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.