Table 1.

MedDRA system organ classes relevant for assessment of drug-related neuropsychiatric risk

Neurological disorders

Peripheral neuropathies, headaches, nervous system neoplasms malignant and unspecified (NEC), spinal cord and nerve root disorders, congenital and peripartum neurological conditions, demyelinating disorders, nervous system neoplasms benign, increased intracranial pressure and hydrocephalus, movement disorders (incl. Parkinsonism), encephalopathies, seizures (incl. subtypes), mental impairment disorders, neurological disorders of the eye, cranial nerve disorders (excl. neoplasms), structural brain disorders, neuromuscular disorders, central nervous system infections and inflammations, sleep disturbances (incl. subtypes), central nervous system vascular disorders

Psychiatric disorders

This is currently based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-IV) and includes changes in physical activity, eating disorders and disturbances, impulse control disorders NEC, cognitive and attention disorders and disturbances, dissociative disorders, somatic symptom and related disorders, sleep disorders and disturbances, psychiatric and behavioural symptoms NEC, disturbances in thinking and perception, schizophrenia and other psychotic disorders, adjustment disorders (incl. subtypes), communication disorders and disturbances, sexual dysfunctions, disturbances and gender identity disorders, developmental disorders NEC, suicidal and self-injurious behaviours NEC, dementia and amnestic conditions, deliria (incl. confusion), manic and bipolar mood disorders and disturbances, anxiety disorders and symptoms, mood disorders and disturbances NEC, personality disorders and disturbances in behaviour, depressed mood disorders and disturbances

NEC not elsewhere classifiable