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A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00733980
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: GSK561679
Other: Placebo
Enrollment 150
Recruitment Details A total of 150 female participants, with major depressive disorder (MDD), were randomized in the study. The study was conducted from 02 October 2008 to 18 June 2010 at 18 centers across the United States.
Pre-assignment Details  
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description The participants in this arm received GSK561679, 350 milligram (mg) orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks. The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening.
Period Title: Overall Study
Started 74 76
Completed 52 55
Not Completed 22 21
Reason Not Completed
Adverse Event             5             2
Lack of Efficacy             0             1
Protocol Violation             2             1
Protocol defined stopping criteria reach             1             1
Lost to Follow-up             6             11
Physician Decision             2             3
Withdrawal by Subject             6             2
Arm/Group Title GSK561679 Placebo Total
Hide Arm/Group Description The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening Total of all reporting groups
Overall Number of Baseline Participants 74 76 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 76 participants 150 participants
38.8  (11.31) 40.8  (12.17) 39.8  (11.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 76 participants 150 participants
Female
74
 100.0%
76
 100.0%
150
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 76 participants 150 participants
American Indian or Alaska Native
0
   0.0%
2
   2.6%
2
   1.3%
Asian
0
   0.0%
1
   1.3%
1
   0.7%
Native Hawaiian or Other Pacific Islander
1
   1.4%
0
   0.0%
1
   0.7%
Black or African American
43
  58.1%
38
  50.0%
81
  54.0%
White
30
  40.5%
35
  46.1%
65
  43.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17).
Hide Description The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.
Time Frame Randomization (Week 0) and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population consisted of all participants who gave informed consent, were randomized, received at least one dose of double-blind medication, and had at least one post-randomization efficacy assessment available (HAM D, IDS-SR CGI, HAM A, MOS, PSS).
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 72 74
Least Squares Mean (Standard Error)
Unit of Measure: Scores on scale
-4.3150  (0.5314) -4.5629  (0.5101)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.703
Comments [Not Specified]
Method Mixed-Model Repeated-Measure analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2479
Confidence Interval 80%
-0.5887 to 1.0846
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score.
Hide Description The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value post randomization (Weeks 1, 2 and 4). Randomization was defined as Week 0.
Time Frame Randomization (Week 0) and Week 1, 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 72 74
Least Squares Mean (Standard Error)
Unit of Measure: Scores on scale
Week 1 -1.6739  (0.3886) -1.6570  (0.3540)
Week 2 -2.6200  (0.4436) -3.0499  (0.4106)
Week 4 -3.1318  (0.4798) -4.0731  (0.4526)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 Vs Placebo, Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.966
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.0169
Confidence Interval (2-Sided) 80%
-0.5231 to 0.4893
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 Vs Placebo, Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.386
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4299
Confidence Interval (2-Sided) 80%
-0.2063 to 1.0661
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 Vs Placebo, Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9413
Confidence Interval (2-Sided) 80%
0.2203 to 1.6624
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)
Hide Description HAM A, is internationally accepted and validated measurement tool for assessment of severity of anxiety symptoms. Used to assess severity of overall anxiety in participants who met criteria for anxiety of depressive disorders and to monitor outcome of treatment. Instrument does not distinguish symptoms of specific anxiety disorder or distinguish an anxiety disorder from an anxious depression. It is clinician-administered and consists of 14 individual questions, each rated on five point scale from 0 (not present) to 4 (very severe). Total HAM A range from 0 to 56 with higher scores reflecting more severe anxiety. Change from randomization was defined as post-baseline value minus value at randomization. Randomization was defined as Week 0. Provided no more than 1 response was missing for any one visit assessment for a participant, total score was calculated adjusting for missing data as follows: Total score = (14/13)* observed total score the score was rounded to nearest integer number.
Time Frame Randomization (Week 0) and Week 1, 2, 4 and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 72 74
Least Squares Mean (Standard Error)
Unit of Measure: Scores on scale
Week 1 -3.4188  (0.7432) -4.3683  (0.6649)
Week 2 -5.2108  (0.8347) -5.9746  (0.7602)
Week 4 -5.8462  (0.9201) -7.3825  (0.8577)
Week 6 -8.2330  (0.9896) -8.8657  (0.9361)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.209
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9495
Confidence Interval (2-Sided) 80%
-0.0185 to 1.9175
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.409
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7638
Confidence Interval (2-Sided) 80%
-0.4243 to 1.9519
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.5363
Confidence Interval (2-Sided) 80%
0.1485 to 2.9241
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.599
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6327
Confidence Interval (2-Sided) 80%
-0.9135 to 2.1789
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.
Hide Description The IDS-SR is self-report rating scale that assesses symptom severity of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), diagnostic criterion for major depressive disorder. The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. Each item has a 4-likert scale and each symptom item is given equivalent weightings and scored on 0 to 3 scale, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Change from randomization was defined as the post-baseline value minus the value post randomization (Weeks 1, 2,3, 4 and 6). Randomization was defined as Week 0.
Time Frame Randomization (Week 0) and Week 1, 2, 3,4 and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 milligram (mg) orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 72 74
Least Squares Mean (Standard Error)
Unit of Measure: Scores on scale
Week 1 -6.9509  (1.4790) -4.9644  (1.3492)
Week 2 -9.9178  (1.6612) -9.6640  (1.5354)
Week 3 -11.4163  (1.7251) -11.0921  (1.6115)
Week 4 -12.3463  (1.9146) -13.1571  (1.8066)
Week 6 -15.5045  (2.0467) -14.8772  (1.9522)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9866
Confidence Interval (2-Sided) 80%
-3.8876 to -0.0856
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.889
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2538
Confidence Interval (2-Sided) 80%
-2.5922 to 2.0846
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.867
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3242
Confidence Interval (2-Sided) 80%
-2.8165 to 2.1681
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.721
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.8107
Confidence Interval (2-Sided) 80%
-2.1036 to 3.7251
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.801
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6273
Confidence Interval (2-Sided) 80%
-3.8337 to 2.5791
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)
Hide Description The HAMD-17 scale is a subset of HAMD-28. It is a standard used to measure depression severity. The HAMD-17 score ranges from 0 to 52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity; a reduction of 50% or more in total score from Baseline indicates clinical response. Thus a higher score was indicative of more severity. Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.
Time Frame Randomization (Week 0) and Week 1, 2, 4 and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 72 74
Least Squares Mean (Standard Error)
Unit of Measure: Scores on scale
Week 1 -3.6342  (0.6816) -4.2782  (0.6198)
Week 2 -5.1998  (0.8009) -6.2523  (0.7425)
Week 4 -6.5337  (0.8734) -8.1810  (0.8262)
Week 6 -8.2503  (0.9770) -8.9786  (0.9376)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.355
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6440
Confidence Interval (2-Sided) 80%
-0.2498 to 1.5378
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.249
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.0524
Confidence Interval (2-Sided) 80%
-0.1194 to 2.2243
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.116
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.6473
Confidence Interval (2-Sided) 80%
0.3078 to 2.9868
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.550
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7283
Confidence Interval (2-Sided) 80%
-0.8353 to 2.2920
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.
Hide Description HAMD-17 Responders were defined as the participants with a > or = 50% reduction from randomization in their HAMD-17 total score at Weeks 1, 2, 4, and 6. The HAMD-17 scale is a subset of HAMD-28. It is a standard used to measure depression severity. The HAMD-17 score ranged from 0 to 52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicated at least moderate severity; a reduction of 50% or more in total score from Baseline indicates clinical response. Thus a higher score was indicative of more severity.
Time Frame Weeks 1, 2, 4, and 6.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 71 74
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 3 4
Week 2 7 15
Week 4 17 24
Week 6 27 28
7.Secondary Outcome
Title Time to Maintained Antidepressant Response at the End of Treatment Phase (Week 6)
Hide Description The time to maintained antidepressant response at the end of treatment phase (week 6), as the participants with a > or = to 50 % reduction from randomization in their HAMD-17 total score, sustained until the end of the Treatment Phase [Week 6]). This OM "time to maintained antidepressant response" was not evaluated due to lower number of participants in the GSK561679 group as compared to placebo
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Endpoint not evaluated.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6.
Hide Description The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. The CGI is psychiatrist rated, and is based on all information available at the time of the rating. Both the CGI-I and CGI-S items are rated on a 1 to 7 point scale. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). Scores, on the CGI-S, range from 1 (normal, not ill at all) to 7 (amongst the most extremely ill). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.
Time Frame Randomization (Week 0) and Weeks 1, 2, 4, and 6.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 72 74
Least Squares Mean (Standard Error)
Unit of Measure: Scores on scale
Week 1 -0.2800  (0.0859) -0.2632  (0.0783)
Week 2 -0.4013  (0.1026) -0.4677  (0.0957)
Week 4 -0.5866  (0.1222) -0.9557  (0.1169)
Week 6 -0.8353  (0.1384) -1.1103  (0.1348)
9.Secondary Outcome
Title Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6.
Hide Description The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. The CGI is psychiatrist rated, and is based on all information available at the time of the rating. The CGI –responders, are defined as participants with a score of 1 (very much improved) or 2 (much improved) in the CGI-I).
Time Frame Weeks 1, 2, 4, and 6.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 72 74
Measure Type: Number
Unit of Measure: perecntage of participants
Week 1 3 5
Week 2 11 16
Week 4 25 32
Week 6 33 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3588
Comments [Not Specified]
Method Logistic Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.6359
Confidence Interval (2-Sided) 80%
0.3378 to 1.1968
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4088
Comments [Not Specified]
Method Logistic Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7347
Confidence Interval (2-Sided) 80%
0.4554 to 1.1853
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments GSK561679 350 mg Vs Placebo, Week 6/ Early withdrawal
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8156
Comments [Not Specified]
Method Logistic Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Logistic Model
Estimated Value 0.9211
Confidence Interval (2-Sided) 80%
0.5863 to 1.4471
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Randomization in the Medical Outcomes Study 12-item Sleep Module (MOS 12) at Week 6
Hide Description The MOS-12 Sleep Scale is a 12-item questionnaire which measures specific aspects of sleep in participants that may have varying co-morbidities, as a result, is appropriate for a medically diverse participant population. It consist of following items: initiation (2 items), maintenance (2 items), respiratory problems (2 items), quantity (1 item), perceived adequacy (2 items), and somnolence (3 items). All items were given equivalent weightage from 1 to 6. Each index summarizes information across most or all sleep dimensions. The total score is transformed linearly to a common metric with a possible range of 0-100 and is averaged across items in the same scale. The higher score indicates a greater degree of the attribute implied by the scale name. Change from randomization was calculated by randomization value minus the value at Week 6. Randomization was defined as Week 0.
Time Frame Randomization (Week 0) and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 72 74
Least Squares Mean (Standard Error)
Unit of Measure: Scores on scale
-16.2738  (3.7112) -19.7203  (3.4794)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.4466
Confidence Interval (2-Sided) 80%
-1.3986 to 8.2917
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Randomization in the Cohen Perceived Stress Scale (PSS) at Week 6.
Hide Description The PSS is most widely used psychological instrument for measuring the perception of stress. It is a 10-item questionnaire that measures an individual's subjective evaluation the stressfulness of situations in their life in past month (how unpredictable, uncontrollable, and overloaded respondents find their lives). Individual items were rated on a scale of 0-4, where 0(never) to 4 (very often) that best describes how often they have had the feelings or thoughts described in the last month for each question. The total scores can range from 0-40, where 0 score indicated no stress and a higher score indicated more stress. Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0. Thus a negative change from randomization indicated improvement.
Time Frame Randomization (Week 0) and Week 6.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 72 74
Least Squares Mean (Standard Error)
Unit of Measure: Scores on scale
-5.6529  (1.3431) -5.7696  (1.2624)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK561679, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.932
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1167
Confidence Interval (2-Sided) 80%
-1.6387 to 1.8722
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Hide Description An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Time Frame Up to 28-day FU (18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All subject population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 74 76
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
55
  74.3%
58
  76.3%
Any SAE
0
   0.0%
1
   1.3%
13.Secondary Outcome
Title Number of Participants With Vital Sign of Potential Clinical Importance (PCI)
Hide Description Vital sign measurements included height (screening only), systolic blood pressure(SBP) and diastolic blood pressure (DBP) and heart rate (HR). Sitting vital signs were measured at all clinic visits. Standing vital signs were measured at screening, Week 3 and at any other times as clinically indicated. Only the PCI values for SBP, DBP and HR were reported.
Time Frame Up to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
All subject population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 74 76
Measure Type: Count of Participants
Unit of Measure: Participants
SBP, High
1
   1.4%
2
   2.6%
SBP, Low
2
   2.7%
3
   3.9%
DBP, HIgh
7
   9.5%
4
   5.3%
DBP, Low
1
   1.4%
0
   0.0%
HR, High
1
   1.4%
2
   2.6%
14.Secondary Outcome
Title Number of Participants With Abnormal Urinalysis Data
Hide Description Urinalysis included analysis for urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine proteins and urine Leukocyte Esterase test (LET) via dipstick analysis. The number of participants with abnormal urinalysis data were reported. In the dipstick test the levels for urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine proteins and urine LET with results of trace, negative, positive,1+=slightly positive, 2+=positive, 3+=high positive were reported.
Time Frame Randomization (Week 0), Week 3, Week 6/ Early withdrawal (EW) and 28 Day follow-up (FU)
Hide Outcome Measure Data
Hide Analysis Population Description
All subject population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 74 76
Measure Type: Count of Participants
Unit of Measure: Participants
Urine Bilirubin, Randomized, negative Number Analyzed 74 participants 74 participants
74
 100.0%
74
 100.0%
Urine Occult Blood, Randomized, 1+ Number Analyzed 74 participants 74 participants
3
   4.1%
3
   4.1%
Urine Occult Blood, Randomized, 2+ Number Analyzed 74 participants 74 participants
6
   8.1%
2
   2.7%
Urine Occult Blood, Randomized, 3+ Number Analyzed 74 participants 74 participants
2
   2.7%
2
   2.7%
Urine Occult Blood, Randomized, negative Number Analyzed 74 participants 74 participants
58
  78.4%
63
  85.1%
Urine Occult Blood, Randomized, trace Number Analyzed 74 participants 74 participants
5
   6.8%
4
   5.4%
Urine Glucose, Randomized, 2+ Number Analyzed 74 participants 74 participants
1
   1.4%
1
   1.4%
Urine Glucose, Randomized, 3+ Number Analyzed 74 participants 74 participants
0
   0.0%
1
   1.4%
Urine Glucose, Randomized, negative Number Analyzed 74 participants 74 participants
73
  98.6%
71
  95.9%
Urine Glucose, Randomized, trace Number Analyzed 74 participants 74 participants
0
   0.0%
1
   1.4%
Urine Ketones, Randomized, negative Number Analyzed 74 participants 74 participants
73
  98.6%
71
  95.9%
Urine Ketones, Randomized, trace Number Analyzed 74 participants 74 participants
1
   1.4%
3
   4.1%
Urine Nitrite, Randomized, negative Number Analyzed 74 participants 74 participants
73
  98.6%
71
  95.9%
Urine Nitrite, Randomized, positive Number Analyzed 74 participants 74 participants
1
   1.4%
3
   4.1%
Urine Protein, Randomized, 1+ Number Analyzed 74 participants 74 participants
3
   4.1%
4
   5.4%
Urine Protein, Randomized, negative Number Analyzed 74 participants 74 participants
64
  86.5%
61
  82.4%
Urine Protein, Randomized, trace Number Analyzed 74 participants 74 participants
7
   9.5%
9
  12.2%
Urine LET for WBC, Randomized, 1+ Number Analyzed 74 participants 74 participants
5
   6.8%
3
   4.1%
Urine LET for WBC, Randomized, 2+ Number Analyzed 74 participants 74 participants
4
   5.4%
7
   9.5%
Urine LET for WBC, Randomized, 3+ Number Analyzed 74 participants 74 participants
1
   1.4%
1
   1.4%
Urine LET for WBC, Randomized, negative Number Analyzed 74 participants 74 participants
60
  81.1%
59
  79.7%
Urine LET for WBC, Randomized, trace Number Analyzed 74 participants 74 participants
4
   5.4%
4
   5.4%
Urine bilirubin, Week 3, negative Number Analyzed 60 participants 63 participants
60
 100.0%
63
 100.0%
Urine Occult Blood, Week 3, 1+ Number Analyzed 60 participants 63 participants
3
   5.0%
3
   4.8%
Urine Occult Blood, Week 3, 2+ Number Analyzed 60 participants 63 participants
2
   3.3%
1
   1.6%
Urine Occult Blood, Week 3, 3+ Number Analyzed 60 participants 63 participants
1
   1.7%
0
   0.0%
Urine Occult Blood, Week 3, negative Number Analyzed 60 participants 63 participants
53
  88.3%
57
  90.5%
Urine Occult Blood, Week 3, trace Number Analyzed 60 participants 63 participants
1
   1.7%
2
   3.2%
Urine Glucose, Negative Number Analyzed 60 participants 63 participants
60
 100.0%
63
 100.0%
Urine Ketones, Week 3, 1+ Number Analyzed 60 participants 63 participants
0
   0.0%
1
   1.6%
