7.09  (4.27)
[1]
Measure Description: WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 ( 0= worst possible quality of life; 25=best possible quality of life).
Participants with Sexual dysfunction   [1] 
Measure Type: Number
Unit of measure:  Percentage of Participants
Number Analyzed 231 participants 232 participants 236 participants 699 participants
66.4 66.1 62.3 194.8
[1]
Measure Description: Arizona Sexual Experiences Scale (ASEX) includes 5 questions that evaluate sexual function exclusively during week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.
Participants with Columbia Suicide-Severity Rating Scale (C-SSRS) total score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 231 participants 232 participants 236 participants 699 participants
Completed Suicide 0 0 0 0
Suicide attempt 0 0 0 0
Preparatory acts toward imminent suicidal behavior 0 0 0 0
Suicidal ideation 31 45 37 113
[1]
Measure Description: C-SSRS was mapped into Columbia Classification Algorithm of Suicide Assessment (C-CASA)(1-4) to prospectively assess whether participants experienced: completed suicide(1),suicide attempt(2),preparatory acts toward imminent suicidal behavior(3),suicidal ideation,any suicidal behavior and ideation(4).Participants with “yes” response were reported.
1.Primary Outcome
Title Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)
Hide Description HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Time Frame Baseline and Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 231 232 236
Mean (Standard Error)
Unit of Measure: Units on a scale
-8.52  (0.44) -8.98  (0.44) -10.02  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.452
Comments A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
-0.75 to 1.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
0.28 to 2.72
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Categorical Scores on CGI–Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)
Hide Description CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 231 232 236
Measure Type: Number
Unit of Measure: Participants
1=Very much improved 48 57 68
2=Much improved 61 61 62
3=Minimally improved 62 70 61
4=No change 52 37 36
5=Minimally worse 4 5 4
6=Much worse 3 1 5
7=Very much worse 1 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of `Row mean scores differences'.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure.p-Value obtained for the alternative hypothesis of `Row mean scores differences'.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)
Hide Description CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Time Frame Baseline and Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 231 232 236
Mean (Standard Error)
Unit of Measure: Units on a scale
-1.03  (0.07) -1.22  (0.07) -1.24  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-0.01 to 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
0.01 to 0.41
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)
Hide Description MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Time Frame Baseline and Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 229 231 235
Mean (Standard Error)
Unit of Measure: Units on a scale
-9.23  (0.61) -10.23  (0.60) -11.29  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.242
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
-0.68 to 2.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.06
Confidence Interval (2-Sided) 95%
0.39 to 3.73
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)
Hide Description HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.
Time Frame Baseline and Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit,LOCF method of imputation was used.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 231 232 236
Mean (Standard Error)
Unit of Measure: Units on a scale
-4.94  (0.26) -5.03  (0.26) -5.65  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.802
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.62 to 0.80
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.01 to 1.43
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Hide Description A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Time Frame Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 231 232 236
Measure Type: Number
Unit of Measure: Participants
80 97 109
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1099
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.363
Confidence Interval (2-Sided) 95%
0.93 to 1.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0154
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.591
Confidence Interval (2-Sided) 95%
1.09 to 2.32
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Hide Description Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Time Frame Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 231 232 236
Measure Type: Number
Unit of Measure: Participants
44 40 62
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5929
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.878
Confidence Interval (2-Sided) 95%
0.54 to 1.41
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0852
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.474
Confidence Interval (2-Sided) 95%
0.95 to 2.29
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)
Hide Description A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Time Frame Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 229 231 235
Measure Type: Number
Unit of Measure: Participants
68 81 102
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2232
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.277
Confidence Interval (2-Sided) 95%
0.86 to 1.89
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.827
Confidence Interval (2-Sided) 95%
1.24 to 2.69
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
Hide Description CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 231 232 236
Measure Type: Number
Unit of Measure: Participants
109 118 130
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted with a logistic regression model with treatment as a factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4313
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.158
Confidence Interval (2-Sided) 95%
0.80 to 1.67
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted with a logistic regression model with treatment as a factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0888
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.372
Confidence Interval (2-Sided) 95%
0.95 to 1.97
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations
Hide Description Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.
Time Frame Week 2, 4 and 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Other Pre-specified Outcome
Title Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)
Hide Description SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.
Time Frame Baseline and Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 231 232 236
Mean (Standard Error)
Unit of Measure: Units on a scale
Total Score (n=227,224,235) -2.17  (0.43) -3.26  (0.43) -3.23  (0.42)
Work/Studies Component (n=227,225,235) -0.77  (0.16) -1.07  (0.15) -1.12  (0.15)
Social Life Component (n=229,231,235) -0.86  (0.16) -1.26  (0.15) -1.21  (0.15)
Family Life/Home Responsibilities (n=14,2,13) -0.54  (0.88) -1.83  (2.12) -0.97  (0.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
-0.10 to 2.29
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
-0.12 to 2.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-0.13 to 0.73
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
-0.08 to 0.77
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
-0.02 to 0.84
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.104
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
-0.07 to 0.78
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.538
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
-2.98 to 5.57
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.689
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
-1.76 to 2.62
Estimation Comments [Not Specified]
12.Other Pre-specified Outcome
Title Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)
Hide Description WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).
Time Frame Baseline and Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 229 231 235
Mean (Standard Error)
Unit of Measure: Units on a scale
2.62  (0.31) 3.43  (0.31) 3.25  (0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.81
Confidence Interval (2-Sided) 95%
-1.67 to 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.48 to 0.23
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)
Hide Description ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week should be instructed to not complete questions 3 through 5.
Time Frame Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 109 112 113
Measure Type: Number
Unit of Measure: Percentage of Participants
55.0 52.7 55.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8758
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.951
Confidence Interval (2-Sided) 95%
0.51 to 1.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6397
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.165
Confidence Interval (2-Sided) 95%
0.61 to 2.21
Estimation Comments [Not Specified]
14.Other Pre-specified Outcome
Title Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)
Hide Description C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of “Yes” on “Actual Attempt”),preparatory acts toward imminent suicidal behavior (3)(“Yes” on “Preparatory Acts or Behavior”),suicidal ideation (4)(“Yes” on “Wish to be dead”,“Non-Specific Active Suicidal Thoughts”,“Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(“Yes” on “Has subject engaged in Non-suicidal Self-Injurious Behavior”).
Time Frame Week 8 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 231 232 236
Measure Type: Number
Unit of Measure: Participants
Completed suicide 0 0 0
Suicide attempt 0 0 1
Preparatory acts toward imminent suicidal behavior 0 0 0
Suicidal ideation 42 50 47
Any suicidal behavior and/or ideation 42 50 47
Self-injurious behavior, no suicidal intent 0 1 1
15.Other Pre-specified Outcome
Title Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
Hide Description 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.
Time Frame Week 8 to 10 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description:
Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed 231 232 236
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (or ET) (n=96,88,100) 0.67  (1.62) 0.63  (1.30) 0.62  (1.53)
Week 9 (or ET + 1 week) (n=93,84,98) 1.08  (2.68) 1.38  (2.58) 1.50  (2.81)
Week 10 (or ET + 2 weeks) (n=83,76,89) 0.94  (2.28) 0.74  (1.23) 0.63  (1.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.847
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.847
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 25 mg
Comments To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Placebo DVS SR 25 mg DVS SR 50 mg
Hide Arm/Group Description Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) . Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET. DVS SR 50 mg daily until Day 56 (Week 8) or ET.
All-Cause Mortality
Placebo DVS SR 25 mg DVS SR 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo DVS SR 25 mg DVS SR 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/231 (1.30%)   1/232 (0.43%)   5/236 (2.12%) 
General disorders       
Chest discomfort * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Infections and infestations       
Peritonsillar abscess * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Injury, poisoning and procedural complications       
Post procedural complication * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pancreatic neuroendocrine tumour metastatic * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Nervous system disorders       
Grand mal convulsion * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Psychiatric disorders       
Depression * 1  1/231 (0.43%)  0/232 (0.00%)  2/236 (0.85%) 
Hallucination, auditory * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Homicidal ideation * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Suicidal ideation * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Suicide attempt * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Respiratory, thoracic and mediastinal disorders       
Pneumothorax * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo DVS SR 25 mg DVS SR 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   158/231 (68.40%)   160/232 (68.97%)   174/236 (73.73%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/231 (0.43%)  1/232 (0.43%)  0/236 (0.00%) 
Lymphadenopathy * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Cardiac disorders       
Palpitations * 1  3/231 (1.30%)  4/232 (1.72%)  2/236 (0.85%) 
Sinus tachycardia * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Tachycardia * 1  1/231 (0.43%)  1/232 (0.43%)  0/236 (0.00%) 
Ear and labyrinth disorders       
Ear discomfort * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Ear pain * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Hyperacusis * 1  2/231 (0.87%)  1/232 (0.43%)  0/236 (0.00%) 
Hypoacusis * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Tinnitus * 1  6/231 (2.60%)  1/232 (0.43%)  3/236 (1.27%) 
Vertigo * 1  1/231 (0.43%)  1/232 (0.43%)  4/236 (1.69%) 
Vertigo positional * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Endocrine disorders       
Hyperprolactinaemia * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Eye disorders       
Abnormal sensation in eye * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Accommodation disorder * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Asthenopia * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Blepharospasm * 1  2/231 (0.87%)  0/232 (0.00%)  0/236 (0.00%) 
Corneal disorder * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Dry eye * 1  1/231 (0.43%)  1/232 (0.43%)  2/236 (0.85%) 
Eye pain * 1  0/231 (0.00%)  1/232 (0.43%)  3/236 (1.27%) 
Eye swelling * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Foreign body sensation in eyes * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Lacrimation increased * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Scintillating scotoma * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Vision blurred * 1  0/231 (0.00%)  5/232 (2.16%)  7/236 (2.97%) 
Visual impairment * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Vitreous detachment * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  3/231 (1.30%)  1/232 (0.43%)  7/236 (2.97%) 
Abdominal distension * 1  3/231 (1.30%)  4/232 (1.72%)  2/236 (0.85%) 
Abdominal mass * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Abdominal pain * 1  2/231 (0.87%)  2/232 (0.86%)  4/236 (1.69%) 
Abdominal pain upper * 1  7/231 (3.03%)  5/232 (2.16%)  8/236 (3.39%) 
Anal fistula * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Aphthous stomatitis * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Cheilitis * 1  1/231 (0.43%)  0/232 (0.00%)  1/236 (0.42%) 
Constipation * 1  4/231 (1.73%)  6/232 (2.59%)  13/236 (5.51%) 
Diarrhoea * 1  14/231 (6.06%)  15/232 (6.47%)  14/236 (5.93%) 
Dry mouth * 1  10/231 (4.33%)  15/232 (6.47%)  10/236 (4.24%) 
Dyspepsia * 1  6/231 (2.60%)  4/232 (1.72%)  6/236 (2.54%) 
Enteritis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Enterocolitis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Flatulence * 1  2/231 (0.87%)  2/232 (0.86%)  1/236 (0.42%) 
Gastritis * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Gastrointestinal disorder * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Glossitis * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Haemorrhoids * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Mouth ulceration * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Nausea * 1  15/231 (6.49%)  23/232 (9.91%)  36/236 (15.25%) 
Paraesthesia oral * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Reflux oesophagitis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Salivary hypersecretion * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Stomatitis * 1  2/231 (0.87%)  2/232 (0.86%)  2/236 (0.85%) 
Tongue disorder * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Toothache * 1  1/231 (0.43%)  4/232 (1.72%)  1/236 (0.42%) 
Vomiting * 1  7/231 (3.03%)  5/232 (2.16%)  7/236 (2.97%) 
General disorders       
Asthenia * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Chest discomfort * 1  2/231 (0.87%)  1/232 (0.43%)  1/236 (0.42%) 
Chills * 1  2/231 (0.87%)  1/232 (0.43%)  1/236 (0.42%) 
Energy increased * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Facial pain * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Fatigue * 1  5/231 (2.16%)  5/232 (2.16%)  11/236 (4.66%) 
Feeling abnormal * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Feeling cold * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Feeling jittery * 1  0/231 (0.00%)  0/232 (0.00%)  2/236 (0.85%) 
Gait disturbance * 1  1/231 (0.43%)  0/232 (0.00%)  2/236 (0.85%) 
Hangover * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Hunger * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Irritability * 1  3/231 (1.30%)  7/232 (3.02%)  6/236 (2.54%) 
Loss of control of legs * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Malaise * 1  2/231 (0.87%)  2/232 (0.86%)  0/236 (0.00%) 
Mass * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Non-cardiac chest pain * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Oedema * 1  0/231 (0.00%)  2/232 (0.86%)  0/236 (0.00%) 
Oedema peripheral * 1  1/231 (0.43%)  1/232 (0.43%)  0/236 (0.00%) 
Pain * 1  1/231 (0.43%)  1/232 (0.43%)  0/236 (0.00%) 
Pyrexia * 1  4/231 (1.73%)  1/232 (0.43%)  1/236 (0.42%) 
Sluggishness * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Thirst * 1  3/231 (1.30%)  3/232 (1.29%)  7/236 (2.97%) 
Vessel puncture site haematoma * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Hepatobiliary disorders       
Hepatic function abnormal * 1  1/231 (0.43%)  1/232 (0.43%)  3/236 (1.27%) 
Immune system disorders       
Hypersensitivity * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Seasonal allergy * 1  1/231 (0.43%)  1/232 (0.43%)  0/236 (0.00%) 
Infections and infestations       
Abscess jaw * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Acne pustular * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Bronchitis * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Cellulitis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Conjunctivitis infective * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Cystitis * 1  1/231 (0.43%)  1/232 (0.43%)  1/236 (0.42%) 
Enteritis infectious * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Gastritis viral * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Gastroenteritis * 1  3/231 (1.30%)  2/232 (0.86%)  2/236 (0.85%) 
Gastroenteritis viral * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
H1N1 influenza * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Herpes zoster * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Hordeolum * 1  1/231 (0.43%)  1/232 (0.43%)  0/236 (0.00%) 
Infected bites * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Influenza * 1  1/231 (0.43%)  5/232 (2.16%)  4/236 (1.69%) 
Laryngitis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Localised infection * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Nasopharyngitis * 1  37/231 (16.02%)  26/232 (11.21%)  30/236 (12.71%) 
Oral herpes * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Otitis media * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Pharyngitis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Pyelonephritis * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Rhinitis * 1  0/231 (0.00%)  2/232 (0.86%)  0/236 (0.00%) 
Sinusitis * 1  0/231 (0.00%)  1/232 (0.43%)  2/236 (0.85%) 
Tinea cruris * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Tonsillitis * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Tooth abscess * 1  0/231 (0.00%)  2/232 (0.86%)  0/236 (0.00%) 
