Trial Outcomes & Findings for A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder (NCT NCT00733980)
NCT ID: NCT00733980
Last Updated: 2017-11-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Randomization (Week 0) and Week 6
Results posted on
2017-11-17
Participant Flow
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.
Participant milestones
| Measure |
GSK561679
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.
|
Placebo
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
76
|
|
Overall Study
COMPLETED
|
52
|
55
|
|
Overall Study
NOT COMPLETED
|
22
|
21
|
Reasons for withdrawal
| Measure |
GSK561679
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.
|
Placebo
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Protocol defined stopping criteria reach
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
11
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
Baseline Characteristics
A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
GSK561679
n=74 Participants
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
|
Placebo
n=76 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.8 Years
STANDARD_DEVIATION 11.31 • n=5 Participants
|
40.8 Years
STANDARD_DEVIATION 12.17 • n=7 Participants
|
39.8 Years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization (Week 0) and Week 6Population: 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).
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.
Outcome measures
| Measure |
GSK561679
n=72 Participants
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
|
Placebo
n=74 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
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).
|
-4.3150 Scores on scale
Standard Error 0.5314
|
-4.5629 Scores on scale
Standard Error 0.5101
|
SECONDARY outcome
Timeframe: Randomization (Week 0) and Week 1, 2 and 4Population: ITT population.
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.
Outcome measures
| Measure |
GSK561679
n=72 Participants
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
|
Placebo
n=74 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score.
Week 1
|
-1.6739 Scores on scale
Standard Error 0.3886
|
-1.6570 Scores on scale
Standard Error 0.3540
|
|
Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score.
Week 2
|
-2.6200 Scores on scale
Standard Error 0.4436
|
-3.0499 Scores on scale
Standard Error 0.4106
|
|
Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score.
Week 4
|
-3.1318 Scores on scale
Standard Error 0.4798
|
-4.0731 Scores on scale
Standard Error 0.4526
|
SECONDARY outcome
Timeframe: Randomization (Week 0) and Week 1, 2, 4 and Week 6Population: ITT population.
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.
Outcome measures
| Measure |
GSK561679
n=72 Participants
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
|
Placebo
n=74 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)
Week 1
|
-3.4188 Scores on scale
Standard Error 0.7432
|
-4.3683 Scores on scale
Standard Error 0.6649
|
|
Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)
Week 2
|
-5.2108 Scores on scale
Standard Error 0.8347
|
-5.9746 Scores on scale
Standard Error 0.7602
|
|
Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)
Week 4
|
-5.8462 Scores on scale
Standard Error 0.9201
|
-7.3825 Scores on scale
Standard Error 0.8577
|
|
Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)
Week 6
|
-8.2330 Scores on scale
Standard Error 0.9896
|
-8.8657 Scores on scale
Standard Error 0.9361
|
SECONDARY outcome
Timeframe: Randomization (Week 0) and Week 1, 2, 3,4 and Week 6Population: ITT population
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.
Outcome measures
| Measure |
GSK561679
n=72 Participants
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
|
Placebo
n=74 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.
Week 1
|
-6.9509 Scores on scale
Standard Error 1.4790
|
-4.9644 Scores on scale
Standard Error 1.3492
|
|
Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.
Week 2
|
-9.9178 Scores on scale
Standard Error 1.6612
|
-9.6640 Scores on scale
Standard Error 1.5354
|
|
Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.
Week 3
|
-11.4163 Scores on scale
Standard Error 1.7251
|
-11.0921 Scores on scale
Standard Error 1.6115
|
|
Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.
Week 4
|
-12.3463 Scores on scale
Standard Error 1.9146
|
-13.1571 Scores on scale
Standard Error 1.8066
|
|
Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.
Week 6
|
-15.5045 Scores on scale
Standard Error 2.0467
|
-14.8772 Scores on scale
Standard Error 1.9522
|
SECONDARY outcome
Timeframe: Randomization (Week 0) and Week 1, 2, 4 and Week 6Population: ITT population.
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.
Outcome measures
| Measure |
GSK561679
n=72 Participants
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
|
Placebo
n=74 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)
Week 1
|
-3.6342 Scores on scale
Standard Error 0.6816
|
-4.2782 Scores on scale
Standard Error 0.6198
|
|
Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)
Week 2
|
-5.1998 Scores on scale
Standard Error 0.8009
|
-6.2523 Scores on scale
Standard Error 0.7425
|
|
Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)
Week 4
|
-6.5337 Scores on scale
Standard Error 0.8734
|
-8.1810 Scores on scale
Standard Error 0.8262
|
|
Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)
Week 6
|
-8.2503 Scores on scale
Standard Error 0.9770
|
-8.9786 Scores on scale
Standard Error 0.9376
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, and 6.Population: ITT population. Only those participants available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
GSK561679
n=71 Participants
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
|
Placebo
n=74 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.
Week 6
|
27 Percentage of participants
|
28 Percentage of participants
|
|
Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.
Week 1
|
3 Percentage of participants
|
4 Percentage of participants
|
|
Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.
Week 2
|
7 Percentage of participants
|
15 Percentage of participants
|
|
Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.
Week 4
|
17 Percentage of participants
|
24 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: Endpoint not evaluated.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization (Week 0) and Weeks 1, 2, 4, and 6.Population: ITT population
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.
Outcome measures
| Measure |
GSK561679
n=72 Participants
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
|
Placebo
n=74 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6.
Week 1
|
-0.2800 Scores on scale
Standard Error 0.0859
|
-0.2632 Scores on scale
Standard Error 0.0783
|
|
Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6.
Week 2
|
-0.4013 Scores on scale
Standard Error 0.1026
|
-0.4677 Scores on scale
Standard Error 0.0957
|
|
Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6.
Week 4
|
-0.5866 Scores on scale
Standard Error 0.1222
|
-0.9557 Scores on scale
Standard Error 0.1169
|
|
Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6.
Week 6
|
-0.8353 Scores on scale
Standard Error 0.1384
|
-1.1103 Scores on scale
Standard Error 0.1348
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, and 6.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).
Outcome measures
| Measure |
GSK561679
n=72 Participants
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
|
Placebo
n=74 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6.
Week 1
|
3 perecntage of participants
|
5 perecntage of participants
|
|
Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6.
Week 2
|
11 perecntage of participants
|
16 perecntage of participants
|
|
Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6.
Week 4
|
25 perecntage of participants
|
32 perecntage of participants
|
|
Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6.
Week 6
|
33 perecntage of participants
|
36 perecntage of participants
|
SECONDARY outcome
Timeframe: Randomization (Week 0) and Week 6Population: ITT population.
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.
Outcome measures
| Measure |
GSK561679
n=72 Participants
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
|
Placebo
n=74 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Change From Randomization in the Medical Outcomes Study 12-item Sleep Module (MOS 12) at Week 6
|
-16.2738 Scores on scale
Standard Error 3.7112
|
-19.7203 Scores on scale
Standard Error 3.4794
|
SECONDARY outcome
Timeframe: Randomization (Week 0) and Week 6.Population: ITT population.
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.
Outcome measures
| Measure |
GSK561679
n=72 Participants
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
|
Placebo
n=74 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Change From Randomization in the Cohen Perceived Stress Scale (PSS) at Week 6.
|
-5.6529 Scores on scale
Standard Error 1.3431
|
-5.7696 Scores on scale
Standard Error 1.2624
|
SECONDARY outcome
Timeframe: Up to 28-day FU (18 months)Population: All subject population.
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.
Outcome measures
| Measure |
GSK561679
n=74 Participants
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
|
Placebo
n=76 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE
|
55 Participants
|
58 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any SAE
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 10Population: All subject population.
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.
Outcome measures
| Measure |
GSK561679
n=74 Participants
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
|
Placebo
n=76 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Number of Participants With Vital Sign of Potential Clinical Importance (PCI)
SBP, High
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vital Sign of Potential Clinical Importance (PCI)
SBP, Low
|
2 Participants
|
3 Participants
|
|
Number of Participants With Vital Sign of Potential Clinical Importance (PCI)
DBP, HIgh
|
7 Participants
|
4 Participants
|
|
Number of Participants With Vital Sign of Potential Clinical Importance (PCI)
DBP, Low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign of Potential Clinical Importance (PCI)
HR, High
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 3, Week 6/ Early withdrawal (EW) and 28 Day follow-up (FU)Population: All subject population.
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.
Outcome measures
| Measure |
GSK561679
n=74 Participants
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
|
Placebo
n=76 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Number of Participants With Abnormal Urinalysis Data
Urine Bilirubin, Randomized, negative
|
74 Participants
|
74 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Randomized, 1+
|
3 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Randomized, 2+
|
6 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Randomized, 3+
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Randomized, negative
|
58 Participants
|
63 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Randomized, trace
|
5 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Glucose, Randomized, 2+
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Glucose, Randomized, 3+
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Glucose, Randomized, negative
|
73 Participants
|
71 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Glucose, Randomized, trace
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Ketones, Randomized, negative
|
73 Participants
|
71 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Ketones, Randomized, trace
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Nitrite, Randomized, negative
|
73 Participants
|
71 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Nitrite, Randomized, positive
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Protein, Randomized, 1+
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Protein, Randomized, negative
|
64 Participants
|
61 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Protein, Randomized, trace
|
7 Participants
|
9 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Randomized, 1+
|
5 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Randomized, 2+
|
4 Participants
|
7 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Randomized, 3+
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Randomized, negative
|
60 Participants
|
59 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Randomized, trace
|
4 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine bilirubin, Week 3, negative
|
60 Participants
|
63 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Week 3, 1+
|
3 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Week 3, 2+
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Week 3, 3+
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Week 3, negative
|
53 Participants
|
57 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Week 3, trace
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Glucose, Negative
|
60 Participants
|
63 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Ketones, Week 3, 1+
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Ketones, Week 3, negative
|
55 Participants
|
61 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Ketones, Week 3, trace
|
5 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine nitrite, Week 3, negative
|
60 Participants
|
60 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine nitrite, Week 3, positive
|
0 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Protein, Week 3, 1+
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Protein, Week 3, negative
|
46 Participants
|
53 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Protein, Week 3, positive
|
10 Participants
|
9 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Week 3, 1+
|
3 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Week 3, 2+
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Week 3, 3+
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Week 3, negative
|
51 Participants
|
48 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Week 3, trace
|
2 Participants
|
7 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Bilirubin, Week 6/EW, negative
|
69 Participants
|
65 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Week 6/EW, 1+
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Week 6/EW, 2+
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Week 6/EW, 3+
|
9 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Week 6/EW, negative
|
54 Participants
|
56 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, Week 6/EW, trace
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Glucose, Week 6/EW, negative
|
69 Participants
|
65 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine ketone, Week 6/EW, negative
|
