TriangleNCT01712490 · OUTCOME
Disease-free Survival (DFS) 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
- From CR until PD or death (approximately up to 4 years)
What was measured
DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.
Analysis population: The ITT included all participants randomized to treatment. The ITT population where participants achieved CR.
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 | 543 |
| ABVD | 528 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A+AVD | NA | Not reported | 42.1 | 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
- 42.1
- 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
- 543
- group Id
- OG001
- value
- 528
- units
- Participants
- description
- DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.
- 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 included all participants randomized to treatment. The ITT population where participants achieved CR.
- reporting Status
- POSTED
- time Frame
- From CR until PD or death (approximately up to 4 years)
- title
- Disease-free Survival (DFS) Per IRF
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice