NCT03088540 · OUTCOME
Overall Survival (OS)
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 94 months
What was measured
OS was defined as the time from randomization to the date of death due to any cause.
Analysis population: FAS included all randomized participants.
Groups in this outcome
Cemiplimab
Participants received cemiplimab monotherapy
Chemotherapy
Participants received platinum-based doublet chemotherapy
| Group | Source count |
|---|---|
| Cemiplimab | 357 |
| Chemotherapy | 355 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cemiplimab | 23.4 | Not reported | 19.4 | 27.6 | Not reported |
| Chemotherapy | 13.7 | Not reported | 11.2 | 16.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.553
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.790
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- All analyses based on final database lock (DBL) were descriptive only with p-values reported as nominal.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.661
- statistical Method
- Stratified log-rank
Complete source fields
- analyses
- ci Lower Limit
- 0.553
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.790
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- All analyses based on final database lock (DBL) were descriptive only with p-values reported as nominal.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.661
- statistical Method
- Stratified log-rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.4
- upper Limit
- 27.6
- value
- 23.4
- group Id
- OG001
- lower Limit
- 11.2
- upper Limit
- 16.2
- value
- 13.7
- denoms
- counts
- group Id
- OG000
- value
- 357
- group Id
- OG001
- value
- 355
- units
- Participants
- description
- OS was defined as the time from randomization to the date of death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received cemiplimab monotherapy
- id
- OG000
- title
- Cemiplimab
- description
- Participants received platinum-based doublet chemotherapy
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- FAS included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to 94 months
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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