Upper respiratory tract infection * 1  7/231 (3.03%)  5/232 (2.16%)  5/236 (2.12%) 
Urinary tract infection * 1  1/231 (0.43%)  1/232 (0.43%)  2/236 (0.85%) 
Viral pharyngitis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Viral upper respiratory tract infection * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Vulvovaginal mycotic infection * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Injury, poisoning and procedural complications       
Animal scratch * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Arthropod bite * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Arthropod sting * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Burns second degree * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Contusion * 1  3/231 (1.30%)  2/232 (0.86%)  3/236 (1.27%) 
Excoriation * 1  1/231 (0.43%)  1/232 (0.43%)  2/236 (0.85%) 
Foot fracture * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Head injury * 1  0/231 (0.00%)  2/232 (0.86%)  0/236 (0.00%) 
Heat stroke * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Joint injury * 1  2/231 (0.87%)  0/232 (0.00%)  0/236 (0.00%) 
Joint sprain * 1  0/231 (0.00%)  4/232 (1.72%)  3/236 (1.27%) 
Ligament rupture * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Muscle strain * 1  1/231 (0.43%)  1/232 (0.43%)  1/236 (0.42%) 
Post procedural complication * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Postoperative fever * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Procedural pain * 1  1/231 (0.43%)  1/232 (0.43%)  1/236 (0.42%) 
Road traffic accident * 1  1/231 (0.43%)  0/232 (0.00%)  1/236 (0.42%) 
Skin laceration * 1  2/231 (0.87%)  0/232 (0.00%)  0/236 (0.00%) 
Soft tissue injury * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Thermal burn * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Wound * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Investigations       
Alanine aminotransferase increased * 1  1/231 (0.43%)  4/232 (1.72%)  0/236 (0.00%) 
Aspartate aminotransferase increased * 1  1/231 (0.43%)  3/232 (1.29%)  1/236 (0.42%) 
Blood bilirubin increased * 1  0/231 (0.00%)  0/232 (0.00%)  2/236 (0.85%) 
Blood cholesterol increased * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Blood pressure increased * 1  1/231 (0.43%)  1/232 (0.43%)  4/236 (1.69%) 
Blood prolactin increased * 1  2/231 (0.87%)  4/232 (1.72%)  4/236 (1.69%) 
Blood triglycerides increased * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Gamma-glutamyltransferase increased * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Glucose urine present * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Hepatic enzyme increased * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Liver function test abnormal * 1  1/231 (0.43%)  1/232 (0.43%)  1/236 (0.42%) 
Neutrophil count decreased * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Occult blood * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Protein urine present * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Urine ketone body present * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Weight decreased * 1  0/231 (0.00%)  2/232 (0.86%)  3/236 (1.27%) 
Weight increased * 1  3/231 (1.30%)  1/232 (0.43%)  1/236 (0.42%) 
White blood cell count decreased * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  7/231 (3.03%)  2/232 (0.86%)  7/236 (2.97%) 
Diabetes mellitus * 1  2/231 (0.87%)  0/232 (0.00%)  1/236 (0.42%) 
Hyperuricaemia * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Hypokalaemia * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Increased appetite * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/231 (0.43%)  2/232 (0.86%)  5/236 (2.12%) 
Arthritis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Back pain * 1  6/231 (2.60%)  4/232 (1.72%)  4/236 (1.69%) 
Flank pain * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Intervertebral disc protrusion * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Joint swelling * 1  2/231 (0.87%)  1/232 (0.43%)  0/236 (0.00%) 
Muscle spasms * 1  5/231 (2.16%)  5/232 (2.16%)  2/236 (0.85%) 
Muscle tightness * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Muscle twitching * 1  0/231 (0.00%)  2/232 (0.86%)  1/236 (0.42%) 
Musculoskeletal chest pain * 1  0/231 (0.00%)  1/232 (0.43%)  2/236 (0.85%) 
Musculoskeletal pain * 1  2/231 (0.87%)  1/232 (0.43%)  3/236 (1.27%) 
Musculoskeletal stiffness * 1  0/231 (0.00%)  3/232 (1.29%)  1/236 (0.42%) 
Myalgia * 1  3/231 (1.30%)  1/232 (0.43%)  4/236 (1.69%) 
Osteoarthritis * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Pain in extremity * 1  0/231 (0.00%)  2/232 (0.86%)  0/236 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Melanocytic naevus * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Skin papilloma * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Nervous system disorders       
Ageusia * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Akathisia * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Aphasia * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Balance disorder * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Burning sensation * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Coordination abnormal * 1  1/231 (0.43%)  1/232 (0.43%)  0/236 (0.00%) 
Crying * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Depressed level of consciousness * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Dizziness * 1  9/231 (3.90%)  21/232 (9.05%)  19/236 (8.05%) 
Dizziness postural * 1  3/231 (1.30%)  3/232 (1.29%)  2/236 (0.85%) 
Dysgeusia * 1  3/231 (1.30%)  0/232 (0.00%)  4/236 (1.69%) 
Headache * 1  25/231 (10.82%)  23/232 (9.91%)  28/236 (11.86%) 
Hyperkinesia * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Hypoaesthesia * 1  3/231 (1.30%)  2/232 (0.86%)  3/236 (1.27%) 
Hypogeusia * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Lethargy * 1  1/231 (0.43%)  0/232 (0.00%)  1/236 (0.42%) 
Loss of consciousness * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Memory impairment * 1  2/231 (0.87%)  2/232 (0.86%)  0/236 (0.00%) 
Migraine * 1  1/231 (0.43%)  1/232 (0.43%)  2/236 (0.85%) 
Paraesthesia * 1  3/231 (1.30%)  0/232 (0.00%)  1/236 (0.42%) 
Parosmia * 1  1/231 (0.43%)  0/232 (0.00%)  1/236 (0.42%) 
Poor quality sleep * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Restless legs syndrome * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Sedation * 1  2/231 (0.87%)  1/232 (0.43%)  2/236 (0.85%) 
Somnolence * 1  12/231 (5.19%)  12/232 (5.17%)  15/236 (6.36%) 
Speech disorder * 1  1/231 (0.43%)  0/232 (0.00%)  2/236 (0.85%) 
Syncope * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Tension headache * 1  1/231 (0.43%)  0/232 (0.00%)  2/236 (0.85%) 
Tongue paralysis * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Tremor * 1  2/231 (0.87%)  2/232 (0.86%)  4/236 (1.69%) 
Psychiatric disorders       
Abnormal dreams * 1  10/231 (4.33%)  9/232 (3.88%)  12/236 (5.08%) 
Agitation * 1  0/231 (0.00%)  2/232 (0.86%)  1/236 (0.42%) 
Alcoholic hangover * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Anger * 1  1/231 (0.43%)  1/232 (0.43%)  1/236 (0.42%) 
Anorgasmia * 1  1/231 (0.43%)  1/232 (0.43%)  4/236 (1.69%) 
Anxiety * 1  4/231 (1.73%)  5/232 (2.16%)  4/236 (1.69%) 
Bipolar I disorder * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Bruxism * 1  2/231 (0.87%)  0/232 (0.00%)  2/236 (0.85%) 
Confusional state * 1  1/231 (0.43%)  1/232 (0.43%)  0/236 (0.00%) 
Depression * 1  9/231 (3.90%)  5/232 (2.16%)  4/236 (1.69%) 
Derealisation * 1  2/231 (0.87%)  1/232 (0.43%)  2/236 (0.85%) 
Dissociation * 1  1/231 (0.43%)  0/232 (0.00%)  2/236 (0.85%) 
Eating disorder * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Elevated mood * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Emotional disorder * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Euphoric mood * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Initial insomnia * 1  1/231 (0.43%)  2/232 (0.86%)  0/236 (0.00%) 
Insomnia * 1  10/231 (4.33%)  10/232 (4.31%)  12/236 (5.08%) 
Intentional self-injury * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Libido decreased * 1  3/231 (1.30%)  2/232 (0.86%)  11/236 (4.66%) 
Libido increased * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Loss of libido * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Middle insomnia * 1  1/231 (0.43%)  1/232 (0.43%)  2/236 (0.85%) 
Mood altered * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Nervousness * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Nightmare * 1  1/231 (0.43%)  0/232 (0.00%)  6/236 (2.54%) 
Orgasm abnormal * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Panic attack * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Restlessness * 1  1/231 (0.43%)  0/232 (0.00%)  3/236 (1.27%) 
Self injurious behaviour * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Sleep disorder * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Sleep inertia * 1  0/231 (0.00%)  0/232 (0.00%)  2/236 (0.85%) 
Suicidal ideation * 1  7/231 (3.03%)  9/232 (3.88%)  4/236 (1.69%) 
Tension * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Terminal insomnia * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Withdrawal syndrome * 1  3/231 (1.30%)  5/232 (2.16%)  12/236 (5.08%) 
Renal and urinary disorders       
Calculus ureteri * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Haematuria * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Micturition urgency * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Nocturia * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Pollakiuria * 1  0/231 (0.00%)  0/232 (0.00%)  4/236 (1.69%) 
Polyuria * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Reproductive system and breast disorders       
Amenorrhoea * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Dysmenorrhoea * 1  1/231 (0.43%)  0/232 (0.00%)  1/236 (0.42%) 
Ejaculation delayed * 1  0/231 (0.00%)  2/232 (0.86%)  1/236 (0.42%) 
Ejaculation disorder * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Erectile dysfunction * 1  2/231 (0.87%)  0/232 (0.00%)  0/236 (0.00%) 
Menorrhagia * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Menstruation irregular * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Premenstrual syndrome * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Sexual dysfunction * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Atelectasis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Bronchospasm * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Cough * 1  1/231 (0.43%)  1/232 (0.43%)  4/236 (1.69%) 
Dysphonia * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Dyspnoea exertional * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Epistaxis * 1  0/231 (0.00%)  2/232 (0.86%)  0/236 (0.00%) 
Hyperventilation * 1  0/231 (0.00%)  2/232 (0.86%)  0/236 (0.00%) 
Nasal congestion * 1  0/231 (0.00%)  1/232 (0.43%)  1/236 (0.42%) 
Oropharyngeal discomfort * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Oropharyngeal pain * 1  2/231 (0.87%)  3/232 (1.29%)  2/236 (0.85%) 
Respiratory tract congestion * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Rhinitis allergic * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Rhinorrhoea * 1  1/231 (0.43%)  1/232 (0.43%)  0/236 (0.00%) 
Rhonchi * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Sinus congestion * 1  3/231 (1.30%)  4/232 (1.72%)  4/236 (1.69%) 
Upper respiratory tract inflammation * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Yawning * 1  0/231 (0.00%)  1/232 (0.43%)  2/236 (0.85%) 
Skin and subcutaneous tissue disorders       
Acne * 1  0/231 (0.00%)  0/232 (0.00%)  2/236 (0.85%) 
Alopecia * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Dermatitis atopic * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Dry skin * 1  1/231 (0.43%)  0/232 (0.00%)  2/236 (0.85%) 
Dyshidrosis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Ecchymosis * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Eczema * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
Heat rash * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Hyperhidrosis * 1  6/231 (2.60%)  1/232 (0.43%)  8/236 (3.39%) 
Night sweats * 1  1/231 (0.43%)  1/232 (0.43%)  5/236 (2.12%) 
Pruritus * 1  4/231 (1.73%)  3/232 (1.29%)  2/236 (0.85%) 
Pruritus generalised * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Rash * 1  2/231 (0.87%)  3/232 (1.29%)  0/236 (0.00%) 
Rash generalised * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Seborrhoeic dermatitis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Skin odour abnormal * 1  0/231 (0.00%)  0/232 (0.00%)  1/236 (0.42%) 
Vascular disorders       
Haematoma * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Hot flush * 1  5/231 (2.16%)  2/232 (0.86%)  5/236 (2.12%) 
Hypertension * 1  2/231 (0.87%)  0/232 (0.00%)  3/236 (1.27%) 
Hypotension * 1  0/231 (0.00%)  0/232 (0.00%)  2/236 (0.85%) 
Orthostatic hypotension * 1  0/231 (0.00%)  2/232 (0.86%)  0/236 (0.00%) 
Phlebitis * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Spider vein * 1  0/231 (0.00%)  1/232 (0.43%)  0/236 (0.00%) 
Vasodilatation * 1  1/231 (0.43%)  0/232 (0.00%)  0/236 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00798707     History of Changes
Other Study ID Numbers: 3151A1-3359
B2061003
3151A1-3359-WW
First Submitted: November 25, 2008
First Posted: November 26, 2008
Results First Submitted: March 7, 2011
Results First Posted: June 6, 2011
Last Update Posted: June 10, 2011