Urine Ketones, Week 3, negative Number Analyzed 60 participants 63 participants
55
  91.7%
61
  96.8%
Urine Ketones, Week 3, trace Number Analyzed 60 participants 63 participants
5
   8.3%
1
   1.6%
Urine nitrite, Week 3, negative Number Analyzed 60 participants 63 participants
60
 100.0%
60
  95.2%
Urine nitrite, Week 3, positive Number Analyzed 60 participants 63 participants
0
   0.0%
3
   4.8%
Urine Protein, Week 3, 1+ Number Analyzed 60 participants 63 participants
4
   6.7%
1
   1.6%
Urine Protein, Week 3, negative Number Analyzed 60 participants 63 participants
46
  76.7%
53
  84.1%
Urine Protein, Week 3, positive Number Analyzed 60 participants 63 participants
10
  16.7%
9
  14.3%
Urine LET for WBC, Week 3, 1+ Number Analyzed 60 participants 63 participants
3
   5.0%
5
   7.9%
Urine LET for WBC, Week 3, 2+ Number Analyzed 60 participants 63 participants
3
   5.0%
2
   3.2%
Urine LET for WBC, Week 3, 3+ Number Analyzed 60 participants 63 participants
1
   1.7%
1
   1.6%
Urine LET for WBC, Week 3, negative Number Analyzed 60 participants 63 participants
51
  85.0%
48
  76.2%
Urine LET for WBC, Week 3, trace Number Analyzed 60 participants 63 participants
2
   3.3%
7
  11.1%
Urine Bilirubin, Week 6/EW, negative Number Analyzed 69 participants 65 participants
69
 100.0%
65
 100.0%
Urine Occult Blood, Week 6/EW, 1+ Number Analyzed 69 participants 65 participants
2
   2.9%
2
   3.1%
Urine Occult Blood, Week 6/EW, 2+ Number Analyzed 69 participants 65 participants
1
   1.4%
3
   4.6%
Urine Occult Blood, Week 6/EW, 3+ Number Analyzed 69 participants 65 participants
9
  13.0%
2
   3.1%
Urine Occult Blood, Week 6/EW, negative Number Analyzed 69 participants 65 participants
54
  78.3%
56
  86.2%
Urine Occult Blood, Week 6/EW, trace Number Analyzed 69 participants 65 participants
3
   4.3%
2
   3.1%
Urine Glucose, Week 6/EW, negative Number Analyzed 69 participants 65 participants
69
 100.0%
65
 100.0%
Urine ketone, Week 6/EW, negative Number Analyzed 69 participants 65 participants
64
  92.8%
63
  96.9%
Urine ketone, Week 6/EW, trace Number Analyzed 69 participants 65 participants
5
   7.2%
2
   3.1%
Urine Nitrite, Week 6/EW, negative Number Analyzed 69 participants 65 participants
68
  98.6%
62
  95.4%
Urine Nitrite, Week 6/EW, positive Number Analyzed 69 participants 65 participants
1
   1.4%
3
   4.6%
Urine protein, Week 6/EW, 1+ Number Analyzed 69 participants 65 participants
7
  10.1%
4
   6.2%
Urine protein, Week 6/EW, 2+ Number Analyzed 69 participants 65 participants
2
   2.9%
1
   1.5%
Urine protein, Week 6/EW, negative Number Analyzed 69 participants 65 participants
52
  75.4%
55
  84.6%
Urine protein, Week 6/EW, trace Number Analyzed 69 participants 65 participants
8
  11.6%
5
   7.7%
Urine LET for WBC , Week 6/EW, 1+ Number Analyzed 69 participants 65 participants
6
   8.7%
4
   6.2%
Urine LET for WBC, Week 6/EW, 2+ Number Analyzed 74 participants 76 participants
1
   1.4%
4
   5.3%
Urine LET for WBC, Week 6/EW, 3+ Number Analyzed 74 participants 76 participants
4
   5.4%
2
   2.6%
Urine LET for WBC, Week 6/EW, negative Number Analyzed 74 participants 76 participants
51
  68.9%
53
  69.7%
Urine LET for WBC, Week 6/EW, trace Number Analyzed 74 participants 76 participants
7
   9.5%
2
   2.6%
Urine Bilirubin, 28-day FU, negative Number Analyzed 18 participants 17 participants
18
 100.0%
17
 100.0%
Urine Occult Blood, 28-day FU, 1+ Number Analyzed 18 participants 17 participants
1
   5.6%
2
  11.8%
Urine Occult Blood, 28-day FU, 2+ Number Analyzed 18 participants 17 participants
1
   5.6%
1
   5.9%
Urine Occult Blood, 28-day FU, 3+ Number Analyzed 18 participants 17 participants
2
  11.1%
0
   0.0%
Urine Occult Blood, 28-day FU, negative Number Analyzed 18 participants 17 participants
13
  72.2%
13
  76.5%
Urine Occult Blood, 28-day FU, trace Number Analyzed 18 participants 17 participants
1
   5.6%
1
   5.9%
Urine Glucose, 28-day FU, negative Number Analyzed 18 participants 17 participants
18
 100.0%
17
 100.0%
Urine Ketones, 28-day FU, 1+ Number Analyzed 18 participants 17 participants
0
   0.0%
1
   5.9%
Urine Ketones, 28-day FU, negative Number Analyzed 18 participants 17 participants
18
 100.0%
16
  94.1%
Urine Nitrite, 28-day FU, negative Number Analyzed 18 participants 17 participants
18
 100.0%
17
 100.0%
Urine Protein, 28-day FU, 1+ Number Analyzed 18 participants 17 participants
2
  11.1%
1
   5.9%
Urine Protein, 28-day FU, 2+ Number Analyzed 18 participants 17 participants
0
   0.0%
1
   5.9%
Urine Protein, 28-day FU, negative Number Analyzed 18 participants 17 participants
13
  72.2%
14
  82.4%
Urine Protein, 28-day FU, trace Number Analyzed 18 participants 17 participants
3
  16.7%
1
   5.9%
Urine LET for WBC, 28-day FU, 1+ Number Analyzed 18 participants 17 participants
2
  11.1%
0
   0.0%
Urine LET for WBC, 28-day FU, 2+ Number Analyzed 18 participants 17 participants
1
   5.6%
2
  11.8%
Urine LET for WBC, 28-day FU, 3+ Number Analyzed 18 participants 17 participants
1
   5.6%
1
   5.9%
Urine LET for WBC, 28-day FU, negative Number Analyzed 18 participants 17 participants
12
  66.7%
13
  76.5%
Urine LET for WBC, 28-day FU, trace Number Analyzed 18 participants 17 participants
2
  11.1%
1
   5.9%
15.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiograph (ECG) Values
Hide Description The 12-lead ECG, were obtained at each time-point during the study using an ECG machine. The number of participants with ECG abnormal values were reported.
Time Frame Randomization (Week 0), Week 4, Week 6 and 28 Day follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All subject population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 74 76
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal, Randomization Number Analyzed 74 participants 76 participants
6
   8.1%
11
  14.5%
Abnormal, Week 4 Number Analyzed 55 participants 58 participants
7
  12.7%
10
  17.2%
Abnormal, Week 6/EW Number Analyzed 70 participants 65 participants
6
   8.6%
13
  20.0%
Abnormal, 28-day FU Number Analyzed 11 participants 17 participants
1
   9.1%
5
  29.4%
16.Secondary Outcome
Title Number of Participants With Abnormal Hematology Values of PCI-Platelet
Hide Description Number of participants with abnormal Hematology values of PCI were reported. The abnormal values were reported only for platelet, diagnosed at Week 6 or Early withdrawal visit.
Time Frame Upto 28-day FU
Hide Outcome Measure Data
Hide Analysis Population Description
All Subject population
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 66 63
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   1.6%
17.Secondary Outcome
Title Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Hide Description The number of participants with clinical chemistry values outside the clinical importance range (CIR) were reported. The values for chemistry parameters outside CRI were reported for Alanine amino transferase (ALT), Aspartate amino transferase, total bilirubin, calcium, Creatine Kinase, carbon dioxide (CO^2) content/bicarbonate (BC), glucose and potassium were reported.
Time Frame Upto Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
All subject population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 74 76
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Week 4, CIR, high Number Analyzed 65 participants 64 participants
0
   0.0%
1
   1.6%
AST, Week 4, CIR, high Number Analyzed 65 participants 64 participants
0
   0.0%
1
   1.6%
Total bilirubin, Randomization, CIR, high Number Analyzed 74 participants 76 participants
0
   0.0%
1
   1.3%
Total bilirubin, Week 2, CIR, high Number Analyzed 74 participants 76 participants
0
   0.0%
1
   1.3%
Total bilirubin, Week 6/EW, CIR, high Number Analyzed 74 participants 76 participants
0
   0.0%
1
   1.3%
Calcium, 28-day FU,CIR, low Number Analyzed 27 participants 22 participants
0
   0.0%
1
   4.5%
Creatine Kinase , Randomization, CIR,high Number Analyzed 74 participants 75 participants
1
   1.4%
1
   1.3%
Creatine Kinase, Week 1, CIR, high Number Analyzed 69 participants 69 participants
0
   0.0%
1
   1.4%
Creatine Kinase, Week 2, CIR, high Number Analyzed 68 participants 70 participants
2
   2.9%
1
   1.4%
Creatine Kinase, 28-day FU, CIR, high Number Analyzed 28 participants 22 participants
1
   3.6%
0
   0.0%
CO^2 content/BC, 28-day FU,CIR, low Number Analyzed 27 participants 22 participants
0
   0.0%
1
   4.5%
Glucose, Randomization, CIR, high Number Analyzed 74 participants 76 participants
0
   0.0%
1
   1.3%
Glucose, Week 6/EW, CIR, low Number Analyzed 69 participants 66 participants
0
   0.0%
1
   1.5%
Glucose, 28-day FU,CIR, low Number Analyzed 28 participants 22 participants
1
   3.6%
0
   0.0%
Potassium, Randomization, CIR, low Number Analyzed 74 participants 76 participants
1
   1.4%
0
   0.0%
Potassium, 28-day FU, CIR, high Number Analyzed 74 participants 76 participants
0
   0.0%
1
   1.3%
18.Secondary Outcome
Title Number of Participants With Hormonal Data of PCI
Hide Description The number of participants with hormone values outside the CRI were reported. The hormone data was analyzed for parameters like Cortisol total, Dehydroepiandrosterone, Thyroxine, free, and thyroid stimulating hormone (TSH) .
Time Frame up to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
All subject population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 74 76
Measure Type: Count of Participants
Unit of Measure: Participants
Cortisol, total, Randomization, CIR, low Number Analyzed 73 participants 76 participants
1
   1.4%
4
   5.3%
Cortisol, total, Week 2, CIR, low Number Analyzed 68 participants 71 participants
0
   0.0%
1
   1.4%
Cortisol, total, Week 4, CIR, low Number Analyzed 65 participants 65 participants
1
   1.5%
1
   1.5%
Cortisol, total, Week 6/EW, CIR, low Number Analyzed 69 participants 66 participants
1
   1.4%
0
   0.0%
Dehydroepiandrosterone, Randomization, CIR, high Number Analyzed 74 participants 76 participants
0
   0.0%
2
   2.6%
Dehydroepiandrosterone, Randomization, CIR, low Number Analyzed 74 participants 76 participants
3
   4.1%
5
   6.6%
Dehydroepiandrosterone, Week 2, CIR, high Number Analyzed 68 participants 71 participants
1
   1.5%
0
   0.0%
Dehydroepiandrosterone, Week 2, CIR, low Number Analyzed 68 participants 71 participants
3
   4.4%
4
   5.6%
Dehydroepiandrosterone , Week 4, CIR, low Number Analyzed 65 participants 64 participants
4
   6.2%
8
  12.5%
Dehydroepiandrosterone, Week 6/EW, CIR, low Number Analyzed 69 participants 66 participants
5
   7.2%
6
   9.1%
Dehydroepiandrosterone, 28-day FU,CIR, low Number Analyzed 17 participants 13 participants
1
   5.9%
0
   0.0%
Thyroxine, free, Week 6/EW, CIR, low Number Analyzed 69 participants 66 participants
1
   1.4%
2
   3.0%
Thyroxine, free, 28-day FU,CIR, low Number Analyzed 27 participants 20 participants
1
   3.7%
2
  10.0%
TSH, Week 6/EW, CIR, high Number Analyzed 69 participants 66 participants
0
   0.0%
1
   1.5%
TSH, Week 6/EW, CIR, low Number Analyzed 69 participants 66 participants
0
   0.0%
3
   4.5%
TSH, 28-day FU, CIR, high Number Analyzed 27 participants 20 participants
1
   3.7%
1
   5.0%
19.Secondary Outcome
Title Discontinuation-Emergent Signs and Symptoms
Hide Description The discontinuation signs and symptoms scale consisted of 43 signs and symptoms, scored as ‘new symptom (NS)’, ‘old symptom (OS) but worse’, ‘OS but improved’ or ‘ symptom not present/old symptom but unchanged’. The total number of new signs and symptoms, old symptoms but worse, and old symptoms but improved was calculated for each participant. The number of participants with Discontinuation-Emergent Signs and Symptoms were reported. The visits were at Week 6 Visit, 7-D FU and 28-D FU visit.
Time Frame At Week 6, 7-day (D) FU and 28-D FU
Hide Outcome Measure Data
Hide Analysis Population Description
All subject population.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Overall Number of Participants Analyzed 74 76
Measure Type: Count of Participants
Unit of Measure: Participants
Anxiety , Week 6/EW, NS
1
   1.4%
1
   1.3%
Anxiety , Week 6/EW, OS but worse
7
   9.5%
4
   5.3%
Anxiety , Week 6/EW, OS but improved
13
  17.6%
14
  18.4%
Anxiety , Week 6/EW, OS but unchanged/absent
48
  64.9%
47
  61.8%
Anxiety , 7-D FU, NS
3
   4.1%
2
   2.6%
Anxiety , 7-D FU, OS but worse
4
   5.4%
4
   5.3%
Anxiety , 7-D FU, OS but improved
11
  14.9%
11
  14.5%
Anxiety , 7-D FU, OS but unchanged/absent
47
  63.5%
45
  59.2%
Anxiety , 28-D FU, NS
3
   4.1%
3
   3.9%
Anxiety , 28-D FU, OS but worse
9
  12.2%
6
   7.9%
Anxiety , 28-D FU, OS but improved
11
  14.9%
13
  17.1%
Anxiety , 28-D FU, OS but unchanged/absent
35
  47.3%
37
  48.7%
Feeling high, Week 6/EW, NS
0
   0.0%
2
   2.6%
Feeling high, Week 6/EW, OS but worse
1
   1.4%
1
   1.3%
Feeling high, Week 6/EW, OS but improved
5
   6.8%
6
   7.9%
Feeling high, Week 6/EW, OS but unchanged/absent
63
  85.1%
56
  73.7%
Feeling high , Week 6/EW, Missing
0
   0.0%
1
   1.3%
Feeling high, 7-D FU, NS
3
   4.1%
1
   1.3%
Feeling high, 7-D FU, OS but worse
0
   0.0%
2
   2.6%
Feeling high, 7-D FU, OS but improved
5
   6.8%
4
   5.3%
Feeling high, 7-D FU, OS but unchanged/absent
57
  77.0%
55
  72.4%
Feeling high , 28-D FU, NS
2
   2.7%
0
   0.0%
Feeling high , 28-D FU, OS but worse
2
   2.7%
1
   1.3%
Feeling high , 28-D FU, OS but improved
6
   8.1%
6
   7.9%
Feeling high , 28-D FU, OS but unchanged/absent
48
  64.9%
52
  68.4%
Irritability, Week 6/EW, NS
1
   1.4%
2
   2.6%
Irritability, Week 6/EW, OS but worse
8
  10.8%
7
   9.2%
Irritability, Week 6/EW, OS but improved
17
  23.0%
18
  23.7%
Irritability, Week 6/EW, OS but unchanged/absent
43
  58.1%
39
  51.3%
Irritability, 7-D FU, NS
1
   1.4%
2
   2.6%
Irritability, 7-D FU, OS but worse
7
   9.5%
9
  11.8%
Irritability, 7-D FU, OS but improved
12
  16.2%
13
  17.1%
Irritability, 7-D FU, OS unchanged/absent
45
  60.8%
38
  50.0%
Irritability, 28-D FU, NS
2
   2.7%
1
   1.3%
Irritability, 28-D FU, OS but worse
8
  10.8%
10
  13.2%
Irritability, 28-D FU, OS but improved
11
  14.9%
10
  13.2%
Irritability, 28-D FU, OS but unchanged/absent
36
  48.6%
38
  50.0%
Sudden worsen mood, Week 6/EW, NS
1
   1.4%
0
   0.0%
Sudden worsen mood, Week 6/EW, OS but worse
6
   8.1%
8
  10.5%
Sudden worsen mood, Week 6/EW, OS but improved
9
  12.2%
13
  17.1%
Sudden worse mood, Week 6/EW, OS; unchanged/absent
53
  71.6%
45
  59.2%
Sudden worsen mood, 7-D FU, NS
1
   1.4%
0
   0.0%
Sudden worsen mood, 7-D FU, OS but worse
6
   8.1%
6
   7.9%
Sudden worsen mood, 7-D FU, OS but improved
11
  14.9%
8
  10.5%
Sudden worsen mood, 7-D FU, OS unchanged/absent
47
  63.5%
48
  63.2%
Sudden worsened mood, 28-D FU, NS
3
   4.1%
0
   0.0%
Sudden worsened mood, 28-D FU, OS but worse
9
  12.2%
4
   5.3%
Sudden worsened mood, 28-D FU, OS but improved
5
   6.8%
8
  10.5%
Sudden worsed mood, 28-D FU, OS; unchanged/absent
41
  55.4%
47
  61.8%
Sudden anger outburst, Week 6/EW, NS
1
   1.4%
1
   1.3%
Sudden anger outburst, Week 6/EW, OS but worse
5
   6.8%
5
   6.6%
Sudden anger outburst, Week 6/EW, OS but improved
