TriangleNCT04569032 · OUTCOME
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment
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
- At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
What was measured
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) following the completion of study treatment (at end of treatment \[EOT\]). CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
Analysis population: Full analysis set (FAS) included all participants who received any amount of brentuximab vedotin or any component of cyclophosphamide, doxorubicin, and prednisone (CHP). Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression.
Groups in this outcome
CD30 <1% [Central Laboratory Assessment]
Participants with \<1% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
CD30 1% to <10% [Central Laboratory Assessment]
Participants with 1% to \<10% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
| Group | Source count |
|---|---|
| CD30 <1% [Central Laboratory Assessment] | 23 |
| CD30 1% to <10% [Central Laboratory Assessment] | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CD30 <1% [Central Laboratory Assessment] | 61 | Not reported | 38.5 | 80.3 | Not reported |
| CD30 1% to <10% [Central Laboratory Assessment] | 81 | Not reported | 62.5 | 92.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38.5
- upper Limit
- 80.3
- value
- 61
- group Id
- OG001
- lower Limit
- 62.5
- upper Limit
- 92.5
- value
- 81
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 31
- units
- Participants
- description
- ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) following the completion of study treatment (at end of treatment \[EOT\]). CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with \<1% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
- id
- OG000
- title
- CD30 <1% [Central Laboratory Assessment]
- description
- Participants with 1% to \<10% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
- id
- OG001
- title
- CD30 1% to <10% [Central Laboratory Assessment]
- param Type
- NUMBER
- population Description
- Full analysis set (FAS) included all participants who received any amount of brentuximab vedotin or any component of cyclophosphamide, doxorubicin, and prednisone (CHP). Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression.
- reporting Status
- POSTED
- time Frame
- At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
- title
- Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice