Clinical study assessing safety and effectiveness of medicine containing two antiemetic drugs (Fosnetupitant 235 mg and Palonosetron 0.25 mg) when they are administered intravenously to prevent nausea and vomiting in cancer patients receiving chemotherapy cycles.

Phase 4

Recruitment & Eligibility

Inclusion Criteria

1. Patient is scheduled to receive their first chemotherapy cycle of a highly

emetogenic or a moderately emetogenic chemotherapy (HEC/MEC).

2. Male/female patients aged above more than or equal to 18 years to less than or equal to 75 years

3. Willing to be part of study and for follow up.

4. Willing to provide written informed consent form.

Exclusion Criteria

1. Patients with serious cardiovascular disease history or predisposition to

cardiac conduction abnormalities or use of medication which can cause

conduction abnormalities as per treating physicians’ assessment.

2. Vomiting, retching, or more than no significant nausea within 24 h before

the informed consent.

3. Women of child bearing potential who are pregnant, planning to becoming

pregnant or breast feeding.

4. Known contraindication to the intravenous administration of 50 mL 5%

glucose solution prior to index date

5. Hypersensitivity to active substances or excipients of Akynzeo® I.V.

6. Patient currently enrolled in another clinical trial.

7. Patients requiring multi-day chemotherapy

8. Patients who are prescribed other NK1RA and 5 HT3 RA

Primary Outcome Measures

Name	Time	Method
-Number of patients with drug related treatment emergent adverse events (TEAEs) as <br/ ><br>assessed by the treating physician <br/ ><br>-Number of patients with TEAEs <br/ ><br>-Number of patients with Serious TEAEs (STEAEs) <br/ ><br>Timepoint: [Time Frame: up to 240 hr (10 days] <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Complete response rate (CR: no emesis, no rescue medication) during acute phase <br/ ><br>2. Complete response rate during delayed phase <br/ ><br>3. Complete response rate during the overall phase <br/ ><br>4. Complete control (CC: no emesis, no rescue medication, and no nausea) during <br/ ><br>overall phase <br/ ><br>5. Complete protection (CP: no emesis, no rescue medication and no significant <br/ ><br>nausea) during overall phase <br/ ><br>6. Complete response rate during extended overall phase. <br/ ><br>7. Severity of nausea assessed using a Visual Analogue Scale (VAS)Timepoint: <br/ ><br>1.[Time Frame: 0 to 24 hrs.(10 days)] <br/ ><br>2.[Time Frame: 24 to 120 hrs.] <br/ ><br>3.[Time Frame: 0 to 120 hrs.] <br/ ><br>4.[Time Frame: 0 to 120 hrs.] <br/ ><br> <br/ ><br>5.[Time Frame: 0 to 120 hrs.] <br/ ><br> <br/ ><br>6.[Time Frame: 0 to 240 hrs(10 days)] <br/ ><br>7.[Time Frame: upto 240 hr (10 days)] <br/ ><br>