TriangleNCT03289910 · OUTCOME
The Highest Grade Adverse Event Experienced
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
- Up to 7 months
What was measured
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Groups in this outcome
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Arm B (Topotecan Hydrochloride, Carboplatin)
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 16 |
| Arm B (Topotecan Hydrochloride, Carboplatin) | 9 |
Reported measurements
Source class 1
Grade 5 Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Topotecan Hydrochloride, Carboplatin) | 1 | Not reported | Not reported | Not reported | Not reported |
Grade 4 Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 14 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Topotecan Hydrochloride, Carboplatin) | 8 | Not reported | Not reported | Not reported | Not reported |
Grade 3 Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Topotecan Hydrochloride, Carboplatin) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Grade 5 Adverse Events
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 8
- title
- Grade 4 Adverse Events
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Grade 3 Adverse Events
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
- groups
- description
- Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
- description
- Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm B (Topotecan Hydrochloride, Carboplatin)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 7 months
- title
- The Highest Grade Adverse Event Experienced
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice