Table 2.
Proportion with clinically meaningful change,an (%) |
||||||
---|---|---|---|---|---|---|
Variable Median (range), unless otherwise stated |
Baselineb | Last follow-upc | Change (LFU ‒ BL) | Improvement | No change | Worsening |
Overall on dialysis (n = 67) | 35.0 (5.0–51.0) | 36.0 (1.0–51.0) | 0.0 (−33.0 to 36.0) | 29 (43.3) | 18 (26.9) | 20 (29.9) |
Overall not on dialysis (n = 423) | 42.0 (0.0–52.0) | 44.0 (3.0–52.0) | 0.0 (−38.6 to 47.0) | 146 (34.5) | 167 (39.5) | 110 (26.0) |
Overall kidney transplant (n = 157) | 44.0 (5.0–52.0) | 42.0 (3.0–52.0) | −1.0 (−38.6 to 36.0) | 42 (26.8) | 66 (42.0) | 49 (31.2) |
Overall no kidney transplant (n = 362) | 39.0 (0.0–52.0) | 43.0 (1.0–52.0) | 1.25 (−31.0 to 47.0) | 148 (40.9) | 127 (35.1) | 87 (24.0) |
Overall with recent hospitalization (n = 197) | 33.0 (0.0–52.0) | 39.0 (1.0–52.0) | 3.0 (−38.6 to 47.0) | 93 (47.2) | 59 (29.9) | 45 (22.8) |
Overall without recent hospitalization (n = 354) | 44.0 (0.0–52.0) | 44.2 (3.0–52.0) | 0.0 (−31.0 to 47.0) | 112 (31.6) | 143 (40.4) | 99 (28.0) |
BL, baseline; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; LFU, last follow-up.
Clinically meaningful improvement is defined as an increase in FACIT-Fatigue score of more than 3 units from the baseline, worsening is a decrease of more than 3 units from baseline, and no change is any change in FACIT-Fatigue score from baseline of −3, −2, −1, 0, 1, 2, or 3.
Baseline is defined as the date of enrollment for never on eculizumab and eculizumab on enrollment groups; and the closest date before eculizumab start for the group that started eculizumab after enrollment.
If the patient discontinued eculizumab, LFU was the last evaluation point while on eculizumab.