TriangleNCT01771107 · OUTCOME
HAART Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to 2 years
What was measured
Log-rank analysis will be used to evaluate HAART status at baseline for difference in outcome in terms of overall survival at 2 years.
Analysis population: All participant had HAART at baseline. Logrank test cannot be performed.
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 m/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
| Group | Source count |
|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 6 |
| Phase II - Brentuximab 1.2 m/kg | 35 |
Reported measurements
HAART yes
| Group | Source count |
|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 6 |
| Phase II - Brentuximab 1.2 m/kg | 35 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 1.0 | Not reported | 1.0 | 1.0 | Not reported |
| Phase II - Brentuximab 1.2 m/kg | 0.911 | Not reported | 0.747 | 0.97 | Not reported |
HAART no
| Group | Source count |
|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 0 |
| Phase II - Brentuximab 1.2 m/kg | 0 |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 1.0
- value
- 1.0
- group Id
- OG001
- lower Limit
- 0.747
- upper Limit
- 0.97
- value
- 0.911
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 35
- units
- Participants
- title
- HAART yes
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- HAART no
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 35
- units
- Participants
- description
- Log-rank analysis will be used to evaluate HAART status at baseline for difference in outcome in terms of overall survival at 2 years.
- dispersion Type
- 95% Confidence Interval
- 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
- id
- OG001
- title
- Phase II - Brentuximab 1.2 m/kg
- param Type
- NUMBER
- population Description
- All participant had HAART at baseline. Logrank test cannot be performed.
- reporting Status
- POSTED
- time Frame
- Baseline up to 2 years
- title
- HAART Status
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice