Table 2. Follow up and outcomes (n = 21).
No. (%) or Median (95% CI) | |
---|---|
Safety and tolerance evaluation | |
At least one Adverse Event Δ | 13 (61.9%) |
At least one drug-related Adverse Event Λ | 4 (19.0%) |
At least one Adverse Event leading to study drug discontinuation ¥ | 2 (9.5%) |
At least one Serious Adverse Event Θ | 8 (38.1%) |
At least one Serious Adverse Event with death | 5 (23.8%) |
Allergy | 1 (4.7%) |
Electrolyte disturbances | |
Deep hypokalemia (<2.5 mmol/L) | 0 |
Renal toxicity | |
Serum creatinine increase (doubled baseline) | 3 (14.3%) |
Serum creatinine increase (threefold baseline) | 2 (9.5%) |
Need for dialysis | 0 |
Other Outcomes | |
Disappearance of Candida colonization | 5 (23.8%) |
Candidemia | 1 (4.7%) |
Length of ICU stay (days) | 13 (8–26) |
Length of hospital stay (days) | 21 (10–27) |
ICU mortality | 5 (23.8%) |
Abbreviations: ICU, Intensive Care Unit
¥ One patient with transient and one patient with definitive study drug discontinuation
Δ Total number of adverse events (one patient may have more than one adverse event) n = 24 (thoracic disorders n = 5; infections n = 5; blood and lymphatic system disorders n = 3; general disorders n = 3; gastrointestinal disorders n = 3; cardiac disorders n = 2; vascular disorders n = 1; hepatobiliary disorders n = 1; surgical and medical procedures n = 1). Classified as mild (n = 10); moderate (n = 1); severe (n = 13).
Λ Leukopaenia/neutropaenia/Thrombocytopenia n = 2; Supraventricular tachycardia n = 1; Hypotension (allergy) n = 1
Θ Total number of serious adverse events (one patient may have more than one serious adverse event) n = 14 (infections n = 5; blood and lymphatic system disorders n = 2; general disorders n = 2; respiratory disorders n = 2; gastrointestinal disorders n = 2; cardiac disorders n = 1).