Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double Blind, Active-Controlled Study of the Safety and Efficacy of Rolapitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy
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 1-2 hours 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: Arm I; Type: EXPERIMENTAL; Interventions: Drug: aprepitant, Drug: cyclophosphamide, Other: placebo | Arm Label: Arm II; Type: EXPERIMENTAL; Interventions: Drug: aprepitant, Drug: cyclophosphamide, Other: placebo | Intervention Type: DRUG; Name: aprepitant; Assigned to Arm(s): Arm I, Arm II | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): Arm I, Arm II | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Arm I, Arm II
B: Arm Label: Placebo + Granisetron + Dexamethasone; Type: PLACEBO_COMPARATOR; Interventions: Drug: Granisetron, Drug: Dexamethasone, Drug: Placebo | Arm Label: Rolapitant; Type: EXPERIMENTAL; Interventions: Drug: Rolapitant, Drug: Granisetron, Drug: Dexamethasone | 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
C: Arm Label: 1; Type: OTHER; Interventions: Drug: aprepitant, Drug: Comparator: ondansetron, Drug: Comparator: dexamethasone, Drug: Comparator; Placebo (unspecified) | Arm Label: 2; Type: OTHER; Interventions: Drug: Comparator: ondansetron, Drug: Comparator: dexamethasone, Drug: Comparator: fosaprepitant dimeglumine, Drug: Comparator; Placebo (unspecified) | Intervention Type: DRUG; Name: aprepitant; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Comparator: ondansetron; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Comparator: dexamethasone; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Comparator: fosaprepitant dimeglumine; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Comparator; Placebo (unspecified); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Comparator; Placebo (unspecified); Assigned to Arm(s): 2
D: Arm Label: Fosaprepitant Regimen; Type: EXPERIMENTAL; Interventions: Drug: Fosaprepitant dimeglumine, Drug: Dexamethasone, Drug: Ondansetron, Drug: Dexamethasone Placebo, Drug: Ondansetron Placebo, Drug: Rescue Therapy | Arm Label: Control Regimen; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fosaprepitant Placebo, Drug: Dexamethasone, Drug: Ondansetron, Drug: Rescue Therapy | Intervention Type: DRUG; Name: Fosaprepitant dimeglumine; Assigned to Arm(s): Fosaprepitant Regimen | Intervention Type: DRUG; Name: Fosaprepitant Placebo; Assigned to Arm(s): Control Regimen | Intervention Type: DRUG; Name: Dexamethasone; Assigned to Arm(s): Control Regimen, Fosaprepitant Regimen | Intervention Type: DRUG; Name: Ondansetron; Assigned to Arm(s): Control Regimen, Fosaprepitant Regimen | Intervention Type: DRUG; Name: Dexamethasone Placebo; Assigned to Arm(s): Fosaprepitant Regimen | Intervention Type: DRUG; Name: Ondansetron Placebo; Assigned to Arm(s): Fosaprepitant Regimen | Intervention Type: DRUG; Name: Rescue Therapy; Assigned to Arm(s): Control Regimen, Fosaprepitant Regimen

Answer: B