TABLE 3.
Overview of Adverse Events
Safety Outcomes | Placeboa (n = 134) | Astegolimab (n = 130) | Efmarodocokin Alfa (n = 132) | All Patients (n = 396) |
---|---|---|---|---|
Number of patients with ≥ 1 AE, n (%) | 87 (65) | 85 (65) | 95 (72) | 267 (67) |
Number of AEs | 344 | 376 | 377 | 1,097 |
Number of deaths, n (%) | 23 (17) | 23 (17) | 21 (16) | 67 (17) |
Number of patients withdrawn from study due to an AE, n (%) | 1 (1) | 1 (1) | 0 | 2 (1) |
Number of patients with ≥ 1 of the following events, n (%) | ||||
Serious AE | 38 (28) | 38 (29) | 34 (26) | 110 (28) |
Serious AE leading to withdrawal from treatment | 2 (2) | 2 (2) | 1 (1) | 5 (1) |
Related serious AE | 0 | 2 (2) | 3 (2) | 5 (1) |
AE leading to withdrawal from treatment | 4 (3) | 3 (2) | 3 (2) | 10 (3) |
Related AE | 15 (11) | 12 (9) | 25 (19) | 52 (13) |
Grade 3–5 AE | 43 (32) | 46 (35) | 41 (31) | 130 (33) |
AE = adverse event.
Matching placebo groups for astegolimab and efmarodocokin alfa were pooled for all analyses.