Adverse events in the suicidality and violence-related adverse event categories, as reported in 4 placebo-controlled trials of duloxetine for stress urinary incontinence
| Adverse event category | Type of adverse event; specific events* reported in trials† | |
|---|---|---|
| Core adverse events‡ | Potential adverse events§ | |
| Activation | Anxiety, central nervous system stimulation, energy increased, euphoric mood, feeling jittery, hostility, irritability, mania, nervousness, psychomotor hyperactivity, restlessness, stress, tension | Insomnia (including initial and middle insomnia), panic attack, panic disorder, poor-quality sleep, restless leg syndrome, sleep disorder and tremor |
| FDA-defined activation symptoms | Agitation, anxiety, insomnia (including initial and middle insomnia), mania, nervousness,¶ panic attack, poor-quality sleep, sleep disorder, stress,¶ tension¶ | |
| Emotional disturbance | Feeling abnormal (verbatim terms included “feeling drugged,” “foggy in the head,” “fuzzy feeling”), apathy, emotional disorder, cognitive disorder (“lack of awareness”), emotional poverty (“emotionless”), listless, mood altered (“be moody”) | |
| Psychotic behaviour | Disorientation, confusional state, euphoric mood, mania, mental disorder (verbatim term “nervous breakdown”) | Abnormal dreams and nightmares |
| Depression | Depression | Depressed mood, dysthymic disorder |
Note: FDA = US Food and Drug Administration, MedDRA = Medical Dictionary for Regulatory Activities.
↵* These adverse events occurred in either the duloxetine arm or the placebo arm, or in both arms.
↵† The data presented in this table are the preferred terms from the MedDRA (version 17.0) that were used for recoding of the original preferred terms (and also the verbatim terms, if available) of adverse events provided in the clinical study reports of the 4 trials of duloxetine for stress urinary incontinence.
↵‡ Core adverse events were those that had been used as search terms in the published research or that were considered relevant by expert opinion.
↵§ Potential adverse events were events for which there was a lack of consistency in the literature or uncertainty over whether they were relevant. The effect of including potential events was explored in sensitivity analyses.
↵¶ Nervousness, stress and tension are not explicitly mentioned in FDA-defined activation. Anxiety is categorized as an FDA-defined activation event, and nervousness, stress and tension all code to the higher-level term of “anxiety symptoms” in the MedDRA. These 3 types of events were therefore included in the analyses of FDA-defined activation.