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Adverse reactions were typically mild to moderate in severity and seldom led to discontinuation in a pivotal Phase III study1,2

Full preview Percentage of adverse events leading to discontinuation of study

Adverse events leading to discontinuation of the study drug occurred in fewer patients receiving anidulafungin compared with fluconazole2 

Adapted from Reboli et al. 2007.2 


Percentage of patients taking anidulafungin and fluconazole experiencing adverse reactions2

  Anidulafungin
(n=131)*
Fluconazole group (n=125) p-value
Treatment-related adverse events 24.4%
(n=32; 
59 events)
26.4% (n=33; 64 events) NS
Treatment-related elevated hepatic enzymes 1.5%
(n=2)
7.2%
(n=9)
0.03
Treatment-related serious adverse events Atrial fibrillation (n=1)
Seizures (n=1)
Deep vein thrombosis (n=1)
Elevated hepatic enzymes (n=1)
NS
Adverse events leading to discontinuation of study drug 11.5% (n=15) 21.6% (n=27) 0.02

Adapted from Reboli et al, 20072
 

*Intention-to-treat (ITT) population

 NS, not significant

    •     Infusion-related adverse reactions have been reported with anidulafungin in clinical studies,

          including flushing, pruritus, rash, urticaria, dyspnoea, bronchospasm and hypotension1

References

  1. Ecalta® Summary of Product Characteristics.
  2. Rebolic AC, et al. N Eng J Med. 2007; 356:2472-2482.