TriangleNCT02899299 · OUTCOME
Objective Response Rate (ORR)
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
- From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)
What was measured
Objective Response Rate is defined as the percentage of randomized participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
Analysis population: All Randomized Participants
Groups in this outcome
Treatment A
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
Treatment B
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
| Group | Source count |
|---|---|
| Treatment A | 303 |
| Treatment B | 302 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment A | 39.3 | Not reported | 33.7 | 45.0 | Not reported |
| Treatment B | 44.4 | Not reported | 38.7 | 50.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33.7
- upper Limit
- 45.0
- value
- 39.3
- group Id
- OG001
- lower Limit
- 38.7
- upper Limit
- 50.2
- value
- 44.4
- denoms
- counts
- group Id
- OG000
- value
- 303
- group Id
- OG001
- value
- 302
- units
- Participants
- description
- Objective Response Rate is defined as the percentage of randomized participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
- id
- OG000
- title
- Treatment A
- description
- Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
- id
- OG001
- title
- Treatment B
- param Type
- NUMBER
- population Description
- All Randomized Participants
- reporting Status
- POSTED
- time Frame
- From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)
- title
- Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice