Table 5.
Frequency of most common adverse events (≥ 5%) in treatment period—safety analysis set sensitivity
| System organ class | Preferred term | Proposed biosimilar pegfilgrastim (APO-Peg) N = 329 | US-licensed pegfilgrastim reference product (US-Neulasta®) N = 135 | EU-approved pegfilgrastim reference product (EU-Neulasta®) N = 125 | Total N = 589 |
|---|---|---|---|---|---|
| Any AE | 295 (89.7) | 128 (94.8) | 116 (92.8) | 539 (91.5) | |
| Blood and lymphatic system disorders | All PTs | 185 (56.2) | 88 (65.2) | 73 (58.4) | 346 (58.7) |
| Anaemia | 14 (4.3) | 8 (5.9) | 8 (6.4) | 30 (5.1) | |
| Febrile Neutropenia | 15 (4.6) | 7 (5.2) | 4 (3.2) | 26 (4.4) | |
| Leukocytosis | 22 (6.7) | 17 (12.6) | 13 (10.4) | 52 (8.8) | |
| Leukopenia | 63 (19.1) | 40 (29.6) | 41 (32.8) | 144 (24.4) | |
| Neutropenia | 169 (51.4) | 79 (58.5) | 63 (50.4) | 311 (52.8) | |
| Neutrophilia | 14 (4.3) | 13 (9.6) | 11 (8.8) | 38 (6.5) | |
| Thrombocytopenia | 12 (3.6) | 5 (3.7) | 16 (12.8) | 33 (5.6) | |
| Ear and labyrinth disorders | All PTs | 17 (5.2) | 11 (8.1) | 15 (12.0) | 43 (7.3) |
| Vertigo | 17 (5.2) | 9 (6.7) | 14 (11.2) | 40 (6.8) | |
| Gastrointestinal disorders | All PTs | 176 (53.5) | 81 (60.0) | 79 (63.2) | 336 (57.0) |
| Abdominal pain | 19 (5.8) | 8 (5.9) | 11 (8.8) | 38 (6.5) | |
| Abdominal pain Upper | 20 (6.1) | 12 (8.9) | 17 (13.6) | 49 (8.3) | |
| Constipation | 8 (2.4) | 5 (3.7) | 7 (5.6) | 20 (3.4) | |
| Diarrhoea | 54 (16.4) | 32 (23.7) | 34 (27.2) | 120 (20.4) | |
| Dyspepsia | 9 (2.7) | 8 (5.9) | 11 (8.8) | 28 (4.8) | |
| Nausea | 145 (44.1) | 67 (49.6) | 65 (52.0) | 277 (47.0) | |
| Stomatitis | 20 (6.1) | 10 (7.4) | 5 (4.0) | 35 (5.9) | |
| Vomiting | 44 (13.4) | 18 (13.3) | 27 (21.6) | 89 (15.1) | |
| General disorders and administration site conditions | All PTs | 147 (44.7) | 71 (52.6) | 69 (55.2) | 287 (48.7) |
| Asthenia | 81 (24.6) | 41 (30.4) | 31 (24.8) | 153 (26.0) | |
| Fatigue | 43 (13.1) | 18 (13.3) | 32 (25.6) | 93 (15.8) | |
| Malaise | 9 (2.7) | 8 (5.9) | 5 (4.0) | 22 (3.7) | |
| Oedema Peripheral | 15 (4.6) | 10 (7.4) | 9 (7.2) | 34 (5.8) | |
| Pyrexia | 22 (6.7) | 12 (8.9) | 18 (14.4) | 52 (8.8) | |
| Metabolism and nutrition disorders | All PTs | 28 (8.5) | 16 (11.9) | 26 (20.8) | 70 (11.9) |
| Decreased Appetite | 12 (3.6) | 9 (6.7) | 17 (13.6) | 38 (6.5) | |
| Musculoskeletal and connective tissue disorders | All PTs | 166 (50.5) | 77 (57.0) | 80 (64.0) | 323 (54.8) |
| Arthralgia | 13 (4.0) | 8 (5.9) | 10 (8.0) | 31 (5.3) | |
| Bone pain | 149 (45.3) | 71 (52.6) | 70 (56.0) | 290 (49.2) | |
| Myalgia | 28 (8.5) | 19 (14.1) | 15 (12.0) | 62 (10.5) | |
| Nervous system disorders | All PTs | 119 (36.2) | 63 (46.7) | 53 (42.4) | 235 (39.9) |
| Dizziness | 68 (20.7) | 24 (17.8) | 21 (16.8) | 113 (19.2) | |
| Headache | 67 (20.4) | 38 (28.1) | 31 (24.8) | 136 (23.1) | |
| Hypoesthesia | 9 (2.7) | 9 (6.7) | 6 (4.8) | 24 (4.1) | |
| Respiratory, thoracic and mediastinal disorders | All PTs | 31 (9.4) | 16 (11.9) | 19 (15.2) | 66 (11.2) |
| Oropharyngeal Pain | 14 (4.3) | 8 (5.9) | 6 (4.8) | 28 (4.8) | |
| Skin and subcutaneous tissue disorders | All PTs | 92 (28.0) | 45 (33.3) | 46 (36.8) | 183 (31.1) |
| Alopecia | 78 (23.7) | 36 (26.7) | 37 (29.6) | 151 (25.6) | |
| Scar pain | 3 (0.9) | 0 (0.0) | 7 (5.6) | 10 (1.7) |