Table 3.

Summary of treatment-emergent adverse events (TEAEs) during both the double-blind and extension studies

	Lansoprazole 15 mg (n=217)		Vonoprazan 10 mg (n=202)		Vonoprazan 20 mg (n=202)
	Events, n	Patients, n (%)	Events, n	Patients, n (%)	Events, n	Patients, n (%)
Summary of TEAEs
Any adverse event	716	184 (84.8)	650	177 (87.6)	637	176 (87.1)
Causal relationship to study drug could not be eliminated	73	53 (24.4)	45	33 (16.3)	55	39 (19.3)
Leading to study discontinuation	21	20 (9.2)	19	16 (7.9)	15	15 (7.4)
Serious adverse events (including deaths)	39	32 (14.7)	43	33 (16.3)	38	32 (15.8)
Causal relationship to study drug could not be eliminated	3	3 (1.4)	5	4 (2.0)	4	4 (2.0)
Deaths	0	0	1	1 (0.5)	0	0
TEAEs of special interest
Fracture*	3	3 (1.4%)	7	7 (3.5%)	5	5 (2.5%)
Clostridium difficile infection†	0	0	0	0	0	0
GI carcinoma‡	1	1 (0.5%)	3	3 (1.5%)	6	6 (3.0%)
TEAEs reported by ≥5% of patients in any group
Nasopharyngitis	68 (31.3)		60 (29.7)		63 (31.2)
Diarrhoea	26 (12.0)		15 (7.4)		19 (9.4)
Constipation	16 (7.4)		13 (6.4)		17 (8.4)
Upper respiratory tract inflammation	10 (4.6)		12 (5.9)		13 (6.4)
Fall	13 (6.0)		11 (5.4)		8 (4.0)
Back pain	5 (2.3)		8 (4.0)		16 (7.9)
Elevated creatine phosphokinase	10 (4.6)		8 (4.0)		11 (5.4)
Contusion	14 (6.5)		7 (3.5)		7 (3.5)
Hypertension	7 (3.2)		8 (4.0)		10 (5.0)
Gastroenteritis	6 (2.8)		10 (5.0)		8 (4.0)
Eczema	7 (3.2)		10 (5.0)		5 (2.5)

*Preferred terms: foot fracture, spinal compression fracture, femur fracture, hand fracture, humerus fracture, lower limb fracture, radius fracture, rib fracture, spinal fracture.

†Preferred terms: Clostridia infections, C. difficile bacillaemia, Clostridium colitis, C. difficile colitis, C. difficile infection, C. difficile sepsis, Clostridia test positive, Clostridia enterogastritis, pseudomembranous colitis.

‡Preferred terms: gastric cancer, oesophageal carcinoma, adenocarcinoma gastric.