Trial Outcomes & Findings for Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors (NCT NCT00296517)
NCT ID: NCT00296517
Last Updated: 2019-12-04
Results Overview
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
325 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2019-12-04
Participant Flow
Pre-treatment period: Paroxetine 40 mg/day was administered for four weeks in subjects treated with marketed paroxetine between doses of 20 and 40 mg/day for four weeks or more prior to tapering pretreatment period. Tapering pretreatment period: Paroxetine was tapered down weekly by 10 mg/day in subjects who were progressed to treatment period.
Participant milestones
| Measure |
Placebo
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Dose Level 1 - Week 1
STARTED
|
159
|
166
|
|
Dose Level 1 - Week 1
COMPLETED
|
159
|
166
|
|
Dose Level 1 - Week 1
NOT COMPLETED
|
0
|
0
|
|
Dose Level 2 - Week 2
STARTED
|
159
|
166
|
|
Dose Level 2 - Week 2
COMPLETED
|
157
|
161
|
|
Dose Level 2 - Week 2
NOT COMPLETED
|
2
|
5
|
|
Dose Level 3 - Weeks 3-12
STARTED
|
157
|
161
|
|
Dose Level 3 - Weeks 3-12
COMPLETED
|
112
|
99
|
|
Dose Level 3 - Weeks 3-12
NOT COMPLETED
|
45
|
62
|
Reasons for withdrawal
| Measure |
Placebo
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Dose Level 2 - Week 2
Adverse Event
|
1
|
5
|
|
Dose Level 2 - Week 2
Withdrawal by Subject
|
1
|
0
|
|
Dose Level 3 - Weeks 3-12
Adverse Event
|
30
|
34
|
|
Dose Level 3 - Weeks 3-12
Lack of Efficacy
|
3
|
6
|
|
Dose Level 3 - Weeks 3-12
Lost to Follow-up
|
3
|
2
|
|
Dose Level 3 - Weeks 3-12
Protocol Violation
|
1
|
0
|
|
Dose Level 3 - Weeks 3-12
Withdrawal by Subject
|
7
|
18
|
|
Dose Level 3 - Weeks 3-12
Non - Compliance
|
1
|
0
|
|
Dose Level 3 - Weeks 3-12
Other
|
0
|
2
|
Baseline Characteristics
Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors
Baseline characteristics by cohort
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
Total
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.0 Years
STANDARD_DEVIATION 8.91 • n=5 Participants
|
36.8 Years
STANDARD_DEVIATION 9.28 • n=7 Participants
|
36.4 Years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
157 participants
n=5 Participants
|
165 participants
n=7 Participants
|
322 participants
0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set was all subjects who entered the treatment phase with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment. Week 12/LOCF placebo = 155, Bupropion SR = 160
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score
Baseline
|
19.8 Score in scale
Standard Deviation 4.34
|
19.4 Score in scale
Standard Deviation 4.39
|
|
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score
Week 12 or Last Observation Carried Forward
|
14.7 Score in scale
Standard Deviation 8.89
|
14.6 Score in scale
Standard Deviation 9.09
|
|
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score
Change from Baseline
|
-5.1 Score in scale
Standard Deviation 8.02
|
-4.9 Score in scale
Standard Deviation 8.34
|
SECONDARY outcome
Timeframe: Week 8 and Week 12Population: Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Hamilton Depression Scale (HAM-D 17 Items) Total Score
Week 8 Mean - Last Observation Carried Forward
|
15.8 Score in scale
Standard Deviation 8.04
|
15.4 Score in scale
Standard Deviation 8.32
|
|
Hamilton Depression Scale (HAM-D 17 Items) Total Score
Week 8 Mean - Observed Cases
|
13.3 Score in scale
Standard Deviation 6.74
|
12.1 Score in scale
Standard Deviation 6.28
|
|
Hamilton Depression Scale (HAM-D 17 Items) Total Score
Week 12 Mean - Observed Cases
|
11.3 Score in scale
Standard Deviation 7.09
|
10.3 Score in scale
Standard Deviation 6.83
|
SECONDARY outcome
Timeframe: Baseline to Week 8 and Week 12Population: Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12
Week 8 Mean - Last Observation Carried Forward
|
-4.1 Score in a scale
Standard Deviation 7.07
|
-4.0 Score in a scale
Standard Deviation 7.60
|
|
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12
Week 8 Mean - Observed Cases
|
-6.4 Score in a scale
Standard Deviation 5.77
|
-7.4 Score in a scale
Standard Deviation 5.75
|
|
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12
Week 12 Mean - Observed Cases
|
-8.3 Score in a scale
Standard Deviation 6.38
|
-9.2 Score in a scale
Standard Deviation 5.98
|
SECONDARY outcome
Timeframe: Baseline to Week 8 and Week 12Population: Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.
Week 8 Mean - Last Observation Carried Forward
|
-21.0 Percent Change in score
Standard Deviation 37.31
|
-20.8 Percent Change in score
Standard Deviation 38.87
|
|
Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.
Week 8 Mean - Observed Cases
|
-33.2 Percent Change in score
Standard Deviation 30.51
|
-38.2 Percent Change in score
Standard Deviation 28.68
|
|
Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.
Week 12 Mean - Last Observation Carried Forward
|
-26.5 Percent Change in score
Standard Deviation 41.65
|
-25.5 Percent Change in score
Standard Deviation 43.05
|
|
Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.
Week 12 Mean - Observed Cases
|
-43.0 Percent Change in score
Standard Deviation 32.51
|
-48.4 Percent Change in score
Standard Deviation 29.96
|
SECONDARY outcome
Timeframe: Baseline to Week 8 and Week 12Population: Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160, Week 12 Observed Cases: placebo = 111, Bupropion = 98
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Responders are defined as subjects with 50% or greater reduction from baseline in HAM-D total score.
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Week 8 Mean Last Observation Carried Forward
|
24 Percentage of Responders
Interval 17.8 to 32.0
|
26 Percentage of Responders
Interval 19.1 to 33.1
|
|
Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Week 8 Mean Observed Cases
|
31 Percentage of Responders
Interval 22.6 to 40.4
|
38 Percentage of Responders
Interval 28.5 to 47.7
|
|
Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Week 12 Mean Last Observation Carried Forward
|
37 Percentage of Responders
Interval 29.8 to 45.5
|
38 Percentage of Responders
Interval 30.6 to 46.1
|
|
Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Week 12 Mean Observed Cases
|
50 Percentage of Responders
Interval 40.8 to 60.1
|
59 Percentage of Responders
Interval 48.8 to 69.0
|
SECONDARY outcome
Timeframe: Baseline to Week 8 and Week 12Population: Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Remitters are defined as subjects with HAM-D total score ≤ 7.
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Week 8 Mean Last Observation Carried Forward
|
18 Percentage of Remitters
Interval 12.0 to 24.8
|
18 Percentage of Remitters
Interval 12.5 to 25.0
|
|
Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Week 8 Mean Observed Cases
|
22 Percentage of Remitters
Interval 14.9 to 30.9
|
26 Percentage of Remitters
Interval 18.3 to 35.9
|
|
Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Week 12 Mean Last Observation Carried Forward
|
25 Percentage of Remitters
Interval 18.5 to 32.8
|
24 Percentage of Remitters
Interval 17.4 to 31.1
|
|
Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Week 12 Mean Observed Cases
|
33 Percentage of Remitters
Interval 24.7 to 42.9
|
38 Percentage of Remitters
Interval 28.2 to 48.1
|
SECONDARY outcome
Timeframe: Baseline to Week 8 and Week 12Population: Full Analysis Set. Week 8 Last Observation Carried Forward (LOCF): placebo=152, Bupropion=160; Week 12 LOCF: placebo=155, Bupropion=160. Gastrointestinal, GI.
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Hypochondriasis, Week 8 Mean LOCF
|
-0.2 points on a scale
Standard Deviation 0.77
|
-0.1 points on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Hypochondriasis, Week 12 Mean LOCF
|
-0.3 points on a scale
Standard Deviation 0.78
|
-0.2 points on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Loss of Weight by History, Week 8 Mean LOCF
|
-0.1 points on a scale
Standard Deviation 0.60
|
-0.0 points on a scale
Standard Deviation 0.58
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Loss of Weight by History, Week 12 Mean LOCF
|
-0.1 points on a scale
Standard Deviation 0.63
|
0.0 points on a scale
Standard Deviation 0.64
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insight, Week 8 Mean LOCF
|
-0.1 points on a scale
Standard Deviation 0.34
|
-0.1 points on a scale
Standard Deviation 0.41
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Depressed Mood, Week 8 Mean LOCF
|
-0.5 points on a scale
Standard Deviation 1.07
|
-0.5 points on a scale
Standard Deviation 1.20
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Depressed Mood, Week 12 Mean LOCF
|
-0.6 points on a scale
Standard Deviation 1.17
|
-0.6 points on a scale
Standard Deviation 1.30
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Feelings of Guilt, Week 8 Mean LOCF
|
-0.3 points on a scale
Standard Deviation 0.91
|
-0.3 points on a scale
Standard Deviation 0.75
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Feelings of Guilt, Week 12 Mean LOCF
|
-0.3 points on a scale
Standard Deviation 0.90
|
-0.4 points on a scale
Standard Deviation 0.77
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Suicide, Week 8 Mean LOCF
|
-0.1 points on a scale
Standard Deviation 0.82
|
-0.1 points on a scale
Standard Deviation 0.73
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Suicide, Week 12 Mean LOCF
|
-0.1 points on a scale
Standard Deviation 0.82
|
-0.1 points on a scale
Standard Deviation 0.72
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Early, Week 8 Mean LOCF
|
-0.3 points on a scale
Standard Deviation 0.83
|
-0.3 points on a scale
Standard Deviation 0.82
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Early, Week 12 Mean LOCF
|
-0.4 points on a scale
Standard Deviation 0.85
|
-0.3 points on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Middle, Week 8 Mean LOCF
|
-0.4 points on a scale
Standard Deviation 0.87
|
-0.3 points on a scale
Standard Deviation 0.73
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Middle, Week 12 Mean LOCF
|
-0.4 points on a scale
Standard Deviation 0.91
|
-0.3 points on a scale
Standard Deviation 0.79
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Late, Week 8 Mean LOCF
|
-0.3 points on a scale
Standard Deviation 0.87
|
-0.3 points on a scale
Standard Deviation 0.78
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Late, Week 12 Mean LOCF
|
-0.3 points on a scale
Standard Deviation 0.91
|
-0.4 points on a scale
Standard Deviation 0.88
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Work and Activities, Week 8 Mean LOCF
|
-0.4 points on a scale
Standard Deviation 0.93
|
-0.4 points on a scale
Standard Deviation 1.18
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Work and Activities, Week 12 Mean LOCF
|
-0.6 points on a scale
Standard Deviation 1.13
|
-0.5 points on a scale
Standard Deviation 1.35
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Retardation, Week 8 Mean LOCF
|
-0.2 points on a scale
Standard Deviation 0.69
|
-0.2 points on a scale
Standard Deviation 0.68
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Retardation, Week 12 Mean LOCF
|
-0.3 points on a scale
Standard Deviation 0.78
|
-0.3 points on a scale
Standard Deviation 0.73
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Agitation, Week 8 Mean LOCF
|
-0.2 points on a scale
Standard Deviation 0.68
|
-0.2 points on a scale
Standard Deviation 0.77
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Agitation, Week 12 Mean LOCF
|
-0.3 points on a scale
Standard Deviation 0.77
|
-0.2 points on a scale
Standard Deviation 0.77
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Anxiety Psychic, Week 8 Mean LOCF
|
-0.3 points on a scale
Standard Deviation 1.16
|
-0.4 points on a scale
Standard Deviation 1.10
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Anxiety Psychic, Week 12 Mean LOCF
|
-0.5 points on a scale
Standard Deviation 1.26
|
-0.5 points on a scale
Standard Deviation 1.19
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Anxiety Somatic, Week 8 Mean LOCF
|
-0.2 points on a scale
Standard Deviation 0.88
|
-0.3 points on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Anxiety Somatic, Week 12 Mean LOCF
|
-0.3 points on a scale
Standard Deviation 0.89
|
-0.4 points on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Somatic Symptoms GI, Week 8 Mean LOCF
|
-0.1 points on a scale
Standard Deviation 0.61
|
0.0 points on a scale
Standard Deviation 0.74
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Somatic Symptoms GI, Week 12 Mean LOCF
|
-0.1 points on a scale
Standard Deviation 0.64
|
-0.0 points on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Somatic Symptoms General, Week 8 Mean LOCF
|
-0.2 points on a scale
Standard Deviation 0.65
|
-0.2 points on a scale
Standard Deviation 0.69
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Somatic Symptoms General, Week 12 Mean LOCF
|
-0.2 points on a scale
Standard Deviation 0.71
|
-0.3 points on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Genital Symptoms, Week 8 Mean LOCF
|
-0.2 points on a scale
Standard Deviation 0.58
|
-0.2 points on a scale
Standard Deviation 0.62
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Genital Symptoms, Week 12 Mean LOCF
|
-0.2 points on a scale
Standard Deviation 0.66
|
-0.3 points on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insight, Week 12 Mean LOCF
|
-0.1 points on a scale
Standard Deviation 0.38
|
-0.1 points on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Baseline to Week 8 and Week 12Population: Full Analysis Set. Last Observation Carried Forward, LOCF; Gastrointestinal, GI; Somatic, Som.; General, Gen.; Week, W.
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Depressed Mood, Week 8 Mean LOCF, n=152, 158
|
-17.7 percent change in score
Standard Deviation 60.38
|
-18.5 percent change in score
Standard Deviation 62.38
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Depressed Mood, Week 12 Mean LOCF, n=155, 158
|
-25.9 percent change in score
Standard Deviation 62.78
|
-22.2 percent change in score
Standard Deviation 68.41
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Feelings of Guilt, Week 8 Mean LOCF, n=128, 131
|
-24.9 percent change in score
Standard Deviation 55.10
|
-25.8 percent change in score
Standard Deviation 52.83
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Feelings of Guilt, Week 12 Mean LOCF, n=129, 131
|
-30.7 percent change in score
Standard Deviation 56.34
|
-30.8 percent change in score
Standard Deviation 53.61
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Suicide, Week 8 Mean LOCF, n=79, 75
|
-34.2 percent change in score
Standard Deviation 60.20
|
-26.7 percent change in score
Standard Deviation 70.87
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Suicide, Week 12 Mean LOCF, n=80, 75
|
-37.5 percent change in score
Standard Deviation 56.53
|
-26.0 percent change in score
Standard Deviation 74.14
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Early, Week 8 Mean LOCF, n=112, 119
|
-34.8 percent change in score
Standard Deviation 53.20
|
-29.8 percent change in score
Standard Deviation 54.59
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Early, Week 12 Mean LOCF, n=114, 119
|
-42.5 percent change in score
Standard Deviation 53.73
|
-31.9 percent change in score
Standard Deviation 58.49
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Middle, Week 8 Mean LOCF, n=119, 124
|
-42.0 percent change in score
Standard Deviation 53.28
|
-32.3 percent change in score
Standard Deviation 51.48
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Middle, Week 12 Mean LOCF, n=122, 124
|
-48.4 percent change in score
Standard Deviation 54.90
|
-37.1 percent change in score
Standard Deviation 54.43
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Late, Week 8 Mean LOCF, n=109, 117
|
-39.9 percent change in score
Standard Deviation 56.43
|
-31.6 percent change in score
Standard Deviation 54.38
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insomnia Late, Week 12 Mean LOCF, n=110, 117
|
-43.2 percent change in score
Standard Deviation 61.88
|
-37.2 percent change in score
Standard Deviation 62.34
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Work and Activities, Week 8 Mean LOCF, n=151, 156
|
-16.6 percent change in score
Standard Deviation 43.93
|
-15.3 percent change in score
Standard Deviation 55.66
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Work and Activities, Week 12 Mean LOCF, n=154, 156
|
-23.3 percent change in score
Standard Deviation 47.61
|
-19.4 percent change in score
Standard Deviation 62.51
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Retardation, Week 8 Mean LOCF, n=114, 124
|
-28.4 percent change in score
Standard Deviation 58.70
|
-31.0 percent change in score
Standard Deviation 53.19
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Retardation, Week 12 Mean LOCF, n=117, 124
|
-32.5 percent change in score
Standard Deviation 63.08
|
-38.3 percent change in score
Standard Deviation 56.71
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Agitation, Week 8 Mean LOCF, n=87, 99
|
-38.7 percent change in score
Standard Deviation 61.87
|
-44.9 percent change in score
Standard Deviation 60.40
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Agitation, Week 12 Mean LOCF, n=89, 99
|
-51.1 percent change in score
Standard Deviation 64.83
|
-44.9 percent change in score
Standard Deviation 63.28
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Anxiety Psychic, Week 8 Mean LOCF, n=146, 151
|
-14.0 percent change in score
Standard Deviation 58.25
|
-17.9 percent change in score
Standard Deviation 55.14
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Anxiety Psychic, Week 12 Mean LOCF, n=148, 151
|
-19.1 percent change in score
Standard Deviation 62.70
|
-21.0 percent change in score
Standard Deviation 66.45
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Anxiety Somatic, Week 8 Mean LOCF, n=144, 155
|
-9.5 percent change in score
Standard Deviation 57.89
|
-13.9 percent change in score
Standard Deviation 60.12
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Anxiety Somatic, Week 12 Mean LOCF, n=147, 155
|
-13.7 percent change in score
Standard Deviation 59.35
|
-17.7 percent change in score
Standard Deviation 63.07
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Somatic Symptoms GI, Week 8 Mean LOCF, n=95, 93
|
-30.5 percent change in score
Standard Deviation 56.16
|
-25.8 percent change in score
Standard Deviation 63.68
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Somatic Symptoms GI, Week 12 Mean LOCF, n=97, 93
|
-23.7 percent change in score
Standard Deviation 62.12
|
-34.9 percent change in score
Standard Deviation 65.02
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Somatic Symptoms Gen., Week 8 Mean LOCF, n=146,152
|
-13.4 percent change in score
Standard Deviation 50.61
|
-18.8 percent change in score
Standard Deviation 48.08
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Som. Symptoms Gen., Week 12 Mean LOCF, n=149, 152
|
-15.8 percent change in score
Standard Deviation 54.55
|
-23.7 percent change in score
Standard Deviation 51.13
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Genital Symptoms, Week 8 Mean LOCF, n=115, 129
|
-15.2 percent change in score
Standard Deviation 45.97
|
-21.7 percent change in score
Standard Deviation 45.86
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Genital Symptoms, Week 12 Mean LOCF, n=118, 129
|
-16.5 percent change in score
Standard Deviation 51.50
|
-29.5 percent change in score
Standard Deviation 50.24
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Hypochondriasis, Week 8 Mean LOCF, n=93, 102
|
-34.6 percent change in score
Standard Deviation 55.78
|
-28.3 percent change in score
Standard Deviation 63.70
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Hypochondriasis, Week 12 Mean LOCF, n=95, 102
|
-38.6 percent change in score
Standard Deviation 56.82
|
-38.1 percent change in score
Standard Deviation 66.27
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Loss of Weight by Hist., W 8 Mean LOCF, n=32, 26
|
-60.9 percent change in score
Standard Deviation 45.32
|
-51.9 percent change in score
Standard Deviation 57.41
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Loss of Weight by Hist., W 12 Mean LOCF, n=34, 26
|
-58.8 percent change in score
Standard Deviation 48.42
|
-57.7 percent change in score
Standard Deviation 57.78
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insight, Week 8 Mean LOCF, n=48, 51
|
-27.1 percent change in score
Standard Deviation 44.91
|
-41.2 percent change in score
Standard Deviation 49.71
|
|
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Insight, Week 12 Mean LOCF, n=49, 51
|
-36.7 percent change in score
Standard Deviation 48.71
|
-47.1 percent change in score
Standard Deviation 50.41
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 2, 3, 4, 8, and 12Population: Full Analysis Set
The 7-point Clinical Global Impressions-Severity of Illness Scale (CGI-S) measures the severity of psychiatric symptoms. The following scores can be given: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients.
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 1 Mean LOCF, n=157, 165
|
-0.0 Points on scale
Standard Deviation 0.45
|
0.0 Points on scale
Standard Deviation 0.51
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 1 Mean OC, n=139, 143
|
-0.1 Points on scale
Standard Deviation 0.40
|
-0.0 Points on scale
Standard Deviation 0.45
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 2 Mean LOCF, n=157, 165
|
-0.1 Points on scale
Standard Deviation 0.63
|
-0.1 Points on scale
Standard Deviation 0.71
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 2 Mean OC, n=134, 132
|
-0.2 Points on scale
Standard Deviation 0.59
|
-0.3 Points on scale
Standard Deviation 0.66
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 3 Mean LOCF, n=157, 165
|
-0.2 Points on scale
Standard Deviation 0.71
|
-0.2 Points on scale
Standard Deviation 0.73
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 3 Mean OC, n=130, 127
|
-0.3 Points on scale
Standard Deviation 0.61
|
-0.4 Points on scale
Standard Deviation 0.65
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 4 Mean LOCF, n=157, 165
|
-0.2 Points on scale
Standard Deviation 0.76
|
-0.2 Points on scale
Standard Deviation 0.83
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 4 Mean OC, n=127, 116
|
-0.4 Points on scale
Standard Deviation 0.65
|
-0.4 Points on scale
Standard Deviation 0.77
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 8 Mean LOCF, n=157, 164
|
-0.5 Points on scale
Standard Deviation 1.02
|
-0.5 Points on scale
Standard Deviation 1.01
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 8 Mean OC, n=113, 106
|
-0.7 Points on scale
Standard Deviation 0.87
|
-0.9 Points on scale
Standard Deviation 0.85
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 12 Mean LOCF, n=157, 163
|
-0.6 Points on scale
Standard Deviation 1.12
|
-0.6 Points on scale
Standard Deviation 1.15
|
|
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Week 12 Mean OC, n=111, 98
|
-0.9 Points on scale
Standard Deviation 0.90
|
-1.1 Points on scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Baseline to Week 8 and Week 12Population: Full Analysis set. Week 8 Last Observation Carried Forward: placebo = 153, Bupropion = 159; Week 8 Observed Cases: placebo = 113, Bupropion = 106; Week 12 Last Observation Carried Forward: placebo = 156, Bupropion = 158; Week 12 Observed Cases: placebo = 111, Bupropion = 98
The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12
Week 8 Mean Last Observation Carried Forward
|
33 Percentage of Responders
Interval 25.9 to 41.4
|
38 Percentage of Responders
Interval 30.8 to 46.4
|
|
Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12
Week 8 Mean Observed Cases
|
42 Percentage of Responders
Interval 32.4 to 51.2
|
57 Percentage of Responders
Interval 46.6 to 66.2
|
|
Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12
Week 12 Mean Last Observation Carried Forward
|
44 Percentage of Responders
Interval 35.7 to 51.8
|
48 Percentage of Responders
Interval 40.1 to 56.2
|
|
Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12
Week 12 Mean Observed Cases
|
57 Percentage of Responders
Interval 47.0 to 66.1
|
73 Percentage of Responders
Interval 63.6 to 81.9
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).
Kaplan-Meier estimates were calculated using event or censoring and time to event or censoring. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).
Outcome measures
| Measure |
Placebo
n=157 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=165 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12
Participants at risk
|
102 participants
|
90 participants
|
|
Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12
Participants not at risk
|
55 participants
|
75 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Safety population: comprised of participants who took at least one dose of the treatment period investigational product. The number of participants analyzed for this outcome measure represents the total number of events at each intensity.
Assessment of intensity was based on investigators/subinvestigator's clinical judgement per protocol instructions: Mild event, easily tolerated, with minimal discomfort and not interfering with Activities of Daily Living (ADLs); moderate event, with discomfort that interferes with ADLs; severe event, prevents ADLs.
Outcome measures
| Measure |
Placebo
n=159 Participants
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=166 Participants
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Rash, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Drug Withdrawal Syndrome, moderate
|
2 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Pigmentation disorder, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Sweat Gland Disorder, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Sweat Gland Disorder, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Sweat Gland Disorder, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Drug Withdrawal Syndrome, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Thirst, mild
|
4 Number of events
|
9 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Thirst, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Thirst, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Malaise, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Malaise, moderate
|
2 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Nervous System Disorders (NSD) - Any Event, mild
|
32 Number of events
|
31 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Any Event, moderate
|
8 Number of events
|
16 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Any Event, severe
|
1 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dizziness, mild
|
11 Number of events
|
8 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dizziness, moderate
|
4 Number of events
|
8 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dizziness, severe
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Headache, mild
|
6 Number of events
|
8 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Headache, moderate
|
3 Number of events
|
6 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Headache, severe
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Somnolence, mild
|
10 Number of events
|
8 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Somnolence, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Somnolence, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Hypoesthesia, mild
|
5 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Hypoesthesia, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Hypoesthesia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dysgeusia, mild
|
0 Number of events
|
4 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dysgeusia, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dysgeusia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Depressed Level of Consciousness, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Depressed Level of Consciousness, moderate
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Depressed Level of Consciousness, severe
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Tremor, mild
|
0 Number of events
|
4 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Tremor, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Tremor, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Convulsion, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Convulsion, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Convulsion, severe
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dizziness postural, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dizziness postural, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dizziness postural, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dysesthesia, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dysesthesia, moderate
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dysesthesia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Parosmia, mild
|
2 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Parosmia, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Parosmia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Akathisia, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Akathisia, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Akathisia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Anterograde Amnesia, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Anterograde Amnesia, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Anterograde Amnesia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dysarthria, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dysarthria, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Dysarthria, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Head discomfort, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Head discomfort, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Head discomfort, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Hyperesthesia, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Hyperesthesia, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Hyperesthesia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Loss of consciousness, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Loss of consciousness, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Loss of consciousness, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Paraesthesia, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Paraesthesia, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
NSD - Paraesthesia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Gastrointestinal Disorders (GID)-Any Event, mild
|
28 Number of events
|
32 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Any Event, moderate
|
15 Number of events
|
14 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Any Event, severe
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Nausea, mild
|
12 Number of events
|
16 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Nausea, moderate
|
8 Number of events
|
10 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Nausea, severe
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Diarrhea, mild
|
6 Number of events
|
6 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Diarrhea, moderate
|
3 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Diarrhea, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Vomiting, mild
|
4 Number of events
|
5 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Vomiting, moderate
|
4 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Vomiting, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Pain upper, mild
|
0 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Pain upper, moderate
|
1 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Pain upper, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Stomach Discomfort, mild
|
2 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Stomach Discomfort, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Stomach Discomfort, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Constipation, mild
|
5 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Constipation, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Constipation, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Pain, mild
|
1 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Pain, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Pain, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Stomatitis, mild
|
1 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Stomatitis, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Stomatitis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Toothache, mild
|
2 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Toothache, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Toothache, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Distension, mild
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Distension, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Distension, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Gastritis, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Gastritis, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Gastritis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Hypoesthesia oral, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Hypoesthesia oral, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Hypoesthesia oral, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Melaena, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Melaena, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Melaena, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Pain Lower, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Pain Lower, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Abdominal Pain Lower, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Dyspepsia, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Dyspepsia, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Dyspepsia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Gingival Swelling, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Gingival Swelling, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GID - Gingival Swelling, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Infections and Infestations (INF)-Any Event, mild
|
38 Number of events
|
30 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Any Event, moderate
|
3 Number of events
|
4 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Nasopharyngitis, mild
|
31 Number of events
|
24 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Nasopharyngitis, moderate
|
0 Number of events
|
4 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Nasopharyngitis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Gastrointestinal infection, mild
|
3 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Gastrointestinal infection, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Gastrointestinal infection, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Bronchitis acute, mild
|
0 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Bronchitis acute, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Bronchitis acute, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Bronchitis, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Bronchitis, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Bronchitis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Gastroenteritis, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Gastroenteritis, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Gastroenteritis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Enteritis Infectious, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Enteritis Infectious, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Enteritis Infectious, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Gastroenteritis viral, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Gastroenteritis viral, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Gastroenteritis viral, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Otitis Externa, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Otitis Externa, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Otitis Externa, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Purulence, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Purulence, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Purulence, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Rhinitis, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Rhinitis, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Rhinitis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Vaginal Candidiasis, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Vaginal Candidiasis, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INF - Vaginal Candidiasis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Psychiatric Disorders (PsyDO) - Any Event, mild
|
8 Number of events
|
10 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Any Event, moderate
|
13 Number of events
|
14 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Any Event, severe
|
7 Number of events
|
5 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Depression, mild
|
2 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Depression, moderate
|
11 Number of events
|
9 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Depression, severe
|
7 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Insomnia, mild
|
0 Number of events
|
4 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Insomnia, moderate
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Insomnia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Mood altered, mild
|
3 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Mood altered, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Mood altered, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Mania, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Mania, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Mania, severe
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Anxiety, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Anxiety, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Anxiety, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Bipolar Disorder, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Bipolar Disorder, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Bipolar Disorder, severe
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Bruxism, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Bruxism, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Bruxism, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Delerium, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Delerium, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Delerium, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Depression suicidal, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Depression suicidal, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Depression suicidal, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Dysphoria, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Dysphoria, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Dysphoria, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Early morning awakening, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Early morning awakening, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Early morning awakening, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Hallucination, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Hallucination, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Hallucination, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Hypomania, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Hypomania, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Hypomania, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Intentional self-injury, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Intentional self-injury, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Intentional self-injury, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Libido decreased, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Libido decreased, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Libido decreased, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Nightmare, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Nightmare, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
PsyDO - Nightmare, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
General Disorders (GD) - Any Event, mild
|
10 Number of events
|
16 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Any Event, moderate
|
5 Number of events
|
5 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Drug Withdrawal Syndrome, mild
|
2 Number of events
|
6 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Malaise, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Feeling abnormal, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Feeling abnormal, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Feeling abnormal, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Irritability, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Irritability, moderate
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Irritability, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Chills, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Chills, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Chills, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Edema, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Edema, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Edema, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Edema peripheral, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Edema peripheral, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Edema peripheral, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Pain, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Pain, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
GD - Pain, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Skin & tissue disorders (SDO) - Any Event, mild
|
6 Number of events
|
8 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Any Event, moderate
|
1 Number of events
|
6 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Any Event, severe
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Urticaria, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Urticaria, moderate
|
0 Number of events
|
4 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Urticaria, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Rash, mild
|
1 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Rash, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Eczema, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Eczema, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Eczema, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hyperhidrosis, mild
|
2 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hyperhidrosis, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hyperhidrosis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hypoesthesia facial, mild
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hypoesthesia facial, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hypoesthesia facial, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Pruritus generalised, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Pruritus generalised, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Pruritus generalised, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Alopecia, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Alopecia, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Alopecia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Alopecia areata, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Alopecia areata, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Alopecia areata, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Dermatitis Contact, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Dermatitis Contact, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Dermatitis Contact, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Erythema, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Erythema, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Erythema, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hemorrhage subcutaneous, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hemorrhage subcutaneous, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hemorrhage subcutaneous, severe
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hyperkeratosis, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hyperkeratosis, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Hyperkeratosis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Pigmentation disorder, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
SDO - Pigmentation disorder, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Investigations (INV) - Any Event, mild
|
5 Number of events
|
10 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Any Event, moderate
|
1 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Alanine Aminotransferase increased, mild
|
3 Number of events
|
4 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Alanine Aminotransferase increased, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Alanine Aminotransferase increased, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Weight decreased, mild
|
0 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Weight decreased, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Weight decreased, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Aspartate Aminotransferase increased, mild
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV-Aspartate Aminotransferase increased, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Aspartate Aminotransferase increased, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Blood Bilirubin increased, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Blood Bilirubin increased, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Blood Bilirubin increased, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Glucose urine present, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Glucose urine present, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Glucose urine present, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Protein urine present, mild
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Protein urine present, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Protein urine present, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - White Blood Cell Count decreased, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - White Blood Cell Count decreased, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - White Blood Cell Count decreased, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Blood pressure decreased, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Blood pressure decreased, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Blood pressure decreased, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Electrocardiogram T wave inversion, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Electrocardiogram T wave inversion, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Electrocardiogram T wave inversion, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Hematocrit decreased, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Hematocrit decreased, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Hematocrit decreased, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Hemoglobin decreased, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Hemoglobin decreased, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Hemoglobin decreased, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Red Blood Cell Count decreased, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Red Blood Cell Count decreased, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
INV - Red Blood Cell Count decreased, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Musculoskeletal Disorders (MD) - Any Event, mild
|
9 Number of events
|
6 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Any Event, moderate
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Back Pain, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Back Pain, moderate
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Back Pain, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Musculoskeletal stiffness, mild
|
3 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Musculoskeletal stiffness, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Musculoskeletal stiffness, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Myalgia, mild
|
2 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Myalgia, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Myalgia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Neck Pain, mild
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Neck Pain, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Neck Pain, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Pain in extremity, mild
|
2 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Pain in extremity, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Pain in extremity, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Arthralgia, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Arthralgia, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Arthralgia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Fasciitis, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Fasciitis, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MD - Fasciitis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Respiratory Disorders (RTM) - Any Event, mild
|
4 Number of events
|
6 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM -Any Event, moderate
|
0 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM -Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM - Upper respiratory Tract inflammation, mild
|
3 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM-Upp. respiratory Tract inflammation, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM-Upp. respiratory Tract inflammation, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM - Asthma, mild
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM - Asthma, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM - Asthma, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM - Cough, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM - Cough, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM - Cough, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM - Pharyngolaryngeal Pain, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM - Pharyngolaryngeal Pain, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RTM - Pharyngolaryngeal Pain, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Injury and complications (IPPC) - Any Event, mild
|
2 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Any Event, moderate
|
1 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Contusion, mild
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Contusion, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Contusion, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Intentional Overdose, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Intentional Overdose, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Intentional Overdose, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Head Injury, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Head Injury, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Head Injury, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Joint sprain, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Joint sprain, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Joint sprain, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Rib fracture, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Rib fracture, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Rib fracture, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Thermal Burn, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Thermal Burn, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Thermal Burn, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Wound, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Wound, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
IPPC - Wound, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Ear Disorders (ED) - Any Event, mild
|
3 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ED - Any Event, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ED - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ED - Tinnitus, mild
|
2 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ED - Tinnitus, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ED - Tinnitus, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ED - Ear Discomfort, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ED - Ear Discomfort, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ED - Ear Discomfort, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Eye Disorders (EyeDO) - Any Event, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Any Event, moderate
|
0 Number of events
|
3 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Chalazion, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Chalazion, moderate
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Chalazion, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Abnormal sensations in eye, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Abnormal sensations in eye, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Abnormal sensations in eye, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Conjunctival haemorrhage, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Conjunctival haemorrhage, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
EyeDO - Conjunctival haemorrhage, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Metabolism Disorders (MetDO) - Any Event, mild
|
2 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Any Event, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Anorexia, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Anorexia, moderate
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Anorexia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Dehydration, mild
|
2 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Dehydration, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Dehydration, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Hyperlipidemia, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Hyperlipidemia, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Hyperlipidemia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Hypovitaminosis, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Hypovitaminosis, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
MetDO - Hypovitaminosis, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Vascular Disorders (VD) - Any Event, mild
|
2 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
VD - Any Event, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
VD - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
VD - Hot Flush, mild
|
1 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
VD - Hot Flush, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
VD - Hot Flush, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
VD - Hypertension, mild
|
1 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
VD - Hypertension, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
VD - Hypertension, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Blood & Lymph Disorders (BLD) - Any Event, mild
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
BLD - Any Event, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
BLD - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
BLD - Anemia, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
BLD - Anemia, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
BLD - Anemia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
BLD - Lymphadenopathy, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
BLD - Lymphadenopathy, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
BLD - Lymphadenopathy, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Hepatobiliary disorders (HD) - Any Event, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
HD - Any Event, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
HD - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
HD - Hepatic Function abnormal, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
HD - Hepatic Function abnormal, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
HD - Hepatic Function abnormal, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Reproductive Disorders (RBD) - Any Event, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Any Event, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Any Event, severe
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Galactorrhea, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Galactorrhea, moderate
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Galactorrhea, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Menometrorrhagia, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Menometrorrhagia, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Menometrorrhagia, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Premenstrual Syndrome, mild
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Premenstrual Syndrome, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RBD - Premenstrual Syndrome, severe
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Cardiac Disorders (CD) - Any Event, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
CD - Any Event, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
CD - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
CD - Palpitations, mild
|
1 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
CD - Palpitations, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
CD - Palpitations, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Renal & Urinary Disorders (RUD) - Any Event, mild
|
0 Number of events
|
2 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RUD - Any Event, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RUD - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RUD - Dysuria, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RUD - Dysuria, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RUD - Dysuria, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RUD - Pollakiuria, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RUD - Pollakiuria, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
RUD - Pollakiuria, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Endocrine Disorders (ENDO) - Any Event, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ENDO - Any Event, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ENDO - Any Event, severe
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ENDO - Hyperprolactinaemia, mild
|
0 Number of events
|
1 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ENDO - Hyperprolactinaemia, moderate
|
0 Number of events
|
0 Number of events
|
|
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
ENDO - Hyperprolactinaemia, severe
|
0 Number of events
|
0 Number of events
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 124 other events
Deaths: 0 deaths
Bupropion SR
Serious events: 5 serious events
Other events: 125 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=159 participants at risk
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=166 participants at risk
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Nervous system disorders
Depressed level of Consciousness
|
0.00%
0/159
|
1.2%
2/166
|
|
Nervous system disorders
Convulsion
|
0.00%
0/159
|
0.60%
1/166
|
|
Psychiatric disorders
Bipolar Disorder
|
0.00%
0/159
|
0.60%
1/166
|
|
Psychiatric disorders
Mania
|
0.00%
0/159
|
0.60%
1/166
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/159
|
0.60%
1/166
|
Other adverse events
| Measure |
Placebo
n=159 participants at risk
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
|
Bupropion SR
n=166 participants at risk
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
19.5%
31/159
|
16.9%
28/166
|
|
Gastrointestinal disorders
Nausea
|
13.2%
21/159
|
15.7%
26/166
|
|
Psychiatric disorders
Depression
|
12.6%
20/159
|
8.4%
14/166
|
|
Nervous system disorders
Dizziness
|
10.1%
16/159
|
9.6%
16/166
|
|
Psychiatric disorders
Somnolence
|
6.3%
10/159
|
4.8%
8/166
|
|
Nervous system disorders
Headache
|
5.7%
9/159
|
9.0%
15/166
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
9/159
|
4.2%
7/166
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
8/159
|
4.2%
7/166
|
|
General disorders
Drug Withdrawal syndrome
|
2.5%
4/159
|
5.4%
9/166
|
|
General disorders
Thirst
|
2.5%
4/159
|
5.4%
9/166
|
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