Table 4.
Summary of Treatment-Emergent Adverse Events During the OL and DB Phases (DB Safety Analysis Set)
| ITT-OL | ITT-DB safety analysis sets | ||
|---|---|---|---|
| No. of patients (%) | |||
| PP1M/PP3M (n = 838) | PP6M (n = 478) | PP3M (n = 224) | |
| Patients with ≥1 TEAEs | 341 (40.7) | 297 (62.1) | 131 (58.5) |
| Patients with ≥1 serious TEAEs | 23 (2.7) | 24 (5.0) | 15 (6.7) |
| Most common (>5 patients) serious TEAE | |||
| Schizophrenia | 6 (0.7) | 8 (1.7) | 1 (0.4) |
| TEAEs leading to drug withdrawala | 31 (3.7) | 16 (3.3) | 6 (2.7) |
| Most common (>5 patients) TEAEs leading to drug withdrawala | |||
| Schizophrenia | 6 (0.7) | 8 (1.7%) | 1 (0.4) |
| TEAEs leading to death | 1 (0.1) | 1 (0.2) | 2 (0.9) |
| Most common (≥2% of patients) TEAEs | |||
| Weight increase | 8 (1.0) | 40 (8.4) | 17 (7.6) |
| Injection site pain | 72 (8.6) | 37 (7.7) | 9 (4.0) |
| Headache | 16 (1.9) | 32 (6.7) | 12 (5.4) |
| Upper respiratory tract infection | 19 (2.3) | 24 (5.0) | 9 (4.0) |
| Nasopharyngitis | 22 (2.6) | 22 (4.6) | 13 (5.8) |
| Akathisia | 21 (2.5) | 17 (3.6) | 8 (3.6) |
| Insomnia | 27 (3.2) | 15 (3.1) | 5 (2.2) |
| Anxiety | 25 (3.0) | 15 (3.1) | 1 (0.4) |
| Influenza | 11 (1.3) | 13 (2.7) | 4 (1.8) |
| Urinary tract infection | 4 (0.5) | 13 (2.7) | 2 (0.9) |
| Schizophrenia | 9 (1.1) | 11 (2.3) | 3 (1.3) |
| Weight decrease | 4 (0.5) | 8 (1.7) | 7 (3.1) |
| Suicidal ideation | 9 (1.1) | 4 (0.8) | 6 (2.7) |
| Patients with ≥1 EPS-related TEAEs | 53 (6.3) | 46 (9.6) | 19 (8.5) |
| Most common (>5 patients) EPS-related TEAEs | |||
| Parkinsonian rest tremor | 11 (1.3) | 9 (1.9) | 2 (0.9) |
| Muscle rigidity | 7 (0.8) | 2 (0.4) | 0 (0.0) |
| Parkinsonism | 7 (0.8) | 6 (1.3) | 2 (0.9) |
| Akathisia | 21 (2.5) | 17 (3.6) | 8 (3.6) |
| Dyskinesia | 11 (1.3) | 6 (1.3) | 2 (0.9) |
| Dystonia | 3 (0.4) | 1 (0.2) | 0 |
| Tremor | 1 (0.1) | 1 (0.2) | 0 (0.0) |
| Patients with ≥1 injection site-related TEAEs | 89 (10.6) | 59 (12.3) | 11 (4.9) |
| Injection site pain | 72 (8.6) | 37 (7.7) | 9 (4.0) |
| Injection site swelling | 8 (1.0) | 8 (1.7) | 1 (0.4) |
| Injection site induration | 8 (1.0) | 7 (1.5) | 2 (0.9) |
| Pain in extremity | 6 (0.7) | 7 (1.5) | 3 (1.3) |
| Injection site discomfort | 2 (0.2) | 3 (0.6) | 1 (0.4) |
| Injection site erythema | 2 (0.2) | 3 (0.6) | 1 (0.4) |
| Musculoskeletal pain | 2 (0.2) | 3 (0.6) | 0 (0.0) |
| Injection site haemorrhage | 0 | 1 (0.2) | 0 (0.0) |
| Injection site nodule | 0 | 1 (0.2) | 0 (0.0) |
| Injection site oedema | 3 (0.4) | 1 (0.2) | 0 (0.0) |
Abbreviations: DB, double-blind; EPS, extrapyramidal syndrome; ITT, intent-to-treat; OL, open label; PP1M, paliperidone palmitate 1-month formulation; PP3M, paliperidone palmitate 3-month formulation; PP6M, paliperidone palmitate 6-month formulation; TEAE, treatment-emergent adverse event.
a An adverse event that started in the open-label phase and resulted in study drug being discontinued in the double-blind phase is counted as treatment-emergent in the open-label phase.