Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparative Study of Intravenous Single Doses of Palonosetron (PALO) With Granisetron Hydrochloride as a Control in Patients Receiving Highly Emetogenic Chemotherapy
Brief Summary: To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as nausea and vomiting induced by highly emetogenic chemotherapy.


Options:
A: Inclusion Criteria:

* Patients aged 20 or more at the time when they give consent.
* Diagnosed as malignant disease.
* Be naive to chemotherapy or have been treated with single administration of anti-tumor drugs which are classified as low emetogenicity in the first edition of the 2006 NCCN Clinical Practice Guidelines.
* Cisplatin ≥50 mg/m2 Doxorubicin + cyclophosphamide: AC Epirubicin + cyclophosphamide: EC
* WBC ≥ 3000 /mm3 AST \< 100 IU/L ALT \< 100 IU/L Creatinine clearance ≥ 60 mL/min
* Performance Status : 0 - 2

Exclusion Criteria:

* Severe (requiring hospitalization) and uncontrollable complications.
* Metastases to the brain which are symptomatic.
* Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
* Symptomatic and invasive procedure indicated ascites or pleural effusion.
* Have either gastric outlet stenosis or intestinal obstruction.
* Have ongoing emesis or CTCAE grade 2 or greater nausea.
* QTc \> 470 msec in the 12-lead ECG within eight days before registration.
* Known anaphylactic to ingredients of the study drug, namely palonosetron or granisetron hydrochloride injection, or other 5-HT3 receptor antagonists.
* Known anaphylactic to ingredients of dexamethasone.
* Pregnant women, breast-feeding women, or any male or female who are not willing to practice adequate contraception during the study period.
B: Inclusion Criteria:

* Men and women \>/= 18 years
* Patients with multiple myeloma receiving high-dose chemotherapy (Melphalan) and autologous peripheral stemcell transplantation
* Signed informed consent

Exclusion Criteria:

* Patients suffering from nausea and vomiting during the last 12 hours prior to planned high-dose chemotherapy
* Patients receiving antiemetics 24 hours prior to planned high-dose chemotherapy
* Intake of steroids
* History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product
* Simultaneous intake of pimozide, terfenadine, astemizole
* Pregnant or nursing woman
* Mental condition rendering the subject incapable to understand the nature, scope and possible consequences of the trial
* Expected non-compliance in completing the subject´s diary and FLIE-score
C: Inclusion Criteria:

* Patient has been diagnosed with histologically or cytologically confirmed solid cancer
* Starting with first cycle of chemotherapy of moderate emetogenic risk, which does not include a combination of anthracycline plus cyclophosphamide
* Age ≥ 18
* WHO ≤ 1
* Patient is able to understand and speak Dutch

Exclusion Criteria:

* Patient with nausea and/or vomiting in 48 hours before start of chemotherapy treatment
* Patient submitted to concomitant radiotherapy or submitted to radiotherapy 15 days before start of chemotherapy or planned to receive radiotherapy during 8 days after administration of chemotherapy
* Patient with concomitant severe comorbidy, such as: o Intestinal obstruction o Active peptic ulcer o Hypercalcemia o Uncontrolled diabetes mellitus o Pheochromocytoma o Tardive dyskinesia o Epilepsia o Active infective diseases o Brain - or leptomeningeal metastases o Psychiatrical disorders o Parkinsonism
* Current use of corticosteroids (similar to prednisone ≥ 10 milligrams per day)
* Current alcohol abuse
* Pregnancy
D: Inclusion Criteria:

* Subject is 18 years of age or older.
* Subject has never been treated with cisplatin and is to receive first course of cisplatin-based chemotherapy (\>=70 mg/m\^2).
* Subject has a Karnofsky performance score of \>=60.
* Subject has a predicted life expectancy of \>=3 months.
* Subject has adequate bone marrow, kidney, and liver function as evidenced by:

  * Absolute neutrophil count \>=1,500/mm3 and white blood cell count \>=3,000/mm3.
  * Platelet count \>=100,000/mm3.
  * Aspartate aminotransferase (AST) \<=2.5 x upper limit of normal (ULN) range.
  * Alanine aminotransferase (ALT) \<=2.5 x ULN.
  * Bilirubin \<=1.5 x ULN, except for subjects with Gilbert's syndrome.
  * Creatinine \<=1.5 x ULN.
* Subject is able to read, understand, and complete the questionnaires.

Exclusion Criteria:

* Any current treatment or medical history (eg, subject is mentally incapacitated or has a psychiatric disorder) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject.
* Subject has contraindication to the administration of cisplatin, ondansetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, hearing impairment, or systemic fungal infection.
* Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6.
* Subject is scheduled to receive any radiation therapy to the abdomen or pelvis within 5 days prior to and/or during Days 1 through 5 following cisplatin infusion.
* Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
* Subject has ongoing vomiting caused by any etiology or has a history of anticipatory nausea and vomiting.

Answer: A