NCT04162210 · OUTCOME
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
- Up to approximately 263 weeks
What was measured
OS is defined as the time from randomization until death due to any cause.
Analysis population: ITT Population
Groups in this outcome
Belantamab Mafodotin
Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
Pomalidomide Plus Dexamethasone
Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
| Group | Source count |
|---|---|
| Belantamab Mafodotin | 218 |
| Pomalidomide Plus Dexamethasone | 107 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belantamab Mafodotin | 24.0 | Not reported | 19.4 | 33.2 | Not reported |
| Pomalidomide Plus Dexamethasone | 22.9 | Not reported | 16.0 | 29.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.73
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.30
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.440
- param Type
- Hazard Ratio (HR)
- param Value
- 0.98
- statistical Comment
- One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38, ISS staging and number of prior lines of therapy.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.73
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.30
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.440
- param Type
- Hazard Ratio (HR)
- param Value
- 0.98
- statistical Comment
- One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38, ISS staging and number of prior lines of therapy.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.4
- upper Limit
- 33.2
- value
- 24.0
- group Id
- OG001
- lower Limit
- 16.0
- upper Limit
- 29.3
- value
- 22.9
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 107
- units
- Participants
- description
- OS is defined as the time from randomization until death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
- id
- OG000
- title
- Belantamab Mafodotin
- description
- Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
- id
- OG001
- title
- Pomalidomide Plus Dexamethasone
- param Type
- MEDIAN
- population Description
- ITT Population
- reporting Status
- POSTED
- time Frame
- Up to approximately 263 weeks
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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