Table 2.
Overview of TEAEs and SAEs (safety analysis set)
| Vonoprazan 20 mg (n=244) | Lansoprazole 30 mg (n=235) | |||
| Events | n (%) | Events | n (%) | |
| TEAEs | 162 | 93 (38.1) | 162 | 86 (36.6) |
| Related* | 70 | 36 (14.8) | 49 | 27 (11.5) |
| Not related | 92 | 57 (23.4) | 113 | 59 (25.1) |
| Mild | 144 | 76 (31.1) | 140 | 71 (30.2) |
| Moderate | 15 | 14 (5.7) | 17 | 13 (5.5) |
| Severe | 3 | 3 (1.2) | 5 | 2 (0.9) |
| Leading to discontinuation | 6 | 5 (2.0) | 4 | 4 (1.7) |
| Related* | 3 | 3 (1.2) | 2 | 2 (0.9) |
| Not related | 3 | 2 (0.8) | 2 | 2 (0.9) |
| Liver function abnormalities | 0 | 0 | 2 | 2 (0.9) |
| SAEs | 3 | 3 (1.2) | 3 | 3 (1.3) |
| Related | 0 | 0 | 0 | 0 |
| Not related | 3 | 3 (1.2) | 3 | 3 (1.3) |
| Leading to discontinuation | 2 | 2 (0.8) | 1 | 1 (0.4) |
| Significant TEAEs† | 29 | 24 (9.8) | 47 | 34 (14.5) |
| Deaths | 0 | 0 | 0 | 0 |
*An adverse event that followed a reasonable temporal sequence from administration of study drug (including the course after withdrawal of the drug) or for which possible involvement of the drug could be argued, although factors other than the drug, such as underlying diseases, complications, concomitant drugs and concurrent treatments, may also have been responsible.
†Any TEAE (excluding serious TEAEs) that led to an intervention, including withdrawal of treatment, dose increase, dose reduction or additional concomitant therapy.
SAEs, serious adverse events; TEAEs, treatment-emergent adverse events.