TriangleNCT02457793 · OUTCOME
Percentage of Participants With at Least One Serious Adverse Event (SAE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 15 months
What was measured
A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.
Analysis population: All participants.
Groups in this outcome
Not Assigned
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
COB 20 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 40 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 80 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 80 mg + GDC 400 mg
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
COB 100 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
| Group | Source count |
|---|---|
| Not Assigned | 1 |
| COB 20 mg + GDC 200 mg | 5 |
| COB 40 mg + GDC 200 mg | 3 |
| COB 80 mg + GDC 200 mg | 5 |
| COB 80 mg + GDC 400 mg | 4 |
| COB 100 mg + GDC 200 mg | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Not Assigned | 100.0 | Not reported | Not reported | Not reported | Not reported |
| COB 20 mg + GDC 200 mg | 40.0 | Not reported | Not reported | Not reported | Not reported |
| COB 40 mg + GDC 200 mg | 66.7 | Not reported | Not reported | Not reported | Not reported |
| COB 80 mg + GDC 200 mg | 60.0 | Not reported | Not reported | Not reported | Not reported |
| COB 80 mg + GDC 400 mg | 50.0 | Not reported | Not reported | Not reported | Not reported |
| COB 100 mg + GDC 200 mg | 66.7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 40.0
- group Id
- OG002
- value
- 66.7
- group Id
- OG003
- value
- 60.0
- group Id
- OG004
- value
- 50.0
- group Id
- OG005
- value
- 66.7
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- units
- Participants
- description
- A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.
- groups
- description
- One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
- id
- OG000
- title
- Not Assigned
- description
- Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
- id
- OG001
- title
- COB 20 mg + GDC 200 mg
- description
- Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
- id
- OG002
- title
- COB 40 mg + GDC 200 mg
- description
- Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
- id
- OG003
- title
- COB 80 mg + GDC 200 mg
- description
- Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
- id
- OG004
- title
- COB 80 mg + GDC 400 mg
- description
- Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
- id
- OG005
- title
- COB 100 mg + GDC 200 mg
- param Type
- NUMBER
- population Description
- All participants.
- reporting Status
- POSTED
- time Frame
- Up to 15 months
- title
- Percentage of Participants With at Least One Serious Adverse Event (SAE)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice