Table 5 Treatment-related SAEs during RENEW treatment phase
SAE | Treatment phase (n = 509) | ||
|---|---|---|---|
| Â | Number of treatment-related events | ||
| Â | Possible | Probable | Total |
Decreased ejection fraction | 1 | 10 | 11 |
Urinary tract infection | 1 | 3 | 4 |
Cardiomyopathy | 0 | 3 | 3 |
Febrile neutropenia | 1 | 2 | 3 |
Leukopenia | 0 | 3 | 3 |
Pneumonia | 0 | 3 | 3 |
Congestive heart failure | 0 | 2 | 2 |
Cellulitis gangrenous | 0 | 1 | 1 |
Herpes zoster | 0 | 1 | 1 |
Upper respiratory tract infection | 0 | 1 | 1 |
Urosepsis | 0 | 1 | 1 |
Ventricular hypokinesia | 0 | 1 | 1 |
Myocardial infarction | 2 | 0 | 2 |
Nausea | 2 | 0 | 2 |
Sepsis | 2 | 0 | 2 |
Septic shock | 2 | 0 | 2 |
Vomiting | 2 | 0 | 2 |
Abortion incomplete | 1 | 0 | 1 |
Cellulitis | 1 | 0 | 1 |
Deep vein thrombosis | 1 | 0 | 1 |
Dizziness | 1 | 0 | 1 |
Fungal skin infection | 1 | 0 | 1 |
Hydronephrosis | 1 | 0 | 1 |
Localized infection | 1 | 0 | 1 |
Lung infection | 1 | 0 | 1 |
Meningitis | 1 | 0 | 1 |
Pituitary tumor | 1 | 0 | 1 |
Pulmonary embolism | 1 | 0 | 1 |
Varicella | 1 | 0 | 1 |