TriangleNCT00561418 · OUTCOME
Safety and Tolerability of Vorinostat (SAHA) After Autologous Stem Cell Transplantation
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- patients
- Interval / dispersion
- Not reported
- Time frame
- Up to 3 years
What was measured
NCI CTCAE version 3.0 was used to assess Adverse Events (AE) Grade 1=Mild AE Grade 2=Moderate AE Grade 3=Severe AE Grade 4=Life-threatening or disabling AE
Groups in this outcome
Vorinostat (SAHA)
Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations. vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles. Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)
| Group | Source count |
|---|---|
| Vorinostat (SAHA) | 23 |
Reported measurements
Fatigue (Grade 1, 2)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat (SAHA) | 12 | Not reported | Not reported | Not reported | Not reported |
Lymphopenia (Grade 1-4)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat (SAHA) | 11 | Not reported | Not reported | Not reported | Not reported |
Thrombocytopenia (Grade 1-3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat (SAHA) | 11 | Not reported | Not reported | Not reported | Not reported |
Leukopenia (Grade 1-3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat (SAHA) | 10 | Not reported | Not reported | Not reported | Not reported |
Anemia (Grade 1-3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat (SAHA) | 10 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- title
- Fatigue (Grade 1, 2)
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- Lymphopenia (Grade 1-4)
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- Thrombocytopenia (Grade 1-3)
- categories
- measurements
- group Id
- OG000
- value
- 10
- title
- Leukopenia (Grade 1-3)
- categories
- measurements
- group Id
- OG000
- value
- 10
- title
- Anemia (Grade 1-3)
- denoms
- counts
- group Id
- OG000
- value
- 23
- units
- Participants
- description
- NCI CTCAE version 3.0 was used to assess Adverse Events (AE) Grade 1=Mild AE Grade 2=Moderate AE Grade 3=Severe AE Grade 4=Life-threatening or disabling AE
- groups
- description
- Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations. vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles. Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)
- id
- OG000
- title
- Vorinostat (SAHA)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Safety and Tolerability of Vorinostat (SAHA) After Autologous Stem Cell Transplantation
- type
- PRIMARY
- unit Of Measure
- patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice