Table 3.
Summary of TEAE occurring in ≥5% of patients across the non-inferiority and extension studies (safety analysis set)
| Event | Lansoprazole 15 mg (n=210) | Vonoprazan 10 mg (n=218) | Vonoprazan 20 mg (n=212) | Statistical test | |||
| Events, n | Patients, n (%) | Events, n | Patients, n (%) | Events, n | Patients, n (%) | ||
| Summary of AEs | Χ2 test | ||||||
| Any AE | 634 | 185 (88.1) |
758 | 184 (84.4) |
731 | 175 (82.5) |
p=0.2673 |
| Drug-related AE | 44 | 40 (19.0) |
52 | 38 (17.4) |
51 | 37 (17.5) |
p=0.8839 |
| Leading to study discontinuation | 17 | 16 (7.6) |
9 | 9 (4.1) |
32 | 27 (12.7) |
p=0.0046 |
| Any serious AE* | 20 | 18 (8.6) |
22 | 18 (8.3) |
36 | 30 (14.2) |
p=0.0796 |
| Serious drug-related AE† | 0 | 0 (0) |
2 | 2 (0.9) |
2 | 2 (0.9) |
p=0.3740 |
| Special interest AE‡ | 2 | 2 (1.0) |
5 | 5 (2.3) |
4 | 3 (1.4) |
p=0.5232 |
| Drug-related special interest AE | 1 | 1 (0.5) |
2 | 2 (0.9) |
0 | 0 (0) |
p=0.3792 |
| TEAEs reported in ≥5% of patients in any treatment group by preferred term, n (%) | |||||||
| Nasopharyngitis | 61 (29.0) | 70 (32.1) | 59 (27.8) | ||||
| Fall | 18 (8.6) | 22 (10.1) | 18 (8.5) | ||||
| Contusion | 20 (9.5) | 17 (7.8) | 14 (6.6) | ||||
| Diarrhoea | 14 (6.7) | 11 (5.0) | 15 (7.1) | ||||
| Upper respiratory tract inflammation | 7 (3.3) | 12 (5.5) | 14 (6.6) | ||||
| Seasonal allergy | 8 (3.8) | 8 (3.7) | 15 (7.1) | ||||
| Eczema | 12 (5.7) | 10 (4.6) | 8 (3.8) | ||||
| Elevated blood creatine phosphokinase | 11 (5.2) | 9 (4.1) | 7 (3.3) | ||||
| Constipation | 5 (2.4) | 15 (6.9) | 7 (3.3) | ||||
| Back pain | 6 (2.9) | 7 (3.2) | 13 (6.1) | ||||
| Contact dermatitis | 6 (2.9) | 8 (3.7) | 12 (5.7) | ||||
| Stomatitis | 7 (3.3) | 11 (5.0) | 4 (1.9) | ||||
| Dental caries | 11 (5.2) | 6 (2.8) | 4 (1.9) | ||||
*Serious AE.
†Serious drug-related AE: putamen haemorrhage.
‡Special interest AE: liver function test abnormal.
AE, adverse event; TEAE, treatment-emergent AE.