TriangleNCT03112174 · OUTCOME
Overall Response Rate (ORR) (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
- NUMBER
- Unit
- percentage of participants
- 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
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 randomized participants and all treatment-naive open-label arm participants.
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 with ibrutinib 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 | 134 |
| Randomization Phase: Ibrutinib + Placebo | 133 |
| Treatment-naive Open-label Arm | 78 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase: Ibrutinb + Venetoclax | 82.1 | Not reported | 74.5 | 88.2 | Not reported |
| Randomization Phase: Ibrutinib + Placebo | 74.4 | Not reported | 66.2 | 81.6 | Not reported |
| Treatment-naive Open-label Arm | 94.9 | Not reported | 87.4 | 98.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.973
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.247
- estimate Comment
- For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1279
- p Value Comment
- Estimate and p-value for rate ratio are based on CMH test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.
- param Type
- Rate Ratio
- param Value
- 1.101
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 0.973
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.247
- estimate Comment
- For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1279
- p Value Comment
- Estimate and p-value for rate ratio are based on CMH test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.
- param Type
- Rate Ratio
- param Value
- 1.101
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 74.5
- upper Limit
- 88.2
- value
- 82.1
- group Id
- OG001
- lower Limit
- 66.2
- upper Limit
- 81.6
- value
- 74.4
- group Id
- OG002
- lower Limit
- 87.4
- upper Limit
- 98.6
- value
- 94.9
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 133
- group Id
- OG002
- value
- 78
- 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 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 with ibrutinib 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
- NUMBER
- population Description
- All randomized participants and all treatment-naive open-label arm participants.
- 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
- Overall Response Rate (ORR) (Randomization Phase and Treatment-Naive Arm)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice