TriangleNCT02823574 · OUTCOME
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
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 to end of study. Approximately 63 Months
What was measured
ORR is defined as percentage of participants with a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: All Randomized Participants - Platinum Eligible Subgroup
Groups in this outcome
Treatment A - Platinum Eligible Subgroup
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Treatment B - Platinum Eligible Subgroup
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
| Group | Source count |
|---|---|
| Treatment A - Platinum Eligible Subgroup | 123 |
| Treatment B - Platinum Eligible Subgroup | 61 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment A - Platinum Eligible Subgroup | 20.3 | Not reported | 13.6 | 28.5 | Not reported |
| Treatment B - Platinum Eligible Subgroup | 29.5 | Not reported | 18.5 | 42.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.6
- upper Limit
- 28.5
- value
- 20.3
- group Id
- OG001
- lower Limit
- 18.5
- upper Limit
- 42.6
- value
- 29.5
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 61
- units
- Participants
- description
- ORR is defined as percentage of participants with a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
- id
- OG000
- title
- Treatment A - Platinum Eligible Subgroup
- description
- Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
- id
- OG001
- title
- Treatment B - Platinum Eligible Subgroup
- param Type
- NUMBER
- population Description
- All Randomized Participants - Platinum Eligible Subgroup
- reporting Status
- POSTED
- time Frame
- From randomization to end of study. Approximately 63 Months
- title
- Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice