ID

20763

Beschreibung

Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01515592

Link

https://clinicaltrials.gov/show/NCT01515592

Stichworte

Versionen (1)
  1. 15.03.17 15.03.17 -
Hochgeladen am

15. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes NCT01515592

Englisch

Eligibility Diabetes NCT01515592

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01515592
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy japanese subjects
Beschreibung

Healthy Volunteers Japanese

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C1556094
bmi (body mass index) between 18.0-27.0 kg/m^2 inclusive
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Beschreibung

Laboratory Results Reference range Different | Electrocardiogram abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0086715
UMLS CUI [1,3]
C1705242
UMLS CUI [2]
C0522055
presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
Beschreibung

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

Datentyp

boolean

Alias
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
hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive
Beschreibung

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0920548
history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0683519
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0025517
UMLS CUI [7]
C0022658
UMLS CUI [8]
C0023895
UMLS CUI [9]
C0017178
UMLS CUI [10]
C0014130
UMLS CUI [11]
C0037274
UMLS CUI [12]
C0036916
UMLS CUI [13]
C0018939
UMLS CUI [14]
C0027765
UMLS CUI [15]
C0004936
history of significant allergy or hypersensitivity
Beschreibung

Hypersensitivity Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0750502
known or suspected allergy to trial product or related products
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C0013230
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
history of drug or alcohol abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
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
Beschreibung

Tobacco use Number of cigarettes per day | Abstinence from smoking Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
UMLS CUI [2,1]
C2042177
UMLS CUI [2,2]
C0558080
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Ähnliche Modelle

Eligibility Diabetes NCT01515592

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01515592
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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