TriangleNCT02812706 · OUTCOME
Phase 2: Overall Survival (OS)
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
- From date of first study treatment administration to the date of death due to any cause (maximum duration of exposure: up to 248 weeks)
What was measured
Overall survival was defined as the time interval (in months) from the date of first study treatment administration to death due to any cause. In the absence of the confirmation of death before the cut-off date, OS was censored at the last date the participant was known to be alive or at the study cut-off date, whichever was earlier. Analysis was performed by Kaplan-Meier method.
Analysis population: Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Phase 1.
Groups in this outcome
Phase 2: Isatuximab 20 mg/kg
Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).
| Group | Source count |
|---|---|
| Phase 2: Isatuximab 20 mg/kg | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Isatuximab 20 mg/kg | NA | Not reported | 20.24 | NA | Median and upper limit of 95% confidence interval (CI) was not estimable due to the smaller number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of 95% confidence interval (CI) was not estimable due to the smaller number of participants with events.
- group Id
- OG000
- lower Limit
- 20.24
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 28
- units
- Participants
- description
- Overall survival was defined as the time interval (in months) from the date of first study treatment administration to death due to any cause. In the absence of the confirmation of death before the cut-off date, OS was censored at the last date the participant was known to be alive or at the study cut-off date, whichever was earlier. Analysis was performed by Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).
- id
- OG000
- title
- Phase 2: Isatuximab 20 mg/kg
- param Type
- MEDIAN
- population Description
- Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Phase 1.
- reporting Status
- POSTED
- time Frame
- From date of first study treatment administration to the date of death due to any cause (maximum duration of exposure: up to 248 weeks)
- title
- Phase 2: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice