TriangleNCT03450057 · OUTCOME
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
- Time from first dose of study treatment to death (approximately up to 30 months)
What was measured
Overall survival was defined as the time, in months, from the first dose of therapy to the date of death from any cause.
Groups in this outcome
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
| Group | Source count |
|---|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 24.5 | Not reported | 5.5 | NA | The upper limit was never reached (NR). |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Comment
- The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.
- non Inferiority Type
- OTHER
- other Analysis Description
- The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Comment
- The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.
- non Inferiority Type
- OTHER
- other Analysis Description
- The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.
- classes
- categories
- measurements
- comment
- The upper limit was never reached (NR).
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- NA
- value
- 24.5
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- description
- Overall survival was defined as the time, in months, from the first dose of therapy to the date of death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
- id
- OG000
- title
- Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Time from first dose of study treatment to death (approximately up to 30 months)
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice