NCT02823574 · OUTCOME
Duration of Response (DOR) 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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to disease progression or death. Approximately 63 Months
What was measured
The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.
Analysis population: Platinum eligible subgroup responders
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 | 25 |
| Treatment B - Platinum Eligible Subgroup | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment A - Platinum Eligible Subgroup | 27.04 | Not reported | 11.01 | NA | Insufficient number of events for median, upper limit not calculable |
| Treatment B - Platinum Eligible Subgroup | 24.61 | Not reported | 6.90 | NA | Insufficient number of events for median, upper limit not calculable |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient number of events for median, upper limit not calculable
- group Id
- OG000
- lower Limit
- 11.01
- upper Limit
- NA
- value
- 27.04
- comment
- Insufficient number of events for median, upper limit not calculable
- group Id
- OG001
- lower Limit
- 6.90
- upper Limit
- NA
- value
- 24.61
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 18
- units
- Participants
- description
- The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.
- 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
- MEDIAN
- population Description
- Platinum eligible subgroup responders
- reporting Status
- POSTED
- time Frame
- From randomization to disease progression or death. Approximately 63 Months
- title
- Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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