Healthy Volunteers Japanese
Item
healthy japanese subjects
boolean
C1708335 (UMLS CUI [1,1])
C1556094 (UMLS CUI [1,2])
Body mass index
Item
bmi (body mass index) between 18.0-27.0 kg/m^2 inclusive
boolean
C1305855 (UMLS CUI [1])
Laboratory Results Reference range Different | Electrocardiogram abnormal
Item
any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ecg (electrocardiogram) findings at the screening
boolean
C1254595 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C1705242 (UMLS CUI [1,3])
C0522055 (UMLS CUI [2])
Diabetes Mellitus | Malignant Neoplasms | Heart Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Dermatologic disorders | Sexually Transmitted Diseases | Hematological Disease | nervous system disorder | Mental disorders
Item
presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
boolean
C0011849 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0037274 (UMLS CUI [10])
C0036916 (UMLS CUI [11])
C0018939 (UMLS CUI [12])
C0027765 (UMLS CUI [13])
C0004936 (UMLS CUI [14])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive
Item
hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
History of diseases | Diabetes Mellitus | Malignant Neoplasms | Heart Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Dermatologic disorders | Sexually Transmitted Diseases | Hematological Disease | nervous system disorder | Mental disorders
Item
history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
boolean
C0683519 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
C0017178 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0037274 (UMLS CUI [11])
C0036916 (UMLS CUI [12])
C0018939 (UMLS CUI [13])
C0027765 (UMLS CUI [14])
C0004936 (UMLS CUI [15])
Hypersensitivity Significant
Item
history of significant allergy or hypersensitivity
boolean
C0020517 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Tobacco use Number of cigarettes per day | Abstinence from smoking Unwilling
Item
the subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C2042177 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])