TriangleNCT04035486 · OUTCOME
Time to Second Subsequent Therapy (TSST) or Death (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
Time to second subsequent therapy (TSST) or death is defined as the time from the date of randomization to the earlier of the date of second subsequent anti-cancer therapy start date following IP discontinuation or death. Any patient not known to have died at the time of the analysis and not known to have had a second subsequent therapy will be censored at the last known time to have not received second subsequent therapy, i.e., the last follow-up visit where this was confirmed. If a patient terminated the study for reason other than death before second subsequent therapy, these patients will be censored at the earliest of their last known to be alive and termination dates. Median time to second subsequent therapy or death 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 | 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. |
| Randomized: AZD9291 | 33.2 | Not reported | 28.2 | 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
- 0.51
- 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
- 0.0157
- param Type
- Hazard Ratio (HR)
- param Value
- 0.69
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.51
- 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
- 0.0157
- param Type
- Hazard Ratio (HR)
- param Value
- 0.69
- statistical Method
- Log Rank
- classes
- categories
- measurements
- 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
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- 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
- 28.2
- upper Limit
- NA
- value
- 33.2
- denoms
- counts
- group Id
- OG000
- value
- 279
- group Id
- OG001
- value
- 278
- units
- Participants
- description
- Time to second subsequent therapy (TSST) or death is defined as the time from the date of randomization to the earlier of the date of second subsequent anti-cancer therapy start date following IP discontinuation or death. Any patient not known to have died at the time of the analysis and not known to have had a second subsequent therapy will be censored at the last known time to have not received second subsequent therapy, i.e., the last follow-up visit where this was confirmed. If a patient terminated the study for reason other than death before second subsequent therapy, these patients will be censored at the earliest of their last known to be alive and termination dates. Median time to second subsequent therapy or death 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
- Time to Second Subsequent Therapy (TSST) or Death (Randomized Component)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice