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Table 2 Number and adverse event of signal detection included in SOC.

From: Analyses of non-benzodiazepine-induced adverse events and prognosis in elderly patients based on the Japanese adverse drug event report database

adverse event: SOC (Number of HGLTs included in SOC)

adverse event: HGLT

Psychiatric disorders (13)

Deliria (include confusion)

Sleep disturbances

Psychiatric and behavioural symptoms NEC

Impulse control disorders NEC

Dementia and amnestic conditions

Suicidal and self-injurious behaviours NEC

Psychiatric disorders NEC

Personality disorders and disturbances in behavior

Changes in physical activity

Manic and bipolar mood disorders and disturbances

Anxiety disorders and symptoms

Disturbances in thinking and perception

Depressed mood disorders and disturbances

Nervous system disorders (5)

Sleep disturbances (include subtypes)

Mental impairment disorders

Neurological disorders NEC

Neurological disorders of the eye

Movement disorders (include parkinsonism)

Movement disorders (include parkinsonism)

Product use issues

Injuries by physical agents

Injuries NEC

Eye disorders (3)

Glaucoma and ocular hypertension

Vision disorders

 

Ocular infections irritations and inflammations

Investigations (2)

Neurological special senses and psychiatric investigations

Enzyme investigations NEC

Respiratory thoracic and mediastinal disorders (1)

Respiratory disorders NEC

General disorders and administration site conditions (1)

Therapeutic and nontherapeutic effects (exclude toxicity)

  1. SOC System Organ Class, HLGT High Level Group Term, NEC not elsewhere classified