NCT04035486 · OUTCOME
Overall Survival (OS) (Safety Run-In Treatment Arms Only)
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 45 months (maximum follow up 44.6 months)
What was measured
Overall survival is defined as the time from the date of first dose until death due to any causes. 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. Per the protocol, the safety run-in treatment arms were combined and analyzed regardless of chemotherapy received for consistency with the randomized component.
Analysis population: Safety Analysis Set, includes all participants in the Safety Run-In Treatment Arms who received at least 1 dose of study treatment (osimertinib, cisplatin, carboplatin, or pemetrexed).
Groups in this outcome
Overall Safety Run-In Participants
Includes all participants in both Safety Run-In treatment arms: AZD9291 + Carboplatin + Pemetrexed and AZD9291 + Cisplatin + Pemetrexed
| Group | Source count |
|---|---|
| Overall Safety Run-In Participants | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Overall Safety Run-In Participants | NA | Not reported | 34.0 | NA | Median and 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. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and 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
- 34.0
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 30
- units
- Participants
- description
- Overall survival is defined as the time from the date of first dose until death due to any causes. 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. Per the protocol, the safety run-in treatment arms were combined and analyzed regardless of chemotherapy received for consistency with the randomized component.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Includes all participants in both Safety Run-In treatment arms: AZD9291 + Carboplatin + Pemetrexed and AZD9291 + Cisplatin + Pemetrexed
- id
- OG000
- title
- Overall Safety Run-In Participants
- param Type
- MEDIAN
- population Description
- Safety Analysis Set, includes all participants in the Safety Run-In Treatment Arms who received at least 1 dose of study treatment (osimertinib, cisplatin, carboplatin, or pemetrexed).
- reporting Status
- POSTED
- time Frame
- Up to 45 months (maximum follow up 44.6 months)
- title
- Overall Survival (OS) (Safety Run-In Treatment Arms Only)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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