TriangleNCT03151811 · 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
- From date of randomization until up to 24 months following confirmed disease progression or initiation of subsequent therapy, up to the data cutoff date of 03 Feb 2023 (ie, assessed up to approximately 67 months).
What was measured
OS defined as the time in months from randomization to date of death due to any cause. Patients who were still alive at end of study, or lost to follow up, were censored at the last day the patient was known to be alive.
Analysis population: Full Analysis Set (all patients randomized to either Arm A or Arm B).
Groups in this outcome
Arm A: Melflufen+Dexamethasone
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Melflufen: Intravenous infusion Dexamethasone: Oral tablets
Arm B: Pomalidomide+Dexamethasone
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Pomalidomide: Oral capsules Dexamethasone: Oral tablets
| Group | Source count |
|---|---|
| Arm A: Melflufen+Dexamethasone | 246 |
| Arm B: Pomalidomide+Dexamethasone | 249 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Melflufen+Dexamethasone | 20.24 | Not reported | 15.84 | 24.15 | Not reported |
| Arm B: Pomalidomide+Dexamethasone | 23.98 | Not reported | 18.92 | 27.86 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.84
- upper Limit
- 24.15
- value
- 20.24
- group Id
- OG001
- lower Limit
- 18.92
- upper Limit
- 27.86
- value
- 23.98
- denoms
- counts
- group Id
- OG000
- value
- 246
- group Id
- OG001
- value
- 249
- units
- Participants
- description
- OS defined as the time in months from randomization to date of death due to any cause. Patients who were still alive at end of study, or lost to follow up, were censored at the last day the patient was known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Melflufen: Intravenous infusion Dexamethasone: Oral tablets
- id
- OG000
- title
- Arm A: Melflufen+Dexamethasone
- description
- Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Pomalidomide: Oral capsules Dexamethasone: Oral tablets
- id
- OG001
- title
- Arm B: Pomalidomide+Dexamethasone
- param Type
- MEDIAN
- population Description
- Full Analysis Set (all patients randomized to either Arm A or Arm B).
- reporting Status
- POSTED
- time Frame
- From date of randomization until up to 24 months following confirmed disease progression or initiation of subsequent therapy, up to the data cutoff date of 03 Feb 2023 (ie, assessed up to approximately 67 months).
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice