TriangleNCT01522976 · OUTCOME
Overall Survival (Phase III)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to 5 years
What was measured
OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow-up for patients last known to be alive is censored at the date of last contact. Stratified Cox regression models will be used to compare OS of the combination arm selected in the Phase II portion of the trial to OS of the single-agent azacitidine arm.
Analysis population: This trial did not proceed to the Phase III portion. Therefore, no patients were analyzed for this outcome measure.
Groups in this outcome
Arm 1: Azacitidine/Lenalidomide
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
Arm 2: Azacitidine
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
Arm 3: Azacitidine/Vorinostat
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
| Group | Source count |
|---|---|
| Arm 1: Azacitidine/Lenalidomide | 0 |
| Arm 2: Azacitidine | 0 |
| Arm 3: Azacitidine/Vorinostat | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow-up for patients last known to be alive is censored at the date of last contact. Stratified Cox regression models will be used to compare OS of the combination arm selected in the Phase II portion of the trial to OS of the single-agent azacitidine arm.
- groups
- description
- Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
- id
- OG000
- title
- Arm 1: Azacitidine/Lenalidomide
- description
- Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
- id
- OG001
- title
- Arm 2: Azacitidine
- description
- Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
- id
- OG002
- title
- Arm 3: Azacitidine/Vorinostat
- population Description
- This trial did not proceed to the Phase III portion. Therefore, no patients were analyzed for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Overall Survival (Phase III)
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice