NCT01523587 · OUTCOME
Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire
LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy · Source last updated 2019-02-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
What was measured
Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time.
Analysis population: RS
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Afatinib | 398 |
|---|
| Erlotinib | 397 |
|---|
Reported measurements
Improved Cough
Analysis denominator · Participants
| Group | Source count |
|---|
| Afatinib | 339 |
|---|
| Erlotinib | 341 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib | 147 | Not reported | Not reported | Not reported | Not reported |
|---|
| Erlotinib | 120 | Not reported | Not reported | Not reported | Not reported |
|---|
Improved Dyspnoea
Analysis denominator · Participants
| Group | Source count |
|---|
| Afatinib | 339 |
|---|
| Erlotinib | 340 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib | 174 | Not reported | Not reported | Not reported | Not reported |
|---|
| Erlotinib | 150 | Not reported | Not reported | Not reported | Not reported |
|---|
Improved Pain Related
Analysis denominator · Participants
| Group | Source count |
|---|
| Afatinib | 343 |
|---|
| Erlotinib | 342 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib | 138 | Not reported | Not reported | Not reported | Not reported |
|---|
| Erlotinib | 134 | Not reported | Not reported | Not reported | Not reported |
|---|
Improved Global Health Status
Analysis denominator · Participants
| Group | Source count |
|---|
| Afatinib | 339 |
|---|
| Erlotinib | 339 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Afatinib | 121 | Not reported | Not reported | Not reported | Not reported |
|---|
| Erlotinib | 96 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 147
- group Id
- OG001
- value
- 120
- denoms
- counts
- group Id
- OG000
- value
- 339
- group Id
- OG001
- value
- 341
- units
- Participants
- title
- Improved Cough
- categories
- measurements
- group Id
- OG000
- value
- 174
- group Id
- OG001
- value
- 150
- denoms
- counts
- group Id
- OG000
- value
- 339
- group Id
- OG001
- value
- 340
- units
- Participants
- title
- Improved Dyspnoea
- categories
- measurements
- group Id
- OG000
- value
- 138
- group Id
- OG001
- value
- 134
- denoms
- counts
- group Id
- OG000
- value
- 343
- group Id
- OG001
- value
- 342
- units
- Participants
- title
- Improved Pain Related
- categories
- measurements
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 96
- denoms
- counts
- group Id
- OG000
- value
- 339
- group Id
- OG001
- value
- 339
- units
- Participants
- title
- Improved Global Health Status
- denoms
- counts
- group Id
- OG000
- value
- 398
- group Id
- OG001
- value
- 397
- units
- Participants
- description
- Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time.
- 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
- NUMBER
- population Description
- RS
- reporting Status
- POSTED
- time Frame
- From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
- title
- Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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