Clinical Study

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 5

Adverse events.

Adverse events (%) with any grade (%) with grades 1-2 (%) with grades 3-4
Overall ONDOND + APRONDOND + APROverallONDOND + APR

Diarrhea 23 (26)11 (26)12 (27)10 (23)11 (25) 3 (3)1 (2)2 (5)
Headache 22 (25)11 (26)11 (25)11 (26)9 (20) 2 (2)0 (0)2 (5)
Fatigue 18 (21)9 (21)9 (20)9 (21)9 (20) 0 (0)0 (0)0 (0)
Constipation 17 (19)7 (16)10 (23)7 (16)10 (23) 0 (0)0 (0)0 (0)
Indigestion 9 (10)3 (7)6 (14)3 (7)6 (14) 0 (0)0 (0)0 (0)
Edema 8 (9)3 (7)5 (11)3 (7)5 (11) 0 (0)0 (0)0 (0)
Abdominal pain 5 (6)2 (5)3 (7)2 (5)3 (7) 0 (0)0 (0)0 (0)
Dizziness 3 (3)1 (2)2 (5)1 (2)2 (5) 0 (0)0 (0)0 (0)
Syncope 1 (1)1 (2)0 (0)0 (0)0 (0) 1 (1)1 (2)0 (0)
Hypotension 1 (1)0 (0)1 (2)0 (0)1 (2) 0 (0)0 (0)0 (0)