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. 2017 May 22;12(5):e0177093. doi: 10.1371/journal.pone.0177093

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).