Table 3.
Treatment-emergent adverse events (safety ITT population; N = 472)
| Patients switched to PP1M from | ARI (n = 46) | OLA (n = 87) | Pali ER (n = 104) | QUE (n = 44) | RIS (n = 191) |
|---|---|---|---|---|---|
| Total number of TEAEsa | 135 | 178 | 158 | 104 | 241 |
| Mild (%) | 74 (54.8) | 112 (62.9) | 106 (67.1) | 53 (51.0) | 134 (55.6) |
| Moderate (%) | 52 (38.5) | 56 (31.5) | 43 (27.2) | 46 (44.2) | 87 (36.1) |
| Severe (%) | 9 (6.7) | 10 (5.6) | 9 (5.7) | 5 (4.8) | 20 (8.3) |
| Subjects with ≥1 TEAEa, n (%) | 24 (52.2) | 45 (51.7) | 39 (37.5) | 19 (43.2) | 53 (27.7) |
| TEAEsa occurring in ≥5 % of patients in any group, n (%) | |||||
| Injection-site pain | 3 (6.5) | 12 (13.8) | 15 (14.4) | 7 (15.9) | 16 (8.4) |
| Akathisia | 4 (8.7) | 5 (5.7) | 5 (4.8) | 2 (4.5) | 5 (2.6) |
| Somnolence | 2 (4.3) | 5 (5.7) | 2 (1.9) | 4 (9.1) | 4 (2.1) |
| Abnormal weight gainb | 3 (6.5) | 1 (1.1) | 0 (0.0) | 2 (4.5) | 3 (1.6) |
| Weight increasedb | 3 (6.5) | 1 (1.1) | 3 (2.9) | 4 (9.1) | 3 (1.6) |
| Insomnia | 0 (0.0) | 7 (8.0) | 1 (1.0) | 2 (4.5) | 2 (1.0) |
| Psychotic disorders | 1 (2.2) | 6 (6.9) | 4 (3.8) | 1 (2.3) | 1 (0.5) |
ARI aripiprazole, ITT intent to treat, MedDRA Medical Dictionary for Regulatory Activities, OLA olanzapine, Pali ER paliperidone extended-release, PP1M once-monthly paliperidone palmitate, QUE quetiapine, RIS risperidone, TEAE treatment-emergent adverse event
aPossibly, probably, or very likely related to PP1M treatment
bBased on the MedDRA coding system, both terms were applicable for coding of TEAEs. None of the identified subjects were recorded under both terms simultaneously