Table 3.
Treatment-emergent adverse events occurring in ≥ 5% of patients (safety population)
| MedDRA system organ class preferred term | Anagrelide n = 76 n (%) |
Hydroxyurea n = 70 n (%) |
|---|---|---|
| Patients with ≥ 1 TEAE | 58 (76.3) | 50 (71.4) |
| Nervous system disorders | 29 (38.2) | 8 (11.4) |
| Headache | 19 (25.0) | 1 (1.4) |
| Cardiac disorders | 23 (30.3) | 4 (5.7) |
| Palpitations | 18 (23.7) | 0 |
| Infections and infestations | 22 (28.9) | 18 (25.7) |
| Urinary tract infection | 4 (5.3) | 2 (2.9) |
| Pharyngitis | 2 (2.6) | 6 (8.6) |
| Upper respiratory tract infection | 4 (5.3) | 1 (1.4) |
| Nasopharyngitis | 2 (2.6) | 5 (7.1) |
| General disorders and administration site conditions | 20 (26.3) | 9 (12.9) |
| Asthenia | 5 (6.6) | 4 (5.7) |
| Chest pain | 4 (5.3) | 1 (1.4) |
| Gastrointestinal disorders | 18 (23.7) | 14 (20.0) |
| Diarrhoea | 6 (7.9) | 3 (4.3) |
| Vascular disorders | 14 (18.4) | 4 (5.7) |
| Hypertension | 9 (11.8) | 1 (1.4) |
| Musculoskeletal and connective tissue disorders | 13 (17.1) | 12 (17.1) |
| Arthralgia | 6 (7.9) | 2 (2.9) |
| Respiratory, thoracic and mediastinal disorders | 9 (11.8) | 7 (10.0) |
| Epistaxis | 4 (5.3) | 2 (2.9) |
| Skin and subcutaneous tissue disorders | 8 (10.5) | 11 (15.7) |
| Investigations | 7 (9.2) | 8 (11.4) |
| Ear and labyrinth disorders | 7 (9.2) | 0 |
| Vertigo | 5 (6.6) | 0 |
| Blood and lymphatic system disorders | 6 (7.9) | 18 (25.7) |
| Anaemia | 4 (5.3) | 8 (11.4) |
| Leukopenia | 1 (1.3) | 7 (10.0) |
| Neutropenia | 0 | 5 (7.1) |
| Eye disorders | 5 (6.6) | 2 (2.9) |
| Metabolism and nutrition disorders | 4 (5.3) | 1 (1.4) |
| Injury, poisoning and procedural complications | 3 (3.9) | 5 (7.1) |
MedDRA Medical Dictionary for Regulatory Activities; TEAE treatment-emergent adverse event