Table 4.
Summary of treatment-emergent adverse events reported in at least 5% of patients compared with the pivotal study at 18 months in the intention-to-treat population6
|
Current study |
Pivotal study |
||||
|---|---|---|---|---|---|
| n (%) of patients (N=230) | n (%) of adverse events | Number of patients (N=264) | Number of adverse events | ||
| Any treatment-emergent adverse events | 214 (93%) | 1261 | 247 (94%) | 1525 | |
| Gastrointestinal disorders | 179 (78%) | 427 | 157 (59%) | 353 | |
| Nausea | 99 (43%) | 125 | 75 (28%) | 101 | |
| Vomiting | 97 (42%) | 114 | 68 (26%) | 73 | |
| Dyspepsia | 46 (20%) | 52 | 34 (13%) | 43 | |
| Upper abdominal pain | 22 (10%) | 27 | 27 (10%) | 32 | |
| Gastritis | 17 (7%) | 24 | 8 (3%) | 13 | |
| Salivary hypersecretion | 16 (7%) | 20 | 16 (6%) | 17 | |
| Abdominal pain | 17 (7%) | 19 | 25 (9%) | 29 | |
| Nervous-system disorders | 142 (62%) | 283 | 158 (60%) | 308 | |
| Headache | 93 (40%) | 134 | 92 (35%) | 134 | |
| Dizziness | 58 (25%) | 74 | 50 (19%) | 56 | |
| Tremor | 52 (23%) | 61 | 58 (22%) | 68 | |
| General disorders and administration-site conditions | 94 (41%) | 151 | 122 (46%) | 184 | |
| Asthenia | 70 (30%) | 86 | 60 (23%) | 73 | |
| Feeling hot | 38 (17%) | 48 | 25 (9%) | 29 | |
| Pyrexia | 3 (1%) | 4 | 23 (9%) | 27 | |
| Chest pain | 4 (2%) | 4 | 23 (9%) | 25 | |
| Psychiatric disorders | 73 (32%) | 110 | 10 (4%) | 159 | |
| Insomnia | 57 (25%) | 69 | 74 (28%) | 83 | |
| Hallucinations | 12 (5%) | 14 | 3 (1%) | 3 | |
| Metabolism and nutrition disorders | 48 (21%) | 58 | 131 (50%) | 190 | |
| Decreased appetite | 44 (19%) | 52 | 56 (21%) | 58 | |
| Hypocalcaemia | 1 (<1%) | 1 | 36 (14%) | 37 | |
| Musculoskeletal and connective tissue disorders | 38 (17%) | 53 | 58 (22%) | 92 | |
| Back pain | 17 (7%) | 21 | 30 (11%) | 36 | |
| Neck pain | 15 (7%) | 18 | 23 (9%) | 27 | |
| Investigations | 41 (18%) | 49 | 7 (3%) | 8 | |
| Blood sodium decreased | 16 (7%) | 17 | 20 (8%) | 21 | |
| Blood potassium increased | 11 (5%) | 11 | 27 (10%) | 29 | |
| Blood albumin decreased | 7 (3%) | 7 | 23 (9%) | 24 | |
| Vascular disorders | 18 (8%) | 20 | 24 (9%) | 26 | |
| Hot flush | 12 (5%) | 13 | 13 (5%) | 13 | |
| Cardiac disorders | 17 (7%) | 18 | 18 (7%) | 21 | |
| Palpitations | 14 (6%) | 15 | 13 (5%) | 16 | |
| Eye disorders | 16 (7%) | 17 | 15 (6%) | 18 | |
| Blood and lymphatic-system disorders | 14 (6%) | 15 | 29 (11%) | 33 | |
| Anaemia | 7 (3%) | 7 | 24 (9%) | 25 | |
| Infections and infestations | 14 (6%) | 16 | 22 (8%) | 33 | |
| Skin and subcutaneous tissue disorders | 13 (6%) | 15 | 22 (8%) | 23 | |
| Respiratory, thoracic, and mediastinal disorders | 9 (4%) | 12 | 32 (12%) | 34 | |
| Cough | 4 (2%) | 4 | 16 (6%) | 16 | |
| Injury, poisoning, and procedural complications | 15 (6%) | 18 | 14 (15%) | 20 | |
| Wound | 1 (<1%) | 1 | 9 (3%) | 9 | |