NCT05460273 · OUTCOME
Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- 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
Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as assessed by ICR per RECIST 1.1.
Analysis population: RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.
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 | 77 |
| NSCLC Cohort | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TNBC Cohort | 33.8 | Not reported | 23.4 | 45.4 | Not reported |
| NSCLC Cohort | 45.0 | Not reported | 29.3 | 61.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.4
- upper Limit
- 45.4
- value
- 33.8
- group Id
- OG001
- lower Limit
- 29.3
- upper Limit
- 61.5
- value
- 45.0
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as assessed by ICR per RECIST 1.1.
- 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
- NUMBER
- population Description
- RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.
- 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
- Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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