TriangleNCT00949650 · OUTCOME
Tumour Shrinkage
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mm.
- Interval / dispersion
- Standard Error
- Time frame
- Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
What was measured
Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.
Analysis population: RS. There were only 203 patients in the Afatinib 40 mg arm and 101 patients in the Pemetrexed/Cisplatin Chemotherapy with tumour measurements.
Groups in this outcome
Afatinib 40 mg
Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
Pemetrexed/Cisplatin Chemotherapy
Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
| Group | Source count |
|---|---|
| Afatinib 40 mg | 203 |
| Pemetrexed/Cisplatin Chemotherapy | 101 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib 40 mg | 33.19 | 1.12 | Not reported | Not reported | Not reported |
| Pemetrexed/Cisplatin Chemotherapy | 43.00 | 1.59 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -13.64
- ci Pct Value
- 95
- ci Upper Limit
- -5.99
- estimate Comment
- Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Final Values)
- param Value
- -9.82
- statistical Comment
- Adjusted for baseline SoD, EGFR mutation group and race.
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -13.64
- ci Pct Value
- 95
- ci Upper Limit
- -5.99
- estimate Comment
- Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Final Values)
- param Value
- -9.82
- statistical Comment
- Adjusted for baseline SoD, EGFR mutation group and race.
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.12
- value
- 33.19
- group Id
- OG001
- spread
- 1.59
- value
- 43.00
- denoms
- counts
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 101
- units
- Participants
- description
- Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.
- dispersion Type
- Standard Error
- groups
- description
- Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
- id
- OG000
- title
- Afatinib 40 mg
- description
- Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
- id
- OG001
- title
- Pemetrexed/Cisplatin Chemotherapy
- param Type
- MEAN
- population Description
- RS. There were only 203 patients in the Afatinib 40 mg arm and 101 patients in the Pemetrexed/Cisplatin Chemotherapy with tumour measurements.
- reporting Status
- POSTED
- time Frame
- Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
- title
- Tumour Shrinkage
- type
- SECONDARY
- unit Of Measure
- mm.
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Preserved source evidence · Not medical advice