TriangleNCT03112174 · OUTCOME
Duration of Response (DOR) (Randomization Phase and Treatment-Naive Arm)
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 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)
What was measured
DOR is defined as the time frame 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 randomized participants and all enrolled treatment-naïve participants achieving response (partial response or better)
Groups in this outcome
Randomization Phase: Ibrutinb + Venetoclax
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
Treatment-naive Open-label Arm
Participants were treated withibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
| Group | Source count |
|---|---|
| Randomization Phase: Ibrutinb + Venetoclax | 110 |
| Randomization Phase: Ibrutinib + Placebo | 99 |
| Treatment-naive Open-label Arm | 74 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase: Ibrutinb + Venetoclax | 42.1 | Not reported | 28.7 | NA | Not estimable due to the small number of events. |
| Randomization Phase: Ibrutinib + Placebo | 27.6 | Not reported | 19.4 | 39.5 | Not reported |
| Treatment-naive Open-label Arm | 37.1 | Not reported | 30.3 | 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
- 28.7
- upper Limit
- NA
- value
- 42.1
- group Id
- OG001
- lower Limit
- 19.4
- upper Limit
- 39.5
- value
- 27.6
- comment
- Not estimable due to the small number of events.
- group Id
- OG002
- lower Limit
- 30.3
- upper Limit
- NA
- value
- 37.1
- denoms
- counts
- group Id
- OG000
- value
- 110
- group Id
- OG001
- value
- 99
- group Id
- OG002
- value
- 74
- units
- Participants
- description
- DOR is defined as the time frame 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 were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
- id
- OG000
- title
- Randomization Phase: Ibrutinb + Venetoclax
- description
- Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
- id
- OG001
- title
- Randomization Phase: Ibrutinib + Placebo
- description
- Participants were treated withibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
- id
- OG002
- title
- Treatment-naive Open-label Arm
- param Type
- MEDIAN
- population Description
- All randomized participants and all enrolled treatment-naïve participants achieving response (partial response or better)
- reporting Status
- POSTED
- time Frame
- For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)
- title
- Duration of Response (DOR) (Randomization Phase and Treatment-Naive Arm)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice