Table 2.

Reasons for failure of and withdrawal from study medication.

	Anidulafungin	Fluconazole
Observed failurea	4	13
Clinical success and microbiologic failureb	0	1
Clinical failure and microbiologic success	1	4
Clinical failure and microbiologic failureb	3	7
Clinically indeterminate and microbiologic failureb	0	1
Indeterminate responsec	10	10
Withdrawal from study medication	12	21
Due to adverse eventd	7	7
Due to withdrawal of consent	2	1
At investigator's discretion	1	3
Worsening clinical status	2	9
Death within 24 hours of end of IV study treatmentb	4	7
Receipt of < 3 doses of study medication	1	1

^a Observed failure was defined as treatment failure declared by the investigator to be clinical failure, microbiologic failure (i.e. positive findings on culture), or both. In these patients mean time to failure was 16.8 days for anidulafungin and 8.9 days for fluconazole.

^b Among those in whom microbiologic failure occurred, two of three patients in the anidulafungin group and eight of nine in the fluconazole group had persistent infection. The other two patients in whom microbiologic failure occurred had superinfections.

^c For the primary efficacy analysis, indeterminate response was treated as failure of global response. Patients could be considered to have an indeterminate response for more than one reason.

^d In the anidulafungin group, adverse events leading to discontinuation included sepsis (2), renal failure (1), elevated liver enzymes (1), multisystem organ failure (1), cardiac failure (1), and hypoglycemia (1). In the fluconazole group, adverse events leading to discontinuation included renal failure (3), elevated liver enzymes (2), cancer (1), and multisystem organ failure (1).