Table 5 Treatment-emergent adverse events in ≥ 5% of patients based on exploratory analysis of the safety data
| Â | Patients who completed the study on 150 mg eq. throughout | Patients who did not complete the study on 150 mg eq. throughout | ||||
|---|---|---|---|---|---|---|
| Â | Group A (N = 100) | Group B (N = 4) | Total (N = 104) | Group C (N = 86) | Group D (N = 22) | Total (N = 108) |
Total no. patients with TEAEs | 83 (83.0) | 4 (100) | 87 (83.7) | 76 (88.4) | 21 (95.5) | 97 (89.8) |
Nasopharyngitis | 19 (19.0) | 1 (25.0) | 20 (19.2) | 14 (16.3) | 3 (13.6) | 17 (15.7) |
Insomnia | 11 (11.0) | 1 (25.0) | 12 (11.5) | 16 (18.6) | 4 (18.2) | 20 (18.5) |
Weight increased | 10 (10.0) | 1 (25.0) | 11 (10.6) | 4 (4.7) | 4 (18.2) | 8 (7.4) |
Upper respiratory tract infection | 6 (6.0) | 1 (25.0) | 7 (6.7) | 3 (3.5) | 2 (9.1) | 5 (4.6) |
Injection site pain | 15 (15.0) | 0 | 15 (14.4) | 10 (11.6) | 7 (31.8) | 17 (15.7) |
Headache | 13 (13.0) | 0 | 13 (12.5) | 11 (12.8) | 4 (18.2) | 15 (13.9) |
Blood prolactin increased | 7 (7.0) | 0 | 7 (6.7) | 8 (9.3) | 4 (18.2) | 12 (11.1) |
Tachycardia | 20 (20.0) | 0 | 20 (19.2) | 4 (4.7) | 3 (13.6) | 7 (6.5) |
Orthostatic hypotension | 9 (9.0) | 0 | 9 (8.7) | 6 (7.0) | 3 (13.6) | 9 (8.3) |
Anxiety | 7 (7.0) | 0 | 7 (6.7) | 4 (4.7) | 4 (18.2) | 8 (7.4) |
Diarrhoea | 6 (6.0) | 0 | 6 (5.8) | 6 (7.0) | 1 (4.5) | 7 (6.5) |
Hypertension | 8 (8.0) | 0 | 8 (7.7) | 1 (1.2) | 2 (9.1) | 3 (2.8) |
Tremor | 6 (6.0) | 0 | 6 (5.8) | 0 | 0 | 0 |
Pyrexia | 5 (5.0) | 1 (25.0) | 6 (5.8) | 0 | 0 | 0 |
Toothache | 6 (6.0) | 0 | 6 (5.8) | 0 | 0 | 0 |
Akathisia | 0 | 0 | 0 | 9 (10.5) | 6 (27.3) | 15 (13.9) |
Psychotic disorder | 0 | 0 | 0 | 8 (9.3) | 1 (4.5) | 9 (8.3) |
Schizophrenia | 0 | 0 | 0 | 8 (9.3) | 1 (4.5) | 9 (8.3) |
Hyperprolactinaemia | 0 | 0 | 0 | 5 (5.8) | 3 (13.6) | 8 (7.4) |
Agitation | 0 | 0 | 0 | 5 (5.8) | 2 (9.1) | 7 (6.5) |