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Ravulizumab (Ultomiris): CADTH Reimbursement Reviews and Recommendations: Therapeutic area: Paroxysmal nocturnal hemoglobinuria [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2022 Apr.
| EORTC QLQ-C30 subscales | Study 301 ravulizumab N = 125 | Study 301 eculizumab N = 121 | Study 302 ravulizumab N = 97 | Study 302 eculizumab N = 98 |
|---|---|---|---|---|
| Mean fatigue symptom scale score, n | 125 | 119 | 94 | 94 |
| Baseline (SD) | 39.3 (22.75) | 37.3 (23.42) | 25.3 (22.63) | 26.3 (21.73) |
| Week 26 (SD) | 19.1 (21.33) | 19.1 (18.57) | 20.2 (20.68) | 25.4 (23.37) |
| Change from baseline to week 26 (SD) | –20.2 (24.51) | –18.6 (24.49) | –4.97 (17.260) | –0.71 (15.271) |
| Mean pain symptom scale score, n | 124 | 117 | 95 | 94 |
| Baseline (SD) | 18.7 (23.44) | 15.3 (20.92) | 6.2 (15.84) | 8.3 (14.99) |
| Week 26 (SD) | 7.3 (15.93) | 8.1 (16.46) | 7.2 (17.47) | 9.9 (18.82) |
| Change from baseline to week 26 (SD) | –11.3 (23.43) | –7.6 (23.41) | 0.87 (12.722) | 1.42 (19.959) |
| Mean dyspnea symptom scale score, n | 125 | 119 | 96 | 94 |
| Baseline (SD) | 27.2 (25.54) | 29.5 (25.89) | 11.7 (19.86) | 19.4 (25.29) |
| Week 26 (SD) | 13.1 (19.80) | 12.6 (19.87) | 10.1 (18.80) | 18.1 (26.63) |
| Change from baseline to week 26 (SD) | –14.1 (24.78) | –17.1 (25.99) | –1.74 (18.950) | –1.06 (20.417) |
EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; SD = standard deviation.
Note: Outcome was outside of the statistical testing hierarchy and was evaluated in the full analysis set. Baseline was defined as the last non-missing value before the first dose of study drug.
From: Clinical Review
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