TriangleNCT01522976 · OUTCOME
Relapse-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5 years
What was measured
RFS is calculated for patients who have achieved a response. RFS will be measured from the date of response to the date of first documentation of relapse from response (as defined in the primary objective), or death due to any cause. The follow-up for patients last known to be alive and without report of relapse is censored at the date of last contact. RFS will be estimated for each of the three arms using the Kaplan-Meier method.
Analysis population: Analysis includes eligible patients who had a response.
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 | 46 |
| Arm 2: Azacitidine | 35 |
| Arm 3: Azacitidine/Vorinostat | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Azacitidine/Lenalidomide | 435 | Not reported | 237 | 546 | Not reported |
| Arm 2: Azacitidine | 311 | Not reported | 182 | 640 | Not reported |
| Arm 3: Azacitidine/Vorinostat | 455 | Not reported | 197 | NA | The upper limit of the confidence interval cannot be estimated. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 237
- upper Limit
- 546
- value
- 435
- group Id
- OG001
- lower Limit
- 182
- upper Limit
- 640
- value
- 311
- comment
- The upper limit of the confidence interval cannot be estimated.
- group Id
- OG002
- lower Limit
- 197
- upper Limit
- NA
- value
- 455
- denoms
- counts
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 25
- units
- Participants
- description
- RFS is calculated for patients who have achieved a response. RFS will be measured from the date of response to the date of first documentation of relapse from response (as defined in the primary objective), or death due to any cause. The follow-up for patients last known to be alive and without report of relapse is censored at the date of last contact. RFS will be estimated for each of the three arms using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- 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
- param Type
- MEDIAN
- population Description
- Analysis includes eligible patients who had a response.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Relapse-free Survival
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice