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Investigator ratings of injection site. Redness and swelling were observed in 2% or less of subjects in the INVEGA TRINZA ‘ and placebo groups during the double-blind phase of the long-term maintenance study, and were rated mild based on investigator ratings using a 4-point scale (0=absent; 1=mild; 2=moderate; 3=severe). There were no reports of induration in either group during the double-blind phase, and no subjects discontinued due to INVEGA TRINZA ‘ injection. Subject ratings of injection site pain. Subject evaluations of injection pain during the double-blind phase also were similar for placebo and INVEGA TRINZA ‘. Subject ratings of injection site pain in the single-dose Phase 1 study allowed for assessment of the temporal course of injection site pain. Residual injection pain peaked 1 or 6 hours after injection, and trended downward 3 days after the injection. Deltoid injections were numerically more painful than gluteal injections, although most pain ratings were below 10 mm on a 100-mm scale. Other Adverse Reactions Observed During The Clinical Trial Evaluation Of INVEGA TRINZA ‘ The following additional adverse reactions were identified in the long-term maintenance trial. The following list does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) occurred at an incidence lower than that of placebo-treated patients. Cardiac disorders : tachycardia. Gastrointestinal disorders : nausea, vomiting. Metabolism and nutrition disorders : hyperinsulinemia. Psychiatric disorders : anxiety. Additional Adverse Reactions Reported In Clinical Trials With The 1-Month Paliperidone Palmitate Extended-Release Injectable Suspension. 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