Comprehension Study Protocol | Informed Consent | Protocol Compliance
Item
patient has been fully informed, has complete understanding fo this study, and has given voluntary written informed consent to comply with the protocol requirements.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
AML de novo Untreated | Secondary Acute Myeloid Leukemia Untreated | Acute biphenotypic leukemia Untreated
Item
previously untreated de novo or secondary acute myeloid leukemia, including biphenotypic leukemia
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0280449 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0023464 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Age
Item
age between 20 and 65 years
boolean
C0001779 (UMLS CUI [1])
Organ function | Exception Abnormality Due to Leukemia
Item
adequate organ functions, unless these abnormalities are attributable to leukemia
boolean
C0678852 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0023418 (UMLS CUI [2,4])
Left ventricular ejection fraction
Item
left ventricular ejection fraction > 45%
boolean
C0428772 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 1.5 x upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin < 1.5 x upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Dysfunction Due to Leukemia
Item
alanine transferase and aspartate transferase < 2.5 x upper limit of normal if liver function abnormality is attributable to underlying leukemia, alt and ast < 5 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0086565 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0023418 (UMLS CUI [3,3])
ECOG performance status
Item
eastern cooperative oncology group performance status score of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs
Item
hypersensitivity to the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Cancer Other | Exception Skin carcinoma Cured | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
any other malignancies within 3 years, except for cured non-melanoma skin cancer and curatively treated in situ carcinoma of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
Heart failure New York Heart Association Classification | Heart Disease Severe Uncontrolled | Myocardial Infarction
Item
new york heart association class iii or iv heart failure, severe uncontrolled cardiac disease or myocardial infarction within the previous 6 months prior to the date of consent
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0027051 (UMLS CUI [3])
Informed Consent incapable | Etiology Drug Intoxication | Etiology Alcoholic Intoxication | Etiology Nervous system disorder | Etiology Mental disorders
Item
incapable of giving voluntary written informed consent to comply with the protocol requirements, which results from drug or alcohol intoxication, or neurological or psychiatric disorders
boolean
C0021430 (UMLS CUI [1,1])
C1550518 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0013221 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0001969 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0027765 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0004936 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy Recent
Item
recent chemotherapy within 4 weeks prior to this study treatment
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Acute Promyelocytic Leukemia
Item
acute promyelocytic leukemia
boolean
C0023487 (UMLS CUI [1])
Investigational New Drugs
Item
current or recent treatment with any other investigational medicinal product within 28 days prior to this study enrollment
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
unsuitable for this study, in the investigator's opinion
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])