NCT03521154 · OUTCOME
Time to Study Treatment Discontinuation
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 earlier of the date of study treatment discontinuation or death. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
What was measured
Time from randomisation to the earlier of the date of study treatment discontinuation (regardless of the reason for study treatment discontinuation) or death (i.e. date of study treatment discontinuation/death or censoring - date of randomisation + 1 day, expressed in months)
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 | 40.28 | Not reported | 32.72 | NA | NA - Not calculated as insufficient number of events to enable the upper limit of the 95% confidence interval to be calculated |
| Placebo | 8.31 | Not reported | 6.14 | 11.10 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.32
- 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
- 0.21
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.32
- 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
- 0.21
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA - Not calculated as insufficient number of events to enable the upper limit of the 95% confidence interval to be calculated
- group Id
- OG000
- lower Limit
- 32.72
- upper Limit
- NA
- value
- 40.28
- group Id
- OG001
- lower Limit
- 6.14
- upper Limit
- 11.10
- value
- 8.31
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 73
- units
- Participants
- description
- Time from randomisation to the earlier of the date of study treatment discontinuation (regardless of the reason for study treatment discontinuation) or death (i.e. date of study treatment discontinuation/death or censoring - date of randomisation + 1 day, expressed in months)
- 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 earlier of the date of study treatment discontinuation or death. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
- title
- Time to Study Treatment Discontinuation
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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