NCT04644237 · OUTCOME
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on scale
- Interval / dispersion
- Standard Deviation
- Time frame
- At baseline and at end of treatment 40-day follow-up visit
What was measured
The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms. The QLQ-LC13 is a 13-item questionnaire designed to assess lung cancer-related symptoms and treatment side effects. The scales ranges from 1=not at all to 4=very much. The summation of scores range from 0 to 100, where higher scores represent increasing symptoms levels. scales.
Analysis population: Full Analysis Set
Groups in this outcome
Trastuzumab Deruxtecan 5.4 mg/kg
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
Trastuzumab Deruxtecan 6.4 mg/kg
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
| Group | Source count |
|---|---|
| Trastuzumab Deruxtecan 5.4 mg/kg | 102 |
| Trastuzumab Deruxtecan 6.4 mg/kg | 50 |
Reported measurements
QLQ-C30: Change from Baseline 40-Day Follow-up
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan 5.4 mg/kg | -1.11 | 17.780 | Not reported | Not reported | Not reported |
| Trastuzumab Deruxtecan 6.4 mg/kg | 15.63 | 31.947 | Not reported | Not reported | Not reported |
QLQ-LC13: Change from Baseline 40-Day Follow-up
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan 5.4 mg/kg | -2.38 | 24.335 | Not reported | Not reported | Not reported |
| Trastuzumab Deruxtecan 6.4 mg/kg | -29.17 | 27.817 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.780
- value
- -1.11
- group Id
- OG001
- spread
- 31.947
- value
- 15.63
- title
- QLQ-C30: Change from Baseline 40-Day Follow-up
- categories
- measurements
- group Id
- OG000
- spread
- 24.335
- value
- -2.38
- group Id
- OG001
- spread
- 27.817
- value
- -29.17
- title
- QLQ-LC13: Change from Baseline 40-Day Follow-up
- denoms
- counts
- group Id
- OG000
- value
- 102
- group Id
- OG001
- value
- 50
- units
- Participants
- description
- The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms. The QLQ-LC13 is a 13-item questionnaire designed to assess lung cancer-related symptoms and treatment side effects. The scales ranges from 1=not at all to 4=very much. The summation of scores range from 0 to 100, where higher scores represent increasing symptoms levels. scales.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- id
- OG000
- title
- Trastuzumab Deruxtecan 5.4 mg/kg
- description
- Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- id
- OG001
- title
- Trastuzumab Deruxtecan 6.4 mg/kg
- param Type
- MEAN
- population Description
- Full Analysis Set
- reporting Status
- POSTED
- time Frame
- At baseline and at end of treatment 40-day follow-up visit
- title
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores
- type
- SECONDARY
- unit Of Measure
- score on scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle