Trial Outcomes & Findings for Study Of 323U66 SR In Major Depressive Disorder (NCT NCT00135512)
NCT ID: NCT00135512
Last Updated: 2019-02-01
Results Overview
The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 8 minus the value at Baseline. Baseline was defined as value at Week 0.
COMPLETED
PHASE2
234 participants
Baseline (Week 0) and Week 8
2019-02-01
Participant Flow
From 01 December 2004 to 28 May 2007, total of 234 participants with major depressive disorder were randomized at 36 centers in Japan.
During the screening (1 week), participants received Dose Level 1; bupropion sustained release (SR) 100 milligrams (mg) placebo tablet once daily in the morning.
Participant milestones
| Measure |
Bupropion SR
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets twice daily (BID; morning and evening) for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks was administered. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
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|---|---|
|
Overall Study
STARTED
|
234
|
|
Overall Study
COMPLETED
|
111
|
|
Overall Study
NOT COMPLETED
|
123
|
Reasons for withdrawal
| Measure |
Bupropion SR
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets twice daily (BID; morning and evening) for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks was administered. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
|
|---|---|
|
Overall Study
Adverse Event
|
56
|
|
Overall Study
Lack of Efficacy
|
25
|
|
Overall Study
Other
|
42
|
Baseline Characteristics
Study Of 323U66 SR In Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Bupropion SR
n=232 Participants
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
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|---|---|
|
Age, Continuous
|
36.1 Years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
231 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Week 8Population: Full analysis set was used.
The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 8 minus the value at Baseline. Baseline was defined as value at Week 0.
Outcome measures
| Measure |
Bupropion SR
n=232 Participants
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
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|---|---|
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Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 in Observed Cases
|
-16.8 Score on a scale
Standard Deviation 8.43
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SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 52Population: Full analysis set was used.
The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 52 minus the value at Baseline. Baseline was defined as value at Week 0.
Outcome measures
| Measure |
Bupropion SR
n=232 Participants
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
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|---|---|
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Change From Baseline in the MADRS Total Score at Week 52 in Observed Cases
|
-24.6 Score on a scale
Standard Deviation 8.34
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 8, 52Population: Full analysis set was used.
Each item was rated on either a 3-point scale (0 to 2; 8 questions) or a 5-point scale (0 to 4; 9 questions), with higher scores indicating greater symptom severity. The total score was calculated by summing the individual response scores. Total score ranged from 0 to 52. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. Change from Baseline in the total score was calculated as the score at Week 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.
Outcome measures
| Measure |
Bupropion SR
n=232 Participants
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
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|---|---|
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Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Weeks 8 and 52 in Observed Cases
Week 8
|
-11.8 Score on a scale
Standard Deviation 6.06
|
|
Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Weeks 8 and 52 in Observed Cases
Week 52
|
-17.3 Score on a scale
Standard Deviation 6.38
|
SECONDARY outcome
Timeframe: Week 8, 52Population: Full analysis set was used.
The CGI-I scale was used to rate improvement in the participant's condition (benefits) since Baseline using the following 7-point scale: 1: very much improved, 2: much improved, 3: minimally improved, 4: not changed, 5: minimally worse, 6: much worse and 7: very much worse. A responder was defined as "very much improved" or "much improved".
Outcome measures
| Measure |
Bupropion SR
n=232 Participants
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
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|---|---|
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Percentage of Participants Who Were Clinical Global Impression Global Improvement (CGI-I) Responders at Weeks 8 and 52 in Observed Cases
Week 8
|
68.7 Percentage of participant
Interval 61.0 to 75.6
|
|
Percentage of Participants Who Were Clinical Global Impression Global Improvement (CGI-I) Responders at Weeks 8 and 52 in Observed Cases
Week 52
|
89.0 Percentage of participant
Interval 81.6 to 94.2
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 8, 52Population: Full analysis set was used.
CGI-SI was assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill and 7, among the most extremely ill. Higher score indicated severely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.
Outcome measures
| Measure |
Bupropion SR
n=232 Participants
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
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|---|---|
|
Change From Baseline in CGI Severity of Illness (CGI-SI) at Weeks 8 and 52 in Observed Cases
Week 8
|
-1.3 Score on a scale
Standard Deviation 0.98
|
|
Change From Baseline in CGI Severity of Illness (CGI-SI) at Weeks 8 and 52 in Observed Cases
Week 52
|
-2.3 Score on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 8, 52Population: Full analysis set was used.
SDISS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. To get a total score, 3 individual scores were added and the total score ranged from "0 = unimpaired" to "30 = highly impaired". Higher scores indicate worsening. The change from Baseline in SDISS total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.
Outcome measures
| Measure |
Bupropion SR
n=232 Participants
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
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|---|---|
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Change From Baseline in the Sheehan Disability Scale (SDISS) Total Score at Weeks 8 and 52 in Observed Cases
Week 8
|
-5.0 Score on a scale
Standard Deviation 5.54
|
|
Change From Baseline in the Sheehan Disability Scale (SDISS) Total Score at Weeks 8 and 52 in Observed Cases
Week 52
|
-9.7 Score on a scale
Standard Deviation 7.31
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 8, 52Population: Full analysis set was used.
The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy and social motivation. Minimal clinically important differences were estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels and items were reverse-scored as necessary such that higher scores represent higher health-related quality of life (HRQoL) total score ranges from 0 to 108 points. Recall period was past week prior to administration. The change from Baseline in MEI-SF total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.
Outcome measures
| Measure |
Bupropion SR
n=232 Participants
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
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|---|---|
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Change From Baseline in the Motivation Energy Inventory Short Form (MEI-SF) Total Score at Weeks 8 and 52 in Observed Cases
Week 8
|
15.2 Score on a scale
Standard Deviation 15.51
|
|
Change From Baseline in the Motivation Energy Inventory Short Form (MEI-SF) Total Score at Weeks 8 and 52 in Observed Cases
Week 52
|
26.7 Score on a scale
Standard Deviation 20.54
|
Adverse Events
Bupropion SR
Serious adverse events
| Measure |
Bupropion SR
n=233 participants at risk
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
|
|---|---|
|
Psychiatric disorders
Depression
|
1.3%
3/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Psychiatric disorders
Suicidal ideation
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Intentional misuse
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Grand mal convulsion
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Tremor
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
General disorders
Death
|
0.43%
1/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
Other adverse events
| Measure |
Bupropion SR
n=233 participants at risk
During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
36.5%
85/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
General disorders
Thirst
|
18.0%
42/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Nausea
|
11.2%
26/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Headache
|
9.4%
22/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Psychiatric disorders
Depression
|
7.3%
17/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Dizziness
|
6.9%
16/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.0%
14/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
14/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
14/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Stomach discomfort
|
6.0%
14/233 • All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
|
Additional Information
GSK Response Center
GlaxoSmithKline
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