TriangleNCT01578499 · OUTCOME
Duration of Response (DOR)
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
- Until disease progression, death or data cutoff (Median follow-up 38.8 months)
What was measured
Duration of response was assessed by the IRF in participants with confirmed response \[CR or Partial Response (PR)\] and is defined as the time between first documentation of response and disease progression. Response Criteria was based on ISCL, USCLC and CLTF of the 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. Responders in ITT population were analyzed in this outcome measure.
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 | 42 |
| Methotrexate or Bexarotene | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 15.1 | Not reported | 9.8 | 25.5 | Not reported |
| Methotrexate or Bexarotene | 18.4 | Not reported | 3.5 | NA | Upper limit of Confidence Interval (CI) was not estimable due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.8
- upper Limit
- 25.5
- value
- 15.1
- comment
- Upper limit of Confidence Interval (CI) was not estimable due to low number of participants with events.
- group Id
- OG001
- lower Limit
- 3.5
- upper Limit
- NA
- value
- 18.4
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Duration of response was assessed by the IRF in participants with confirmed response \[CR or Partial Response (PR)\] and is defined as the time between first documentation of response and disease progression. Response Criteria was based on ISCL, USCLC and CLTF of the 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
- MEDIAN
- 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. Responders in ITT population were analyzed in this outcome measure.
- reporting Status
- POSTED
- time Frame
- Until disease progression, death or data cutoff (Median follow-up 38.8 months)
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice