Table 6.
Summary of TEAEs (mITT safety analysis set).
| Characteristic, n (%) | Total (n = 303) | Achieved SR at LOCF endpoint (n = 172) | Did not achieve SR at LOCF endpoint (n = 131) |
|---|---|---|---|
| Patients with ⩾1 TEAE | 161 (53.1) | 79 (45.9) | 82 (62.6) |
| TEAEs possibly related to study medication | 91 (30.0) | 39 (22.7) | 52 (39.7) |
| Serious TEAEs | 18 (5.9) | 2 (1.2) | 16 (12.2) |
| TEAEs leading to treatment/study withdrawal | 4 (1.3) | 0 | 4 (3.1) |
| Thrombocytopenia | 1 (0.3) | 0 | 1 (0.8) |
| Delusion | 2 (0.7) | 0 | 2 (1.5) |
| Hallucination, auditory | 2 (0.7) | 0 | 2 (1.5) |
| TEAEs experienced by ⩾3% of patients | |||
| Weight increased | 26 (8.6) | 12 (7.0) | 14 (10.7) |
| Injection site pain | 18 (5.9) | 11 (6.4) | 7 (5.3) |
| Viral upper respiratory tract infection | 11 (3.6) | 9 (5.2) | 2 (1.5) |
| Insomnia | 11 (3.6) | 9 (5.2) | 2 (1.5) |
| Schizophrenia | 10 (3.3) | 1 (0.6) | 9 (6.9) |
| Weight decreased | 10 (3.3) | 2 (1.2) | 8 (6.1) |
| Potentially prolactin-related TEAEs | 14 (4.6) | 10 (5.8) | 4 (3.1) |
| Amenorrhea | 6 (2.0) | 4 (2.3) | 2 (1.5) |
| Sexual/erectile dysfunction | 3 (1.0) | 2 (1.2) | 1 (0.8) |
| Galactorrhea | 1 (0.3) | 1 (0.6) | 0 |
| Hyperprolactinemia/blood prolactin increased | 8 (2.6) | 5 (2.9) | 3 (2.3) |
| Loss of libido | 1 (0.3) | 0 | 1 (0.8) |
| Menstruation irregular | 2 (0.7) | 2 (1.2) | 0 |
LOCF, last observation carried forward; mITT, modified intent-to-treat; SR, symptomatic remission; TEAE, treatment-emergent adverse event.