Table 5.
TEAEs in patients in the safety analysis set.
| Rabeprazole | Anaprazole | |||||
|---|---|---|---|---|---|---|
| 10 mg (n = 50) | 20 mg (n = 47) | 40 mg (n = 48) | ||||
| Patients (%) | Events | Patients (%) | Events | Patients (%) | Events | |
| Any TEAE | 17 (34.0) | 39 | 16 (34.0) | 22 | 14 (29.2) | 20 |
| Mild | 17 (34.0) | 35 | 14 (29.8) | 20 | 14 (29.2) | 18 |
| Moderate | 4 (8.0) | 4 | 2 (4.3) | 2 | 1 (2.1) | 2 |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 |
| Drug-related TEAEs | 9 (18.0) | 16 | 9 (19.1) | 9 | 6 (12.5) | 7 |
| Drug-related SAEs | 0 | 0 | 0 | 0 | 0 | 0 |
| TESAEs (not drug-related) leading to drug discontinuation and withdrawal | 1 (2.0) | 1 | 0 | 0 | 0 | 0 |
| TEAE leading to death | 0 | 0 | 0 | 0 | 0 | 0 |
| Frequently reported TEAEs | ||||||
| Gastrointestinal disorders | 5 (10.0) | 6 | 6 (12.8) | 6 | 7 (14.6) | 9 |
| Abdominal distension | 2 (4.0) | 2 | 0 | 0 | 1 (2.1) | 1 |
| Nervous system disorders | 5 (10.0) | 7 | 2 (4.3) | 2 | 1 (2.1) | 1 |
| Dizziness | 2 (4.0) | 2 | 1 (2.1) | 1 | 0 | 0 |
| Headache | 2 (4.0) | 4 | 0 | 0 | 0 | 0 |
| Liver dysfunction | 6 (12.0) | 7 | 0 | 0 | 0 | 0 |
| Infections and infestation | 2 (4.0) | 2 | 2 (4.3) | 2 | 2 (4.2) | 2 |
| Upper respiratory infection | 0 | 0 | 1 (2.1) | 1 | 1 (2.1) | 1 |
SAE, serious adverse event; TEAEs, treatment-emergent adverse events; TESAEs, treatment-emergent serious adverse events.