TriangleNCT03639610 · OUTCOME
Time to Clinical Benefit
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).
What was measured
Time to clinical benefit was defined as the time from first dose of therapy to first documented confirmed response of minimal response (MR) or better.
Analysis population: This analysis included patients who achieved a best response of MR or better.
Groups in this outcome
Cohort 1a, Melflufen 40 mg
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
Cohort 1b, Melflufen 30 mg
Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
Cohort 2a, Melflufen 20 mg
Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
| Group | Source count |
|---|---|
| Cohort 1a, Melflufen 40 mg | 11 |
| Cohort 1b, Melflufen 30 mg | 8 |
| Cohort 2a, Melflufen 20 mg | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1a, Melflufen 40 mg | 1.12 | Not reported | 1.0 | 8.7 | Not reported |
| Cohort 1b, Melflufen 30 mg | 1.12 | Not reported | 0.9 | 5.9 | Not reported |
| Cohort 2a, Melflufen 20 mg | 2.83 | Not reported | 2.83 | 2.83 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 8.7
- value
- 1.12
- group Id
- OG001
- lower Limit
- 0.9
- upper Limit
- 5.9
- value
- 1.12
- group Id
- OG002
- lower Limit
- 2.83
- upper Limit
- 2.83
- value
- 2.83
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- Time to clinical benefit was defined as the time from first dose of therapy to first documented confirmed response of minimal response (MR) or better.
- dispersion Type
- Full Range
- groups
- description
- Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
- id
- OG000
- title
- Cohort 1a, Melflufen 40 mg
- description
- Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
- id
- OG001
- title
- Cohort 1b, Melflufen 30 mg
- description
- Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
- id
- OG002
- title
- Cohort 2a, Melflufen 20 mg
- param Type
- MEDIAN
- population Description
- This analysis included patients who achieved a best response of MR or better.
- reporting Status
- POSTED
- time Frame
- Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).
- title
- Time to Clinical Benefit
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice