Table 3.
Treatment-emergent adverse events (all-causality, ≥ 2%) (safety population)
| Category | PF-05280586 N = 196 n (%) |
Rituximab-EU N = 197 n (%) |
|---|---|---|
| Subjects with AE | 156 (79.6) | 145 (73.6) |
| Injury, poisonings, and procedural complications | 61 (31.1) | 65 (33.0) |
| Infusion-related reaction | 49 (25.0) | 59 (29.9) |
| Fall | 5 (2.6) | 2 (1.0) |
| Gastrointestinal disorders | 58 (29.6) | 52 (26.4) |
| Nausea | 15 (7.7) | 17 (8.6) |
| Diarrhea | 14 (7.1) | 12 (6.1) |
| Abdominal pain upper | 9 (4.6) | 5 (2.5) |
| Constipation | 8 (4.1) | 8 (4.1) |
| Abdominal pain | 8 (4.1) | 3 (1.5) |
| Vomiting | 3 (1.5) | 7 (3.6) |
| Dyspepsia | 5 (2.6) | 2 (1.0) |
| Infections and infestations | 52 (26.5) | 63 (32.0) |
| Upper respiratory tract infection | 9 (4.6) | 5 (2.5) |
| Nasopharyngitis | 5 (2.6) | 9 (4.6) |
| Urinary tract infection | 5 (2.6) | 5 (2.5) |
| Sinusitis | 5 (2.6) | 2 (1.0) |
| Influenza | 4 (2.0) | 6 (3.0) |
| Pharyngitis | 4 (2.0) | 4 (2.0) |
| Bronchitis | 3 (1.5) | 7 (3.6) |
| Respiratory, thoracic, and mediastinal disorders | 46 (23.5) | 56 (28.4) |
| Throat irritation | 14 (7.1) | 10 (5.1) |
| Cough | 11 (5.6) | 11 (5.6) |
| Oropharyngeal pain | 2 (1.0) | 10 (5.1) |
| Dyspnea | 6 (3.1) | 9 (4.6) |
| Oropharyngeal discomfort | 4 (2.0) | 1 (0.5) |
| General disorders and administration-site conditions | 52 (26.5) | 53 (26.9) |
| Fatigue | 12 (6.1) | 13 (6.6) |
| Asthenia | 9 (4.6) | 13 (6.6) |
| Pyrexia | 12 (6.1) | 11 (5.6) |
| Edema peripheral | 2 (1.0) | 7 (3.6) |
| Influenza-like illness | 2 (1.0) | 4 (2.0) |
| Skin and subcutaneous tissue disorders | 39 (19.9) | 47 (23.9) |
| Pruritus | 13 (6.6) | 22 (11.2) |
| Rash | 10 (5.1) | 8 (4.1) |
| Erythema | 7 (3.6) | 2 (1.0) |
| Urticaria | 3 (1.5) | 6 (3.0) |
| Musculoskeletal and connective-tissue disorders | 38 (19.4) | 42 (21.3) |
| Back pain | 8 (4.1) | 10 (5.1) |
| Myalgia | 9 (4.6) | 5 (2.5) |
| Pain in extremity | 7 (3.6) | 4 (2.0) |
| Arthralgia | 7 (3.6) | 6 (3.0) |
| Nervous system disorders | 34 (17.3) | 33 (16.8) |
| Headache | 16 (8.2) | 19 (9.6) |
| Dizziness | 2 (1.0) | 6 (3.0) |
| Psychiatric disorders | 15 (7.7) | 17 (8.6) |
| Insomnia | 5 (2.6) | 8 (4.1) |
| Anxiety | 6 (3.1) | 7 (3.6) |
| Investigations | 15 (7.7) | 14 (7.1) |
| Neutrophil count decreased | 5 (2.6) | 0 |
| White blood cell count decreased | 4 (2.0) | 1 (0.5) |
| Vascular disorders | 11 (5.6) | 15 (7.6) |
| Hypertension | 5 (2.6) | 7 (3.6) |
| Flushing | 1 (0.5) | 4 (2.0) |
| Metabolism and nutrition disorders | 13 (6.6) | 12 (6.1) |
| Hyperglycemia | 1 (0.5) | 4 (2.0) |
| Cardiac disorders | 7 (3.6) | 9 (4.6) |
| Palpitations | 5 (2.6) | 2 (1.0) |
Subjects were only counted once per treatment for each row. Events are displayed by MedDRA (v21.0) system organ class and preferred term
AE adverse event, n number of subjects, N total number of subjects receiving treatment in each group, rituximab-EU rituximab reference product from the European Union