TriangleNCT01712490 · OUTCOME
Event-free Survival (EFS) Per IRF
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
- Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)
What was measured
EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir per IRF.
Analysis population: The ITT population included all participants randomized to treatment.
Groups in this outcome
A+AVD
Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
ABVD
Doxorubicin 25 mg/m\^2, bleomycin 10 units per square meter (units/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.
| Group | Source count |
|---|---|
| A+AVD | 664 |
| ABVD | 670 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A+AVD | NA | Not reported | 43.8 | NA | Median and confidence interval was not estimable due to low number of participants with events. |
| ABVD | NA | Not reported | NA | NA | Median and confidence interval was not estimable due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and confidence interval was not estimable due to low number of participants with events.
- group Id
- OG000
- lower Limit
- 43.8
- upper Limit
- NA
- value
- NA
- comment
- Median and confidence interval was not estimable due to low number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 664
- group Id
- OG001
- value
- 670
- units
- Participants
- description
- EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir per IRF.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
- id
- OG000
- title
- A+AVD
- description
- Doxorubicin 25 mg/m\^2, bleomycin 10 units per square meter (units/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.
- id
- OG001
- title
- ABVD
- param Type
- MEDIAN
- population Description
- The ITT population included all participants randomized to treatment.
- reporting Status
- POSTED
- time Frame
- Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)
- title
- Event-free Survival (EFS) Per IRF
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice