Table 5.
Summary of Serious Treatment-Emergent Adverse Events in Open-Label Extension
n (%) | PP3M/PP6M n = 57 |
PP6M/PP6M n = 121 |
Total N = 178 |
---|---|---|---|
≥1 Serious TEAEs | 2 (3.5) | 6 (5.0) | 8 (4.5) |
Schizophrenia | 1 (1.8) | 3 (2.5) | 4 (2.2) |
Psychiatric symptom | 0 | 1 (0.8) | 1 (0.6) |
Hallucination, auditory | 1 (1.8) | 0 | 1 (0.6) |
Colon cancer | 0 | 1 (0.8) | 1 (0.6) |
Metastases to peritoneum | 0 | 1 (0.8) | 1 (0.6) |
Nephrotic syndrome | 0 | 1 (0.8) | 1 (0.6) |
Abbreviations: PP3M, paliperidone palmitate 3-month formulation; PP6M, paliperidone palmitate 6-month formulation; TEAE, treatment-emergent adverse event.