TriangleNCT04035486 · OUTCOME
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Items (EORTC QLQ-LC13) (Randomized Component)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Scores on a Scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 33 months after the first patient is randomized.
What was measured
EORTC QLQ-LC13 has 13 questions and scores range from 0-100 after a linear transformation. Questions assess cough, hemoptysis, dyspnea, site specific pain, sore mouth, dysphagia, peripheral neuropathy, and alopecia and pain medication. While the QLQ-LC13 includes more scales, only the Coughing, Pain in chest, and Dyspnea subscale scores were analyzed for this endpoint. Negative change from baseline scores indicates less symptom severity, and thus improvement on health status. The score values calculated by averaging across patients overall mean across all visits. The analysis was performed using a MMRM analysis on the change from baseline in the score at each visit, including subject (as a random effect), treatment, visit (as fixed effect and repeated measure) and treatment by visit interaction as explanatory variables, with the baseline score as a covariate along with the baseline score by assessment interaction.
Analysis population: Full Analysis Set, includes all randomized participants.
Groups in this outcome
Randomized: AZD9291 + Chemo
Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
Randomized: AZD9291
Osimertinib (AZD9291) 80mg QD.
| Group | Source count |
|---|---|
| Randomized: AZD9291 + Chemo | 253 |
| Randomized: AZD9291 | 251 |
Reported measurements
Coughing Score (Change from Baseline)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: AZD9291 + Chemo | -13.23 | Not reported | -14.85 | -11.62 | Not reported |
| Randomized: AZD9291 | -11.19 | Not reported | -12.83 | -9.55 | Not reported |
Pain in Chest Score (Change from Baseline)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: AZD9291 + Chemo | -6.33 | Not reported | -7.66 | -4.99 | Not reported |
| Randomized: AZD9291 | -6.61 | Not reported | -7.98 | -5.25 | Not reported |
Dyspnea Score (Change from Baseline)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: AZD9291 + Chemo | -3.09 | Not reported | -4.70 | -1.49 | Not reported |
| Randomized: AZD9291 | -5.67 | Not reported | -7.30 | -4.04 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -14.85
- upper Limit
- -11.62
- value
- -13.23
- group Id
- OG001
- lower Limit
- -12.83
- upper Limit
- -9.55
- value
- -11.19
- title
- Coughing Score (Change from Baseline)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -7.66
- upper Limit
- -4.99
- value
- -6.33
- group Id
- OG001
- lower Limit
- -7.98
- upper Limit
- -5.25
- value
- -6.61
- title
- Pain in Chest Score (Change from Baseline)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -4.70
- upper Limit
- -1.49
- value
- -3.09
- group Id
- OG001
- lower Limit
- -7.30
- upper Limit
- -4.04
- value
- -5.67
- title
- Dyspnea Score (Change from Baseline)
- denoms
- counts
- group Id
- OG000
- value
- 253
- group Id
- OG001
- value
- 251
- units
- Participants
- description
- EORTC QLQ-LC13 has 13 questions and scores range from 0-100 after a linear transformation. Questions assess cough, hemoptysis, dyspnea, site specific pain, sore mouth, dysphagia, peripheral neuropathy, and alopecia and pain medication. While the QLQ-LC13 includes more scales, only the Coughing, Pain in chest, and Dyspnea subscale scores were analyzed for this endpoint. Negative change from baseline scores indicates less symptom severity, and thus improvement on health status. The score values calculated by averaging across patients overall mean across all visits. The analysis was performed using a MMRM analysis on the change from baseline in the score at each visit, including subject (as a random effect), treatment, visit (as fixed effect and repeated measure) and treatment by visit interaction as explanatory variables, with the baseline score as a covariate along with the baseline score by assessment interaction.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
- id
- OG000
- title
- Randomized: AZD9291 + Chemo
- description
- Osimertinib (AZD9291) 80mg QD.
- id
- OG001
- title
- Randomized: AZD9291
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Full Analysis Set, includes all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 33 months after the first patient is randomized.
- title
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Items (EORTC QLQ-LC13) (Randomized Component)
- type
- SECONDARY
- unit Of Measure
- Scores on a Scale
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Preserved source evidence · Not medical advice