TriangleNCT02654990 · OUTCOME
ORR Throughout the Study
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5.2 years
What was measured
ORR is defined as the percentage of participants with a confirmed PR or better (iCR or sCR or CR or VGPR) as their best overall response throughout the entire study. Best overall response was the best post-baseline confirmed overall response observed in a given participant and was determined based on overall responses observed at all post-baseline response assessments, recorded from randomization until PD, death, start of new therapy, withdrawal of consent or end of study, whatever came first. ORR was assessed blindly per IRC according to IMWG criteria.
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) | 62.2 | Not reported | 50.8 | 72.7 | Not reported |
| Arm B - Panobinostat (20 mg, BIW) | 67.5 | Not reported | 56.3 | 77.4 | Not reported |
| Arm C - Panobinostat (10 mg, TIW) | 53.0 | Not reported | 41.7 | 64.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.8
- upper Limit
- 72.7
- value
- 62.2
- group Id
- OG001
- lower Limit
- 56.3
- upper Limit
- 77.4
- value
- 67.5
- group Id
- OG002
- lower Limit
- 41.7
- upper Limit
- 64.1
- value
- 53.0
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 83
- group Id
- OG002
- value
- 83
- units
- Participants
- description
- ORR is defined as the percentage of participants with a confirmed PR or better (iCR or sCR or CR or VGPR) as their best overall response throughout the entire study. Best overall response was the best post-baseline confirmed overall response observed in a given participant and was determined based on overall responses observed at all post-baseline response assessments, recorded from randomization until PD, death, start of new therapy, withdrawal of consent or end of study, whatever came first. ORR was assessed blindly per IRC according to IMWG criteria.
- 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
- NUMBER
- 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
- ORR Throughout the Study
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice