NCT03180736 · 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
- From randomization until death from any cause (up to 5 years)
What was measured
Overall survival is defined as the time, in months, from randomization to the date of death from any cause.
Analysis population: Final OS analysis with the CCO of 31 May 2022 and a median (range) follow-up of 39.6 (0.1-56.9) months
Groups in this outcome
Daratumumab+Pomalidomide+Dexamethasone
Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a 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.
Pomalidomide + Dexamethasone
Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
| Group | Source count |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 151 |
| Pomalidomide + Dexamethasone | 153 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 34.40 | Not reported | 23.69 | 40.25 | Not reported |
| Pomalidomide + Dexamethasone | 23.72 | Not reported | 19.61 | 29.37 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.69
- upper Limit
- 40.25
- value
- 34.40
- group Id
- OG001
- lower Limit
- 19.61
- upper Limit
- 29.37
- value
- 23.72
- denoms
- counts
- group Id
- OG000
- value
- 151
- group Id
- OG001
- value
- 153
- units
- Participants
- description
- Overall survival is defined as the time, in months, from randomization to the date of death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a 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.
- id
- OG000
- title
- Daratumumab+Pomalidomide+Dexamethasone
- description
- Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
- id
- OG001
- title
- Pomalidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- Final OS analysis with the CCO of 31 May 2022 and a median (range) follow-up of 39.6 (0.1-56.9) months
- reporting Status
- POSTED
- time Frame
- From randomization until death from any cause (up to 5 years)
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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