TriangleNCT03639610 · OUTCOME
Overall Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until disease progression (confirmed on 2 consecutive assessments) (maximum duration 127.1 weeks).
What was measured
Overall response rate (ORR) is the percentage of patients who achieved a confirmed response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as best response, as assessed by the Investigator.
Analysis population: This analysis was performed in the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.
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 | 21 |
| Cohort 1b, Melflufen 30 mg | 10 |
| Cohort 2a, Melflufen 20 mg | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1a, Melflufen 40 mg | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1b, Melflufen 30 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2a, Melflufen 20 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- Overall response rate (ORR) is the percentage of patients who achieved a confirmed response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as best response, as assessed by the Investigator.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- This analysis was performed in the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.
- reporting Status
- POSTED
- time Frame
- Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until disease progression (confirmed on 2 consecutive assessments) (maximum duration 127.1 weeks).
- title
- Overall Response Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice