Safety study in patients receiving either Highly Emetogenic Chemotherapy or Moderately Emetogenic Chemotherapy In one multicentre, multinational, randomised, activecontrolled, doubleblind, doubledummy, unbalanced (3:1), parallel group, clinical study the safety and the efficacy of a single oral dose of AKYNZEO was compared to an antiemetic regimen with aprepitant and palonosetron in cancer patients scheduled to receive either a highly emetogenic chemotherapy or a moderately emetogenic chemotherapy regimen. Patients were randomised (3:1) on Day 1 of their first chemotherapy cycle, before administration of chemotherapy, to the two treatment groups, as displayed in the following table (Table 5), according to the emetogenicity regimen: Table 5 Treatment Day 1 Day 2 Day 3 Day 4 Regimen HEC patients AKYNZEO Netupitant 300 Dexamethasone Dexamethasone Dexamethasone mg PO 8 mg PO 8 mg PO 8 mg PO Palonosetron 500 mcg PO Dexamethasone 12 mg PO Aprepitant Aprepitant 125 Aprepitant 80 mg Aprepitant 80 Dexamethasone and mg PO PO mg PO 8 mg PO Palonosetron Palonosetron Dexamethasone Dexamethasone 500 mcg PO 8 mg PO 8 mg PO Dexamethasone 12 mg PO MEC patients AKYNZEO Netupitant 300 No Antiemetic No Antiemetic No Antiemetic mg PO Treatment Treatment Treatment Palonosetron 500 mcg PO Dexamethasone 12 mg PO Aprepitant Aprepitant 125 Aprepitant 80 mg Aprepitant 80 No Antiemetic and mg PO PO mg PO Treatment Palonosetron Palonosetron 500 mcg PO Dexamethasone 12 mg PO A total of 413 patients were randomised in the study, to receive either AKYNZEO (n=309) or aprepitant and palonosetron (n=104).
Safety study in patients receiving either Highly Emetogenic Chemotherapy or Moderately Emetogenic Chemotherapy In one multicentre, multinational, randomised, activecontrolled, doubleblind, doubledummy, unbalanced (3:1), parallel group, clinical study the safety and the efficacy of a single oral dose of AKYNZEO was compared to an antiemetic regimen with aprepitant and palonosetron in cancer patients scheduled to receive either a highly emetogenic chemotherapy or a moderately emetogenic chemotherapy regimen. Patients were randomised (3:1) on Day 1 of their first chemotherapy cycle, before administration of chemotherapy, to the two treatment groups, as displayed in the following table (Table 5), according to the emetogenicity regimen: Table 5 Treatment Regimen Day 1 Day 2 Day 3 Day 4 HEC patients AKYNZEO Netupitant 300 mg PO Palonosetron 500 mcg PO Dexamethasone 12 mg PO Dexamethasone 8 mg PO Dexamethasone 8 mg PO Dexamethasone 8 mg PO Aprepitant and Palonosetron Aprepitant 125 mg PO Palonosetron 500 mcg PO Dexamethasone 12 mg PO Aprepitant 80 mg PO Dexamethasone 8 mg PO Aprepitant 80 mg PO Dexamethasone 8 mg PO Dexamethasone 8 mg PO MEC patients AKYNZEO Netupitant 300 mg PO Palonosetron 500 mcg PO Dexamethasone 12 mg PO No Antiemetic Treatment No Antiemetic Treatment No Antiemetic Treatment Aprepitant and Palonosetron Aprepitant 125 mg PO Palonosetron 500 mcg PO Dexamethasone 12 mg PO Aprepitant 80 mg PO Aprepitant 80 mg PO No Antiemetic Treatment A total of 413 patients were randomised in the study, to receive either AKYNZEO (n=309) or aprepitant and palonosetron (n=104).