Table 4.
Most common (> 5%) serious and non-serious treatment-emergent adverse events (TEAEs)
| Placebo (n = 47) | Meropenem (n = 44) | p value | |
|---|---|---|---|
| At least one serious TEAE, n (%) | 24 (51.1) | 27 (61.4) | 0.399 |
| Type of serious TEAEs, n (%) | |||
| Severe anemia and blood transfusion | 4 (8.7) | 4 (9.1) | 1.00 |
| Hemoptysis | 0 | 3 (6.8) | 0.113 |
| New hospitalization | 7 (15.2) | 9 (20.5) | 0.588 |
| At least one non-serious TEAE, n (%) | 44 (93.6) | 37 (84.1) | 0.188 |
| Type of non-serious TEAEs, n (%) | |||
| Diarrhea | 7 (14.9) | 5 (11.4) | 0.605 |
| Constipation | 2 (4.3) | 4 (9.1) | 0.425 |
| Mild anemia | 4 (8.7) | 6 (13.6) | 0.518 |
| Thrombocytopenia | 5 (10.9) | 5 (11.4) | 1.00 |
| Eosinophilia | 3 (6.5) | 1 (2.3) | 0.617 |
| Increased creatinine | 4 (8.7) | 6 (13.6) | 0.518 |
| Increased liver enzymes | 9 (19.6) | 11 (25.6) | 0.613 |
| Blood coagulation disorders | 3 (6.5) | 3 (6.8) | 1.00 |
| Dyspnea | 3 (6.5) | 2 (4.5) | 1.00 |
| Rash | 6 (13) | 1 (2.3) | 0.111 |
| Peripheral edema | 3 (6.5) | 1 (2.3) | 0.617 |
| Hyperglycemia | 4 (8.7) | 1 (2.3) | 0.361 |
| Hypoglycemia | 2 (4.3) | 5 (11.4) | 0.257 |
| Hyponatremia | 5 (10.9) | 6 (13.6) | 0.755 |
| Hypokalemia | 11 (23.9) | 9 (20.5) | 0.802 |
| Hypophosphatemia | 3 (6.5) | 4 (9.1) | 0.711 |
| Hypomagnesemia | 2 (4.3) | 3 (6.8) | 0.673 |
n Number of patients