TriangleNCT04035486 · OUTCOME
Progression-free Survival (PFS) by Investigator by Plasma Epidermal Growth Factor Receptor Mutation Status: L858R - Participants With an Event (Randomized Component)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 33 months after the first patient is randomized.
What was measured
PFS is defined as the time from randomization until an event. An event is defined as the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the subject withdraws from study treatment or receives another anti-cancer therapy prior to progression. Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.
Analysis population: Subgroup of Full Analysis Set, includes all randomized participants with L858R EGFR mutation.
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 | 106 |
| Randomized: AZD9291 | 107 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: AZD9291 + Chemo | 55 | Not reported | Not reported | Not reported | Not reported |
| Randomized: AZD9291 | 70 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.90
- estimate Comment
- A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.
- group Description
- Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.63
Complete source fields
- analyses
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.90
- estimate Comment
- A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.
- group Description
- Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.63
- classes
- categories
- measurements
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 70
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 107
- units
- Participants
- description
- PFS is defined as the time from randomization until an event. An event is defined as the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the subject withdraws from study treatment or receives another anti-cancer therapy prior to progression. Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Subgroup of Full Analysis Set, includes all randomized participants with L858R EGFR mutation.
- reporting Status
- POSTED
- time Frame
- Up to approximately 33 months after the first patient is randomized.
- title
- Progression-free Survival (PFS) by Investigator by Plasma Epidermal Growth Factor Receptor Mutation Status: L858R - Participants With an Event (Randomized Component)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice