TriangleNCT02654990 · OUTCOME
Cmax: Bortezomib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)
What was measured
Serial blood samples were collected for bortezomib Cmax analysis. Results are reported in ng/mL.
Analysis population: Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of bortezomib after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
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) | 61 |
| Arm B - Panobinostat (20 mg, BIW) | 69 |
| Arm C - Panobinostat (10 mg, TIW) | 63 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A - Panobinostat (20 mg, TIW) | 16.67 | 7.79 | Not reported | Not reported | Not reported |
| Arm B - Panobinostat (20 mg, BIW) | 19.47 | 10.00 | Not reported | Not reported | Not reported |
| Arm C - Panobinostat (10 mg, TIW) | 18.29 | 8.80 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 7.79
- value
- 16.67
- group Id
- OG001
- spread
- 10.00
- value
- 19.47
- group Id
- OG002
- spread
- 8.80
- value
- 18.29
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 69
- group Id
- OG002
- value
- 63
- units
- Participants
- description
- Serial blood samples were collected for bortezomib Cmax analysis. Results are reported in ng/mL.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of bortezomib after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)
- title
- Cmax: Bortezomib
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice