TriangleNCT03439293 · 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 years
What was measured
TTR is defined as the time from first dose of any study drug treatment to the date of first documentation of PR or better. PR is defined as \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions.
Analysis population: Response-evaluable population included participants who received at least 1 dose of ixazomib, had measurable disease during the screening period, and had at least 1 postbaseline disease assessment.
Groups in this outcome
Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg
Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
| Group | Source count |
|---|---|
| Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg | 59 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg | 2.7 | Not reported | 1.9 | 5.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 5.8
- value
- 2.7
- denoms
- counts
- group Id
- OG000
- value
- 59
- units
- Participants
- description
- TTR is defined as the time from first dose of any study drug treatment to the date of first documentation of PR or better. PR is defined as \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
- id
- OG000
- title
- Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg
- param Type
- MEDIAN
- population Description
- Response-evaluable population included participants who received at least 1 dose of ixazomib, had measurable disease during the screening period, and had at least 1 postbaseline disease assessment.
- reporting Status
- POSTED
- time Frame
- Up to 5 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