TriangleNCT01523587 · OUTCOME
Tumour Shrinkage
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Millimeter (mm)
- Interval / dispersion
- Standard Error
- Time frame
- First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
What was measured
Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review. The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation. A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size. Post-baseline mean is adjusted for baseline sum of diameters and race.
Analysis population: Patients from the randomised set with tumour assessments are considered for the analysis of this endpoint.
Groups in this outcome
Afatinib
Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
Erlotinib
Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
| Group | Source count |
|---|---|
| Afatinib | 307 |
| Erlotinib | 311 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib | 78.8 | 1.26 | Not reported | Not reported | Not reported |
| Erlotinib | 80.0 | 1.24 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.28
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.77
- estimate Comment
- Mean was adjusted for baseline sum of diameters and race.
- group Description
- The analysis will compare the treatments using analysis of covariance (ANCOVA) for minimum sum of diameters, using baseline sum of diameters as a covariate. The randomization strata will be included as classification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.500
- param Type
- Adjusted mean
- param Value
- -1.2
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -4.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.28
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.77
- estimate Comment
- Mean was adjusted for baseline sum of diameters and race.
- group Description
- The analysis will compare the treatments using analysis of covariance (ANCOVA) for minimum sum of diameters, using baseline sum of diameters as a covariate. The randomization strata will be included as classification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.500
- param Type
- Adjusted mean
- param Value
- -1.2
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.26
- value
- 78.8
- group Id
- OG001
- spread
- 1.24
- value
- 80.0
- denoms
- counts
- group Id
- OG000
- value
- 307
- group Id
- OG001
- value
- 311
- units
- Participants
- description
- Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review. The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation. A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size. Post-baseline mean is adjusted for baseline sum of diameters and race.
- dispersion Type
- Standard Error
- groups
- description
- Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
- id
- OG000
- title
- Afatinib
- description
- Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
- id
- OG001
- title
- Erlotinib
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Patients from the randomised set with tumour assessments are considered for the analysis of this endpoint.
- reporting Status
- POSTED
- time Frame
- First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
- title
- Tumour Shrinkage
- type
- SECONDARY
- unit Of Measure
- Millimeter (mm)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice