TriangleNCT02296125 · OUTCOME
Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
What was measured
Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS.
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
Progression free at 6 months (%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib 80 mg (Global Cohort) | 88.4 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (Global Cohort) | 75.2 | Not reported | Not reported | Not reported | Not reported |
| Osimertinib 80 mg (China Cohort) | 78.8 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (China Cohort) | 72.3 | Not reported | Not reported | Not reported | Not reported |
Progression free at 12 months (%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib 80 mg (Global Cohort) | 68.2 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (Global Cohort) | 42.3 | Not reported | Not reported | Not reported | Not reported |
| Osimertinib 80 mg (China Cohort) | 67.3 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (China Cohort) | 44.6 | Not reported | Not reported | Not reported | Not reported |
Progression free at 18 months (%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib 80 mg (Global Cohort) | 50.9 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (Global Cohort) | 24.4 | Not reported | Not reported | Not reported | Not reported |
| Osimertinib 80 mg (China Cohort) | 46.9 | Not reported | Not reported | Not reported | Not reported |
| SoC EGFR-TKI (China Cohort) | 25.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 88.4
- group Id
- OG001
- value
- 75.2
- group Id
- OG002
- value
- 78.8
- group Id
- OG003
- value
- 72.3
- title
- Progression free at 6 months (%)
- categories
- measurements
- group Id
- OG000
- value
- 68.2
- group Id
- OG001
- value
- 42.3
- group Id
- OG002
- value
- 67.3
- group Id
- OG003
- value
- 44.6
- title
- Progression free at 12 months (%)
- categories
- measurements
- group Id
- OG000
- value
- 50.9
- group Id
- OG001
- value
- 24.4
- group Id
- OG002
- value
- 46.9
- group Id
- OG003
- value
- 25.8
- title
- Progression free at 18 months (%)
- 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
- Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS.
- 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
- NUMBER
- 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
- At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
- title
- Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice