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Listed Serious Non- Total

System Organ Serious Cases


Class (SOC) HLGT Event (PT)
for BR
period
Screaming No 0 31 31
Deliria (incl confusion) Disorientation No 0 2 2
Depressed mood Psychomotor retardation No 0 1 1
disorders
and
disturbances Tearfulness Yes 0 2 2
Dissociative disorders Dissociation No 0 1 1
Disturbances in thinking Delusion No 0 1 1
and
perception
Eating disorders Eating disorder No 0 2 2
and
disturbances
Food aversion Yes 0 5 5
Mood disorders Apathy No 0 19 19
and
disturbances
NEC Emotional distress No 0 1 1
Listless No 0 3 3
Moaning No 0 4 4
Personality disorders Indifference No 0 2 2
and
disturbances in
behaviour Personality change No 0 3 3
Psychiatric and Abnormal behaviour No 0 10 10
symptoms
behavioural
NEC Breath holding No 0 2 2
Decreased eye contact No 0 3 3
Staring No 0 42 42
Schizophrenia and Psychotic disorder No 1 0 1
other
psychotic
disorders
Sleep disorders Insomnia No 0 19 19
and
disturbances
Middle insomnia No 0 3 3
Sleep disorder No 0 12 12
Renal and Renal disorders Oliguria No 0 1 1
urinary
disorders (excl
nephropathies)
Pyelocaliectasis No 0 1 1
Renal impairment No 0 2 2
Ureteric disorders Ureteric stenosis No 0 1 1
Urinary tract signs Enuresis No 0 1 1
and
symptoms
Polyuria No 0 2 2
Reproductive Reproductive tract Oedema genital No 0 1 1
system and disorders
NEC
breast
disorders
Respiratory, Bronchial disorders Asthma No 2 0 2
thoracic (excl
neoplasms)
mediastinal
and
disorders