Table 3.
Adverse events.
| Adverse event | Treatment group N = 72 |
Control group N = 72 |
P value |
|---|---|---|---|
| Total (N, %) | 7 (9.72%) | 11 (15.28%) | 0.3135 |
| Heart dysfunction (N, %) | 0 (0%) | 1 (1.39%) | |
| Gastrointestinal dysfunction (N, %) | 1 (1.39%) | 6 (8.33%) | |
| Hepatobiliary dysfunction (N, %) | 1 (1.39%) | 1 (1.39%) | |
| Infections (N, %) | 1 (1.39%) | 1 (1.39%) | |
| Metabolic disorders (N, %) | 3 (4.17%) | 2 (2.78%) | |
| Neurological disorders (N, %) | 1 (1.39%) | 0 (0%) | |
| Severity[1] | 0.3889 | ||
| Mild (N, %) | 6 (8.33) | 11 (15.28) | |
| Moderate (N, %) | 1 (1.39) | 0 (0.00) | |
| Severe (N, %) | 0 (0.00) | 0 (0.00) | |
| Related to treatment | 0.7484 | ||
| Definitely related | 0 (0.00) | 0 (0.00) | |
| Probably related | 0 (0.00) | 0 (0.00) | |
| Definitely not related | 1 (1.39) | 1 (1.39) | |
| Probably not related | 6 (8.33) | 8 (11.11) | |
| Not sure | 0 (0.00) | 2 (2.78) | |
| Death (N, %) | 0 (0.00) | 0 (0.00) | 1.0000 |
P value, comparison between the treatment group and the control group. P < 0.05 indicates a significant difference. [1]Definition of severity: mild, confirmed cases with fever (measured or subjective) or respiratory symptoms; moderate, confirmed cases with fever (measured or subjective) or respiratory symptoms and radiographic evidence of pneumonia; severe, confirmed cases with evidence including fever, respiratory symptoms, radiographic evidence of pneumonia, and at least one of the following symptoms: respiratory distress, RR ≥30 times/min; resting state, mean oxygen saturation ≤93%; and PaO2/FiO2 ≤ 300 mmHg (1 mmHg = 0.133 kPa).