TriangleNCT02151981 · OUTCOME
Progression Free Survival (PFS) by Investigator Assessment
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
- RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
What was measured
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (by investigator assessment) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
Analysis population: Full Analysis Set (All randomised patients)
Groups in this outcome
Osimertinib 80mg
Daily single dose of Osimertinib 80mg
Chemotherapy
Platinum-based doublet chemotherapy
| Group | Source count |
|---|---|
| Osimertinib 80mg | 279 |
| Chemotherapy | 140 |
| Group | Source count |
|---|---|
| Osimertinib 80mg | 140 |
| Chemotherapy | 110 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib 80mg | 10.1 | Not reported | 8.3 | 12.3 | Not reported |
| Chemotherapy | 4.4 | Not reported | 4.2 | 5.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.41
- estimate Comment
- A hazard ratio \<1 favours Osimertinib 80mg
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.30
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.41
- estimate Comment
- A hazard ratio \<1 favours Osimertinib 80mg
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.30
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- 12.3
- value
- 10.1
- group Id
- OG001
- lower Limit
- 4.2
- upper Limit
- 5.6
- value
- 4.4
- denom Units Selected
- Events
- denoms
- counts
- group Id
- OG000
- value
- 279
- group Id
- OG001
- value
- 140
- units
- Participants
- counts
- group Id
- OG000
- value
- 140
- group Id
- OG001
- value
- 110
- units
- Events
- description
- Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (by investigator assessment) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Daily single dose of Osimertinib 80mg
- id
- OG000
- title
- Osimertinib 80mg
- description
- Platinum-based doublet chemotherapy
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- Full Analysis Set (All randomised patients)
- reporting Status
- POSTED
- time Frame
- RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
- title
- Progression Free Survival (PFS) by Investigator Assessment
- type
- PRIMARY
- type Units Analyzed
- Events
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice