TriangleNCT02296125 · OUTCOME
Overall Survival (OS)- Number of Participants With an Event
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks (approximately 29 months)
What was measured
Overall survival was defined as the time from the date of randomisation until death from any cause and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy
Analysis population: The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
Groups in this outcome
Osimertinib 80 mg (Global Cohort)
Randomized participants received Osimertinib 80 mg orally once daily (QD)
SoC EGFR-TKI (Global Cohort)
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
Osimertinib 80 mg (China Cohort)
Randomized participants received Osimertinib 80 mg orally once daily (QD)
SoC EGFR-TKI (China Cohort)
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
| Group | Source count |
|---|---|
| Osimertinib 80 mg (Global Cohort) | 279 |
| SoC EGFR-TKI (Global Cohort) | 277 |
| Osimertinib 80 mg (China Cohort) | 71 |
| SoC EGFR-TKI (China Cohort) | 65 |
Reported measurements
Death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib 80 mg (Global Cohort) | 155 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (Global Cohort) | 166 | Not reported | Not reported | Not reported | Not reported |
| Osimertinib 80 mg (China Cohort) | 45 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (China Cohort) | 44 | Not reported | Not reported | Not reported | Not reported |
Still in survival follow-up
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib 80 mg (Global Cohort) | 104 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (Global Cohort) | 86 | Not reported | Not reported | Not reported | Not reported |
| Osimertinib 80 mg (China Cohort) | 25 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (China Cohort) | 17 | Not reported | Not reported | Not reported | Not reported |
Terminated prior to death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib 80 mg (Global Cohort) | 20 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (Global Cohort) | 25 | Not reported | Not reported | Not reported | Not reported |
| Osimertinib 80 mg (China Cohort) | 1 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (China Cohort) | 4 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.6409
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.9963
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0462
- param Type
- Hazard Ratio (HR)
- param Value
- 0.799
- statistical Method
- Log Rank
- ci Lower Limit
- 0.5568
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.2910
- group Ids
- OG002
- OG003
- non Inferiority Comment
- The china cohort was not powered for superiority
- non Inferiority Type
- OTHER
- p Value
- 0.4416
- param Type
- Hazard Ratio (HR)
- param Value
- 0.848
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.6409
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.9963
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0462
- param Type
- Hazard Ratio (HR)
- param Value
- 0.799
- statistical Method
- Log Rank
- ci Lower Limit
- 0.5568
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.2910
- group Ids
- OG002
- OG003
- non Inferiority Comment
- The china cohort was not powered for superiority
- non Inferiority Type
- OTHER
- p Value
- 0.4416
- param Type
- Hazard Ratio (HR)
- param Value
- 0.848
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 166
- group Id
- OG002
- value
- 45
- group Id
- OG003
- value
- 44
- title
- Death
- categories
- measurements
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 86
- group Id
- OG002
- value
- 25
- group Id
- OG003
- value
- 17
- title
- Still in survival follow-up
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- title
- Terminated prior to death
- denoms
- counts
- group Id
- OG000
- value
- 279
- group Id
- OG001
- value
- 277
- group Id
- OG002
- value
- 71
- group Id
- OG003
- value
- 65
- units
- Participants
- description
- Overall survival was defined as the time from the date of randomisation until death from any cause and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy
- groups
- description
- Randomized participants received Osimertinib 80 mg orally once daily (QD)
- id
- OG000
- title
- Osimertinib 80 mg (Global Cohort)
- description
- Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
- id
- OG001
- title
- SoC EGFR-TKI (Global Cohort)
- description
- Randomized participants received Osimertinib 80 mg orally once daily (QD)
- id
- OG002
- title
- Osimertinib 80 mg (China Cohort)
- description
- Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
- id
- OG003
- title
- SoC EGFR-TKI (China Cohort)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
- reporting Status
- POSTED
- time Frame
- From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks (approximately 29 months)
- title
- Overall Survival (OS)- Number of Participants With an Event
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice