Table 5.

Incidence of treatment-emergent adverse events in the safety analysis set

	Placebo (n=15)	50+50 mg PB-201 (n=16)	100+50 mg PB-201 (n=15)	100+100 mg PB-201 (n=15)
Any TEAEs	11 (32·4)	5 (14·7)	6 (17·7)	12 (35·3)
Related to study drug*	0	2 (12·5)	0	0
Gastrointestinal disorders
Constipation	2 (13·3)	1 (6·3)	2 (13·3)	0
Diarrhoea	1 (6·7)	0	0	1 (6·7)
Mouth ulcers	0	0	0	1 (6·7)
Toothache	1 (6·7)	0	1 (6·7)	0
Injury, poisoning, and procedural complications
Fall	0	0	1 (6·7)	0
Bruising	0	1 (6·3)	0	0
Laboratory tests
Bacteraemia	0	0	0	1 (6·7)
Haematuria	0	0	0	2 (13·3)
Glomerular filtration rate decreased	0	0	1 (6·7)	1 (6·7)
HDL decreased	0	0	0	1 (6·7)
Haemoglobinuria	0	0	0	2 (13·3)
Urine ketone positive	0	0	0	2 (13·3)
Urine WBC positive	2 (13·3)	0	0	0
Metabolism and nutrition disorders
Hyperglycaemia†	0	1 (6·3)	0	0
Hypertriglyceridemia	0	0	1 (6·7)	1 (6·7)
Relative hypoglycaemia‡	0	2 (12·5)	0	0
Hypokalaemia	2 (13·3)	0	0	0
Musculoskeletal and connective tissue disorders
Pain in extremity	1 (6·7)	0	0	0
Skin and subcutaneous tissue disorders
Hyperhidrosis	1 (6·7)	0	0	0
Vascular disorders
Hypertension	1 (6·7)	0	0	0

HDL=high-density lipoprotein. TEAE=treatment-emergent adverse event. WBC=white blood cell.

^⁎These two events were considered definitely related to the study drug. ^†Hyperglycaemia was defined by fasting plasma glucose ≥13·3 mmol/L measured over 3 consecutive days. ^‡Hypoglycaemia was defined in accord with guidelines for clinical trials of antidiabetic agent and biologics released by the Center for Drug Evaluation of China National Medical Products Administration, and relative hypoglycaemia was defined by having classic hypoglycaemia symptoms and glucose reduced but >3·9 mmol/L .