TriangleNCT00949650 · OUTCOME
Percentage of Participants With Disease Control (DC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants with DC.
- Interval / dispersion
- 95% Confidence Interval
- 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
DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.
Analysis population: RS.
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 | 230 |
| Pemetrexed/Cisplatin Chemotherapy | 115 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib 40 mg | 90.4 | Not reported | 85.9 | 93.9 | Not reported |
| Pemetrexed/Cisplatin Chemotherapy | 80.9 | Not reported | 72.5 | 87.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.202
- ci Pct Value
- 95
- ci Upper Limit
- 4.356
- estimate Comment
- Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0118
- param Type
- Odds Ratio (OR)
- param Value
- 2.288
- statistical Comment
- Logistic regression stratified for EGFR mutation group and race.
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 1.202
- ci Pct Value
- 95
- ci Upper Limit
- 4.356
- estimate Comment
- Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0118
- param Type
- Odds Ratio (OR)
- param Value
- 2.288
- statistical Comment
- Logistic regression stratified for EGFR mutation group and race.
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 85.9
- upper Limit
- 93.9
- value
- 90.4
- group Id
- OG001
- lower Limit
- 72.5
- upper Limit
- 87.6
- value
- 80.9
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- RS.
- 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
- Percentage of Participants With Disease Control (DC)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants with DC.
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice