Table 1.
Mixed-effects model for repeated measures results
| Domains/scalesa | Change from baseline, mean (SE) |
Difference in mean change (95% CI)b | |
|---|---|---|---|
| Nivolumab (n = 136) | Dacarbazine (n = 123) | ||
| EORTC QLQ-C30 functional domains | |||
| Global health status | 1.8 (1.8) | 0.9 (3.4) | 0.9 (−6.0, 7.8) |
| Physical functioning | −4.4 (1.6)c | −2.7 (2.6) | −1.7 (−7.1, 3.8) |
| Role functioning | −1.2 (2.3) | 3.6 (3.9) | −4.8 (−12.9, 3.2) |
| Emotional functioning | 6.3 (1.6)d | 5.3 (2.7)d | 1.0 (−4.5, 6.5) |
| Cognitive functioning | 0.4 (1.7) | 1.0 (3.2) | −0.7 (−7.2, 5.9) |
| Social functioning | −0.8 (2.0) | 0.3 (3.7) | −1.1 (−8.6, 6.3) |
| EORTC QLQ-C30 symptom/single-item scales | |||
| Fatigue | 2.0 (1.9) | 2.2 (3.3) | −0.2 (−6.9, 6.4) |
| Nausea and vomiting | −2.6 (1.0)d | 0.0 (1.7) | −2.6 (−6.0, 0.8) |
| Pain | −1.1 (2.5) | −1.6 (4.6) | 0.4 (−9.1, 9.9) |
| Dyspnea | 0.5 (2.1) | 7.4 (3.6)c | −6.9 (−14.2, 0.4) |
| Insomnia | −7.2 (2.2)d | −4.6 (4.0) | −2.6 (−10.7, 5.5) |
| Appetite loss | −3.6 (2.0) | 1.7 (3.5) | −5.2 (−12.2, 1.8) |
| Constipation | 0.1 (2.1) | 1.8 (3.9) | −1.7 (−9.7, 6.4) |
| Diarrhea | −0.5 (1.6) | −0.2 (2.9) | −0.3 (−6.4, 5.7) |
| Financial difficulties | 0.3 (2.2) | 0.8 (4.2) | −0.5 (−9.2, 8.2) |
| Nivolumab (n = 135) | Dacarbazine (n = 122) | ||
| EQ-5D utility index score | 0.040 (0.021) | 0.027 (0.038) | 0.013 (−0.065, 0.091) |
| EQ-5D VAS score | 2.2 (1.8) | 1.8 (3.4) | 0.4 (−6.6, 7.4) |
aHigher scores represent better outcomes on the EORTC QLQ-C30 functioning domains and worse outcomes on the EORTC QLQ-C30 symptom/single-item scales. Higher scores represent better outcomes on the EQ-5D utility index and EQ-5D VAS.
bA positive difference favors nivolumab on the EORTC QLQ-C30 functional domains and EQ-5D; negative difference favors nivolumab on the EORTC QLQ-C30 symptom scales. Differences in mean changes were not significant for all domains/scales.
cSignificant deterioration within arm (P < 0.05).
dSignificant improvement within arm (P < 0.05).
CI, confidence interval; EORTC QLQ-C30, European Organisation for Research and Treatment of Care Core Quality of Life Questionnaire; EQ-5D, EuroQoL Five Dimensions Questionnaire; SE, standard error; VAS, visual analog scale.