TriangleNCT00574288 · OUTCOME
Part 2: Overall Survival
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
- Approximately 3 years
What was measured
Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.
Analysis population: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Groups in this outcome
Daratumumab 8 mg/kg
Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
| Group | Source count |
|---|---|
| Daratumumab 8 mg/kg | 30 |
| Daratumumab 16 mg/kg | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab 8 mg/kg | 18.2 | Not reported | 7.5 | 22.6 | Not reported |
| Daratumumab 16 mg/kg | 34.3 | Not reported | 19.9 | NA | Upper limit of CI was not estimable due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.5
- upper Limit
- 22.6
- value
- 18.2
- comment
- Upper limit of CI was not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 19.9
- upper Limit
- NA
- value
- 34.3
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
- id
- OG000
- title
- Daratumumab 8 mg/kg
- description
- Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
- id
- OG001
- title
- Daratumumab 16 mg/kg
- param Type
- MEDIAN
- population Description
- All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Approximately 3 years
- title
- Part 2: Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice