TriangleNCT03439293 · OUTCOME
Duration of Response (DOR)
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
DOR is defined as the time from the date of first documentation of PR or better to the date of the first documented PD among participants who responded to the treatment.
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. The data is reported for the responders.
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 | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg | 24.0 | Not reported | 15.9 | NA | Upper limit of 95% CI was not estimable due to low number of responders with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable due to low number of responders with events.
- group Id
- OG000
- lower Limit
- 15.9
- upper Limit
- NA
- value
- 24.0
- denoms
- counts
- group Id
- OG000
- value
- 39
- units
- Participants
- description
- DOR is defined as the time from the date of first documentation of PR or better to the date of the first documented PD among participants who responded to the treatment.
- 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. The data is reported for the responders.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice