TriangleNCT02314169 · OUTCOME
Overall Response Rate (Part B)
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
- Up to 2 years
What was measured
Responses assessed using CT scans or magnetic resonance imaging according to standard RECIST 1.1 criteria in order to assess disease progression. CR: Disappearance all target lesions; any pathological lymph nodes reduction in short axis to \< 10 mm (\< 1 cm). PR: \> 30% decrease in sum diameters of target lesions. PD: \> 20% increase in sum diameters lesions. (Note: appearance of one or \> new lesions considered progressions). SD: Neither shrinkage qualify for PR nor increase for PD.
Analysis population: Of the 100 participants enrolled into Part B of the study, 88 participants were evaluable for response per RECIST 1.1. The remaining 12 participants were not evaluable for treatment response.
Groups in this outcome
Part B Arm I (Nivolumab)
Participants enrolled into Arm I received single agent Nivolumab.
Part B Arm II (Nivolumab, Ipilimumab
Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
| Group | Source count |
|---|---|
| Part B Arm I (Nivolumab) | 46 |
| Part B Arm II (Nivolumab, Ipilimumab | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B Arm I (Nivolumab) | 17.4 | Not reported | 9.1 | 31 | Not reported |
| Part B Arm II (Nivolumab, Ipilimumab | 21.5 | Not reported | 12 | 36 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.89
- statistical Method
- Chi-squared
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.89
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.1
- upper Limit
- 31
- value
- 17.4
- group Id
- OG001
- lower Limit
- 12
- upper Limit
- 36
- value
- 21.5
- denoms
- counts
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- Responses assessed using CT scans or magnetic resonance imaging according to standard RECIST 1.1 criteria in order to assess disease progression. CR: Disappearance all target lesions; any pathological lymph nodes reduction in short axis to \< 10 mm (\< 1 cm). PR: \> 30% decrease in sum diameters of target lesions. PD: \> 20% increase in sum diameters lesions. (Note: appearance of one or \> new lesions considered progressions). SD: Neither shrinkage qualify for PR nor increase for PD.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants enrolled into Arm I received single agent Nivolumab.
- id
- OG000
- title
- Part B Arm I (Nivolumab)
- description
- Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
- id
- OG001
- title
- Part B Arm II (Nivolumab, Ipilimumab
- param Type
- NUMBER
- population Description
- Of the 100 participants enrolled into Part B of the study, 88 participants were evaluable for response per RECIST 1.1. The remaining 12 participants were not evaluable for treatment response.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Overall Response Rate (Part B)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice