Aripiprazole 5 mg (n=38)* Desvenlafaxine 100 mg (n=36)* Desvenlafaxine 100 mg + Aripiprazole 5 mg (n=35)*   All TR All TR All TR Number of adverse events 32 27 8 6 19 17 Subjects with adverse events 14 12 5 4 9 9 Subjects with severe adverse events 0   0   0   Subjects with severe adverse events 0   0   0   Subjects discontinued due to adverse events 0   0   0   Subjects with dose reduced or temporary discontinuation due to adverse events 0   0   0   Treatment-Emergent Adverse Events Occurring in ≥2 Subjects in Any Treatment Category† Gastrointestinal disorders 9 8 3 2 6 6 Nausea 6 6 2 2 5 5 Vomiting 3 3 0   2 2 General disorders and administration site conditions 1 1 0   2 2 Chills 0   0   2 2 Nervous system disorders 6 6 3 3 5 5 Dizziness 3 3 0   1 1 Headache 1 1 2 2 1 1 Presyncope 2 2 0   1 1 Vascular disorders 8 7 0   0   Hot flush 7 7 0   0   Except for the number of adverse events row, subjects are counted only once per treatment in each row All= all causality; MedDRA= Medical Dictionary for Regulatory Activities; TR= treatment related *Subjects evaluable for adverse events †If the same subject in a given treatment had >1 occurrence in the same preferred term event category, only the most severe occurrence was taken. Subjects were counted only once per treatment in each row. Includes all data collected since first dose of study drug. MedDRA (version 13.1) coding applied

Table 5: Summary of Treatment-Emergent Adverse Events.

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