64 Participants
|
63 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine ketone, Week 6/EW, trace
|
5 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Nitrite, Week 6/EW, negative
|
68 Participants
|
62 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Nitrite, Week 6/EW, positive
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine protein, Week 6/EW, 1+
|
7 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine protein, Week 6/EW, 2+
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine protein, Week 6/EW, negative
|
52 Participants
|
55 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine protein, Week 6/EW, trace
|
8 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC , Week 6/EW, 1+
|
6 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Week 6/EW, 2+
|
1 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Week 6/EW, 3+
|
4 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Week 6/EW, negative
|
51 Participants
|
53 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, Week 6/EW, trace
|
7 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Bilirubin, 28-day FU, negative
|
18 Participants
|
17 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, 28-day FU, 1+
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, 28-day FU, 2+
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, 28-day FU, 3+
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, 28-day FU, negative
|
13 Participants
|
13 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Occult Blood, 28-day FU, trace
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Glucose, 28-day FU, negative
|
18 Participants
|
17 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Ketones, 28-day FU, 1+
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Ketones, 28-day FU, negative
|
18 Participants
|
16 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Nitrite, 28-day FU, negative
|
18 Participants
|
17 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Protein, 28-day FU, 1+
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Protein, 28-day FU, 2+
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Protein, 28-day FU, negative
|
13 Participants
|
14 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine Protein, 28-day FU, trace
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, 28-day FU, 1+
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, 28-day FU, 2+
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, 28-day FU, 3+
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, 28-day FU, negative
|
12 Participants
|
13 Participants
|
|
Number of Participants With Abnormal Urinalysis Data
Urine LET for WBC, 28-day FU, trace
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 4, Week 6 and 28 Day follow-upPopulation: All subject population. Only those participants available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
GSK561679
n=74 Participants
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
|
Placebo
n=76 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Number of Participants With Abnormal Electrocardiograph (ECG) Values
Abnormal, Randomization
|
6 Participants
|
11 Participants
|
|
Number of Participants With Abnormal Electrocardiograph (ECG) Values
Abnormal, Week 4
|
7 Participants
|
10 Participants
|
|
Number of Participants With Abnormal Electrocardiograph (ECG) Values
Abnormal, Week 6/EW
|
6 Participants
|
13 Participants
|
|
Number of Participants With Abnormal Electrocardiograph (ECG) Values
Abnormal, 28-day FU
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Upto 28-day FUPopulation: All Subject population
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.
Outcome measures
| Measure |
GSK561679
n=66 Participants
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
|
Placebo
n=63 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Number of Participants With Abnormal Hematology Values of PCI-Platelet
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Upto Week 10Population: All subject population.
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.
Outcome measures
| Measure |
GSK561679
n=74 Participants
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
|
Placebo
n=76 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
ALT, Week 4, CIR, high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
AST, Week 4, CIR, high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Total bilirubin, Randomization, CIR, high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Total bilirubin, Week 2, CIR, high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Total bilirubin, Week 6/EW, CIR, high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Calcium, 28-day FU,CIR, low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Creatine Kinase , Randomization, CIR,high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Creatine Kinase, Week 1, CIR, high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Creatine Kinase, Week 2, CIR, high
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Creatine Kinase, 28-day FU, CIR, high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
CO^2 content/BC, 28-day FU,CIR, low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Glucose, Randomization, CIR, high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Glucose, Week 6/EW, CIR, low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Glucose, 28-day FU,CIR, low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Potassium, Randomization, CIR, low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range
Potassium, 28-day FU, CIR, high
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to Week 10Population: All subject population.
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) .
Outcome measures
| Measure |
GSK561679
n=74 Participants
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
|
Placebo
n=76 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Number of Participants With Hormonal Data of PCI
Thyroxine, free, 28-day FU,CIR, low
|
1 Participants
|
2 Participants
|
|
Number of Participants With Hormonal Data of PCI
Cortisol, total, Randomization, CIR, low
|
1 Participants
|
4 Participants
|
|
Number of Participants With Hormonal Data of PCI
Cortisol, total, Week 2, CIR, low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hormonal Data of PCI
Cortisol, total, Week 4, CIR, low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hormonal Data of PCI
Cortisol, total, Week 6/EW, CIR, low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hormonal Data of PCI
Dehydroepiandrosterone, Randomization, CIR, high
|
0 Participants
|
2 Participants
|
|
Number of Participants With Hormonal Data of PCI
Dehydroepiandrosterone, Randomization, CIR, low
|
3 Participants
|
5 Participants
|
|
Number of Participants With Hormonal Data of PCI
Dehydroepiandrosterone, Week 2, CIR, high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hormonal Data of PCI
Dehydroepiandrosterone, Week 2, CIR, low
|
3 Participants
|
4 Participants
|
|
Number of Participants With Hormonal Data of PCI
Dehydroepiandrosterone , Week 4, CIR, low
|
4 Participants
|
8 Participants
|
|
Number of Participants With Hormonal Data of PCI
Dehydroepiandrosterone, Week 6/EW, CIR, low
|
5 Participants
|
6 Participants
|
|
Number of Participants With Hormonal Data of PCI
Dehydroepiandrosterone, 28-day FU,CIR, low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hormonal Data of PCI
Thyroxine, free, Week 6/EW, CIR, low
|
1 Participants
|
2 Participants
|
|
Number of Participants With Hormonal Data of PCI
TSH, Week 6/EW, CIR, high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hormonal Data of PCI
TSH, Week 6/EW, CIR, low
|
0 Participants
|
3 Participants
|
|
Number of Participants With Hormonal Data of PCI
TSH, 28-day FU, CIR, high
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Week 6, 7-day (D) FU and 28-D FUPopulation: All subject population.
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.
Outcome measures
| Measure |
GSK561679
n=74 Participants
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
|
Placebo
n=76 Participants
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, Week 6/EW, OS but unchanged/absent
|
66 Participants
|
63 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, Week 6/EW, OS but improved
|
2 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, Week 6/EW, OS unchanged/absent
|
63 Participants
|
60 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, Week 6/EW, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, Week 6/EW, OS but worse
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, Week 6/EW, OS but worse
|
9 Participants
|
9 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, 28-D FU, OS but unchanged/absent
|
45 Participants
|
41 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, Missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move, Week 6/EW, NS
|
2 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, 7-D FU, OS but unchanged/absent
|
61 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, Week 6/EW, NS
|
4 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, Week 6/EW, OS but improved
|
12 Participants
|
10 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, 7-D FU, OS but improved
|
12 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased saliva, 28-D FU, OS but improved
|
3 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, Week 6/EW, OS but unchanged/absent
|
63 Participants
|
65 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, 28-D FU, OS but unchanged/absent
|
56 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, 7-D FU, OS but worse
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, Week 6/EW, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, Week 6/EW, OS but worse
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, 7-D FU, OS but improved
|
2 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, 7-D FU, OS but unchanged/absent
|
62 Participants
|
59 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, 28-D FU, OS but worse
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, 28-D FU, OS but improved
|
1 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, 28-D FU, OS but unchanged/absent
|
55 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, Week 6/EW, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, Week 6/EW, OS but worse
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, 28-D FU, OS but unchanged/absent
|
36 Participants
|
38 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, 28-D FU, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsen mood, Week 6/EW, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, 7-D FU, OS but improved
|
2 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, Week 6/EW, OS but improved
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, 7-D FU, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, 7-D FU, OS but improved
|
2 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, 7-D FU, OS but unchanged/absent
|
63 Participants
|
58 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, 28-D FU, OS but worse
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, 28-D FU, OS but improved
|
1 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, 28-D FU, OS but unchanged/absent
|
54 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sense of burn, 28-D FU,missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, 7-D FU, OS but unchanged/absent
|
63 Participants
|
59 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, 28-D FU, OS but worse
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, 28-D FU, OS but improved
|
1 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, 28-D FU, OS but unchanged/absent
|
55 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual taste/smell, Week 6/EW, OS but worse
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual taste/smell, Week 6/EW, OS but improved
|
2 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual taste/smell, Week 6/EW,OS unchanged/absent
|
66 Participants
|
64 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual taste/smell, 7-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual taste/smell, 7-D FU, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual taste/smell, 7-D FU, OS but improved
|
2 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual taste/smell, 7-D FU, OS unchanged/absent
|
62 Participants
|
58 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual taste/smell, 28-D FU, OS but improved
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, 7-D FU, OS but worse
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, 7-D FU, OS but improved
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, 7-D FU, OS unchanged/absent
|
61 Participants
|
59 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, 28-D FU, OS but worse
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, 28-D FU, OS but improved
|
1 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, 28-D FU, OS unchanged/absent
|
54 Participants
|
54 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual sound feel, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, Week 6/EW, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, Week 6/EW, OS but worse
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, Week 6/EW, OS but improved
|
1 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, Week 6/EW, OS but unchanged/absent
|
67 Participants
|
61 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Noise in ear, 7-D FU, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual taste/smell, 28-D FU, OS unchanged/absent
|
56 Participants
|
57 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual taste/smell, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, 28-D FU, OS but unchanged/absent
|
53 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, Week 6/EW, NS
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsen mood, Week 6/EW, OS but worse
|
6 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsen mood, Week 6/EW, OS but improved
|
9 Participants
|
13 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, Week 6/EW, OS but worse
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, 28-D FU, OS but worse
|
4 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, 28-D FU, OS but improved
|
3 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, 28-D FU, OS but unchanged/absent
|
48 Participants
|
51 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, Week 6/EW, NS
|
0 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, Week 6/EW, OS but worse
|
4 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, Week 6/EW, OS but improved
|
4 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, Week 6/EW, OS but unchanged/absent
|
61 Participants
|
57 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, 7-D FU, NS
|
0 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, 7-D FU, OS but worse
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, 7-D FU, OS but improved
|
2 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, 7-D FU, OS but unchanged/absent
|
60 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, 28-D FU, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, 28-D FU, OS but worse
|
5 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, 28-D FU, OS but improved
|
3 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Restless leg, 28-D FU, OS but unchanged/absent
|
48 Participants
|
53 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, Week 6/EW, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, Week 6/EW, OS but worse
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, Week 6/EW, OS but improved
|
3 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, Week 6/EW, OS but improved
|
0 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, Week 6/EW, OS but unchanged/absent
|
67 Participants
|
60 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, 7-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, 7-D FU, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , Week 6/EW, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , Week 6/EW, OS but worse
|
7 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , Week 6/EW, OS but improved
|
13 Participants
|
14 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , Week 6/EW, OS but unchanged/absent
|
48 Participants
|
47 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , 7-D FU, NS
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , 7-D FU, OS but worse
|
4 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , 7-D FU, OS but improved
|
11 Participants
|
11 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , 7-D FU, OS but unchanged/absent
|
47 Participants
|
45 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , 28-D FU, NS
|
3 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , 28-D FU, OS but worse
|
9 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , 28-D FU, OS but improved
|
11 Participants
|
13 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Anxiety , 28-D FU, OS but unchanged/absent
|
35 Participants
|
37 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high, Week 6/EW, NS
|
0 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high, Week 6/EW, OS but worse
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high, Week 6/EW, OS but improved
|
5 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high, Week 6/EW, OS but unchanged/absent
|
63 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high , Week 6/EW, Missing
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high, 7-D FU, NS
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high, 7-D FU, OS but worse
|
0 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high, 7-D FU, OS but improved
|
5 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high, 7-D FU, OS but unchanged/absent
|
57 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high , 28-D FU, NS
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high , 28-D FU, OS but worse
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high , 28-D FU, OS but improved
|
6 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Feeling high , 28-D FU, OS but unchanged/absent
|
48 Participants
|
52 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, Week 6/EW, NS
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, Week 6/EW, OS but worse
|
8 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, Week 6/EW, OS but improved
|
17 Participants
|
18 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, Week 6/EW, OS but unchanged/absent
|
43 Participants
|
39 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, 7-D FU, NS
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, 7-D FU, OS but worse
|
7 Participants
|
9 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, 7-D FU, OS but improved
|
12 Participants
|
13 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, 7-D FU, OS unchanged/absent
|
45 Participants
|
38 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, 28-D FU, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, 28-D FU, OS but worse
|
8 Participants
|
10 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Irritability, 28-D FU, OS but improved
|
11 Participants
|
10 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worse mood, Week 6/EW, OS; unchanged/absent
|
53 Participants
|
45 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsen mood, 7-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsen mood, 7-D FU, OS but worse
|
6 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsen mood, 7-D FU, OS but improved
|
11 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsen mood, 7-D FU, OS unchanged/absent
|
47 Participants
|
48 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsened mood, 28-D FU, NS
|
3 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsened mood, 28-D FU, OS but worse
|
9 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsened mood, 28-D FU, OS but improved
|
5 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden worsed mood, 28-D FU, OS; unchanged/absent
|
41 Participants
|
47 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, Week 6/EW, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, Week 6/EW, OS but worse
|
5 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, Week 6/EW, OS but improved
|
8 Participants
|
9 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst,Week 6EW,OS unchanged/absent
|
55 Participants
|
51 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, 7-D FU, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, 7-D FU, OS but worse
|
4 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, 7-D FU, OS but improved
|
7 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst,7-D FU, OS unchanged/absent
|
52 Participants
|
48 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, 28-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, 28-D FU, OS but worse
|
4 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, 28-D FU, OS but improved
|
7 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, 28-D FU, OS unchang/absent
|
45 Participants
|
50 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden anger outburst, 28-D FU,missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety, Week 6/EW, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety, Week 6/EW, OS but worse
|
5 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety, Week 6/EW, OS but improved
|
4 Participants
|
10 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety, Wk 6/EW, OS;unchanged/absent
|
59 Participants
|
53 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety, 7-D FU, NS
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety , 7-D FU, OS but worse
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety , 7-D FU, OS but improved
|
3 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety, 7-D FU, OS unchange/absent
|
57 Participants
|
54 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety, 28-D FU, NS
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety, 28-D FU, OS; worse
|
5 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety, 28-D FU, OS; improved
|
5 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sudden panic/anxiety, 28-D FU,OS; unchanged/absent
|
46 Participants
|
50 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, Week 6/EW, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, Week 6/EW, OS but worse
|
9 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, Week 6/EW, OS but improved
|
16 Participants
|
12 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, Week 6/EW, OS unchanged/absent
|
44 Participants
|
46 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, 7-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, 7-D FU, OS but worse
|
8 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, 7-D FU, OS but improved
|
6 Participants
|
11 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, 7-D FU, OS unchanged/absent
|
50 Participants
|
44 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, 28-D FU, NS
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, 28-D FU, OS but worse
|
8 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, 28-D FU, OS but improved
|
11 Participants
|
10 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, 28-D FU, OS unchanged/absent
|
37 Participants
|
40 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Bouts of cry/tear, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, Week 6/EW, NS
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, Week 6/EW, OS but worse
|
6 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, Week 6/EW, OS but improved
|
8 Participants
|
13 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, Week 6/EW, OS but unchanged/absent
|
54 Participants
|
46 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, 7-D FU, NS
|
3 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, 7-D FU, OS but worse
|
5 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, 7-D FU, OS but improved
|
5 Participants
|
10 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, 7-D FU, OS but unchanged/absent
|
52 Participants
|
47 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, 28-D FU, OS but worse
|
6 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, 28-D FU, OS but improved
|
5 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, 28-D FU, OS but unchanged/absent
|
46 Participants
|
48 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Agitation, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, Week 6, NS
|
4 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, Week 6, OS but worse
|
4 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, Week 6, OS but improved
|
7 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, Week 6, OS unchanged/absent
|
54 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, 7-D FU, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, 7-D FU, OS but worse
|
4 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, 7-D FU, OS but improved
|
5 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, 7-D FU, OS unchanged/absent
|
54 Participants
|
54 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, 28-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, 28-D FU, OS but worse
|
4 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, 28-D FU, OS but improved
|
4 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, 28-D FU, OS;unchanged/absent
|
48 Participants
|
49 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unreal/detached feel, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, Week 6/EW, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, Week 6/EW, OS but worse
|
10 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, Week 6/EW, OS but improved
|
11 Participants
|
15 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, Week 6/EW, OS but unchanged/absent
|
47 Participants
|
43 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, 7-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, 7-D FU, OS but worse
|
3 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, 7-D FU, OS but improved
|
14 Participants
|
11 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, 7-D FU, OS but unchanged/absent
|
47 Participants
|
44 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, 28-D FU, NS
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, 28-D FU, OS but worse
|
7 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, 28-D FU, OS but improved
|
10 Participants
|
12 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Confusion, 28-D FU, OS but unchanged/absent
|
40 Participants
|
42 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, Week 6/EW, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, Week 6/EW, OS but improved
|
8 Participants
|
12 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, Week 6/EW, OS but unchanged/absent
|
51 Participants
|
45 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, 7-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, 7-D FU, OS but worse
|
4 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, 7-D FU, OS but improved
|
8 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, 7-D FU, OS but unchanged/absent
|
52 Participants
|
48 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, 28-D FU, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, 28-D FU, OS but worse
|
6 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Forgetfulness, 28-D FU, OS but improved
|
7 Participants
|
9 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, Week 6/EW, NS
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, Week 6/EW, OS but worse
|
7 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, Week 6/EW, OS but improved
|
11 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, Week 6/EW, OS but unchanged/absent
|
49 Participants
|
51 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, 7-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, 7-D FU, OS but worse
|
7 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, 7-D FU, OS but improved
|
10 Participants
|
9 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, 7-D FU, OS but unchanged/absent
|
47 Participants
|
46 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, 28-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, 28-D FU, OS but worse
|
9 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, 28-D FU, OS but improved
|
6 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Mood swings, 28-D FU, OS but unchanged/absent
|
42 Participants
|
47 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Insomnia, Week 6/EW, OS but worse
|
7 Participants
|
10 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Insomnia, Week 6/EW, OS but improved
|
15 Participants
|
18 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Insomnia, Week 6/EW, OS but unchanged/absent
|
47 Participants
|
38 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Insomnia, 7-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Insomnia, 7-D FU, OS but worse
|
2 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Insomnia, 7-D FU, OS but improved
|
17 Participants
|
13 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Insomnia, 7-D FU, OS but unchanged/absent
|
45 Participants
|
41 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Insomnia, 28-D FU, OS but worse
|
13 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Insomnia, 28-D FU, OS but improved
|
10 Participants
|
13 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Insomnia, 28-D FU, OS but unchanged/absent
|
35 Participants
|
39 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, Week 6/EW, NS
|
2 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, Week 6/EW, OS but worse
|
2 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, Week 6/EW, OS but improved
|
3 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, Week 6/EW, OS unchanged/absent
|
62 Participants
|
53 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, 7-D FU, NS
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, 7-D FU, OS but worse
|
0 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, 7-D FU, OS but improved
|
5 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, 7-D FU, OS unchanged/absent
|
57 Participants
|
54 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, 28-D FU, NS
|
2 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, 28-D FU, OS but worse
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, 28-D FU, OS but improved
|
5 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased dreams, 28-D FU, OS unchanged/absent
|
48 Participants
|
46 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, Week 6/EW, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, Week 6/EW, OS but worse
|
1 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, Week 6/EW, OS but improved
|
3 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, Week 6/EW, OS but unchanged/absent
|
64 Participants
|
57 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, 7-D FU, NS
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, 7-D FU, OS but worse
|
1 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, 7-D FU, OS but improved
|
2 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, 7-D FU, OS but unchanged/absent
|
59 Participants
|
49 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, 28-D FU, NS
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, 28-D FU, OS but worse
|
0 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, 28-D FU, OS but improved
|
4 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, 28-D FU, OS but unchanged/absent
|
52 Participants
|
49 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
More sweating, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, Week 6/EW, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, Week 6/EW, OS but unchanged/absent
|
62 Participants
|
57 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, 7-D FU, NS
|
2 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, 7-D FU, OS but worse
|
3 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, 7-D FU, OS but improved
|
3 Participants
|
9 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, 7-D FU, OS but unchanged/absent
|
57 Participants
|
48 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, 28-D FU, OS but worse
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, 28-D FU, OS but improved
|
1 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, 28-D FU, OS but unchanged/absent
|
53 Participants
|
53 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle cramps, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, Week 6/EW, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, Week 6/EW, OS but worse
|
10 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, Week 6/EW, OS but improved
|
15 Participants
|
17 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, Week 6/EW, OS but unchanged/absent
|
43 Participants
|
41 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, 7-D FU, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, 7-D FU, OS but worse
|
8 Participants
|
9 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, 7-D FU, OS but improved
|
10 Participants
|
9 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, 7-D FU, OS but unchanged/absent
|
45 Participants
|
43 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, 28-D FU, NS
|
2 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, 28-D FU, OS but worse
|
7 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, 28-D FU, OS but improved
|
8 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fatigue, 28-D FU, OS but unchanged/absent
|
41 Participants
|
45 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, Week 6/EW, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, Week 6/EW, OS but worse
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, Week 6/EW, OS but improved
|
2 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, Week 6/EW, OS but unchanged/absent
|
64 Participants
|
60 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, 7-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, 7-D FU, OS but worse
|
0 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, 7-D FU, OS but improved
|
1 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, 7-D FU, OS but unchanged/absent
|
63 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, 28-D FU, OS but worse
|
2 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, 28-D FU, OS but improved
|
3 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, 28-D FU, OS but unchanged/absent
|
52 Participants
|
54 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Incoordination, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, Week 6/EW, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, Week 6/EW, OS but worse
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, Week 6/EW, OS but improved
|
1 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, Week 6/EW, OS but unchanged/absent
|
64 Participants
|
62 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, 7-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, 7-D FU, OS but improved
|
2 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, 7-D FU, OS but unchanged/absent
|
62 Participants
|
57 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, 28-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, 28-D FU, OS but worse
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Blurred vision, 28-D FU, OS but improved
|
0 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, 7-D FU, OS but improved
|
2 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, 28-D FU, NS
|
0 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, 7-D FU, OS but unchanged/absent
|
62 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, 28-D FU, OS but worse
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, 28-D FU, OS but improved
|
0 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, 28-D FU, OS but unchanged/absent
|
55 Participants
|
53 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, Week 6/EW, OS but worse
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, Week 6/EW, OS but improved
|
6 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, Week 6/EW, OS but unchanged/absent
