TriangleNCT03112174 · OUTCOME
Duration of Response (DOR) (Safety Run-in)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- For an overall median time on study of 74.78 months
What was measured
DOR is defined for participants who achieve an overall response as the time from the first occurrence of response (CR or PR according to the Revised Response Criteria for Malignant Lymphoma \[Cheson 2014\]) to disease progression or death, whichever occurs first.
Analysis population: All Enrolled Safety Run-in Subjects Achieving Response (Partial Response or Better)
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 | 12 |
| Safety Run-in: Low TLS Risk at Baseline | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-in: Increased TLS Risk at Baseline | 44.1 | Not reported | 12.5 | NA | Not estimable due to the small number of events. |
| Safety Run-in: Low TLS Risk at Baseline | NA | Not reported | 26.5 | NA | Not estimable due to the small number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable due to the small number of events.
- group Id
- OG000
- lower Limit
- 12.5
- upper Limit
- NA
- value
- 44.1
- comment
- Not estimable due to the small number of events.
- group Id
- OG001
- lower Limit
- 26.5
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- DOR is defined for participants who achieve an overall response as the time from the first occurrence of response (CR or PR according to the Revised Response Criteria for Malignant Lymphoma \[Cheson 2014\]) to disease progression or death, whichever occurs first.
- 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
- MEDIAN
- population Description
- All Enrolled Safety Run-in Subjects Achieving Response (Partial Response or Better)
- reporting Status
- POSTED
- time Frame
- For an overall median time on study of 74.78 months
- title
- Duration of Response (DOR) (Safety Run-in)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice