Table 5.
Summary of adverse events (safety population)
| Safety parameters | RIE N = 149, n (%) |
LIE N = 414, n (%) |
BRLIE N = 47, n (%) |
|---|---|---|---|
| AEs | 16 (10.7) | 98 (23.7) | 10 (21.3) |
| SAEs | 9 (6.0) | 70 (16.9) | 10 (21.3) |
| Discontinuations due to AEs | 5 (3.4)) | 30 (7.2) | 2 (4.3) |
| AEs possibly related to daptomycin, n (%) | 2 (1.3) | 18 (4.3) | 1 (2.1) |
| Blood CPK increased | 2 (1.3) | 8 (1.9) | 1 (2.1) |
| Myalgia | 1 (0.7) | – | – |
| Agranulocytosis | – | 1 (0.2) | – |
| Eosinophilia | – | 1 (0.2) | – |
| Eye pain | – | 1 (0.2) | – |
| Mouth ulceration | – | 1 (0.2) | – |
| Cholestasis | – | 1 (0.2) | – |
| Pneumonia | – | 1 (0.2) | – |
| Rhabdomyolysis | – | 1 (0.2) | – |
| Eosinophilic pneumonia | – | 2 (0.5) | – |
| Pulmonary interstitial emphysema syndrome | – | 1 (0.2) | – |
| Dermatitis allergic | – | 1 (0.2) | – |
| Rash | – | 1 (0.2) | – |
| Rash generalized | – | 1 (0.2) | – |
| SAEs possibly related to daptomycin, n (%) | – | 6 (1.4) | – |
| Agranulocytosis | – | 1 (0.2) | – |
| Cholestasis | – | 1 (0.2) | – |
| Blood CPK increased | – | 2 (0.5) | – |
| Rhabdomyolysis | – | 1 (0.2) | – |
| Eosinophilic pneumonia | – | 2 (0.5) | – |
| Pulmonary interstitial emphysema syndrome | – | 1 (0.2) | – |
| Rash generalized | – | 1 (0.2) | – |
AE adverse event, BRLIE both right- and left- sided infective endocarditis, CPK creatine phosphokinase, LIE left-sided infective endocarditis, RIE right-sided infective endocarditis, SAE serious AE