TriangleNCT00949650 · OUTCOME
HRQOL: Time to Deterioration in Dyspnoea
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
- Throughout the trial until progression (every 3 weeks).
What was measured
HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
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 | 10.41 | Not reported | 5.59 | 15.93 | Not reported |
| Pemetrexed/Cisplatin Chemotherapy | 2.86 | Not reported | 2.17 | 4.90 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0129
- p Value Comment
- Two-sided p-value from log-rank test stratified by EGFR mutation group and race.
- statistical Method
- Log Rank
- ci Lower Limit
- 0.499
- ci Pct Value
- 95
- ci Upper Limit
- 0.927
- estimate Comment
- Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0078
- param Type
- Hazard Ratio (HR)
- param Value
- 0.680
- statistical Comment
- Cox PH regression stratified by EGFR mutation group and race.
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0129
- p Value Comment
- Two-sided p-value from log-rank test stratified by EGFR mutation group and race.
- statistical Method
- Log Rank
- ci Lower Limit
- 0.499
- ci Pct Value
- 95
- ci Upper Limit
- 0.927
- estimate Comment
- Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0078
- param Type
- Hazard Ratio (HR)
- param Value
- 0.680
- statistical Comment
- Cox PH regression stratified by EGFR mutation group and race.
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.59
- upper Limit
- 15.93
- value
- 10.41
- group Id
- OG001
- lower Limit
- 2.17
- upper Limit
- 4.90
- value
- 2.86
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
- 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
- MEDIAN
- population Description
- RS.
- reporting Status
- POSTED
- time Frame
- Throughout the trial until progression (every 3 weeks).
- title
- HRQOL: Time to Deterioration in Dyspnoea
- type
- SECONDARY
- unit Of Measure
- Months.
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Preserved source evidence · Not medical advice