TABLE 5.
Safety summary
| Adverse event | No. of patients (%) from anidulafungin dose group (mg)
|
||
|---|---|---|---|
| 50 | 75 | 100 | |
| Any event | 38 (95) | 38 (95) | 38 (95) |
| Related eventa | 11 (28) | 11 (28) | 12 (30) |
| Hypokalemia | 4 (10) | 2 (5) | 2 (5) |
| Increased GGT | 1 (3) | 0 | 2 (5) |
| Hypomagnesemia | 1 (3) | 1 (3) | 1 (3) |
| Serious eventb | 20 (50) | 17 (43) | 18 (45) |
| Death | 12 (30) | 10 (25) | 11 (28) |
| Sepsisc | 4 (10) | 2 (5) | 0 |
| Cardiac arrestc | 1 (3) | 3 (8) | 1 (3) |
| Respiratory distressc | 0 | 2 (5) | 3 (8) |
| Multiorgan failure | 3 (8) | 1 (3) | 0 |
| Septic shock | 1 (3) | 2 (5) | 0 |
a
Considered by the investigator to have a probable or possible relationship to treatment with anidulafungin. Related adverse events occurring in at least two patients overall are displayed. GGT, gamma glutamyl transferase.
b
Serious adverse events reported by ≥2 patients in any treatment group are presented.
c
Three cases of respiratory distress, two cases of sepsis, and one cardiac arrest were nonfatal.