TEAEs occurring in ≥2% of patients in either treatment group (safety analysis set)
| Preferred term | Patients*, n (%) | |
| Vonoprazan (n=244) | Lansoprazole (n=235) | |
| Patients with any TEAE | 93 (38.1) | 86 (36.6) |
| GI disorders | 45 (18.4) | 45 (19.1) |
| Diarrhoea | 7 (2.9) | 9 (3.8) |
| Abdominal distension | 5 (2.0) | 6 (2.6) |
| Investigations | 26 (10.7) | 21 (8.9) |
| Blood gastrin increased | 13 (5.3) | 4 (1.7) |
| Enzyme level increased† | 9 (3.7) | 2 (0.9) |
| Pepsinogen I increased | 9 (3.7) | 1 (0.4) |
| Alanine aminotransferase increased | 4 (1.6) | 5 (2.1) |
| Nervous system disorders | 8 (3.3) | 10 (4.3) |
| Headache | 2 (0.8) | 8 (3.4) |
*A patient was counted once, even if the patient reported the same event more than once. Adverse events were coded using MedDRA V.18.0.
†Increased enzyme levels were associated with 10 events in 9 patients in the vonoprazan treatment group: raised serum pepsinogen 2, increased pepsinogen II (×5), increased pepsinogen I/II (×2) and high pepsinogen II (×2); and 2 events in 2 patients in the lansoprazole treatment group: pepsinogen I/II increase and high pepsinogen.
MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse events.