Terms for adverse events, defined a priori, in the suicidality and violence-related adverse event categories
| Adverse event category | Terms for core adverse events* | Terms for potential adverse events† |
|---|---|---|
| Suicidality | Accident-, attempt, burn, cut, drown, gas, gun, hang, hung, immolat-, injur-, jump, monoxide, mutilat-, overdos-, self damage-, self harm, self inflict, self injur-, shoot, slash, suic-, poison, asphyxiation, suffocation, firearm | |
| Violent behaviour | Homicide, physical assault, physical abuse, homicidal ideation, violence-related symptoms (e.g., criminal behaviour, antisocial behaviour) | |
| Depression | Depression | |
| Emotional disturbance | Anhedonia, apathy, depersonalization, derealization, disinhibition, emotional detachment, emotional lability, flat affect, impulsivity, lack of empathy | |
| Psychotic behaviour | Abnormal thinking (intrusive thoughts, unusual thoughts), confusion (disorientation, incoherent thoughts), delirium, delusions, hallucinations, hysteria, manic reaction, paranoia, psychosis | Abnormal dreams, nightmares |
| Activation‡ | Agitation (aggression, hostility), akathisia, anxiety, increased energy (euphoria, irritability, jitteriness, mania§), restlessness (hyperactivity), shakiness | Insomnia, panic, tension,¶ tremor |
| FDA-defined activation symptoms | Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania |
Note: FDA = US Food and Drug Administration.
↵* 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.
↵‡ Activation refers to stimulating effects, such as insomnia, anxiety and agitation.
↵§ Mania was reported as both an activation event and a psychotic event, because patients can report being “manic” when they are describing being more active than usual (i.e., experiencing activation).
↵¶ Tension was originally categorized as a potential activation event; however, tension codes to the higher-level term of “anxiety symptoms” in the Medical Dictionary for Regulatory Activities. Tension was therefore considered a core event in the main analyses. A sensitivity analysis was performed to evaluate the effect of this decision.