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Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00863798
Recruitment Status : Completed
First Posted : March 18, 2009
Results First Posted : May 6, 2011
Last Update Posted : May 6, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of 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 10mg
Drug: Desvenlafaxine Succinate Sustained-Release 50 mg
Drug: placebo
Enrollment 682
Recruitment Details  
Pre-assignment Details A total of 898 potential participants were screened for this study. 804 participants were enrolled and received single-blind placebo during the screening period prior to randomization.
Arm/Group Title Placebo DVS SR 10 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) 10 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 227 228 227
Treated 223 226 224
Completed 195 198 202
Not Completed 32 30 25
Reason Not Completed
Adverse Event             5             2             4
Participant failed to return             2             1             0
Investigator request             1             2             1
Lack of Efficacy             4             3             6
Lost to Follow-up             6             9             5
Other             2             3             1
Protocol Violation             0             1             1
Withdrawal by Subject             8             7             4
Randomized not treated             4             2             3
Arm/Group Title Placebo DVS SR 10 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) 10 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 223 226 224 673
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 223 participants 226 participants 224 participants 673 participants
41.75  (12.85) 41.01  (13.75) 42.47  (13.47) 41.74  (13.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 226 participants 224 participants 673 participants
Female
139
  62.3%
135
  59.7%
135
  60.3%
409
  60.8%
Male
84
  37.7%
91
  40.3%
89
  39.7%
264
  39.2%
Hamilton Psychiatric Scale for Depression-17 item HAM-D17) total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 223 participants 226 participants 224 participants 673 participants
23.23  (2.63) 22.83  (2.26) 23.12  (2.62) 23.06  (2.51)
[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 223 participants 226 participants 224 participants 673 participants
4.14  (0.35) 4.14  (0.34) 4.16  (0.39) 4.14  (0.36)
[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 223 participants 226 participants 224 participants 673 participants
28.33  (4.71) 27.59  (4.49) 28.44  (4.83) 28.12  (4.69)
[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 223 participants 226 participants 224 participants 673 participants
12.72  (1.51) 12.77  (1.41) 12.63  (1.49) 12.71  (1.47)
[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 223 participants 226 participants 224 participants 673 participants
16.88  (8.25) 16.42  (8.37) 17.06  (7.73) 16.78  (8.12)
[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 223 participants 226 participants 224 participants 673 participants
7.39  (4.80) 7.47  (4.86) 7.06  (4.26) 7.31  (4.65)
[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 223 participants 226 participants 224 participants 673 participants
58.8 61.3 65.8 185.9
[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 223 participants 226 participants 224 participants 673 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 37 31 29 97
[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 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)
Hide 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 10 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) 10 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 223 226 224
Mean (Standard Error)
Unit of Measure: Units on a scale
-8.42  (0.45) -9.28  (0.45) -8.92  (0.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 DVS SR 10 mg 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 0.175
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 0.86
Confidence Interval (2-Sided) 95%
-0.38 to 2.10
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 DVS SR 10 mg 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 0.421
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 0.51
Confidence Interval (2-Sided) 95%
-0.73 to 1.75
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)
Hide 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 10 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) 10 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 223 226 224
Measure Type: Number
Unit of Measure: Participants
1=Very much improved 49 50 55
2=Much improved 54 75 53
3=Minimally improved 51 51 64
4=No change 61 46 49
5=Minimally worse 5 4 3
6=Much worse 3 0 0
7=Very much worse 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.076
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 0.204
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 )
Hide 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 10 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) 10 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 223 226 224
Mean (Standard Error)
Unit of Measure: Units on a scale
-1.08  (0.07) -1.23  (0.07) -1.11  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.130
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.04 to 0.35
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 0.757
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.16 to 0.23
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)
Hide 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 10 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) 10 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 222 224 222
Mean (Standard Error)
Unit of Measure: Units on a scale
-9.87  (0.63) -11.28  (0.63) -10.76  (0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.114
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
-0.34 to 3.16
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 0.316
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
-0.85 to 2.64
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. 0=none/absent and 22=most severe.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 )
Hide 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 10 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) 10 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 223 226 224
Mean (Standard Error)
Unit of Measure: Units on a scale
-4.75  (0.27) -5.49  (0.27) -5.19  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.054
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
-0.01 to 1.50
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 0.253
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
-0.32 to 1.20
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)
Hide 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 10 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) 10 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 223 226 224
Measure Type: Number
Unit of Measure: Participants
85 100 91
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.2415
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.254
Confidence Interval (2-Sided) 95%
0.86 to 1.83
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 0.6169
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.102
Confidence Interval (2-Sided) 95%
0.75 to 1.61
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)
Hide 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 10 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) 10 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 223 226 224
Measure Type: Number
Unit of Measure: Participants
42 52 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.3667
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.236
Confidence Interval (2-Sided) 95%
0.78 to 1.96
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 0.6509
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.894
Confidence Interval (2-Sided) 95%
0.55 to 1.45
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)
Hide 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 10 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) 10 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 222 224 222
Measure Type: Number
Unit of Measure: Participants
84 95 90
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 mg
Comments Analysis would be 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 0.3893
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.182
Confidence Interval (2-Sided) 95%
0.81 to 1.73
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 would be 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 0.5510
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.123
Confidence Interval (2-Sided) 95%
0.77 to 1.65
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)
Hide 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 10 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) 10 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 223 226 224
Measure Type: Number
Unit of Measure: Participants
103 125 108
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 mg
Comments Analysis would be 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 0.0536
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.442
Confidence Interval (2-Sided) 95%
0.99 to 2.09
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 would be 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 0.6679
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.085
Confidence Interval (2-Sided) 95%
0.75 to 1.57
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)
Hide 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 10 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) 10 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 tools 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)
Hide 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 10 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) 10 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 223 226 224
Mean (Standard Error)
Unit of Measure: Units on a scale
Total Score (n=220,223,219) -2.63  (0.48) -4.09  (0.48) -3.78  (0.49)
Work/Studies Component(n=220,223,219) -0.61  (0.17) -1.10  (0.17) -1.14  (0.17)
Social Life and Leisure Activities(n=222,224,221) -1.08  (0.18) -1.58  (0.17) -1.36  (0.18)
Family Life/Home Responsibilities (n=222,224,221) -0.98  (0.17) -1.43  (0.17) -1.20  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.033
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.46
Confidence Interval (2-Sided) 95%
0.12 to 2.79
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 0.096
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
-0.20 to 2.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.043
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.02 to 0.95
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 0.027
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.06 to 1.00
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 and leisure activities component score".
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.01 to 0.98
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 and leisure activities component score".
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.22 to 0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.056
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
-0.01 to 0.91
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 0.355
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-0.24 to 0.68
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)
Hide 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 10 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) 10 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 222 224 221
Mean (Standard Error)
Unit of Measure: Units on a scale
2.96  (0.36) 4.51  (0.35) 3.73  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.54
Confidence Interval (2-Sided) 95%
-2.53 to -0.56
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 0.129
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-1.75 to 0.22
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 were instructed to not complete questions 3 through 5.
Time Frame Week 8 (or ET)
Hide 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 10 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) 10 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 221 222 220
Measure Type: Number
Unit of Measure: Percentage of Participants
52.0 48.6 59.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 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 0.3097
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.800
Confidence Interval (2-Sided) 95%
0.52 to 1.23
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 0.2794
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.272
Confidence Interval (2-Sided) 95%
0.82 to 1.97
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)
Hide 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 10 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) 10 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 223 226 224
Measure Type: Number
Unit of Measure: Participants
Completed suicide 0 0 0
Suicide attempt 0 1 0
Preparatory acts toward imminent suicidal behavior 0 0 1
Suicidal ideation 56 43 45
Any suicidal behavior and/or ideation 56 43 45
Self-injurious behavior, no suicidal intent 1 0 0
15.Other Pre-specified Outcome
Title Discontinuation-Emergent Signs and Symptoms (DESS)
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 that appeared during tapering of the test article. A higher score indicates more symptoms.
Time Frame Week 8 to 10 (or ET)
Hide 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 10 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) 10 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 223 226 224
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (or ET) (n=190,194,191) 0.72  (1.81) 0.80  (1.78) 0.83  (2.05)
Week 9 ( or ET + 1 week) (n=178,185,186) 1.26  (2.78) 1.08  (2.31) 1.98  (3.29)
Week 10 (or ET + 2 weeks (n=170,182,182) 0.90  (2.30) 0.91  (2.24) 1.07  (2.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 10 mg
Comments To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
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 10 mg
Comments To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
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 10 mg
Comments To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.978
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 was used at Week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
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 was used at Week 9.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
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 was used at Week 10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
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 10 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) 10 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 10 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 10 mg DVS SR 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/223 (1.35%)   1/226 (0.44%)   1/224 (0.45%) 
General disorders       
Non-cardiac chest pain * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Infections and infestations       
Appendicitis * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Scrotal abscess * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Renal and urinary disorders       
Urinary retention * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Reproductive system and breast disorders       
Epididymitis * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
*
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 10 mg DVS SR 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   166/223 (74.44%)   168/226 (74.34%)   170/224 (75.89%) 
Blood and lymphatic system disorders       
Leukocytosis * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Lymphadenopathy * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Polycythaemia * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Cardiac disorders       
Atrioventricular block first degree * 1  2/223 (0.90%)  0/226 (0.00%)  1/224 (0.45%) 
Bradycardia * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Cardiac hypertrophy * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Palpitations * 1  1/223 (0.45%)  5/226 (2.21%)  1/224 (0.45%) 
Supraventricular extrasystoles * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Tachycardia * 1  2/223 (0.90%)  1/226 (0.44%)  4/224 (1.79%) 
Ventricular extrasystoles * 1  2/223 (0.90%)  1/226 (0.44%)  1/224 (0.45%) 
Ear and labyrinth disorders       
Ear discomfort * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Ear pain * 1  1/223 (0.45%)  1/226 (0.44%)  2/224 (0.89%) 
Hyperacusis * 1  1/223 (0.45%)  0/226 (0.00%)  1/224 (0.45%) 
Tinnitus * 1  1/223 (0.45%)  0/226 (0.00%)  2/224 (0.89%) 
Vertigo * 1  0/223 (0.00%)  1/226 (0.44%)  1/224 (0.45%) 
Eye disorders       
Blepharospasm * 1  2/223 (0.90%)  0/226 (0.00%)  1/224 (0.45%) 
Conjunctivitis * 1  0/223 (0.00%)  0/226 (0.00%)  3/224 (1.34%) 
Diabetic retinopathy * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Dry eye * 1  0/223 (0.00%)  1/226 (0.44%)  1/224 (0.45%) 
Excessive eye blinking * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Eye pain * 1  2/223 (0.90%)  2/226 (0.88%)  1/224 (0.45%) 
Eye pruritus * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Miosis * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Photophobia * 1  0/223 (0.00%)  1/226 (0.44%)  1/224 (0.45%) 
Photopsia * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Vision blurred * 1  3/223 (1.35%)  3/226 (1.33%)  4/224 (1.79%) 
Visual impairment * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  2/223 (0.90%)  2/226 (0.88%)  2/224 (0.89%) 
Abdominal distension * 1  4/223 (1.79%)  4/226 (1.77%)  4/224 (1.79%) 
Abdominal pain * 1  2/223 (0.90%)  5/226 (2.21%)  4/224 (1.79%) 
Abdominal pain upper * 1  6/223 (2.69%)  3/226 (1.33%)  3/224 (1.34%) 
Chapped lips * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Constipation * 1  7/223 (3.14%)  8/226 (3.54%)  15/224 (6.70%) 
Dental caries * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Diarrhoea * 1  17/223 (7.62%)  20/226 (8.85%)  19/224 (8.48%) 
Diverticulum * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Dry mouth * 1  13/223 (5.83%)  20/226 (8.85%)  25/224 (11.16%) 
Dyspepsia * 1  7/223 (3.14%)  6/226 (2.65%)  9/224 (4.02%) 
Eructation * 1  0/223 (0.00%)  3/226 (1.33%)  0/224 (0.00%) 
Faecaloma * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Faeces discoloured * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Faeces pale * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Flatulence * 1  7/223 (3.14%)  5/226 (2.21%)  2/224 (0.89%) 
Food poisoning * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Frequent bowel movements * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Gastritis * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Gastrooesophageal reflux disease * 1  1/223 (0.45%)  2/226 (0.88%)  1/224 (0.45%) 
Haematochezia * 1  0/223 (0.00%)  0/226 (0.00%)  2/224 (0.89%) 
Nausea * 1  21/223 (9.42%)  26/226 (11.50%)  42/224 (18.75%) 
Pancreatic cyst * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Salivary hypersecretion * 1  2/223 (0.90%)  2/226 (0.88%)  1/224 (0.45%) 
Toothache * 1  2/223 (0.90%)  0/226 (0.00%)  5/224 (2.23%) 
Umbilical hernia * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Vomiting * 1  5/223 (2.24%)  9/226 (3.98%)  6/224 (2.68%) 
Vomiting in pregnancy * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
General disorders       
Asthenia * 1  2/223 (0.90%)  1/226 (0.44%)  0/224 (0.00%) 
Chest discomfort * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Chest pain * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Chills * 1  2/223 (0.90%)  0/226 (0.00%)  2/224 (0.89%) 
Fatigue * 1  8/223 (3.59%)  10/226 (4.42%)  16/224 (7.14%) 
Feeling abnormal * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Feeling jittery * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Inflammation * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Influenza like illness * 1  1/223 (0.45%)  2/226 (0.88%)  4/224 (1.79%) 
Injection site pruritus * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Irritability * 1  12/223 (5.38%)  8/226 (3.54%)  8/224 (3.57%) 
Non-cardiac chest pain * 1  0/223 (0.00%)  1/226 (0.44%)  3/224 (1.34%) 
Oedema peripheral * 1  1/223 (0.45%)  2/226 (0.88%)  0/224 (0.00%) 
Pain * 1  2/223 (0.90%)  0/226 (0.00%)  0/224 (0.00%) 
Pyrexia * 1  0/223 (0.00%)  0/226 (0.00%)  4/224 (1.79%) 
Temperature intolerance * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Thirst * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Immune system disorders       
Seasonal allergy * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Infections and infestations       
Acarodermatitis * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Acute sinusitis * 1  0/223 (0.00%)  1/226 (0.44%)  1/224 (0.45%) 
Bronchitis * 1  3/223 (1.35%)  2/226 (0.88%)  3/224 (1.34%) 
Bronchitis viral * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Cellulitis * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Ear infection * 1  1/223 (0.45%)  0/226 (0.00%)  1/224 (0.45%) 
Folliculitis * 1  1/223 (0.45%)  0/226 (0.00%)  1/224 (0.45%) 
Gastroenteritis * 1  1/223 (0.45%)  4/226 (1.77%)  2/224 (0.89%) 
Gastroenteritis viral * 1  1/223 (0.45%)  4/226 (1.77%)  1/224 (0.45%) 
Gingival infection * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
H1N1 influenza * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Infected bites * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Infected cyst * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Influenza * 1  7/223 (3.14%)  8/226 (3.54%)  5/224 (2.23%) 
Meningitis viral * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Nasopharyngitis * 1  6/223 (2.69%)  5/226 (2.21%)  7/224 (3.13%) 
Otitis media * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Pharyngitis * 1  3/223 (1.35%)  3/226 (1.33%)  1/224 (0.45%) 
Pharyngitis streptococcal * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Pneumonia * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Pyelonephritis * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Respiratory tract infection viral * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Rhinitis * 1  2/223 (0.90%)  0/226 (0.00%)  2/224 (0.89%) 
Sinusitis * 1  2/223 (0.90%)  3/226 (1.33%)  2/224 (0.89%) 
Tonsillitis * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Tooth abscess * 1  2/223 (0.90%)  1/226 (0.44%)  0/224 (0.00%) 
Tooth infection * 1  2/223 (0.90%)  0/226 (0.00%)  0/224 (0.00%) 
Upper respiratory tract infection * 1  17/223 (7.62%)  21/226 (9.29%)  16/224 (7.14%) 
Urinary tract infection * 1  4/223 (1.79%)  1/226 (0.44%)  1/224 (0.45%) 
Vaginitis bacterial * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Viral infection * 1  4/223 (1.79%)  1/226 (0.44%)  1/224 (0.45%) 
Viral upper respiratory tract infection * 1  0/223 (0.00%)  2/226 (0.88%)  0/224 (0.00%) 
Vulvovaginal candidiasis * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Vulvovaginal mycotic infection * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Arthropod sting * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Back injury * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Contusion * 1  2/223 (0.90%)  0/226 (0.00%)  2/224 (0.89%) 
Epicondylitis * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Excoriation * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Fall * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Intentional overdose * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Joint injury * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Joint sprain * 1  2/223 (0.90%)  1/226 (0.44%)  2/224 (0.89%) 
Ligament rupture * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Limb injury * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Meniscus lesion * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Muscle strain * 1  2/223 (0.90%)  1/226 (0.44%)  0/224 (0.00%) 
Procedural pain * 1  1/223 (0.45%)  0/226 (0.00%)  1/224 (0.45%) 
Road traffic accident * 1  0/223 (0.00%)  0/226 (0.00%)  2/224 (0.89%) 
Skin laceration * 1  2/223 (0.90%)  0/226 (0.00%)  1/224 (0.45%) 
Tooth fracture * 1  0/223 (0.00%)  0/226 (0.00%)  3/224 (1.34%) 
Upper limb fracture * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  1/223 (0.45%)  1/226 (0.44%)  2/224 (0.89%) 
Aspartate aminotransferase increased * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Blood alkaline phosphatase increased * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Blood bilirubin increased * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Blood calcium increased * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Blood glucose increased * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Blood human chorionic gonadotropin * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Blood pressure decreased * 1  0/223 (0.00%)  2/226 (0.88%)  0/224 (0.00%) 
Blood pressure diastolic decreased * 1  1/223 (0.45%)  1/226 (0.44%)  1/224 (0.45%) 
Blood pressure diastolic increased * 1  1/223 (0.45%)  2/226 (0.88%)  0/224 (0.00%) 
Blood pressure increased * 1  0/223 (0.00%)  1/226 (0.44%)  4/224 (1.79%) 
Blood pressure orthostatic decreased * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Blood pressure systolic decreased * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Blood prolactin increased * 1  1/223 (0.45%)  0/226 (0.00%)  1/224 (0.45%) 
Blood triglycerides increased * 1  2/223 (0.90%)  1/226 (0.44%)  0/224 (0.00%) 
Body temperature increased * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Electrocardiogram T wave amplitude decreased * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Electrocardiogram T wave inversion * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Heart rate increased * 1  0/223 (0.00%)  3/226 (1.33%)  1/224 (0.45%) 
Heart rate irregular * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Hepatic enzyme increased * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Liver function test abnormal * 1  1/223 (0.45%)  2/226 (0.88%)  1/224 (0.45%) 
Neutrophil count decreased * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Platelet count decreased * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Platelet count increased * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Protein urine * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Tuberculin test positive * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Weight decreased * 1  3/223 (1.35%)  1/226 (0.44%)  1/224 (0.45%) 
Weight increased * 1  2/223 (0.90%)  1/226 (0.44%)  3/224 (1.34%) 
White blood cell count decreased * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Metabolism and nutrition disorders       
Alcohol intolerance * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Decreased appetite * 1  9/223 (4.04%)  10/226 (4.42%)  20/224 (8.93%) 
Fluid retention * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Food craving * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Glucose tolerance impaired * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Hypercalcaemia * 1  0/223 (0.00%)  2/226 (0.88%)  0/224 (0.00%) 
Hyperkalaemia * 1  0/223 (0.00%)  1/226 (0.44%)  1/224 (0.45%) 
Hypernatraemia * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Hyperphagia * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Hyperproteinaemia * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Increased appetite * 1  4/223 (1.79%)  2/226 (0.88%)  0/224 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  3/223 (1.35%)  4/226 (1.77%)  1/224 (0.45%) 
Arthritis * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Back pain * 1  3/223 (1.35%)  3/226 (1.33%)  5/224 (2.23%) 
Costochondritis * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Fibromyalgia * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Flank pain * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Joint stiffness * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Joint swelling * 1  1/223 (0.45%)  2/226 (0.88%)  1/224 (0.45%) 
Muscle spasms * 1  1/223 (0.45%)  4/226 (1.77%)  4/224 (1.79%) 
Muscle tightness * 1  4/223 (1.79%)  0/226 (0.00%)  1/224 (0.45%) 
Muscle twitching * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Musculoskeletal chest pain * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Musculoskeletal discomfort * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Musculoskeletal pain * 1  1/223 (0.45%)  1/226 (0.44%)  1/224 (0.45%) 
Musculoskeletal stiffness * 1  2/223 (0.90%)  2/226 (0.88%)  1/224 (0.45%) 
Myalgia * 1  7/223 (3.14%)  5/226 (2.21%)  6/224 (2.68%) 
Myokymia * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Neck pain * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Pain in extremity * 1  1/223 (0.45%)  5/226 (2.21%)  1/224 (0.45%) 
Plantar fasciitis * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Rotator cuff syndrome * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Sensation of heaviness * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Abdominal neoplasm * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Melanocytic naevus * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Nervous system disorders       
Akathisia * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Cognitive disorder * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Crying * 1  2/223 (0.90%)  1/226 (0.44%)  3/224 (1.34%) 
Diabetic neuropathy * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Disturbance in attention * 1  1/223 (0.45%)  7/226 (3.10%)  3/224 (1.34%) 
Dizziness * 1  17/223 (7.62%)  11/226 (4.87%)  29/224 (12.95%) 
Dizziness postural * 1  1/223 (0.45%)  2/226 (0.88%)  5/224 (2.23%) 
Drug withdrawal headache * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Dysgeusia * 1  1/223 (0.45%)  0/226 (0.00%)  2/224 (0.89%) 
Dyskinesia * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Exaggerated startle response * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Headache * 1  23/223 (10.31%)  32/226 (14.16%)  24/224 (10.71%) 
Hypersomnia * 1  0/223 (0.00%)  2/226 (0.88%)  1/224 (0.45%) 
Hypoaesthesia * 1  0/223 (0.00%)  0/226 (0.00%)  2/224 (0.89%) 
Hypogeusia * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Lethargy * 1  2/223 (0.90%)  0/226 (0.00%)  0/224 (0.00%) 
Loss of consciousness * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Memory impairment * 1  1/223 (0.45%)  1/226 (0.44%)  1/224 (0.45%) 
Migraine * 1  2/223 (0.90%)  0/226 (0.00%)  3/224 (1.34%) 
Paraesthesia * 1  4/223 (1.79%)  3/226 (1.33%)  5/224 (2.23%) 
Poor quality sleep * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Presyncope * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Restless legs syndrome * 1  3/223 (1.35%)  1/226 (0.44%)  1/224 (0.45%) 
Sedation * 1  1/223 (0.45%)  1/226 (0.44%)  1/224 (0.45%) 
Sinus headache * 1  1/223 (0.45%)  1/226 (0.44%)  4/224 (1.79%) 
Somnolence * 1  12/223 (5.38%)  10/226 (4.42%)  13/224 (5.80%) 
Syncop * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Tension headache * 1  8/223 (3.59%)  7/226 (3.10%)  11/224 (4.91%) 
Tremor * 1  5/223 (2.24%)  3/226 (1.33%)  2/224 (0.89%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy * 1  1/223 (0.45%)  2/226 (0.88%)  1/224 (0.45%) 
Psychiatric disorders       
Abnormal dreams * 1  8/223 (3.59%)  11/226 (4.87%)  14/224 (6.25%) 
Agitation * 1  0/223 (0.00%)  0/226 (0.00%)  2/224 (0.89%) 
Anger * 1  0/223 (0.00%)  1/226 (0.44%)  2/224 (0.89%) 
Anorgasmia * 1  0/223 (0.00%)  2/226 (0.88%)  3/224 (1.34%) 
Anxiety * 1  6/223 (2.69%)  7/226 (3.10%)  7/224 (3.13%) 
Bradyphrenia * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Bruxism * 1  1/223 (0.45%)  2/226 (0.88%)  0/224 (0.00%) 
Depersonalisation * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Depressed mood * 1  0/223 (0.00%)  1/226 (0.44%)  1/224 (0.45%) 
Depression * 1  1/223 (0.45%)  8/226 (3.54%)  0/224 (0.00%) 
Derealisation * 1  1/223 (0.45%)  0/226 (0.00%)  1/224 (0.45%) 
Disorientation * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Dissociation * 1  2/223 (0.90%)  3/226 (1.33%)  1/224 (0.45%) 
Distractibility * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Elevated mood * 1  2/223 (0.90%)  0/226 (0.00%)  0/224 (0.00%) 
Impulse-control disorder * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Initial insomnia * 1  2/223 (0.90%)  1/226 (0.44%)  5/224 (2.23%) 
Insomnia * 1  14/223 (6.28%)  16/226 (7.08%)  20/224 (8.93%) 
Libido decreased * 1  5/223 (2.24%)  5/226 (2.21%)  6/224 (2.68%) 
Loss of libido * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Major depression * 1  2/223 (0.90%)  0/226 (0.00%)  0/224 (0.00%) 
Middle insomnia * 1  1/223 (0.45%)  5/226 (2.21%)  5/224 (2.23%) 
Mood altered * 1  0/223 (0.00%)  2/226 (0.88%)  3/224 (1.34%) 
Mood swings * 1  1/223 (0.45%)  1/226 (0.44%)  2/224 (0.89%) 
Nervousness * 1  0/223 (0.00%)  1/226 (0.44%)  1/224 (0.45%) 
Nightmare * 1  0/223 (0.00%)  6/226 (2.65%)  4/224 (1.79%) 
Orgasm abnormal * 1  1/223 (0.45%)  2/226 (0.88%)  2/224 (0.89%) 
Orgasmic sensation decreased * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Panic attack * 1  1/223 (0.45%)  3/226 (1.33%)  0/224 (0.00%) 
Panic disorder * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Restlessness * 1  1/223 (0.45%)  1/226 (0.44%)  2/224 (0.89%) 
Self injurious behaviour * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Suicidal ideation * 1  5/223 (2.24%)  3/226 (1.33%)  6/224 (2.68%) 
Suicide attempt * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Tearfulness * 1  1/223 (0.45%)  3/226 (1.33%)  4/224 (1.79%) 
Terminal insomnia * 1  2/223 (0.90%)  0/226 (0.00%)  3/224 (1.34%) 
Withdrawal syndrome * 1  8/223 (3.59%)  12/226 (5.31%)  16/224 (7.14%) 
Renal and urinary disorders       
Chromaturia * 1  0/223 (0.00%)  1/226 (0.44%)  1/224 (0.45%) 
Haematuria * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Incontinence * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Micturition urgency * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Nephrolithiasis * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Pollakiuria * 1  0/223 (0.00%)  3/226 (1.33%)  2/224 (0.89%) 
Polyuria * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Proteinuria * 1  0/223 (0.00%)  1/226 (0.44%)  2/224 (0.89%) 
Urge incontinence * 1  2/223 (0.90%)  0/226 (0.00%)  0/224 (0.00%) 
Urinary hesitation * 1  0/223 (0.00%)  0/226 (0.00%)  4/224 (1.79%) 
Urine odour abnormal * 1  1/223 (0.45%)  0/226 (0.00%)  1/224 (0.45%) 
Reproductive system and breast disorders       
Breast enlargement * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Breast mass * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Breast tenderness * 1  2/223 (0.90%)  1/226 (0.44%)  0/224 (0.00%) 
Dysmenorrhoea * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Ejaculation delayed * 1  1/223 (0.45%)  2/226 (0.88%)  2/224 (0.89%) 
Erectile dysfunction * 1  0/223 (0.00%)  2/226 (0.88%)  3/224 (1.34%) 
Menorrhagia * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Menstruation irregular * 1  1/223 (0.45%)  1/226 (0.44%)  1/224 (0.45%) 
Metrorrhagia * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Oligomenorrhoea * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Pelvic pain * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Prostatomegaly * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Sexual dysfunction * 1  0/223 (0.00%)  0/226 (0.00%)  2/224 (0.89%) 
Spontaneous penile erection * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Vaginal discharge * 1  1/223 (0.45%)  0/226 (0.00%)  1/224 (0.45%) 
Vaginal odour * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Atelectasis * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Choking * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Cough * 1  3/223 (1.35%)  2/226 (0.88%)  2/224 (0.89%) 
Dysphonia * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Dyspnoea * 1  2/223 (0.90%)  0/226 (0.00%)  1/224 (0.45%) 
Epistaxis * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Nasal congestion * 1  2/223 (0.90%)  2/226 (0.88%)  0/224 (0.00%) 
Oropharyngeal pain * 1  1/223 (0.45%)  5/226 (2.21%)  2/224 (0.89%) 
Rhinorrhoea * 1  1/223 (0.45%)  0/226 (0.00%)  2/224 (0.89%) 
Sinus congestion * 1  2/223 (0.90%)  2/226 (0.88%)  3/224 (1.34%) 
Wheezing * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Yawning * 1  3/223 (1.35%)  2/226 (0.88%)  4/224 (1.79%) 
Skin and subcutaneous tissue disorders       
Acne * 1  0/223 (0.00%)  1/226 (0.44%)  4/224 (1.79%) 
Alopecia * 1  3/223 (1.35%)  0/226 (0.00%)  1/224 (0.45%) 
Cold sweat * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Dermal cyst * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Dermatitis atopic * 1  1/223 (0.45%)  0/226 (0.00%)  1/224 (0.45%) 
Dermatitis contact * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Dry skin * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Ecchymosis * 1  1/223 (0.45%)  1/226 (0.44%)  2/224 (0.89%) 
Hyperhidrosis * 1  11/223 (4.93%)  11/226 (4.87%)  12/224 (5.36%) 
Hypoaesthesia facial * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Increased tendency to bruise * 1  0/223 (0.00%)  1/226 (0.44%)  1/224 (0.45%) 
Ingrowing nail * 1  2/223 (0.90%)  0/226 (0.00%)  0/224 (0.00%) 
Keloid scar * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (0.00%) 
Night sweats * 1  0/223 (0.00%)  1/226 (0.44%)  3/224 (1.34%) 
Pruritus * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Pruritus generalised * 1  1/223 (0.45%)  1/226 (0.44%)  0/224 (0.00%) 
Rash * 1  0/223 (0.00%)  2/226 (0.88%)  1/224 (0.45%) 
Rash generalised * 1  1/223 (0.45%)  0/226 (0.00%)  0/224 (0.00%) 
Vascular disorders       
Haematoma * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Hot flush * 1  6/223 (2.69%)  3/226 (1.33%)  4/224 (1.79%) 
Hypertension * 1  4/223 (1.79%)  0/226 (0.00%)  2/224 (0.89%) 
Orthostatic hypertension * 1  0/223 (0.00%)  0/226 (0.00%)  1/224 (0.45%) 
Systolic hypertension * 1  0/223 (0.00%)  1/226 (0.44%)  0/224 (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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00863798     History of Changes
Other Study ID Numbers: 3151A1-3362
B2061005
3151A1-3362-US
First Submitted: March 17, 2009
First Posted: March 18, 2009
Results First Submitted: March 8, 2011
Results First Posted: May 6, 2011
Last Update Posted: May 6, 2011