Table 5 AEs reported by subject incidence (n, %), event rate (events/person-years), and total number of events
Exposure, person-years | Parent study (n = 80) | Extension study (n = 68) | Overall phase 2 treatment (n = 80)a | |||
|---|---|---|---|---|---|---|
25.1 | 230.0 | 256.0 | ||||
Incidence n (%) | Event rate (total number of events) | Incidence n (%) | Event rate (total number of events) | Incidence n (%) | Event rate (total number of events) | |
AEs | 79 (98.8%) | 58.3 (1463) | 68 (100%) | 18.6 (4284) | 80 (100%) | 22.5 (5747) |
AEs causing early pegvaliase discontinuation | 5 (6.3%) | 0.20 (5) | 4 (5.9%) | 0.05 (12) | 9 (11.3%) | 0.07 (17) |
SAEs | 4 (5.0%) | 0.16 (4) | 11 (16.2%) | 0.07 (16) | 15 (18.8%) | 0.08 (20) |
SAEs causing early pegvaliase discontinuation | 1 (1.3%) | 0.04 (1) | 2 (2.9%) | 0.01 (3) | 3 (3.8%) | 0.02 (4) |
Death | 0 | 0 | 0 | 0 | 0 | 0 |
AEs of special interest | ||||||
Hypersensitivity events | 69 (86.3%) | 14.9 (373) | 62 (91.2%) | 4.3 (997) | 75 (93.8%) | 5.4 (1370) |
Generalized skin reaction (≥14 days) | 9 (11.3%) | 0.44 (11) | 37 (54.4%) | 0.40 (93) | 39 (48.8%) | 0.41 (104) |
Injection-site reaction | 68 (85.0%) | 19.1 (479) | 59 (86.8%) | 3.8 (875) | 76 (95.0%) | 5.3 (1354) |
Injection-site skin reaction (≥14 days) | 13 (16.3%) | 0.88 (22) | 25 (36.8%) | 0.27 (62) | 36 (45.0%) | 0.33 (84) |
Arthralgia | 41 (51.3%) | 5.6 (140) | 34 (50.0%) | 0.74 (171) | 52 (65.0%) | 1.2 (311) |
Acute systemic hypersensitivity event of anaphylaxis | 3 (3.8%) | 15.9 (4) | 1 (1.5%) | 0.01 (2) | 3 (3.8%) | 0.02 (6) |
Acute systemic hypersensitivity event per Brown’s severe criteria | 1 (1.3%) | 0.04 (1) | 1 (1.5%) | 0.01 (2) | 2 (2.5%) | 0.01 (3) |