Table 1

Baseline characteristics for modified intention-to-treat subjects (N = 97)

Treatment armP*
Control, n = 49Granulocytes, n = 48
Age, y46.9 + 20.254.9 + 17.1.04
 <18, n (%)6 (12)4 (8).24
 18-64, n (%)33 (67)27 (56)
 >65, n (%)10 (20)17 (35)
Male sex, n (%)27 (55)28 (58).84
Race, n (%).18
 White31(63)37 (77)
 Asian4 (8)1 (2)
 Black/African American1 (2)3 (6)
 Other/unknown13 (27)7 (15)
ANC at randomization, cells/μL43 ± 8859 ± 100.38
Cause of neutropenia, n (%).83
 HSC transplantation8 (16)8 (17)
 Chemotherapy36 (73)37 (77)
 Other5 (10)3 (6)
Underlying disorder, n (%).73
 Acute lymphocytic leukemia6 (12)6 (13)
 Acute nonlymphocytic leukemia31 (63)32 (67)
 Chronic myelogenous leukemia2 (4)0 (0)
 Chronic lymphocytic leukemia1 (2)0 (0)
 Non-Hodgkin lymphoma3 (6)4 (8)
 Myelodysplasia1 (2)2 (4)
 Myeloma1 (2)0 (0)
 Aplastic anemia2 (4)0 (0)
 Other malignancy0 (0)1 (2)
 Other2 (4)3 (6)
Infection at enrollment, n (%).48
 Proven fungal15 (31)11 (23)
  Bloodstream
   Candida6 (12)3 (6)
   Zygomycetes1 (2)0 (0)
   Mold not specified1 (2)0 (0)
  Pulmonary
   Aspergillus1 (2)2 (4)
   Zygomycetes1 (2)0 (0)
  Facial/sinus
   Aspergillus0 (0)2 (4)
   Zygomycetes0 (0)1 (2)
  Skin/soft tissue
   Aspergillus1 (2)1 (2)
   Fusarium0 (0)1 (2)
  Disseminated
   Candida1 (2)2 (4)
   Fusarium1 (2)0 (0)
  Other
   Aspergillus1 (2)0 (0)
   Mold not specified1 (2)0 (0)
 Probable/presumptive pulmonary fungal9 (18)11 (23)
  Typhlitis2 (4)5 (10)
 Invasive bacterial13 (27)8 (17)
 Bacteremia alone10 (20)13 (27)
Signs/symptoms
 Fever46 (94)41 (85).20
 Pulmonary Sx/signs, n (%)30 (61)30 (63)>.99
  Dyspnea, n (%)10 (20)10 (21)>.99
  Respiratory rate, per min23.4 ± 6.120.6 ± 4.6.03
  FIO20.42 ± .230.40 ± .24.76
  Arterial O2 saturation, %96.0 ± 3.595.4 ± 5.5.83
  Ventilator, n (%)10 (20)9 (19)>.99
 Nasal/sinus Sx/signs, n (%)4 (8)9 (19).15
 CNS Sx/signs, n (%)11 (22)7 (15).31
 Skin nodules/papules, n (%)5 (10)7 (15).76
 Zubrod score, >2, n (%)34 (69)36 (75).65
  • Continuous variables are displayed as mean ± standard deviation, and categorical variables are displayed as n (%).

  • CNS, central nervous system; HSC, hematopoietic stem cell; Sx, symptoms.

  • * P values: Fisher exact test for categorical variables and Kruskal-Wallis test for continuous variables.

  • P value for 5 infection groups: proven fungal, probable/presumptive pulmonary fungal, typhlitis, invasive bacterial, bacteremia alone.

  • Zubrod score defined as: 0, asymptomatic; 1, symptomatic, fully ambulatory; 2, symptomatic, in bed <50% of the day but not bedridden; 3, symptomatic, in bed >50% of the day but not bedridden; 4, bedridden; 5, death.