Table 2.

Invasive fungal disease rates

Patient population	L-AMB	Placebo	P valuea
IFD assessment by IDRB	N = 228	N = 111
Proven or probable IFD (primary endpoint)	18 (7.9%)	13 (11.7%)	0.24
proven candidaemia	1 (0.4%)b	3 (2.7%)c	0.07
proven filamentous IFD	0	0
probable IFD	17 (7.5%)	10 (9.0%)	0.60
Possible IFD	11 (4.8%)	6 (5.4%)	0.82
Pulmonary infiltrates	46 (20.2%)	30 (27.0%)	0.15
Deaths due to IFD	2 (0.9%)d	0	0.32
IFD assessment by investigator	N = 228	N = 111
Proven or probable IFD	25 (11.0%)	12 (10.8%)	0.97
Requirement for antifungal treatment	37 (16.2%)	24 (21.6%)	0.22
Deaths due to IFD	2 (0.9%)	0	0.32
Post hoc analysis on patients without major protocol deviationse	N = 184	N = 90
Proven or probable IFD	14 (7.6%)	13 (14.4%)	0.07
Neutropenic for ≥10 days (ANC <500 cells/μL)	N = 174	N = 84
Proven or probable IFD	12 (6.9%)	11 (13.1%)	0.10

ANC, absolute neutrophil count.

Three subjects (one L-AMB, two placebo) had Pneumocystis spp. in bronchoalveolar lavage (BAL) and were not considered to have IFD as it is not part of the EORTC/MSG criteria.

^aStratum-adjusted (stratified by region) CMH test.

^bC. kefyr.

^cC. albicans (2×), C. tropicalis bloodstream infections.

^dProbable invasive pulmonary aspergillosis, proven candidaemia.

^eMajor protocol deviations were protocol-prohibited systemic antifungals, baseline IFD or chemotherapy not expected to induce sufficient neutropenia.