TriangleNCT03639610 · OUTCOME
Duration of 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
- 95% Confidence Interval
- Time frame
- Patients were assessed from the first measure of a confirmed MR or better until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).
What was measured
Duration of clinical benefit (DOCB) was calculated as time in months from the first evidence of confirmed assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) to first confirmed disease progression, or to death due to any cause. DOCB was defined only for patients with a confirmed MR or better. DOCB was summarized using the Kaplan-Meier (K-M) method. The median DOCB was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median DOCB was constructed using the method of Brookmeyer (Brookmeyer, 1982).
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 | 9.26 | Not reported | 5.82 | 23.49 | Not reported |
| Cohort 1b, Melflufen 30 mg | 10.58 | Not reported | 4.63 | NA | Data not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events |
| Cohort 2a, Melflufen 20 mg | NA | Not reported | NA | NA | Data not estimable due to an insufficient number of events. Only one patient had a best response of confirmed MR or better. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.82
- upper Limit
- 23.49
- value
- 9.26
- comment
- Data not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events
- group Id
- OG001
- lower Limit
- 4.63
- upper Limit
- NA
- value
- 10.58
- comment
- Data not estimable due to an insufficient number of events. Only one patient had a best response of confirmed MR or better.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- Duration of clinical benefit (DOCB) was calculated as time in months from the first evidence of confirmed assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) to first confirmed disease progression, or to death due to any cause. DOCB was defined only for patients with a confirmed MR or better. DOCB was summarized using the Kaplan-Meier (K-M) method. The median DOCB was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median DOCB was constructed using the method of Brookmeyer (Brookmeyer, 1982).
- dispersion Type
- 95% Confidence Interval
- 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 from the first measure of a confirmed MR or better until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).
- title
- Duration of Clinical Benefit
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice