TriangleNCT01522976 · OUTCOME
Pre-study Cytogenetic Abnormalities
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
- Up to 5 years
What was measured
Cytogenetic risk group is used to identify cytogenetic abnormalities.
Analysis population: Analysis includes eligible patients only.
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 | 93 |
| Arm 2: Azacitidine | 92 |
| Arm 3: Azacitidine/Vorinostat | 92 |
Reported measurements
Good/very good
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Azacitidine/Lenalidomide | 35 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Azacitidine | 29 | Not reported | Not reported | Not reported | Not reported |
| Arm 3: Azacitidine/Vorinostat | 34 | Not reported | Not reported | Not reported | Not reported |
Intermediate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Azacitidine/Lenalidomide | 13 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Azacitidine | 16 | Not reported | Not reported | Not reported | Not reported |
| Arm 3: Azacitidine/Vorinostat | 18 | Not reported | Not reported | Not reported | Not reported |
Poor
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Azacitidine/Lenalidomide | 8 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Azacitidine | 10 | Not reported | Not reported | Not reported | Not reported |
| Arm 3: Azacitidine/Vorinostat | 8 | Not reported | Not reported | Not reported | Not reported |
Very poor
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Azacitidine/Lenalidomide | 23 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Azacitidine | 23 | Not reported | Not reported | Not reported | Not reported |
| Arm 3: Azacitidine/Vorinostat | 19 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Azacitidine/Lenalidomide | 14 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Azacitidine | 14 | Not reported | Not reported | Not reported | Not reported |
| Arm 3: Azacitidine/Vorinostat | 13 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 34
- title
- Good/very good
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 18
- title
- Intermediate
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 8
- title
- Poor
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 19
- title
- Very poor
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 13
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 93
- group Id
- OG001
- value
- 92
- group Id
- OG002
- value
- 92
- units
- Participants
- description
- Cytogenetic risk group is used to identify cytogenetic abnormalities.
- 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
- NUMBER
- population Description
- Analysis includes eligible patients only.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Pre-study Cytogenetic Abnormalities
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice