Table 2 Pre-specified event /ADR for which there is mandatory reporting of all events

Fall/s

New fall/s

New onset unsteady gait

New onset of unsteady gait that results in poor mobility and unsteady balance

Acute kidney injury

An increase in serum creatinine by 0.3 mg/dl (26.5 μmol/l) within 48 h or an increase in serum creatinine by 1.5 baseline, which is known or presumed to have occurred within the prior 7 days

Symptomatic orthostatic hypotension

A systolic blood pressure drop ≥20 mmHg ± diastolic blood pressure drop ≥10 mmHg within 3 min of standing from the lying or sitting posture associated with symptoms

Major serum electrolyte disturbance

A sodium (Na) of < 130 mmol/l or > 145 mmol/l and/or

a potassium (K+) < 3.5 mmol/l or > 5.2 mmol/l and/or

a corrected calcium (Ca++) < 2.1 mmol/l or > 2.7 mmol/l

Symptomatic bradycardia

Heart rate of < 50 beats with symptoms

New major constipation

Subjective symptoms of hard stools and/or less than 3 bowel movements per week and/or supported by nursing records

Acute bleeding

Malaena or haematuria or haematemesis or haemoptysis with or without a drop in haemoglobin level > 2 g/dl (not due to rehydration) or associated symptoms (hypotension, tachycardia, pallor) or secondary renal failure

Acute dyspepsia/nausea/vomiting

Subjective symptoms of acute ‘indigestion’/‘upset stomach’ or acute abdominal pain or acute refusal to eat or acute heartburn/acid reflux or acute nausea/vomiting

Acute diarrhoea

New liquid stools reported by the patient or the nursing staff or new liquid stools detected by medical staff on physical examination or new liquid (non-solid) stools occurring more than 3 times in 24 h

Acute delirium

Confirmed by a reliable witness and the DSM-V criteria. Supported by a 4AT ≥ 4 and/or MMSE < 23/30

Symptomatic hypoglycaemia

Symptoms with a blood glucose of < 3.5 mmol/L or < 63 mg/dl.

Unspecified adverse event

For ADEs not specified above e.g. acute liver failure, anaphylaxis