Table 4 AEs (incidence ≥25% all participants) reported as subject incidence (n, %), and 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) |
Headache | 33 (41.3%) | 2.8 (69) | 43 (63.2%) | 0.97 (223) | 54 (67.5%) | 1.1 (292) |
Nasopharyngitis | 15 (18.8%) | 0.6 (15) | 40 (58.8%) | 0.43 (98) | 47 (58.8%) | 0.44 (113) |
Rash | 22 (27.5%) | 1.3 (32) | 35 (51.5%) | 0.51 (118) | 46 (57.5%) | 0.59 (150) |
Injection-site reaction | 45 (56.3%) | 9.1 (229) | 35 (51.5%) | 0.50 (115) | 58 (72.5%) | 1.3 (344) |
Arthralgia | 41 (51.3%) | 5.6 (140) | 34 (50.0%) | 0.74 (171) | 52 (65.0%) | 1.2 (311) |
Injection-site erythema | 36 (45.0%) | 3.6 (91) | 34 (50.0%) | 0.68 (157) | 54 (67.5%) | 0.97 (248) |
Injection-site bruising | 21 (26.3%) | 1.2 (30) | 33 (48.5%) | 1.0 (240) | 47 (58.8%) | 1.1 (270) |
Upper respiratory tract infection | 17 (21.3%) | 0.72 (18) | 31 (45.6%) | 0.64 (147) | 39 (48.8%) | 0.65 (165) |
Oropharyngeal pain | 11 (13.8%) | 0.48 (12) | 31 (45.6%) | 0.28 (64) | 37 (46.3%) | 0.30 (76) |
Urticaria | 8 (10.0%) | 0.44 (11) | 30 (44.1%) | 1.2 (281) | 33 (41.3%) | 1.1 (292) |
Nausea | 24 (30.0%) | 1.3 (33) | 30 (44.1%) | 0.27 (62) | 41 (51.3%) | 0.37 (95) |
Cough | 15 (18.8%) | 0.68 (17) | 30 (44.1%) | 0.20 (45) | 39 (48.8%) | 0.24 (62) |
Back pain | 5 (6.3%) | 0.40 (10) | 29 (42.6%) | 0.30 (70) | 32 (40.0%) | 0.31 (80) |
Pruritus | 15 (18.8%) | 0.92 (23) | 27 (39.7%) | 0.29 (66) | 33 (41.3%) | 0.35 (89) |
Diarrhea | 12 (15.0%) | 0.68 (17) | 25 (36.8%) | 0.30 (70) | 31 (38.8%) | 0.34 (87) |
Vomiting | 9 (11.3%) | 0.76 (19) | 24 (35.3%) | 0.22 (51) | 28 (35.0%) | 0.27 (70) |
Contusion | 5 (6.3%) | 0.20 (5) | 23 (33.8%) | 0.24 (56) | 26 (32.5%) | 0.24 (61) |
Pain in extremity | 14 (17.5%) | 0.76 (19) | 23 (33.8%) | 0.23 (52) | 30 (37.5%) | 0.28 (71) |
Pyrexia | 15 (18.8%) | 0.76 (19) | 23 (33.8%) | 0.15 (35) | 33 (41.3%) | 0.21 (54) |
Injection-site pruritus | 9 (11.3%) | 0.60 (15) | 21 (30.9%) | 0.32 (73) | 25 (31.3%) | 0.34 (88) |
Myalgia | 9 (11.3%) | 0.44 (11) | 21 (30.9%) | 0.28 (64) | 26 (32.5%) | 0.29 (75) |
Sinusitis | 5 (6.3%) | 0.20 (5) | 21 (30.9%) | 0.14 (32) | 24 (30.0%) | 0.15 (37) |
Dizziness | 20 (25.0%) | 1.2 (30) | 20 (29.4%) | 0.22 (51) | 36 (45.0%) | 0.32 (81) |
Abdominal pain | 8 (10.0%) | 0.44 (11) | 18 (26.5%) | 0.16 (36) | 22 (27.5%) | 0.18 (47) |