NCT01712490 · OUTCOME
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to 30 days after last dose of study drug (approximately 1 year)
Analysis population: The safety population included all enrolled participants who received at least 1 dose of any study drug.
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 | 662 |
| ABVD | 659 |
Reported measurements
TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A+AVD | 653 | Not reported | Not reported | Not reported | Not reported |
| ABVD | 646 | Not reported | Not reported | Not reported | Not reported |
SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A+AVD | 284 | Not reported | Not reported | Not reported | Not reported |
| ABVD | 178 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 653
- group Id
- OG001
- value
- 646
- title
- TEAE
- categories
- measurements
- group Id
- OG000
- value
- 284
- group Id
- OG001
- value
- 178
- title
- SAE
- denoms
- counts
- group Id
- OG000
- value
- 662
- group Id
- OG001
- value
- 659
- units
- Participants
- 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
- NUMBER
- population Description
- The safety population included all enrolled participants who received at least 1 dose of any study drug.
- reporting Status
- POSTED
- time Frame
- Baseline up to 30 days after last dose of study drug (approximately 1 year)
- title
- Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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