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Table 4 AEs (incidence ≥25% all participants) reported as subject incidence (n, %), and event rate (events/person-years) and total number of events

From: Long-term safety and efficacy of pegvaliase for the treatment of phenylketonuria in adults: combined phase 2 outcomes through PAL-003 extension study

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)
  1. Event rate was calculated as total number of events divided by person-years of exposure. Incidence rates counted participants who reported more than 1 adverse event within a preferred term only once
  2. AE adverse event
  3. aAll phase 2 data are included