TriangleNCT02654990 · OUTCOME
Overall Response Rate (ORR)
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 168 days
What was measured
ORR is defined as the percentage of participants with a confirmed partial response (PR) or better (immunophenotypic complete response \[iCR\] or stringent complete response \[sCR\] or complete response \[CR\] or very good partial response \[VGPR\]) as their best overall response after completion of up to 8 cycles of assigned study regimen. Each cycle was 21 days long. 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 progressive disease (PD), death, start of new therapy, withdrawal of consent, or end of study, whatever came first. ORR was assessed blindly per independent review committee (IRC) according to International Myeloma Working Group (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) | 65.1 | Not reported | 53.8 | 75.2 | Not reported |
| Arm C - Panobinostat (10 mg, TIW) | 50.6 | Not reported | 39.4 | 61.8 | 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
- 53.8
- upper Limit
- 75.2
- value
- 65.1
- group Id
- OG002
- lower Limit
- 39.4
- upper Limit
- 61.8
- value
- 50.6
- 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 partial response (PR) or better (immunophenotypic complete response \[iCR\] or stringent complete response \[sCR\] or complete response \[CR\] or very good partial response \[VGPR\]) as their best overall response after completion of up to 8 cycles of assigned study regimen. Each cycle was 21 days long. 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 progressive disease (PD), death, start of new therapy, withdrawal of consent, or end of study, whatever came first. ORR was assessed blindly per independent review committee (IRC) according to International Myeloma Working Group (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 168 days
- title
- Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice