Phase II, Open Label, Randomized Comparative Trial of Ondansetron Alone versus the Combination of Ondansetron and Aprepitant for the Prevention of Nausea and Vomiting in Patients with Hematologic Malignancies Receiving Regimens Containing High-Dose Cytarabine
Table 1
Baseline characteristics.
Ondansetron; Arm 1 = 49 (%)
Ondansetron + aprepitant; Arm 2 = 49 (%)
Sex
Women
21 (43)
22 (45)
0.53
Men
28 (57)
27 (55)
Race/ethnicity
Caucasian
40 (83)
37 (76)
0.24
Hispanic
3 (6)
6 (12)
0.62
African American
5 (10)
4 (8)
0.50
Asian
0 (0)
2 (4)
0.50
Median age, y (range)
53 (30–68)
49 (21–70)
Diagnosis
AML
47 (96)
47 (96)
0.69
MDS
1 (2)
2 (4)
0.50
CMML
1 (2)
0 (0)
0.50
Ind. chemotherapy
44 (90)
38 (78)
0.08
Sal. chemotherapy
5 (10)
11 (22)
Chemotherapy agents used in combination with cytarabine
Idarubicin
7 (14)
7 (14)
0.61
Fludarabine
10 (20)
8 (16)
0.30
Idarubicin + clofarabine
24 (49)
24 (49)
0.50
Clofarabine, idarubicin, and decitabine
1 (2)
1 (2)
0.75
Investigational drug + idarubicin
4 (8)
7 (14)
0.50
GO + fludarabine
2 (4)
1 (2)
0.50
Infection at baseline
10 (20)
9 (18)
0.45
Use of antibiotic at baseline
9 (18)
9 (18)
0.56
Ind: induction, Sal: salvage, and GO: gemtuzumab ozogamicin.
