TriangleNCT02576509 · OUTCOME
Objective Response Rate (ORR) Per BICR RECIST 1.1
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
- the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)
What was measured
ORR is defined as the proportion of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR is defined as the best response designation, as determined based on BICR-assessed tumor response according to RECIST 1.1, recorded between the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For a BOR of CR or PR, the initial response assessment must be confirmed by a consecutive assessment no less than 4 weeks (28 days) later. Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors
Analysis population: all randomized participants
Groups in this outcome
Nivolumab 240 mg
Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity
Sorafenib 400 mg
Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity
| Group | Source count |
|---|---|
| Nivolumab 240 mg | 371 |
| Sorafenib 400 mg | 372 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab 240 mg | 15.4 | Not reported | 11.8 | 19.4 | Not reported |
| Sorafenib 400 mg | 7.0 | Not reported | 4.6 | 10.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 3.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.7
- estimate Comment
- Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors
- group Ids
- OG000
- OG001
- non Inferiority Comment
- no test was performed due to OS p-value result above the prior threshold
- non Inferiority Type
- OTHER
- param Type
- Difference of ORRs
- param Value
- 8.3
- ci Lower Limit
- 1.48
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.92
- estimate Comment
- Nivolumab over Sorafenib; Mantel-Haenszel estimator
- group Ids
- OG000
- OG001
- non Inferiority Comment
- no test was performed due to OS p-value result above the prior threshold
- non Inferiority Type
- OTHER
- param Type
- Odds Ratio (OR)
- param Value
- 2.41
Complete source fields
- analyses
- ci Lower Limit
- 3.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.7
- estimate Comment
- Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors
- group Ids
- OG000
- OG001
- non Inferiority Comment
- no test was performed due to OS p-value result above the prior threshold
- non Inferiority Type
- OTHER
- param Type
- Difference of ORRs
- param Value
- 8.3
- ci Lower Limit
- 1.48
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.92
- estimate Comment
- Nivolumab over Sorafenib; Mantel-Haenszel estimator
- group Ids
- OG000
- OG001
- non Inferiority Comment
- no test was performed due to OS p-value result above the prior threshold
- non Inferiority Type
- OTHER
- param Type
- Odds Ratio (OR)
- param Value
- 2.41
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.8
- upper Limit
- 19.4
- value
- 15.4
- group Id
- OG001
- lower Limit
- 4.6
- upper Limit
- 10.1
- value
- 7.0
- denoms
- counts
- group Id
- OG000
- value
- 371
- group Id
- OG001
- value
- 372
- units
- Participants
- description
- ORR is defined as the proportion of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR is defined as the best response designation, as determined based on BICR-assessed tumor response according to RECIST 1.1, recorded between the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For a BOR of CR or PR, the initial response assessment must be confirmed by a consecutive assessment no less than 4 weeks (28 days) later. Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity
- id
- OG000
- title
- Nivolumab 240 mg
- description
- Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity
- id
- OG001
- title
- Sorafenib 400 mg
- param Type
- NUMBER
- population Description
- all randomized participants
- reporting Status
- POSTED
- time Frame
- the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)
- title
- Objective Response Rate (ORR) Per BICR RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice