TriangleNCT02046070 · OUTCOME
Tmax: Time to First Occurrence of Cmax for Ixazomib in NDMM Participants
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hour (hr)
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose
Analysis population: PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.
Groups in this outcome
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
| Group | Source count |
|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 6 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 6 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 6 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 1.250 | Not reported | 0.92 | 1.58 | Not reported |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 1.040 | Not reported | 0.50 | 2.00 | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 6 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 1.000 | Not reported | 0.45 | 4.00 | Not reported |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 1.000 | Not reported | 0.50 | 1.50 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.92
- upper Limit
- 1.58
- value
- 1.250
- group Id
- OG001
- lower Limit
- 0.50
- upper Limit
- 2.00
- value
- 1.040
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.45
- upper Limit
- 4.00
- value
- 1.000
- group Id
- OG001
- lower Limit
- 0.50
- upper Limit
- 1.50
- value
- 1.000
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
- id
- OG000
- title
- Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
- description
- Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
- id
- OG001
- title
- Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
- param Type
- MEDIAN
- population Description
- PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose
- title
- Tmax: Time to First Occurrence of Cmax for Ixazomib in NDMM Participants
- type
- SECONDARY
- unit Of Measure
- hour (hr)
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Preserved source evidence · Not medical advice