Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT01788605
Eligibility Criteria:
Inclusion Criteria:
1. Patients undergoing hematopoietic stem cell transplantation conditioned with highly or moderately emetogenic drugs or total body irradiation (TBI) for hematologic malignancies
2. aged over 18 yrs
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
4. patients who are able to take oral medications
5. patients who get well-informed and sign the consent
Exclusion Criteria:
1. Patients complicating
* severe hypertension (systolic blood pressure \> 210 mmHg or diastolic blood pressure \> 120 mmHg)
* significant heart disease such as congestive heart failure
* renal insufficiency (serum Cr \>= 3.0 mg/dL)
* liver disease (Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3 upper normal limit; alkaline phosphatase (ALP) \> 2 upper normal limit)
2. Patients complicated by conditions such as gastrointestinal obstruction or active peptic ulcer causing emesis
3. Patients with brain tumor, brain metastasis and epilepsy
4. Patients with the history of extrapyramidal symptom
5. Patients with the history of allergy to serotonin antagonists
6. pregnant or lactating women
7. Patients with drug abuse or psychiatric illness, or patients who are not capable of the normal communications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01788605
Study Brief:
Protocol Section:
NCT01788605