TriangleNCT03112174 · OUTCOME
Overall Response Rate (ORR) (Safety Run-in)
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
- 95% Confidence Interval
- Time frame
- For an overall median time on study of 74.78 months
What was measured
ORR is defined as the percentage of participants with CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).
Analysis population: All enrolled Safety Run-in participants
Groups in this outcome
Safety Run-in: Increased TLS Risk at Baseline
Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
Safety Run-in: Low TLS Risk at Baseline
Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
| Group | Source count |
|---|---|
| Safety Run-in: Increased TLS Risk at Baseline | 15 |
| Safety Run-in: Low TLS Risk at Baseline | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-in: Increased TLS Risk at Baseline | 80.0 | Not reported | 51.9 | 95.7 | Not reported |
| Safety Run-in: Low TLS Risk at Baseline | 83.3 | Not reported | 35.9 | 99.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.9
- upper Limit
- 95.7
- value
- 80.0
- group Id
- OG001
- lower Limit
- 35.9
- upper Limit
- 99.6
- value
- 83.3
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- ORR is defined as the percentage of participants with CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
- id
- OG000
- title
- Safety Run-in: Increased TLS Risk at Baseline
- description
- Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
- id
- OG001
- title
- Safety Run-in: Low TLS Risk at Baseline
- param Type
- NUMBER
- population Description
- All enrolled Safety Run-in participants
- reporting Status
- POSTED
- time Frame
- For an overall median time on study of 74.78 months
- title
- Overall Response Rate (ORR) (Safety Run-in)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice