TriangleNCT04035486 · OUTCOME
Progression Free Survival 2 (PFS2) (Randomized Component)
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
- Up to approximately 33 months after the first patient is randomized.
What was measured
Progression Free Survival 2 is defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary Progression Free Survival (PFS), or death in absence of a first or second progression. The second progression event must have occurred after subsequent treatment administered after the initial progression free survival event. Any participant that was lost to follow-up, withdrew consent or discontinued for other reasons at the time of the analysis were censored at the last evaluable progression assessment. Median second progression free survival (months) calculated using the Kaplan-Meier method.
Analysis population: Full Analysis Set, includes all randomized participants.
Groups in this outcome
Randomized: AZD9291 + Chemo
Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
Randomized: AZD9291
Osimertinib (AZD9291) 80mg QD.
| Group | Source count |
|---|---|
| Randomized: AZD9291 + Chemo | 279 |
| Randomized: AZD9291 | 278 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: AZD9291 + Chemo | 30.6 | Not reported | 29.0 | NA | Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation. |
| Randomized: AZD9291 | 27.8 | Not reported | 26.0 | NA | Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation. |
Source statistical analyses
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.93
- estimate Comment
- A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.
- group Description
- The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0132
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.93
- estimate Comment
- A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.
- group Description
- The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0132
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
- group Id
- OG000
- lower Limit
- 29.0
- upper Limit
- NA
- value
- 30.6
- comment
- Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
- group Id
- OG001
- lower Limit
- 26.0
- upper Limit
- NA
- value
- 27.8
- denoms
- counts
- group Id
- OG000
- value
- 279
- group Id
- OG001
- value
- 278
- units
- Participants
- description
- Progression Free Survival 2 is defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary Progression Free Survival (PFS), or death in absence of a first or second progression. The second progression event must have occurred after subsequent treatment administered after the initial progression free survival event. Any participant that was lost to follow-up, withdrew consent or discontinued for other reasons at the time of the analysis were censored at the last evaluable progression assessment. Median second progression free survival (months) calculated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
- id
- OG000
- title
- Randomized: AZD9291 + Chemo
- description
- Osimertinib (AZD9291) 80mg QD.
- id
- OG001
- title
- Randomized: AZD9291
- param Type
- MEDIAN
- population Description
- Full Analysis Set, includes all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 33 months after the first patient is randomized.
- title
- Progression Free Survival 2 (PFS2) (Randomized Component)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice