NCT02075840 · 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
- From randomization until death (up to 10.5 years)
What was measured
Overall survival (OS) was defined as the time from randomization to death from any cause.
Analysis population: ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Groups in this outcome
Alectinib
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Crizotinib
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
| Group | Source count |
|---|---|
| Alectinib | 152 |
| Crizotinib | 151 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib | 81.1 | Not reported | 62.3 | NA | Value is NA due to an insufficient number of participants with the event. |
| Crizotinib | 54.2 | Not reported | 34.6 | 75.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.08
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1320
- p Value Comment
- Stratified analysis
- param Type
- Hazard Ratio (HR)
- param Value
- 0.78
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.08
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1320
- p Value Comment
- Stratified analysis
- param Type
- Hazard Ratio (HR)
- param Value
- 0.78
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Value is NA due to an insufficient number of participants with the event.
- group Id
- OG000
- lower Limit
- 62.3
- upper Limit
- NA
- value
- 81.1
- group Id
- OG001
- lower Limit
- 34.6
- upper Limit
- 75.6
- value
- 54.2
- denoms
- counts
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 151
- units
- Participants
- description
- Overall survival (OS) was defined as the time from randomization to death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
- id
- OG000
- title
- Alectinib
- description
- Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
- id
- OG001
- title
- Crizotinib
- param Type
- MEDIAN
- population Description
- ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From randomization until death (up to 10.5 years)
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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