TriangleNCT01771107 · OUTCOME
Frequency of Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 5 years
What was measured
Number of Participants who had one or more adverse events
Analysis population: Participants who were treated with brentuximab and combination chemotherapy
Groups in this outcome
Phase I - Brentuximab 1.2 mg/kg
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
Phase II - Brentuximab 1.2 mg/kg
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
| Group | Source count |
|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 6 |
| Phase II - Brentuximab 1.2 mg/kg | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase II - Brentuximab 1.2 mg/kg | 35 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 35
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 35
- units
- Participants
- description
- Number of Participants who had one or more adverse events
- groups
- description
- Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
- id
- OG000
- title
- Phase I - Brentuximab 1.2 mg/kg
- description
- Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
- id
- OG001
- title
- Phase II - Brentuximab 1.2 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who were treated with brentuximab and combination chemotherapy
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Frequency of Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice