NCT05460273 · OUTCOME
Duration of Response (DoR), Assessed by ICR
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Month
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
What was measured
Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by ICR, or death due to any cause.
Analysis population: RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR. The analysis for DOR assessed by ICR was based on the responders in the RES of each cohort.
Groups in this outcome
TNBC Cohort
Final Analysis with DCO on 06May2024
NSCLC Cohort
Final Analysis with DCO on 27Nov2024
| Group | Source count |
|---|---|
| TNBC Cohort | 26 |
| NSCLC Cohort | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TNBC Cohort | 6.7 | Not reported | 4.53 | 12.6 | Not reported |
| NSCLC Cohort | 8.3 | Not reported | 5.9 | 9.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.53
- upper Limit
- 12.6
- value
- 6.7
- group Id
- OG001
- lower Limit
- 5.9
- upper Limit
- 9.4
- value
- 8.3
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 18
- units
- Participants
- description
- Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by ICR, or death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Final Analysis with DCO on 06May2024
- id
- OG000
- title
- TNBC Cohort
- description
- Final Analysis with DCO on 27Nov2024
- id
- OG001
- title
- NSCLC Cohort
- param Type
- MEDIAN
- population Description
- RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR. The analysis for DOR assessed by ICR was based on the responders in the RES of each cohort.
- reporting Status
- POSTED
- time Frame
- TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
- title
- Duration of Response (DoR), Assessed by ICR
- type
- SECONDARY
- unit Of Measure
- Month
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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