TriangleNCT03521154 · OUTCOME
Time to Death or Distant Metastases by Blinded Independent Central Review (BICR)
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 date of distant metastases 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 until the first date of distant metastases or date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is detected on a scan that is anywhere other than lung or regional lymph node according to RECIST v1.1 or proven by biopsy
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 | NA | Not reported | 39.29 | NA | NA - Not calculated as median not reached and insufficient number of events to enable upper limit of 95% confidence interval to be calculated |
| Placebo | 13.04 | Not reported | 9.03 | NA | NA - Not calculated as insufficient number of events to enable upper limit of 95% confidence interval to be calculated |
Source statistical analyses
- ci Lower Limit
- 0.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.38
- 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
- 0.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.38
- 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 median not reached and insufficient number of events to enable upper limit of 95% confidence interval to be calculated
- group Id
- OG000
- lower Limit
- 39.29
- upper Limit
- NA
- value
- NA
- comment
- NA - Not calculated as insufficient number of events to enable upper limit of 95% confidence interval to be calculated
- group Id
- OG001
- lower Limit
- 9.03
- upper Limit
- NA
- value
- 13.04
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 73
- units
- Participants
- description
- Time from the date of randomisation until the first date of distant metastases or date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is detected on a scan that is anywhere other than lung or regional lymph node according to RECIST v1.1 or proven by biopsy
- 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 date of distant metastases or death. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
- title
- Time to Death or Distant Metastases by Blinded Independent Central Review (BICR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice