NCT03088540 · OUTCOME
Progression-free Survival (PFS) Per Blinded IRC
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
PFS as assessed by blinded IRC per RECIST 1.1 was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.
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 | 6.3 | Not reported | 4.6 | 8.3 | Not reported |
| Chemotherapy | 5.3 | Not reported | 4.3 | 6.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.469
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.665
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- All analyses based on final DBL were descriptive only with p-values reported as nominal.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.559
- statistical Method
- Stratified log-rank
Complete source fields
- analyses
- ci Lower Limit
- 0.469
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.665
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- All analyses based on final DBL were descriptive only with p-values reported as nominal.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.559
- statistical Method
- Stratified log-rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.6
- upper Limit
- 8.3
- value
- 6.3
- group Id
- OG001
- lower Limit
- 4.3
- upper Limit
- 6.0
- value
- 5.3
- denoms
- counts
- group Id
- OG000
- value
- 357
- group Id
- OG001
- value
- 355
- units
- Participants
- description
- PFS as assessed by blinded IRC per RECIST 1.1 was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.
- 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
- Progression-free Survival (PFS) Per Blinded IRC
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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