TriangleNCT01712490 · OUTCOME
Duration of Response (DOR) 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 first documented response until PD (approximately 4 years)
What was measured
DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Analysis population: The ITT population included all participants randomized to treatment. The ITT population where participants achieved confirmed response of CR or PR.
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 | 628 |
| ABVD | 623 |
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
- 628
- group Id
- OG001
- value
- 623
- units
- Participants
- description
- DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
- 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. The ITT population where participants achieved confirmed response of CR or PR.
- reporting Status
- POSTED
- time Frame
- From first documented response until PD (approximately 4 years)
- title
- Duration of Response (DOR) Per IRF
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice