Table 4.
Summary of Treatment Emergent Adverse Events during the Study (ITT [OL] Analysis Set and Safety Analysis Set)
| ITT (OL) | Safety | ||
|---|---|---|---|
| OL PP1M (N=1429) n (%) | PP3M (N=504) n (%) | PP1M (N=512)n (%) | |
| Patients with adverse events | 846 (59) | 342 (68) | 340 (66) |
| At least 1 possibly related TEAE | 562 (39) | 210 (42) | 209 (41) |
| 1 or more serious TEAE | 101 (7) | 26 (5) | 37 (7) |
| Most common (>2%) serious TEAEs | |||
| Schizophrenia | 31 (2) | 12 (2) | 11 (2) |
| TEAEs leading to drug withdrawala | 60 (4) | 15 (3) | 13 (3) |
| Most common (>0.3%) TEAEs leading to drug withdrawal | |||
| Akathisia | 7 (0.5) | 1 (0.2) | 2 (0.4) |
| Anxiety | 3 (0.2) | 2 (0.4) | 0 |
| Delusion | 1 (0.1) | 2 (0.4) | 0 |
| Galactorrhoea | 1 (0.1) | 1 (0.2) | 2 (0.4) |
| TEAEs leading to death | 2 (0.1) | 1 (0.2) | 3 (1) |
| Most common (≥2%) TEAEs | |||
| Weight increased | 64 (4) | 105 (21) | 109 (21) |
| Nasopharyngitis | 66 (5) | 36 (7) | 33 (6) |
| Anxiety | 83 (6) | 27 (5) | 24 (5) |
| Headache | 46 (3) | 18 (4) | 26 (5) |
| Insomnia | 96 (7) | 16 (3) | 24 (5) |
| Akathisia | 82 (6) | 20 (4) | 14 (3) |
| Schizophrenia | 41 (3) | 18 (4) | 14 (3) |
| Weight decreased | 10 (1) | 14 (3) | 14 (3) |
| Injection site pain | 127 (9) | 12 (2) | 14 (3) |
| Somnolence | 29 (2) | 5 (1) | 5 (1) |
| Hyperglycemia | 3 (0.2) | 4 (1) | 10 (2) |
| Depression | 11 (1) | 11 (2) | 6 (1) |
| Hypertension | 11 (1) | 12 (2) | 7 (1) |
| Diarrhea | 13 (1) | 10 (2) | 6 (1) |
| Fatigue | 17 (1) | 10 (2) | 5 (1) |
| Injection site induration | 40 (3) | 14 (3) | 6 (1) |
| EPS-related TEAEs | 180 (13) | 42 (8) | 38 (7) |
| Akathisia | 82 (6) | 20 (4) | 14 (3) |
| Restlessness | 8 (1) | 2 (<1) | 2 (<1) |
| Restless legs syndrome | 2 (<1) | 0 | 0 |
| Parkinsonism | 17 (1) | 1 (<1) | 5 (1) |
| Hypertonia | 15 (1) | 2 (<1) | 0 |
| Muscle rigidity | 15 (1) | 5 (1) | 0 |
| Musculoskeletal stiffness | 10 (1) | 3 (1) | 9 (2) |
| Extrapyramidal disorder | 4 (<1) | 1 (<1) | 1 (<1) |
| Drooling | 3 (<1) | 0 | 0 |
| Bradykinesia | 2 (<1) | 2 (<1) | 1 (<1) |
| Muscle tightness | 2 (<1) | 2 (<1) | 1 (<1) |
| Akinesia | 1 (<1) | 0 | 0 |
| Cogwheel rigidity | 1 (<1) | 1 (<1) | 0 |
| Hypokinesia | 1 (<1) | 1 (<1) | 1 (<1) |
| Masked facies | 1 (<1) | 0 | 0 |
| Nuchal rigidity | 1 (<1) | 0 | 0 |
| Parkinsonian gait | 0 | 1 (<1) | 0 |
| Tremor | 22 (2) | 9 (2) | 3 (1) |
| Dyskinesia | 11 (1) | 3 (1) | 3 (1) |
| Muscle twitching | 3 (<1) | 0 | 0 |
| Tardive dyskinesia | 2 (<1) | 1 (<1) | 1 (<1) |
| Dystonia | 4 (<1) | 0 | 1 (<1) |
| Muscle spasms | 1 (<1) | 0 | 1 (<1) |
| Myotonia | 1 (<1) | 0 | 0 |
| Trismus | 1 (<1) | 0 | 0 |
| Oculogyric crisis | 0 | 0 | 1 (<1) |
| Torticollis | 0 | 0 | 1 (<1) |
Abbreviations: DB, double-blind; EPS, extrapyramidal syndrome; OL, open-label; PP1M, paliperidone palmitate 1-month formulation; PP3M, paliperidone palmitate 3-month formulation; TEAE, treatment-emergent adverse event.
All percentages are rounded off to nearest whole integer.
a An adverse event that started in the OL phase and resulted in study drug being discontinued in the DB phase was counted as treatment-emergent in the OL phase.