NCT03180294 · OUTCOME
Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Adverse events were evaluated 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).
What was measured
Common Terminology Criteria for Adverse Events (version 4) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure.; see Adverse Events Module for specific adverse event data.
Analysis population: Eligible with adverse event data and started study treatment.
Groups in this outcome
Bupropion 150 mg
One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
Bupropion 300 mg
One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
Placebo
One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
| Group | Source count |
|---|---|
| Bupropion 150 mg | 77 |
| Bupropion 300 mg | 73 |
| Placebo | 76 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bupropion 150 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Bupropion 300 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 73
- group Id
- OG002
- value
- 76
- units
- Participants
- description
- Common Terminology Criteria for Adverse Events (version 4) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure.; see Adverse Events Module for specific adverse event data.
- groups
- description
- One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
- id
- OG000
- title
- Bupropion 150 mg
- description
- One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
- id
- OG001
- title
- Bupropion 300 mg
- description
- One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
- id
- OG002
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Eligible with adverse event data and started study treatment.
- reporting Status
- POSTED
- time Frame
- Adverse events were evaluated 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).
- title
- Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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