Table 4.
Treatment-Emergent Adverse Events in ≥5% of Participants in Any Group in the Open-Label Extension (Intent-to-Treat Set)
| n (%) | PP3M/PP6M (n = 57) |
PP6M/PP6M (n = 121) |
Total (N = 178) |
|---|---|---|---|
| ≥1 TEAEs | 35 (61.4) | 76 (62.8) | 111 (62.4) |
| Headache | 8 (14.0) | 16 (13.2) | 24 (13.5) |
| Blood prolactin increaseda | 5 (8.8) | 14 (11.6) | 19 (10.7) |
| Hyperprolactinemiaa | 4 (7.0) | 9 (7.4) | 13 (7.3) |
| Diarrhea | 4 (7.0) | 7 (5.8) | 11 (6.2) |
| Weight increased | 4 (7.0) | 5 (4.1) | 9 (5.1) |
| Nasopharyngitis | 2 (3.5) | 7 (5.8) | 9 (5.1) |
| Blood creatinine phosphokinase increased | 3 (5.3) | 2 (1.7) | 5 (2.8) |
| Insomnia | 3 (5.3) | 2 (1.7) | 5 (2.8) |
Abbreviations: PP3M, paliperidone palmitate 3-month formulation; PP6M, paliperidone palmitate 6-month formulation; TEAE, treatment-emergent adverse event.
aIt was investigators’ discretion in how they categorized “blood prolactin increased” and “hyperprolactinaemia” as TEAE.