NCT02654990 · OUTCOME
Time to Response (TTR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5.2 years
What was measured
TTR, based on IMWG criteria per blinded IRC assessment, is the time between date of randomization to the date of first onset of PR or better response (iCR or sCR or CR or VGPR).
Analysis population: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
Groups in this outcome
Arm A - Panobinostat (20 mg, TIW)
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
Arm B - Panobinostat (20 mg, BIW)
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
Arm C - Panobinostat (10 mg, TIW)
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
| Group | Source count |
|---|---|
| Arm A - Panobinostat (20 mg, TIW) | 82 |
| Arm B - Panobinostat (20 mg, BIW) | 83 |
| Arm C - Panobinostat (10 mg, TIW) | 83 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A - Panobinostat (20 mg, TIW) | 3 | Not reported | 1 | NA | Not evaluable due to insufficient number of events |
| Arm B - Panobinostat (20 mg, BIW) | 3 | Not reported | 1 | NA | Not evaluable due to insufficient number of events |
| Arm C - Panobinostat (10 mg, TIW) | 3 | Not reported | 1 | NA | Not evaluable due to insufficient number of events |
Complete source fields
- classes
- categories
- measurements
- comment
- Not evaluable due to insufficient number of events
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- NA
- value
- 3
- comment
- Not evaluable due to insufficient number of events
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- NA
- value
- 3
- comment
- Not evaluable due to insufficient number of events
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- NA
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 83
- group Id
- OG002
- value
- 83
- units
- Participants
- description
- TTR, based on IMWG criteria per blinded IRC assessment, is the time between date of randomization to the date of first onset of PR or better response (iCR or sCR or CR or VGPR).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
- id
- OG000
- title
- Arm A - Panobinostat (20 mg, TIW)
- description
- Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
- id
- OG001
- title
- Arm B - Panobinostat (20 mg, BIW)
- description
- Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
- id
- OG002
- title
- Arm C - Panobinostat (10 mg, TIW)
- param Type
- MEDIAN
- population Description
- Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
- reporting Status
- POSTED
- time Frame
- Up to 5.2 years
- title
- Time to Response (TTR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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