Table 3.
Summary of adverse events in safety population
| Group | Oxygen group (n = 54) | Hydrogen/oxygen group (n = 54) |
|---|---|---|
| Number of patients, n (%) | ||
| Any adverse events | 42 (77.8%) | 34 (63.0%) |
| Main AEs | ||
| Hypokalemia | 3 (5.6%) | 2 (3.7%) |
| Abnormal liver function | 3 (5.6%) | 1 (1.9%) |
| Upper respiratory infection | 3 (5.6%) | 3 (5.6%) |
| Elevated C-reactive protein | 2 (3.7%) | 4 (7.4%) |
| Elevated blood pressure | 2 (3.7%) | 2 (3.7%) |
| Cough | 2 (3.7%) | 2 (3.7%) |
| Phlegm-retention | 3 (5.6%) | 0 (0.0%) |
| Wheezing | 4 (7.4%) | 0 (0.0%) |
| Agrypnia | 2 (3.7%) | 2 (3.7%) |
| Any severe adverse events | 7 (13.0%) | 2 (3.7%) |
| Abnormal liver function | 1 (1.9%) | 0 (0.0%) |
| Infection (lung, upper respiratory) | 3 (5.6%) | 0 (0.0%) |
| Bacterial infection | 1 (1.9%) | 0 (0.0%) |
| Pulmonary inflammation | 0 (0.0%) | 1 (1.9%) |
| Wheezing | 2 (3.7%) | 0 (0.0%) |
| Ileus | 0 (0.0%) | 1 (1.9%) |
| Any device-related adverse events | 3 (5.6%) | 2 (3.7%) |
| Any adverse events leading to withdrawal | 2 (3.7%) | 2 (3.7%) |
| Number of events, n | ||
| Any adverse events | 82 | 63 |
| An severe adverse event | 7 | 2 |
| Any device-related adverse events | 3 | 3 |
| Upper respiratory tract infection | 31(14.69) | 26(20.31) |