TriangleNCT02151981 · OUTCOME
Tumour Shrinkage by Investigator Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- % change from baseline
- Interval / dispersion
- Standard Deviation
- 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: Tumour size was calculated as the sum of the longest diameters (SLD) of the Target Lesions. Tumour shrinkage is percentage change in tumour size from baseline using RECIST v1.1 tumour response.
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 | 278 |
| Chemotherapy | 131 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib 80mg | -46.1 | 29.50 | Not reported | Not reported | Not reported |
| Chemotherapy | -24.4 | 29.27 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -27.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -15.52
- estimate Comment
- LS Mean: Osimertinib -46.93, Chemo -25.3 A difference in LS means \<0 favours Osimertinib 80mg
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.001
- param Type
- Difference in LS means
- param Value
- -21.62
- statistical Comment
- Covariates for ethnicity (Asian, non-Asian) and the baseline sum of diameters of target lesions
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -27.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -15.52
- estimate Comment
- LS Mean: Osimertinib -46.93, Chemo -25.3 A difference in LS means \<0 favours Osimertinib 80mg
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.001
- param Type
- Difference in LS means
- param Value
- -21.62
- statistical Comment
- Covariates for ethnicity (Asian, non-Asian) and the baseline sum of diameters of target lesions
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 29.50
- value
- -46.1
- group Id
- OG001
- spread
- 29.27
- value
- -24.4
- denoms
- counts
- group Id
- OG000
- value
- 278
- group Id
- OG001
- value
- 131
- units
- Participants
- description
- Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Tumour size was calculated as the sum of the longest diameters (SLD) of the Target Lesions. Tumour shrinkage is percentage change in tumour size from baseline using RECIST v1.1 tumour response.
- dispersion Type
- Standard Deviation
- groups
- description
- Daily single dose of Osimertinib 80mg
- id
- OG000
- title
- Osimertinib 80mg
- description
- Platinum-based doublet chemotherapy
- id
- OG001
- title
- Chemotherapy
- param Type
- MEAN
- 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
- Tumour Shrinkage by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- % change from baseline
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice