TriangleNCT04035486 · OUTCOME
Overall Survival (OS) (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 (maximum follow up of 34.1 months)
What was measured
Overall survival is defined as the time from the date of randomization until death due to any cause. Subjects not known to have died at the time of analysis are censored at the last recorded date on which the subject was known to be alive. Median overall Survival 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 | NA | Not reported | 31.9 | NA | Median and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off. |
| Randomized: AZD9291 | NA | Not reported | NA | NA | Median, Lower Limit and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off. |
Source statistical analyses
- ci Lower Limit
- 0.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.24
- estimate Comment
- A hazard ratio of 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
- other Analysis Description
- An adjusted CI of (0.54, 1.51) was computed at the 2-sided 99.84% level, considering a 2-sided significance level of 0.00158 for the overall survival interim analysis, based on the O'Brien and Fleming spending function, assuming 334 deaths for the final overall survival analysis.
- p Value
- 0.5238
- param Type
- Hazard Ratio (HR)
- param Value
- 0.90
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.24
- estimate Comment
- A hazard ratio of 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
- other Analysis Description
- An adjusted CI of (0.54, 1.51) was computed at the 2-sided 99.84% level, considering a 2-sided significance level of 0.00158 for the overall survival interim analysis, based on the O'Brien and Fleming spending function, assuming 334 deaths for the final overall survival analysis.
- p Value
- 0.5238
- param Type
- Hazard Ratio (HR)
- param Value
- 0.90
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Median and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
- group Id
- OG000
- lower Limit
- 31.9
- upper Limit
- NA
- value
- NA
- comment
- Median, Lower Limit and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 279
- group Id
- OG001
- value
- 278
- units
- Participants
- description
- Overall survival is defined as the time from the date of randomization until death due to any cause. Subjects not known to have died at the time of analysis are censored at the last recorded date on which the subject was known to be alive. Median overall Survival 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 (maximum follow up of 34.1 months)
- title
- Overall Survival (OS) (Randomized Component)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice