Table 3

LEGEND-T2DM study outcomes

Phenotype	Brief logical description	Prior development
3-point MACE	Condition record of acute myocardial infarction, haemorrhagic or ischaemic stroke or sudden cardiac death during an inpatient or ER visit	49–61
4-point MACE	3-point MACE+inpatient or ER visit (hospitalisation) with heart failure condition record	44 49–67
Acute myocardial infarction	Condition record of acute myocardial infarction during an inpatient or ER vist	49–54
Acute renal failure	Condition record of acute renal failure during an inpatient or ER visit	47 68–75
Glycaemic control	First haemoglobin A1c measurement with value ≤7%	76
Hospitalisation with heart failure	Inpatient or ER visit with heart failure condition record	44 62–67
Measured renal dysfunction	First creatinine measurement with value >3 mg/dL	75
Coronary revascularisation	Procedure record of percutaneous coronary intervention or coronary artery bypass grafting during an inpatient or ER visit	45
Stroke	Condition record of haemorrhagic or ischaemic stroke during an inpatient or ER visit	55–60
Sudden cardiac death	Condition record of sudden cardiac death during an inpatient or ER visit	52 61
Abnormal weight gain	Abnormal weight gain record of any type; successive records with >90-day gap are considered independent episodes; note, weight measurements not used	77
Abnormal weight loss	Abnormal weight loss record of any type; successive records with >90-day gap are considered independent episodes; note, weight measurements not used	78
Acute pancreatitis	Condition record of acute pancreatitis during an inpatient or ER visit	79–82
All-cause mortality	Death record of any type	52 83 84
Bladder cancer	Malignant tumour of urinary bladder condition record of any type; limited to earliest event per person
Bone fracture	Bone fracture condition record of any type; successive records with >90-day gap are considered independent episodes
Breast cancer	Malignant tumour of breast condition record of any type; limited to earliest event per person
Diabetic ketoacidosis	Diabetic ketoacidosis condition record during an inpatient or ER visit	46 85
Diarrhoea	Diarrhoea condition record of any type; successive records with >30-day gap are considered independent episodes	86–88
GU infection	Condition record of any type of genital or urinary tract infection during an outpatient or ER vists	89
Hyperkalaemia	Condition record for hyperkalaemia or potassium measurements >5.6 mmol/L; successive records with >90-day gap are considered independent episodes	90–92
Hypoglycaemia	Hypoglycaemia condition record of any type; successive records with >90-day gap are considered independent episodes	93
Hypotension	Hypotension condition record of any type; successive records with >90-day gap are considered independent episodes	94
Joint pain	Joint pain condition record of any type; successive records with >90-day gap are considered independent episodes
Lower extremity amputation	Procedure record of below knee lower extremity amputation during inpatient or outpatient visit	44 48
Nausea	Nausea condition record of any type; successive records with >30-day gap are considered independent episodes	95–97
Peripheral oedema	Oedema condition record of any type; successive records with >180-day gap are considered independent episodes
Photosensitivity	Condition record of drug-induced photosensitivity during any type of visit
Renal cancer	Primary malignant neoplasm of kidney condition record of any type; limited to earliest event per person
Thyroid tumour	Neoplasm of thyroid gland condition record of any type; limited to earliest event per person
Venous thromboembolism	Venous thromboembolism condition record of any type; successive records with >180-day gap are considered independent episodes	98–101
Vomiting	Vomiting condition record of any type; successive records with >30-day gap are considered independent episodes	95–97

ER, emergence room; GU, genitourinary; LEGEND-T2DM, large-scale evidence generation and evaluation across a network of databases for type 2 diabetes mellitus; MACE, major adverse cardiovascular events.