TriangleNCT01578499 · OUTCOME
Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)
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
- Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)
What was measured
ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011).
Analysis population: The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Groups in this outcome
Brentuximab Vedotin
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate or Bexarotene
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
| Group | Source count |
|---|---|
| Brentuximab Vedotin | 64 |
| Methotrexate or Bexarotene | 64 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 54.7 | Not reported | 42.5 | 66.9 | Not reported |
| Methotrexate or Bexarotene | 12.5 | Not reported | 4.4 | 20.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 27.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 56.8
- group Description
- Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.001
- p Value Comment
- P-value was stratified by baseline disease diagnosis (pcALCL and MF).
- param Type
- Risk Difference (RD)
- param Value
- 42.2
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 27.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 56.8
- group Description
- Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.001
- p Value Comment
- P-value was stratified by baseline disease diagnosis (pcALCL and MF).
- param Type
- Risk Difference (RD)
- param Value
- 42.2
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 42.5
- upper Limit
- 66.9
- value
- 54.7
- group Id
- OG001
- lower Limit
- 4.4
- upper Limit
- 20.6
- value
- 12.5
- denoms
- counts
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 64
- units
- Participants
- description
- ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
- id
- OG000
- title
- Brentuximab Vedotin
- description
- Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
- id
- OG001
- title
- Methotrexate or Bexarotene
- param Type
- NUMBER
- population Description
- The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
- reporting Status
- POSTED
- time Frame
- Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)
- title
- Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice