Summary of TEAEs in first-line VPZ-based and LPZ-based triple therapy (in combination with AMX and CLR) and in second-line VPZ-based triple-therapy (in combination with AMX and MTZ) (safety analysis set)
| First-line triple therapy | Second-line triple therapy | |||||
|---|---|---|---|---|---|---|
| VPZ/AMX/CLR (n=329) | LPZ/AMX/CLR (n=321) | VPZ/AMX/MTZ (n=50) | ||||
| Events | Subjects | Events | Subjects | Events | Subjects | |
| TEAEs | 153 | 112 (34.0) | 178 | 132 (41.1) | 26 | 15 (30.0) |
| Related | 85 | 67 (20.4) | 93 | 79 (24.6) | 11 | 8 (16.0) |
| Not related | 68 | 45 (13.7) | 85 | 53 (16.5) | 15 | 7 (14.0) |
| Mild | 145 | 104 (31.6) | 168 | 124 (38.6) | 22 | 14 (28.0) |
| Moderate | 7 | 7 (2.1) | 8 | 6 (1.9) | 2 | 0 (0.0) |
| Severe | 1 | 1 (0.3) | 2 | 2 (0.6) | 2 | 1 (2.0) |
| Leading to study drug discontinuation | 3 | 3 (0.9) | 2 | 2 (0.6) | 0 | 0 (0.0) |
| Serious TEAEs | 4 | 4 (1.2) | 2 | 2 (0.6) | 2 | 1 (2.0) |
| Related | 1 | 1 (0.3) | 0 | 0 (0.0) | 0 | 0 (0.0) |
| Not related | 3 | 3 (0.9) | 2 | 2 (0.6) | 2 | 1 (2.0) |
| Deaths | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Data are expressed as number of events or as number of subjects with percentage in parentheses.
AMX, amoxicillin; CLR, clarithromycin; LPZ, lansoprazole; MTZ, metronidazole; TEAE, treatment-emergent adverse event; VPZ, vonoprazan.