NCT03521154 · OUTCOME
Time to First Subsequent Treatment
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
- Time from randomisation to the start of first subsequent anti-cancer therapy or death. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
What was measured
Time from the date of randomisation to the earlier of the date of anti-cancer therapy start date following study drug discontinuation or death
Analysis population: Full analysis set
Groups in this outcome
Osimertinib
80mg once daily tablet
Placebo
Matching Placebo
| Group | Source count |
|---|---|
| Osimertinib | 143 |
| Placebo | 73 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib | 43.83 | Not reported | 38.87 | NA | NA - Not calculated as insufficient number of events to enable the upper limit of 95% confidence interval to be calculated |
| Placebo | 9.46 | Not reported | 6.60 | 11.53 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.08
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.21
- estimate Comment
- A hazard ratio \< 1 favours osimertinib
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.13
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.08
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.21
- estimate Comment
- A hazard ratio \< 1 favours osimertinib
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.13
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA - Not calculated as insufficient number of events to enable the upper limit of 95% confidence interval to be calculated
- group Id
- OG000
- lower Limit
- 38.87
- upper Limit
- NA
- value
- 43.83
- group Id
- OG001
- lower Limit
- 6.60
- upper Limit
- 11.53
- value
- 9.46
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 73
- units
- Participants
- description
- Time from the date of randomisation to the earlier of the date of anti-cancer therapy start date following study drug discontinuation or death
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 80mg once daily tablet
- id
- OG000
- title
- Osimertinib
- description
- Matching Placebo
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- Time from randomisation to the start of first subsequent anti-cancer therapy or death. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
- title
- Time to First Subsequent Treatment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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