|
60 Participants
|
61 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, 7-D FU, NS
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, 7-D FU, OS but worse
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, 7-D FU, OS but improved
|
2 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, 7-D FU, OS but unchanged/absent
|
58 Participants
|
58 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, 28-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, 28-D FU, OS but worse
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, 28-D FU, OS but improved
|
2 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Shake/tremble, 28-D FU, OS but unchanged/absent
|
53 Participants
|
53 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, Week 6/EW, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, Week 6/EW, OS but worse
|
4 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, Week 6/EW, OS but improved
|
8 Participants
|
10 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, Week 6/EW, OS but unchanged/absent
|
55 Participants
|
50 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, 7-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, 7-D FU, OS but worse
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, 7-D FU, OS but improved
|
4 Participants
|
8 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, 7-D FU, OS but unchanged/absent
|
57 Participants
|
51 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, 28-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, 28-D FU, OS but worse
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, 28-D FU, OS but improved
|
1 Participants
|
6 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle tension, 28-D FU, OS but unchanged/absent
|
52 Participants
|
51 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, Week 6/EW, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, Week 6/EW, OS but worse
|
6 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, Week 6/EW, OS but improved
|
7 Participants
|
12 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, Week 6/EW, OS but unchanged/absent
|
55 Participants
|
49 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, 7-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, 7-D FU, OS but worse
|
3 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, 7-D FU, OS but improved
|
5 Participants
|
9 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, 7-D FU, OS but unchanged/absent
|
56 Participants
|
48 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Muscle ache, 28-D FU, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Sore eyes, Missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move, Week 6/EW, OS but improved
|
0 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move,Week6/EW,OS unchanged/absent
|
67 Participants
|
61 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move, 7-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move, 7-D FU, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move, 7-D FU, OS but improved
|
1 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move, 7-D FU,OS unchanged/absent
|
63 Participants
|
57 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move, 28-D FU, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move, 28-D FU, OS but worse
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move, 28-D FU, OS but improved
|
2 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move,28-D FU, OS unchanged/absent
|
53 Participants
|
52 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Uncontrol mouth move, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, Week 6/EW, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, Week 6/EW, OS but worse
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, Week 6/EW, OS but improved
|
4 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, Week 6/EW, OS but unchanged/absent
|
64 Participants
|
60 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, 7-D FU, OS but worse
|
0 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, 7-D FU, OS but improved
|
4 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, 28-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, 28-D FU, OS but improved
|
3 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, 28-D FU, OS but unchanged/absent
|
53 Participants
|
54 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Speech problem, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, Week 6/EW, OS but worse
|
5 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, Week 6/EW, OS but unchanged/absent
|
48 Participants
|
50 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, 7-D FU, NS
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, 7-D FU, OS but worse
|
4 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, 7-D FU, OS but unchanged/absent
|
47 Participants
|
52 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, 28-D FU, NS
|
1 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, 28-D FU, OS but worse
|
5 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, 28-D FU, OS but improved
|
6 Participants
|
7 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Headache, 28-D FU, OS but unchanged/absent
|
46 Participants
|
47 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased saliva, Week 6/EW, NS
|
0 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased saliva, Week 6/EW, OS but worse
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased saliva, Week 6/EW, OS but improved
|
0 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased saliva, Week 6/EW, OS unchanged/absent
|
67 Participants
|
64 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased saliva, 7-D FU, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased saliva, 7-D FU, OS but improved
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased saliva, 7-D FU, OS unchanged/absent
|
62 Participants
|
59 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased saliva, 28-D FU, OS unchanged/absent
|
54 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Increased saliva, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, Week 6/EW, NS
|
2 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, Week 6/EW, OS but worse
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, Week 6/EW, OS but improved
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, Week 6/EW, OS but unchanged/absent
|
61 Participants
|
58 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, 7-D FU, NS
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, 7-D FU, OS but worse
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, 7-D FU, OS but improved
|
4 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, 7-D FU, OS but unchanged/absent
|
55 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, 28-D FU, OS but worse
|
4 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, 28-D FU, NS
|
0 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, 28-D FU, OS but improved
|
1 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Dizziness, 28-D FU, OS but unchanged/absent
|
53 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, Week 6/EW, NS
|
2 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, Week 6/EW, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, Week 6/EW, OS but improved
|
5 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, Week 6/EW, OS but unchanged/absent
|
62 Participants
|
60 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, 7-D FU, NS
|
1 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, 7-D FU, OS but improved
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, 7-D FU, OS but unchanged/absent
|
61 Participants
|
57 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, 28-D FU, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, 28-D FU, OS but worse
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, 28-D FU, OS but improved
|
1 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, 28-D FU, OS but unchanged/absent
|
55 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nose running, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Breath shortness, Week 6/EW, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Breath shortness, Week 6/EW, OS but improved
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Breath shortness, Week 6/EW, OS unchanged/absent
|
66 Participants
|
63 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Breath shortness, 7-D FU, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Breath shortness, 7-D FU, OS but improved
|
3 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Breath shortness, 7-D FU, OS unchanged/absent
|
62 Participants
|
57 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Breath shortness, 28-D FU, OS but worse
|
0 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Breath shortness, 28-D FU, OS but improved
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Breath shortness, 28-D FU, OS unchanged/absent
|
56 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Breath shortness, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, Week 6/EW, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, Week 6/EW, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, Week 6/EW, OS but improved
|
4 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, Week 6/EW, OS but unchanged/absent
|
64 Participants
|
62 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, 7-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, 7-D FU, OS but worse
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, 7-D FU, OS but improved
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, 7-D FU, OS but unchanged/absent
|
62 Participants
|
57 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, 28-D FU, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, 28-D FU, OS but worse
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, 28-D FU, OS but improved
|
1 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, 28-D FU, OS but unchanged/absent
|
55 Participants
|
54 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Chills, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fever, Week 6/EW, OS but improved
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fever, Week 6/EW, OS but unchanged/absent
|
67 Participants
|
65 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fever, 7-D FU, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fever, 7-D FU, OS but improved
|
2 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fever, 7-D FU, OS but unchanged/absent
|
63 Participants
|
59 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fever, 28-D FU, OS but improved
|
0 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fever, 28-D FU, OS but unchanged/absent
|
57 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, Week 6/EW, OS but improved
|
1 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, Week 6/EW, OS but unchanged/absent
|
65 Participants
|
61 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Fever, 28-D FU, missing
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Vomiting, Week 6/EW, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Vomiting, Week 6/EW, OS but improved
|
3 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Vomiting, Week 6/EW, OS but unchanged/absent
|
66 Participants
|
64 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Vomiting, 7-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Vomiting, 7-D FU, OS but improved
|
2 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Vomiting, 7-D FU, OS but unchanged/absent
|
62 Participants
|
58 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Vomiting, 28-D FU, OS but worse
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Vomiting, 28-D FU, OS but improved
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Vomiting, 28-D FU, OS but unchanged/absent
|
56 Participants
|
57 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, Week 6/EW, NS
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, Week 6/EW, OS but worse
|
4 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, Week 6/EW, OS but improved
|
4 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, Week 6/EW, OS but unchanged/absent
|
59 Participants
|
62 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, 7-D FU, NS
|
5 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, 7-D FU, OS but worse
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, 7-D FU, OS but improved
|
4 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, 7-D FU, OS but unchanged/absent
|
55 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, 28-D FU, NS
|
1 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, 28-D FU, OS but worse
|
3 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Unusual vision, 7-D FU, NS
|
1 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, 28-D FU, OS but improved
|
2 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Nausea, 28-D FU, OS but unchanged/absent
|
52 Participants
|
52 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, Week 6/EW, NS
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, Week 6/EW, OS but worse
|
2 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, Week 6/EW, OS but improved
|
2 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, 7-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, 7-D FU, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, 7-D FU, OS but improved
|
4 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, 7-D FU, OS but unchanged/absent
|
60 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, 28-D FU, OS but worse
|
0 Participants
|
0 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Diarrhea, 28-D FU, OS but improved
|
0 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, Week 6/EW, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, Week 6/EW, OS but worse
|
4 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, Week 6/EW, OS but improved
|
2 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, Week 6/EW, OS but unchanged/absent
|
63 Participants
|
61 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, 7-D FU, NS
|
1 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, 7-D FU, OS but worse
|
1 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, 7-D FU, OS but improved
|
4 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, 7-D FU, OS but unchanged/absent
|
59 Participants
|
54 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, 28-D FU, NS
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, 28-D FU, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, 28-D FU, OS but improved
|
3 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach cramps, 28-D FU, OS but unchanged/absent
|
55 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, Week 6/EW, NS
|
1 Participants
|
3 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, Week 6/EW, OS but worse
|
4 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, Week 6/EW, OS but improved
|
1 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, Week 6/EW, OS but unchanged/absent
|
63 Participants
|
56 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, 7-D FU, NS
|
2 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, 7-D FU, OS but improved
|
3 Participants
|
5 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, 7-D FU, OS but unchanged/absent
|
59 Participants
|
55 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, 28-D FU, NS
|
0 Participants
|
2 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, 28-D FU, OS but worse
|
0 Participants
|
1 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, 28-D FU, OS but improved
|
3 Participants
|
4 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, 28-D FU, OS but unchanged/absent
|
54 Participants
|
52 Participants
|
|
Discontinuation-Emergent Signs and Symptoms
Stomach bloat, 28-D FU, Missing
|
1 Participants
|
0 Participants
|
Adverse Events
GSK561679
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK561679
n=74 participants at risk
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
|
Placebo
n=76 participants at risk
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/74 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
1.3%
1/76 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
Other adverse events
| Measure |
GSK561679
n=74 participants at risk
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
|
Placebo
n=76 participants at risk
The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
|
|---|---|---|
|
Nervous system disorders
Headache
|
12.2%
9/74 • Number of events 9 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
22.4%
17/76 • Number of events 19 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
Gastrointestinal disorders
Nausea
|
20.3%
15/74 • Number of events 18 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
13.2%
10/76 • Number of events 10 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
6/74 • Number of events 6 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
6.6%
5/76 • Number of events 5 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
5/74 • Number of events 5 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
6.6%
5/76 • Number of events 5 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
3/74 • Number of events 3 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
6.6%
5/76 • Number of events 5 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
Gastrointestinal disorders
Constipation
|
6.8%
5/74 • Number of events 5 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
2.6%
2/76 • Number of events 2 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
Nervous system disorders
Dizziness
|
4.1%
3/74 • Number of events 3 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
5.3%
4/76 • Number of events 4 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
General disorders
Fatigue
|
2.7%
2/74 • Number of events 2 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
6.6%
5/76 • Number of events 5 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
2/74 • Number of events 3 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
5.3%
4/76 • Number of events 4 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
Gastrointestinal disorders
Flatulence
|
1.4%
1/74 • Number of events 1 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
5.3%
4/76 • Number of events 4 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
Psychiatric disorders
Insomnia
|
5.4%
4/74 • Number of events 4 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
1.3%
1/76 • Number of events 1 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
|
General disorders
Irritability
|
0.00%
0/74 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
5.3%
4/76 • Number of events 5 • Up to 28 Day Follow-up (18 months)
All Subject Population
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER