TriangleNCT01848834 · OUTCOME
Overall RECIST 1.1 Response Rate Based on BICR Review, Cohort D Asia-Pacific (AP) Participants
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
- Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016
What was measured
ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who were from the Asia Pacific region and experienced a CR or PR in Cohort D was presented for the first course of pembrolizumab treatment per protocol.
Analysis population: The population consisted of all Cohort D participants from AP region who received ≥1 dose of study treatment.
Groups in this outcome
Cohort D: Gastric Cancer AP Participants
Participants who were from the Asia Pacific region received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
| Group | Source count |
|---|---|
| Cohort D: Gastric Cancer AP Participants | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort D: Gastric Cancer AP Participants | 21.1 | Not reported | 6.1 | 45.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.1
- upper Limit
- 45.6
- value
- 21.1
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- description
- ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who were from the Asia Pacific region and experienced a CR or PR in Cohort D was presented for the first course of pembrolizumab treatment per protocol.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who were from the Asia Pacific region received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
- id
- OG000
- title
- Cohort D: Gastric Cancer AP Participants
- param Type
- NUMBER
- population Description
- The population consisted of all Cohort D participants from AP region who received ≥1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016
- title
- Overall RECIST 1.1 Response Rate Based on BICR Review, Cohort D Asia-Pacific (AP) Participants
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice