Table 1. Adverse Event Categories and Reaction Terms Used or Excluded in the Analysis.
Adverse Event Category | Reaction Terms |
---|---|
Attention-deficit/hyperactivity disorder | Attention-deficit/hyperactivity disorder |
Anxiety disorders | Generalized anxiety disorder; anxiety; panic attack; anxiety NEC; obsessive-compulsive disorder |
Bipolar and mood disorders | Bipolar disorder; affective disorder |
Depressive disorders | Depression; depression NEC; depression NOS; major depression; depression aggravated; depressed mood; anhedonia |
Eating disorders | Bulimia nervosa; eating disorder |
Emotional lability | Emotional distress; mood swings; mood altered; affect lability; mood alteration NOS; emotional disturbance NOS; irritability |
Insomnia | Insomnia |
Psychotic disorders and psychotic symptoms | Psychotic disorder; psychotic disorder NOS; paranoia; hallucination; hallucination, auditory; delusion |
Self-injurious behavior | Self-injurious ideation; intentional self-injury |
Suicidal ideation | Suicidal ideation |
Suicide attempt | Suicide attempt |
Completed suicide | Completed suicide |
Excluded | Abnormal behavior; abnormal behavior NOS; social avoidant behavior; personality change; disturbance in attention; stress; nervousness; mental disorder; apathy; aggression; crying; somnolence |
Abbreviations: NEC, not elsewhere classifiable; NOS, not otherwise specified.