NCT05460273 · OUTCOME
Time To Response (TTR) , Assessed by Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Month
- Interval / dispersion
- Inter-Quartile Range
- 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
Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1.
Analysis population: FAS: Enrolled participants who have received at least one dose of treatment. Participants who were enrolled but did not subsequently receive study intervention are not included in the analysis. The analysis for TTR assessed by investigator was based on the responders in the FAS 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 | 25 |
| NSCLC Cohort | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TNBC Cohort | 1.4 | Not reported | 1.4 | 1.6 | Not reported |
| NSCLC Cohort | 1.4 | Not reported | 1.3 | 1.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 1.6
- value
- 1.4
- group Id
- OG001
- lower Limit
- 1.3
- upper Limit
- 1.4
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1.
- dispersion Type
- Inter-Quartile Range
- 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
- FAS: Enrolled participants who have received at least one dose of treatment. Participants who were enrolled but did not subsequently receive study intervention are not included in the analysis. The analysis for TTR assessed by investigator was based on the responders in the FAS 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
- Time To Response (TTR) , Assessed by Investigator
- type
- SECONDARY
- unit Of Measure
- Month
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Preserved source evidence · Not medical advice
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