Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 3, Multicenter, Randomized, Double Blind, Active-Controlled Study of the Safety & Efficacy of Rolapitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)
Brief Summary: This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.


Options:
A: Arm Label: APF530 500 mg SC; Type: EXPERIMENTAL; Interventions: Drug: APF530, Drug: Ondansetron placebo, Drug: Fosaprepitant, Drug: Dexamethasone | Arm Label: ondansetron 0.15 mg/kg IV; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ondansetron, Drug: APF530 placebo, Drug: Fosaprepitant, Drug: Dexamethasone | Intervention Type: DRUG; Name: APF530; Assigned to Arm(s): APF530 500 mg SC | Intervention Type: DRUG; Name: Ondansetron; Assigned to Arm(s): ondansetron 0.15 mg/kg IV | Intervention Type: DRUG; Name: Ondansetron placebo; Assigned to Arm(s): APF530 500 mg SC | Intervention Type: DRUG; Name: APF530 placebo; Assigned to Arm(s): ondansetron 0.15 mg/kg IV | Intervention Type: DRUG; Name: Fosaprepitant; Assigned to Arm(s): APF530 500 mg SC, ondansetron 0.15 mg/kg IV | Intervention Type: DRUG; Name: Dexamethasone; Assigned to Arm(s): APF530 500 mg SC, ondansetron 0.15 mg/kg IV
B: Arm Label: Netupitant and Palonosetron+dexamethasone-cycle 1; Type: EXPERIMENTAL; Interventions: Drug: Netupitant and Palonosetron, Drug: Dexamethasone | Arm Label: Palonosetron+dexamethasone-cycle 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Palonosetron, Drug: Dexamethasone | Arm Label: Netupitant and Palonosetron+dexamethasone-multicycle extension; Type: EXPERIMENTAL; Interventions: Drug: Netupitant and Palonosetron, Drug: Dexamethasone | Arm Label: Palonosetron+dexamethasone-multicycle extension; Type: ACTIVE_COMPARATOR; Interventions: Drug: Palonosetron, Drug: Dexamethasone | Intervention Type: DRUG; Name: Netupitant and Palonosetron; Assigned to Arm(s): Netupitant and Palonosetron+dexamethasone-cycle 1, Netupitant and Palonosetron+dexamethasone-multicycle extension | Intervention Type: DRUG; Name: Palonosetron; Assigned to Arm(s): Palonosetron+dexamethasone-cycle 1, Palonosetron+dexamethasone-multicycle extension | Intervention Type: DRUG; Name: Dexamethasone; Assigned to Arm(s): Netupitant and Palonosetron+dexamethasone-cycle 1, Netupitant and Palonosetron+dexamethasone-multicycle extension, Palonosetron+dexamethasone-cycle 1, Palonosetron+dexamethasone-multicycle extension
C: Arm Label: Rolapitant; Type: EXPERIMENTAL; Interventions: Drug: Rolapitant, Drug: Granisetron, Drug: dexamethasone | Arm Label: Placebo + Granisetron + Dexamethasone; Type: PLACEBO_COMPARATOR; Interventions: Drug: Granisetron, Drug: dexamethasone, Drug: Placebo | Intervention Type: DRUG; Name: Rolapitant; Assigned to Arm(s): Rolapitant | Intervention Type: DRUG; Name: Granisetron; Assigned to Arm(s): Placebo + Granisetron + Dexamethasone, Rolapitant | Intervention Type: DRUG; Name: dexamethasone; Assigned to Arm(s): Placebo + Granisetron + Dexamethasone, Rolapitant | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo + Granisetron + Dexamethasone
D: Arm Label: Arm I; Type: ACTIVE_COMPARATOR; Interventions: Drug: dexamethasone, Drug: Palonosetron Hydrochloride, Other: placebo | Arm Label: Arm II; Type: EXPERIMENTAL; Interventions: Drug: APF530, Drug: dexamethasone, Other: placebo | Arm Label: Arm III; Type: EXPERIMENTAL; Interventions: Drug: APF530, Drug: dexamethasone, Other: placebo | Intervention Type: DRUG; Name: APF530; Assigned to Arm(s): Arm II, Arm III | Intervention Type: DRUG; Name: dexamethasone; Assigned to Arm(s): Arm I, Arm II, Arm III | Intervention Type: DRUG; Name: Palonosetron Hydrochloride; Assigned to Arm(s): Arm I | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Arm I, Arm II, Arm III

Answer: C