TriangleNCT03151811 · OUTCOME
Duration of Response (DOR)
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 first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause, up to the data cutoff date of 03 Feb 2021 (ie, assessed up to approximately 43 months).
What was measured
DOR defined as the duration in months from first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause.
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 | 11.17 | Not reported | 8.48 | 17.48 | Not reported |
| Arm B: Pomalidomide+Dexamethasone | 11.07 | Not reported | 7.62 | 15.44 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.48
- upper Limit
- 17.48
- value
- 11.17
- group Id
- OG001
- lower Limit
- 7.62
- upper Limit
- 15.44
- value
- 11.07
- denoms
- counts
- group Id
- OG000
- value
- 246
- group Id
- OG001
- value
- 249
- units
- Participants
- description
- DOR defined as the duration in months from first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause.
- 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 first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause, up to the data cutoff date of 03 Feb 2021 (ie, assessed up to approximately 43 months).
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice