Femme et Homme
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Extrait
E.2.1 Main objective: 1. To demonstrate that the aprepitant regimen is superior to the control regimen with respect to the proportion of patient with no vomiting in the 120 hours following initiation of moderately emetogenic chemotherapy (MEC). 2. To demonstrate that the aprepitant regimen is non-inferior to the control regimen with respect to the proportion of patients with complete response (no vomiting and no use of rescue therapy) in the 120 hours following initiation of MEC. If non-inferiority is established the following will also be evaluated: aprepitant regimen is superior to the control regimen with respect to the proportion of patients with complete response in the 120 hours following initiation of MEC. 3. To evaluate the safety and tolerability of the aprepitant regimen for CINV.
Critère d'inclusion
- Chemotherapy-induced Nausea and Vomitting