TriangleNCT03615326 · OUTCOME
Duration of Response (DOR) Per RECIST 1.1 Assessed by BICR
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
- Up to 63 months
What was measured
For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Analysis population: All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm and who had CR or PR per RECIST 1.1 as assessed by BICR were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Groups in this outcome
Global Pembrolizumab + Standard of Care First Course
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
Global Standard of Care First Course
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
| Group | Source count |
|---|---|
| Global Pembrolizumab + Standard of Care First Course | 254 |
| Global Standard of Care First Course | 209 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Global Pembrolizumab + Standard of Care First Course | 11.13 | Not reported | 9.8 | 12.7 | Not reported |
| Global Standard of Care First Course | 9.5 | Not reported | 7.2 | 11.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.8
- upper Limit
- 12.7
- value
- 11.13
- group Id
- OG001
- lower Limit
- 7.2
- upper Limit
- 11.2
- value
- 9.5
- denoms
- counts
- group Id
- OG000
- value
- 254
- group Id
- OG001
- value
- 209
- units
- Participants
- description
- For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
- id
- OG000
- title
- Global Pembrolizumab + Standard of Care First Course
- description
- Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
- id
- OG001
- title
- Global Standard of Care First Course
- param Type
- MEDIAN
- population Description
- All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm and who had CR or PR per RECIST 1.1 as assessed by BICR were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
- reporting Status
- POSTED
- time Frame
- Up to 63 months
- title
- Duration of Response (DOR) Per RECIST 1.1 Assessed by BICR
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice