NCT03599713 · OUTCOME
Overall Survival
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
- up to 60.4 months
What was measured
Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.
Analysis population: Safety Evaluable Population. Analysis was based on the chemotherapy-naïve subset of the population. Median overall survival time was estimated using the Kaplan-Meier method. CI for median overall survival time was calculated using the method of Brookmeyer and Crowley.
Groups in this outcome
Chemotherapy: Naïve
Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
Chemotherapy: Refractory
Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
| Group | Source count |
|---|---|
| Chemotherapy: Naïve | 101 |
| Chemotherapy: Refractory | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy: Naïve | NA | Not reported | 45.24 | NA | The median and the upper limit of the confidence interval were not estimable because too few participants died. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median and the upper limit of the confidence interval were not estimable because too few participants died.
- group Id
- OG000
- lower Limit
- 45.24
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 101
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
- id
- OG000
- title
- Chemotherapy: Naïve
- description
- Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
- id
- OG001
- title
- Chemotherapy: Refractory
- param Type
- MEDIAN
- population Description
- Safety Evaluable Population. Analysis was based on the chemotherapy-naïve subset of the population. Median overall survival time was estimated using the Kaplan-Meier method. CI for median overall survival time was calculated using the method of Brookmeyer and Crowley.
- reporting Status
- POSTED
- time Frame
- up to 60.4 months
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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