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Table 5 Frequency of most common adverse events (≥ 5%) in treatment period—safety analysis set sensitivity

From: Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy

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)