Table 4.
Mean Change From Baseline in the EORTC QLQ-C30 GHS/QoL Scale Score
| Assessment | Pembrolizumab Plus Chemotherapy n = 65 | Placebo Plus Chemotherapy n = 60 |
|---|---|---|
| Baseline | ||
| Completed questionnaire, n | 64 | 60 |
| Mean (SD) score | 74.3 (21.2) | 77.6 (15.1) |
| Week 9 | ||
| Completed questionnaire, n | 52 | 49 |
| Mean (SD) score | 77.7 (16.6) | 72.6 (20.2) |
| Change from baselinea | ||
| Included in analysis, n | 65 | 60 |
| LS mean score (95% CI) | 1.8 (–3.1 to 6.7) | –4.9 (–10.0 to 0.1) |
| Difference in LS mean (95% CI) | 6.7 (0.2‒13.2) | |
| Week 18 | ||
| Completed questionnaire, n | 55 | 42 |
| Mean (SD) score | 82.9 (13.7) | 76.2 (17.6) |
| Change from baselinea | ||
| Included in analysis, n | 65 | 60 |
| LS mean score (95% CI) | 6.8 (2.0‒11.7) | –0.8 (–6.1 to 4.5) |
| Difference in LS mean (95% CI) | 7.6 (1.5‒13.7) | |
CI, confidence interval; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; GHS/QoL, global health status/quality of life; LS, least squares; PRO, patient-related outcome.
a
Based on constrained longitudinal data analysis model with the PRO scores as the response variable and treatment by study visit interaction as covariates.