8
  10.8%
9
  11.8%
Sudden anger outburst,Week 6EW,OS unchanged/absent
55
  74.3%
51
  67.1%
Sudden anger outburst, 7-D FU, NS
2
   2.7%
1
   1.3%
Sudden anger outburst, 7-D FU, OS but worse
4
   5.4%
5
   6.6%
Sudden anger outburst, 7-D FU, OS but improved
7
   9.5%
8
  10.5%
Sudden anger outburst,7-D FU, OS unchanged/absent
52
  70.3%
48
  63.2%
Sudden anger outburst, 28-D FU, NS
1
   1.4%
0
   0.0%
Sudden anger outburst, 28-D FU, OS but worse
4
   5.4%
2
   2.6%
Sudden anger outburst, 28-D FU, OS but improved
7
   9.5%
7
   9.2%
Sudden anger outburst, 28-D FU, OS unchang/absent
45
  60.8%
50
  65.8%
Sudden anger outburst, 28-D FU,missing
1
   1.4%
0
   0.0%
Sudden panic/anxiety, Week 6/EW, NS
1
   1.4%
0
   0.0%
Sudden panic/anxiety, Week 6/EW, OS but worse
5
   6.8%
3
   3.9%
Sudden panic/anxiety, Week 6/EW, OS but improved
4
   5.4%
10
  13.2%
Sudden panic/anxiety, Wk 6/EW, OS;unchanged/absent
59
  79.7%
53
  69.7%
Sudden panic/anxiety, 7-D FU, NS
2
   2.7%
0
   0.0%
Sudden panic/anxiety , 7-D FU, OS but worse
3
   4.1%
1
   1.3%
Sudden panic/anxiety , 7-D FU, OS but improved
3
   4.1%
7
   9.2%
Sudden panic/anxiety, 7-D FU, OS unchange/absent
57
  77.0%
54
  71.1%
Sudden panic/anxiety, 28-D FU, NS
2
   2.7%
0
   0.0%
Sudden panic/anxiety, 28-D FU, OS; worse
5
   6.8%
1
   1.3%
Sudden panic/anxiety, 28-D FU, OS; improved
5
   6.8%
8
  10.5%
Sudden panic/anxiety, 28-D FU,OS; unchanged/absent
46
  62.2%
50
  65.8%
Bouts of cry/tear, Week 6/EW, NS
0
   0.0%
1
   1.3%
Bouts of cry/tear, Week 6/EW, OS but worse
9
  12.2%
7
   9.2%
Bouts of cry/tear, Week 6/EW, OS but improved
16
  21.6%
12
  15.8%
Bouts of cry/tear, Week 6/EW, OS unchanged/absent
44
  59.5%
46
  60.5%
Bouts of cry/tear, 7-D FU, NS
1
   1.4%
0
   0.0%
Bouts of cry/tear, 7-D FU, OS but worse
8
  10.8%
7
   9.2%
Bouts of cry/tear, 7-D FU, OS but improved
6
   8.1%
11
  14.5%
Bouts of cry/tear, 7-D FU, OS unchanged/absent
50
  67.6%
44
  57.9%
Bouts of cry/tear, 28-D FU, NS
1
   1.4%
2
   2.6%
Bouts of cry/tear, 28-D FU, OS but worse
8
  10.8%
7
   9.2%
Bouts of cry/tear, 28-D FU, OS but improved
11
  14.9%
10
  13.2%
Bouts of cry/tear, 28-D FU, OS unchanged/absent
37
  50.0%
40
  52.6%
Bouts of cry/tear, 28-D FU, missing
1
   1.4%
0
   0.0%
Agitation, Week 6/EW, NS
1
   1.4%
2
   2.6%
Agitation, Week 6/EW, OS but worse
6
   8.1%
5
   6.6%
Agitation, Week 6/EW, OS but improved
8
  10.8%
13
  17.1%
Agitation, Week 6/EW, OS but unchanged/absent
54
  73.0%
46
  60.5%
Agitation, 7-D FU, NS
3
   4.1%
0
   0.0%
Agitation, 7-D FU, OS but worse
5
   6.8%
5
   6.6%
Agitation, 7-D FU, OS but improved
5
   6.8%
10
  13.2%
Agitation, 7-D FU, OS but unchanged/absent
52
  70.3%
47
  61.8%
Agitation, 28-D FU, OS but worse
6
   8.1%
5
   6.6%
Agitation, 28-D FU, OS but improved
5
   6.8%
6
   7.9%
Agitation, 28-D FU, OS but unchanged/absent
46
  62.2%
48
  63.2%
Agitation, 28-D FU, missing
1
   1.4%
0
   0.0%
Unreal/detached feel, Week 6, NS
4
   5.4%
2
   2.6%
Unreal/detached feel, Week 6, OS but worse
4
   5.4%
1
   1.3%
Unreal/detached feel, Week 6, OS but improved
7
   9.5%
7
   9.2%
Unreal/detached feel, Week 6, OS unchanged/absent
54
  73.0%
56
  73.7%
Unreal/detached feel, 7-D FU, NS
2
   2.7%
1
   1.3%
Unreal/detached feel, 7-D FU, OS but worse
4
   5.4%
2
   2.6%
Unreal/detached feel, 7-D FU, OS but improved
5
   6.8%
5
   6.6%
Unreal/detached feel, 7-D FU, OS unchanged/absent
54
  73.0%
54
  71.1%
Unreal/detached feel, 28-D FU, NS
1
   1.4%
1
   1.3%
Unreal/detached feel, 28-D FU, OS but worse
4
   5.4%
2
   2.6%
Unreal/detached feel, 28-D FU, OS but improved
4
   5.4%
7
   9.2%
Unreal/detached feel, 28-D FU, OS;unchanged/absent
48
  64.9%
49
  64.5%
Unreal/detached feel, 28-D FU, missing
1
   1.4%
0
   0.0%
Confusion, Week 6/EW, NS
1
   1.4%
0
   0.0%
Confusion, Week 6/EW, OS but worse
10
  13.5%
8
  10.5%
Confusion, Week 6/EW, OS but improved
11
  14.9%
15
  19.7%
Confusion, Week 6/EW, OS but unchanged/absent
47
  63.5%
43
  56.6%
Confusion, 7-D FU, NS
1
   1.4%
0
   0.0%
Confusion, 7-D FU, OS but worse
3
   4.1%
7
   9.2%
Confusion, 7-D FU, OS but improved
14
  18.9%
11
  14.5%
Confusion, 7-D FU, OS but unchanged/absent
47
  63.5%
44
  57.9%
Confusion, 28-D FU, NS
1
   1.4%
2
   2.6%
Confusion, 28-D FU, OS but worse
7
   9.5%
3
   3.9%
Confusion, 28-D FU, OS but improved
10
  13.5%
12
  15.8%
Confusion, 28-D FU, OS but unchanged/absent
40
  54.1%
42
  55.3%
Forgetfulness, Week 6/EW, NS
1
   1.4%
0
   0.0%
Forgetfulness, Week 6/EW, OS but worse
9
  12.2%
9
  11.8%
Forgetfulness, Week 6/EW, OS but improved
8
  10.8%
12
  15.8%
Forgetfulness, Week 6/EW, OS but unchanged/absent
51
  68.9%
45
  59.2%
Forgetfulness, 7-D FU, NS
1
   1.4%
0
   0.0%
Forgetfulness, 7-D FU, OS but worse
4
   5.4%
7
   9.2%
Forgetfulness, 7-D FU, OS but improved
8
  10.8%
7
   9.2%
Forgetfulness, 7-D FU, OS but unchanged/absent
52
  70.3%
48
  63.2%
Forgetfulness, 28-D FU, NS
0
   0.0%
1
   1.3%
Forgetfulness, 28-D FU, OS but worse
6
   8.1%
8
  10.5%
Forgetfulness, 28-D FU, OS but improved
7
   9.5%
9
  11.8%
Forgetfulness, 28-D FU, OS but unchanged/absent
45
  60.8%
41
  53.9%
Mood swings, Week 6/EW, NS
2
   2.7%
0
   0.0%
Mood swings, Week 6/EW, OS but worse
7
   9.5%
7
   9.2%
Mood swings, Week 6/EW, OS but improved
11
  14.9%
8
  10.5%
Mood swings, Week 6/EW, OS but unchanged/absent
49
  66.2%
51
  67.1%
Mood swings, 7-D FU, NS
1
   1.4%
0
   0.0%
Mood swings, 7-D FU, OS but worse
7
   9.5%
7
   9.2%
Mood swings, 7-D FU, OS but improved
10
  13.5%
9
  11.8%
Mood swings, 7-D FU, OS but unchanged/absent
47
  63.5%
46
  60.5%
Mood swings, 28-D FU, NS
1
   1.4%
1
   1.3%
Mood swings, 28-D FU, OS but worse
9
  12.2%
3
   3.9%
Mood swings, 28-D FU, OS but improved
6
   8.1%
8
  10.5%
Mood swings, 28-D FU, OS but unchanged/absent
42
  56.8%
47
  61.8%
Insomnia, Week 6/EW, OS but worse
7
   9.5%
10
  13.2%
Insomnia, Week 6/EW, OS but improved
15
  20.3%
18
  23.7%
Insomnia, Week 6/EW, OS but unchanged/absent
47
  63.5%
38
  50.0%
Insomnia, 7-D FU, NS
1
   1.4%
1
   1.3%
Insomnia, 7-D FU, OS but worse
2
   2.7%
7
   9.2%
Insomnia, 7-D FU, OS but improved
17
  23.0%
13
  17.1%
Insomnia, 7-D FU, OS but unchanged/absent
45
  60.8%
41
  53.9%
Insomnia, 28-D FU, OS but worse
13
  17.6%
7
   9.2%
Insomnia, 28-D FU, OS but improved
10
  13.5%
13
  17.1%
Insomnia, 28-D FU, OS but unchanged/absent
35
  47.3%
39
  51.3%
Increased dreams, Week 6/EW, NS
2
   2.7%
4
   5.3%
Increased dreams, Week 6/EW, OS but worse
2
   2.7%
3
   3.9%
Increased dreams, Week 6/EW, OS but improved
3
   4.1%
6
   7.9%
Increased dreams, Week 6/EW, OS unchanged/absent
62
  83.8%
53
  69.7%
Increased dreams, 7-D FU, NS
3
   4.1%
2
   2.6%
Increased dreams, 7-D FU, OS but worse
0
   0.0%
2
   2.6%
Increased dreams, 7-D FU, OS but improved
5
   6.8%
4
   5.3%
Increased dreams, 7-D FU, OS unchanged/absent
57
  77.0%
54
  71.1%
Increased dreams, 28-D FU, NS
2
   2.7%
3
   3.9%
Increased dreams, 28-D FU, OS but worse
3
   4.1%
2
   2.6%
Increased dreams, 28-D FU, OS but improved
5
   6.8%
8
  10.5%
Increased dreams, 28-D FU, OS unchanged/absent
48
  64.9%
46
  60.5%
More sweating, Week 6/EW, NS
1
   1.4%
1
   1.3%
More sweating, Week 6/EW, OS but worse
1
   1.4%
5
   6.6%
More sweating, Week 6/EW, OS but improved
3
   4.1%
3
   3.9%
More sweating, Week 6/EW, OS but unchanged/absent
64
  86.5%
57
  75.0%
More sweating, 7-D FU, NS
3
   4.1%
1
   1.3%
More sweating, 7-D FU, OS but worse
1
   1.4%
6
   7.9%
More sweating, 7-D FU, OS but improved
2
   2.7%
6
   7.9%
More sweating, 7-D FU, OS but unchanged/absent
59
  79.7%
49
  64.5%
More sweating, 28-D FU, NS
1
   1.4%
2
   2.6%
More sweating, 28-D FU, OS but worse
0
   0.0%
3
   3.9%
More sweating, 28-D FU, OS but improved
4
   5.4%
5
   6.6%
More sweating, 28-D FU, OS but unchanged/absent
52
  70.3%
49
  64.5%
More sweating, 28-D FU, missing
1
   1.4%
0
   0.0%
Shake/tremble, Week 6/EW, NS
1
   1.4%
0
   0.0%
Shake/tremble, Week 6/EW, OS but worse
2
   2.7%
0
   0.0%
Shake/tremble, Week 6/EW, OS but improved
6
   8.1%
5
   6.6%
Shake/tremble, Week 6/EW, OS but unchanged/absent
60
  81.1%
61
  80.3%
Shake/tremble, 7-D FU, NS
2
   2.7%
0
   0.0%
Shake/tremble, 7-D FU, OS but worse
3
   4.1%
1
   1.3%
Shake/tremble, 7-D FU, OS but improved
2
   2.7%
3
   3.9%
Shake/tremble, 7-D FU, OS but unchanged/absent
58
  78.4%
58
  76.3%
Shake/tremble, 28-D FU, NS
1
   1.4%
1
   1.3%
Shake/tremble, 28-D FU, OS but worse
1
   1.4%
0
   0.0%
Shake/tremble, 28-D FU, OS but improved
2
   2.7%
5
   6.6%
Shake/tremble, 28-D FU, OS but unchanged/absent
53
  71.6%
53
  69.7%
Shake/tremble, Missing
1
   1.4%
0
   0.0%
Muscle tension, Week 6/EW, NS
2
   2.7%
1
   1.3%
Muscle tension, Week 6/EW, OS but worse
4
   5.4%
5
   6.6%
Muscle tension, Week 6/EW, OS but improved
8
  10.8%
10
  13.2%
Muscle tension, Week 6/EW, OS but unchanged/absent
55
  74.3%
50
  65.8%
Muscle tension, 7-D FU, NS
1
   1.4%
1
   1.3%
Muscle tension, 7-D FU, OS but worse
3
   4.1%
2
   2.6%
Muscle tension, 7-D FU, OS but improved
4
   5.4%
8
  10.5%
Muscle tension, 7-D FU, OS but unchanged/absent
57
  77.0%
51
  67.1%
Muscle tension, 28-D FU, NS
1
   1.4%
0
   0.0%
Muscle tension, 28-D FU, OS but worse
3
   4.1%
2
   2.6%
Muscle tension, 28-D FU, OS but improved
1
   1.4%
6
   7.9%
Muscle tension, 28-D FU, OS but unchanged/absent
52
  70.3%
51
  67.1%
Muscle ache, Week 6/EW, NS
1
   1.4%
0
   0.0%
Muscle ache, Week 6/EW, OS but worse
6
   8.1%
5
   6.6%
Muscle ache, Week 6/EW, OS but improved
7
   9.5%
12
  15.8%
Muscle ache, Week 6/EW, OS but unchanged/absent
55
  74.3%
49
  64.5%
Muscle ache, 7-D FU, NS
1
   1.4%
0
   0.0%
Muscle ache, 7-D FU, OS but worse
3
   4.1%
5
   6.6%
Muscle ache, 7-D FU, OS but improved
5
   6.8%
9
  11.8%
Muscle ache, 7-D FU, OS but unchanged/absent
56
  75.7%
48
  63.2%
Muscle ache, 28-D FU, NS
2
   2.7%
1
   1.3%
Muscle ache, 28-D FU, OS but worse
4
   5.4%
1
   1.3%
Muscle ache, 28-D FU, OS but improved
3
   4.1%
6
   7.9%
Muscle ache, 28-D FU, OS but unchanged/absent
48
  64.9%
51
  67.1%
Muscle ache, 28-D FU, missing
1
   1.4%
0
   0.0%
Restless leg, Week 6/EW, NS
0
   0.0%
0
   0.0%
Restless leg, Week 6/EW, OS but worse
4
   5.4%
4
   5.3%
Restless leg, Week 6/EW, OS but improved
4
   5.4%
5
   6.6%
Restless leg, Week 6/EW, OS but unchanged/absent
61
  82.4%
57
  75.0%
Restless leg, 7-D FU, NS
0
   0.0%
0
   0.0%
Restless leg, 7-D FU, OS but worse
3
   4.1%
1
   1.3%
Restless leg, 7-D FU, OS but improved
2
   2.7%
5
   6.6%
Restless leg, 7-D FU, OS but unchanged/absent
60
  81.1%
56
  73.7%
Restless leg, 28-D FU, NS
2
   2.7%
1
   1.3%
Restless leg, 28-D FU, OS but worse
5
   6.8%
1
   1.3%
Restless leg, 28-D FU, OS but improved
3
   4.1%
4
   5.3%
Restless leg, 28-D FU, OS but unchanged/absent
48
  64.9%
53
  69.7%
Muscle cramps, Week 6/EW, NS
1
   1.4%
0
   0.0%
Muscle cramps, Week 6/EW, OS but worse
3
   4.1%
2
   2.6%
Muscle cramps, Week 6/EW, OS but improved
3
   4.1%
7
   9.2%
Muscle cramps, Week 6/EW, OS but unchanged/absent
62
  83.8%
57
  75.0%
Muscle cramps, 7-D FU, NS
2
   2.7%
2
   2.6%
Muscle cramps, 7-D FU, OS but worse
3
   4.1%
3
   3.9%
Muscle cramps, 7-D FU, OS but improved
3
   4.1%
9
  11.8%
Muscle cramps, 7-D FU, OS but unchanged/absent
57
  77.0%
48
  63.2%
Muscle cramps, 28-D FU, OS but worse
3
   4.1%
1
   1.3%
Muscle cramps, 28-D FU, OS but improved
1
   1.4%
5
   6.6%
Muscle cramps, 28-D FU, OS but unchanged/absent
53
  71.6%
53
  69.7%
Muscle cramps, 28-D FU, missing
1
   1.4%
0
   0.0%
Fatigue, Week 6/EW, NS
1
   1.4%
0
   0.0%
Fatigue, Week 6/EW, OS but worse
10
  13.5%
8
  10.5%
Fatigue, Week 6/EW, OS but improved
15
  20.3%
17
  22.4%
Fatigue, Week 6/EW, OS but unchanged/absent
43
  58.1%
41
  53.9%
Fatigue, 7-D FU, NS
2
   2.7%
1
   1.3%
Fatigue, 7-D FU, OS but worse
8
  10.8%
9
  11.8%
Fatigue, 7-D FU, OS but improved
10
  13.5%
9
  11.8%
Fatigue, 7-D FU, OS but unchanged/absent
45
  60.8%
43
  56.6%
Fatigue, 28-D FU, NS
2
   2.7%
2
   2.6%
Fatigue, 28-D FU, OS but worse
7
   9.5%
5
   6.6%
Fatigue, 28-D FU, OS but improved
8
  10.8%
7
   9.2%
Fatigue, 28-D FU, OS but unchanged/absent
41
  55.4%
45
  59.2%
Incoordination, Week 6/EW, NS
0
   0.0%
1
   1.3%
Incoordination, Week 6/EW, OS but worse
3
   4.1%
1
   1.3%
Incoordination, Week 6/EW, OS but improved
2
   2.7%
4
   5.3%
Incoordination, Week 6/EW, OS but unchanged/absent
64
  86.5%
60
  78.9%
Incoordination, 7-D FU, NS
1
   1.4%
1
   1.3%
Incoordination, 7-D FU, OS but worse
0
   0.0%
2
   2.6%
Incoordination, 7-D FU, OS but improved
1
   1.4%
4
   5.3%
Incoordination, 7-D FU, OS but unchanged/absent
63
  85.1%
55
  72.4%
Incoordination, 28-D FU, OS but worse
2
   2.7%
2
   2.6%
Incoordination, 28-D FU, OS but improved
3
   4.1%
3
   3.9%
Incoordination, 28-D FU, OS but unchanged/absent
52
  70.3%
54
  71.1%
Incoordination, 28-D FU, missing
1
   1.4%
0
   0.0%
Blurred vision, Week 6/EW, NS
2
   2.7%
1
   1.3%
Blurred vision, Week 6/EW, OS but worse
2
   2.7%
0
   0.0%
Blurred vision, Week 6/EW, OS but improved
1
   1.4%
3
   3.9%
Blurred vision, Week 6/EW, OS but unchanged/absent
64
  86.5%
62
  81.6%
Blurred vision, 7-D FU, NS
1
   1.4%
1
   1.3%
Blurred vision, 7-D FU, OS but improved
2
   2.7%
4
   5.3%
Blurred vision, 7-D FU, OS but unchanged/absent
62
  83.8%
57
  75.0%
Blurred vision, 28-D FU, NS
1
   1.4%
0
   0.0%
Blurred vision, 28-D FU, OS but worse
3
   4.1%
1
   1.3%
Blurred vision, 28-D FU, OS but improved
0
   0.0%
2
   2.6%
Blurred vision, 28-D FU, OS but unchanged/absent
53
  71.6%
56
  73.7%
Blurred vision, 28-D FU, missing
1
   1.4%
0
   0.0%
Sore eyes, Week 6/EW, NS
1
   1.4%
2
   2.6%
Sore eyes, Week 6/EW, OS but worse
1
   1.4%
1
   1.3%
Sore eyes, Week 6/EW, OS but improved
0
   0.0%
3
   3.9%
Sore eyes, Week 6/EW, OS but unchanged/absent
67
  90.5%
60
  78.9%
Sore eyes, 7-D FU, NS
1
   1.4%
1
   1.3%
Sore eyes, 7-D FU, OS but worse
0
   0.0%
1
   1.3%
Sore eyes, 7-D FU, OS but improved
2
   2.7%
4
   5.3%
Sore eyes, 28-D FU, NS
0
   0.0%
2
   2.6%
Sore eyes, 7-D FU, OS but unchanged/absent
62
  83.8%
56
  73.7%
Sore eyes, 28-D FU, OS but worse
2
   2.7%
1
   1.3%
Sore eyes, 28-D FU, OS but improved
0
   0.0%
3
   3.9%
Sore eyes, 28-D FU, OS but unchanged/absent
55
  74.3%
53
  69.7%
Sore eyes, Missing
1
   1.4%
0
   0.0%
Uncontrol mouth move, Week 6/EW, NS
2
   2.7%
2
   2.6%
Uncontrol mouth move, Week 6/EW, OS but improved
0
   0.0%
3
   3.9%
Uncontrol mouth move,Week6/EW,OS unchanged/absent
67
  90.5%
61
  80.3%
Uncontrol mouth move, 7-D FU, NS
1
   1.4%
1
   1.3%
Uncontrol mouth move, 7-D FU, OS but worse
0
   0.0%
1
   1.3%
Uncontrol mouth move, 7-D FU, OS but improved
1
   1.4%
3
   3.9%
Uncontrol mouth move, 7-D FU,OS unchanged/absent
63
  85.1%
57
  75.0%
Uncontrol mouth move, 28-D FU, NS
0
   0.0%
1
   1.3%
Uncontrol mouth move, 28-D FU, OS but worse
2
   2.7%
1
   1.3%
Uncontrol mouth move, 28-D FU, OS but improved
2
   2.7%
5
   6.6%
Uncontrol mouth move,28-D FU, OS unchanged/absent
53
  71.6%
52
  68.4%
Uncontrol mouth move, missing
1
   1.4%
0
   0.0%
Speech problem, Week 6/EW, NS
0
   0.0%
1
   1.3%
Speech problem, Week 6/EW, OS but worse
1
   1.4%
1
   1.3%
Speech problem, Week 6/EW, OS but improved
4
   5.4%
4
   5.3%
Speech problem, Week 6/EW, OS but unchanged/absent
64
  86.5%
60
  78.9%
Speech problem, 7-D FU, OS but worse
0
   0.0%
3
   3.9%
Speech problem, 7-D FU, OS but improved
4
   5.4%
3
   3.9%
Speech problem, 7-D FU, OS but unchanged/absent
61
  82.4%
56
  73.7%
Speech problem, 28-D FU, NS
1
   1.4%
0
   0.0%
Speech problem, 28-D FU, OS but improved
3
   4.1%
5
   6.6%
Speech problem, 28-D FU, OS but unchanged/absent
53
  71.6%
54
  71.1%
Speech problem, 28-D FU, missing
1
   1.4%
0
   0.0%
Headache, Week 6/EW, NS
4
   5.4%
2
   2.6%
Headache, Week 6/EW, OS but worse
5
   6.8%
4
   5.3%
Headache, Week 6/EW, OS but improved
12
  16.2%
10
  13.2%
Headache, Week 6/EW, OS but unchanged/absent
48
  64.9%
50
  65.8%
Headache, 7-D FU, NS
2
   2.7%
1
   1.3%
Headache, 7-D FU, OS but worse
4
   5.4%
3
   3.9%
Headache, 7-D FU, OS but improved
12
  16.2%
6
   7.9%
Headache, 7-D FU, OS but unchanged/absent
47
  63.5%
52
  68.4%
Headache, 28-D FU, NS
1
   1.4%
3
   3.9%
Headache, 28-D FU, OS but worse
5
   6.8%
2
   2.6%
Headache, 28-D FU, OS but improved
6
   8.1%
7
   9.2%
Headache, 28-D FU, OS but unchanged/absent
46
  62.2%
47
  61.8%
Increased saliva, Week 6/EW, NS
0
   0.0%
0
   0.0%
Increased saliva, Week 6/EW, OS but worse
2
   2.7%
0
   0.0%
Increased saliva, Week 6/EW, OS but improved
0
   0.0%
2
   2.6%
Increased saliva, Week 6/EW, OS unchanged/absent
67
  90.5%
64
  84.2%
Increased saliva, 7-D FU, NS
0
   0.0%
1
   1.3%
Increased saliva, 7-D FU, OS but improved
3
   4.1%
2
   2.6%
Increased saliva, 7-D FU, OS unchanged/absent
62
  83.8%
59
  77.6%
Increased saliva, 28-D FU, OS but improved
3
   4.1%
3
   3.9%
Increased saliva, 28-D FU, OS unchanged/absent
54
  73.0%
56
  73.7%
Increased saliva, 28-D FU, missing
1
   1.4%
0
   0.0%
Dizziness, Week 6/EW, NS
2
   2.7%
5
   6.6%
Dizziness, Week 6/EW, OS but worse
3
   4.1%
1
   1.3%
Dizziness, Week 6/EW, OS but improved
3
   4.1%
2
   2.6%
Dizziness, Week 6/EW, OS but unchanged/absent
61
  82.4%
58
  76.3%
Dizziness, 7-D FU, NS
3
   4.1%
1
   1.3%
Dizziness, 7-D FU, OS but worse
3
   4.1%
1
   1.3%
Dizziness, 7-D FU, OS but improved
4
   5.4%
4
   5.3%
Dizziness, 7-D FU, OS but unchanged/absent
55
  74.3%
56
  73.7%
Dizziness, 28-D FU, OS but worse
4
   5.4%
1
   1.3%
Dizziness, 28-D FU, NS
0
   0.0%
0
   0.0%
Dizziness, 28-D FU, OS but improved
1
   1.4%
3
   3.9%
Dizziness, 28-D FU, OS but unchanged/absent
53
  71.6%
55
  72.4%
Nose running, Week 6/EW, NS
2
   2.7%
2
   2.6%
Nose running, Week 6/EW, OS but worse
0
   0.0%
1
   1.3%
Nose running, Week 6/EW, OS but improved
5
   6.8%
3
   3.9%
Nose running, Week 6/EW, OS but unchanged/absent
62
  83.8%
60
  78.9%
Nose running, 7-D FU, NS
1
   1.4%
3
   3.9%
Nose running, 7-D FU, OS but improved
3
   4.1%
2
   2.6%
Nose running, 7-D FU, OS but unchanged/absent
61
  82.4%
57
  75.0%
Nose running, 28-D FU, NS
0
   0.0%
1
   1.3%
Nose running, 28-D FU, OS but worse
1
   1.4%
0
   0.0%
Nose running, 28-D FU, OS but improved
1
   1.4%
3
   3.9%
Nose running, 28-D FU, OS but unchanged/absent
55
  74.3%
55
  72.4%
Nose running, 28-D FU, missing
1
   1.4%
0
   0.0%
Breath shortness, Week 6/EW, NS
0
   0.0%
1
   1.3%
Breath shortness, Week 6/EW, OS but improved
3
   4.1%
2
   2.6%
Breath shortness, Week 6/EW, OS unchanged/absent
66
  89.2%
63
  82.9%
Breath shortness, 7-D FU, NS
0
   0.0%
1
   1.3%
Breath shortness, 7-D FU, OS but improved
3
   4.1%
4
   5.3%
Breath shortness, 7-D FU, OS unchanged/absent
62
  83.8%
57
  75.0%
Breath shortness, 28-D FU, OS but worse
0
   0.0%
2
   2.6%
Breath shortness, 28-D FU, OS but improved
1
   1.4%
2
   2.6%
Breath shortness, 28-D FU, OS unchanged/absent
56
  75.7%
55
  72.4%
Breath shortness, 28-D FU, missing
1
   1.4%
0
   0.0%
Chills, Week 6/EW, NS
1
   1.4%
1
   1.3%
Chills, Week 6/EW, OS but worse
0
   0.0%
1
   1.3%
Chills, Week 6/EW, OS but improved
4
   5.4%
2
   2.6%
Chills, Week 6/EW, OS but unchanged/absent
64
  86.5%
62
  81.6%
Chills, 7-D FU, NS
1
   1.4%
1
   1.3%
Chills, 7-D FU, OS but worse
1
   1.4%
2
   2.6%
Chills, 7-D FU, OS but improved
1
   1.4%
2
   2.6%
Chills, 7-D FU, OS but unchanged/absent
62
  83.8%
57
  75.0%
Chills, 28-D FU, NS
0
   0.0%
1
   1.3%
Chills, 28-D FU, OS but worse
1
   1.4%
0
   0.0%
Chills, 28-D FU, OS but improved
1
   1.4%
4
   5.3%
Chills, 28-D FU, OS but unchanged/absent
55
  74.3%
54
  71.1%
Chills, 28-D FU, missing
1
   1.4%
0
   0.0%
Fever, Week 6/EW, OS but improved
2
   2.7%
1
   1.3%
Fever, Week 6/EW, OS but unchanged/absent
67
  90.5%
65
  85.5%
Fever, 7-D FU, NS
0
   0.0%
1
   1.3%
Fever, 7-D FU, OS but improved
2
   2.7%
2
   2.6%
Fever, 7-D FU, OS but unchanged/absent
63
  85.1%
59
  77.6%
Fever, 28-D FU, OS but improved
0
   0.0%
3
   3.9%
Fever, 28-D FU, OS but unchanged/absent
57
  77.0%
56
  73.7%
Fever, 28-D FU, missing
1
   1.4%
0
   0.0%
Vomiting, Week 6/EW, OS but worse
0
   0.0%
1
   1.3%
Vomiting, Week 6/EW, OS but improved
3
   4.1%
1
   1.3%
Vomiting, Week 6/EW, OS but unchanged/absent
66
  89.2%
64
  84.2%
Vomiting, 7-D FU, NS
1
   1.4%
1
   1.3%
Vomiting, 7-D FU, OS but improved
2
   2.7%
3
   3.9%
Vomiting, 7-D FU, OS but unchanged/absent
62
  83.8%
58
  76.3%
Vomiting, 28-D FU, OS but worse
1
   1.4%
0
   0.0%
Vomiting, 28-D FU, OS but improved
1
   1.4%
2
   2.6%
Vomiting, 28-D FU, OS but unchanged/absent
56
  75.7%
57
  75.0%
Nausea, Week 6/EW, NS
2
   2.7%
0
   0.0%
Nausea, Week 6/EW, OS but worse
4
   5.4%
2
   2.6%
Nausea, Week 6/EW, OS but improved
4
   5.4%
2
   2.6%
Nausea, Week 6/EW, OS but unchanged/absent
59
  79.7%
62
  81.6%
Nausea, 7-D FU, NS
5
   6.8%
1
   1.3%
Nausea, 7-D FU, OS but worse
1
   1.4%
2
   2.6%
Nausea, 7-D FU, OS but improved
4
   5.4%
4
   5.3%
Nausea, 7-D FU, OS but unchanged/absent
55
  74.3%
55
  72.4%
Nausea, 28-D FU, NS
1
   1.4%
3
   3.9%
Nausea, 28-D FU, OS but worse
3
   4.1%
0
   0.0%
Nausea, 28-D FU, OS but improved
2
   2.7%
4
   5.3%
Nausea, 28-D FU, OS but unchanged/absent
52
  70.3%
52
  68.4%
Diarrhea, Week 6/EW, NS
2
   2.7%
0
   0.0%
Diarrhea, Week 6/EW, OS but worse
2
   2.7%
0
   0.0%
Diarrhea, Week 6/EW, OS but improved
2
   2.7%
1
   1.3%
Diarrhea, Week 6/EW, OS but unchanged/absent
63
  85.1%
65
  85.5%
Diarrhea, 7-D FU, NS
1
   1.4%
1
   1.3%
Diarrhea, 7-D FU, OS but worse
0
   0.0%
1
   1.3%
Diarrhea, 7-D FU, OS but improved
4
   5.4%
4
   5.3%
Diarrhea, 7-D FU, OS but unchanged/absent
60
  81.1%
56
  73.7%
Diarrhea, 28-D FU, NS
2
   2.7%
1
   1.3%
Diarrhea, 28-D FU, OS but worse
0
   0.0%
0
   0.0%
Diarrhea, 28-D FU, OS but improved
0
   0.0%
3
   3.9%
Diarrhea, 28-D FU, OS but unchanged/absent
56
  75.7%
55
  72.4%
Stomach cramps, Week 6/EW, NS
0
   0.0%
1
   1.3%
Stomach cramps, Week 6/EW, OS but worse
4
   5.4%
1
   1.3%
Stomach cramps, Week 6/EW, OS but improved
2
   2.7%
3
   3.9%
Stomach cramps, Week 6/EW, OS but unchanged/absent
63
  85.1%
61
  80.3%
Stomach cramps, 7-D FU, NS
1
   1.4%
1
   1.3%
Stomach cramps, 7-D FU, OS but worse
1
   1.4%
2
   2.6%
Stomach cramps, 7-D FU, OS but improved
4
   5.4%
5
   6.6%
Stomach cramps, 7-D FU, OS but unchanged/absent
59
  79.7%
54
  71.1%
Stomach cramps, 28-D FU, NS
0
   0.0%
1
   1.3%
Stomach cramps, 28-D FU, OS but worse
0
   0.0%
1
   1.3%
Stomach cramps, 28-D FU, OS but improved
3
   4.1%
2
   2.6%
Stomach cramps, 28-D FU, OS but unchanged/absent
55
  74.3%
55
  72.4%
Stomach bloat, Week 6/EW, NS
1
   1.4%
3
   3.9%
Stomach bloat, Week 6/EW, OS but worse
4
   5.4%
2
   2.6%
Stomach bloat, Week 6/EW, OS but improved
1
   1.4%
5
   6.6%
Stomach bloat, Week 6/EW, OS but unchanged/absent
63
  85.1%
56
  73.7%
Stomach bloat, 7-D FU, NS
2
   2.7%
2
   2.6%
Stomach bloat, 7-D FU, OS but worse
1
   1.4%
0
   0.0%
Stomach bloat, 7-D FU, OS but improved
3
   4.1%
5
   6.6%
Stomach bloat, 7-D FU, OS but unchanged/absent
59
  79.7%
55
  72.4%
Stomach bloat, 28-D FU, NS
0
   0.0%
2
   2.6%
Stomach bloat, 28-D FU, OS but worse
0
   0.0%
1
   1.3%
Stomach bloat, 28-D FU, OS but improved
3
   4.1%
4
   5.3%
Stomach bloat, 28-D FU, OS but unchanged/absent
54
  73.0%
52
  68.4%
Stomach bloat, 28-D FU, Missing
1
   1.4%
0
   0.0%
Unusual vision, Week 6/EW, NS
2
   2.7%
1
   1.3%
Unusual vision, Week 6/EW, OS but worse
1
   1.4%
1