ID

33735

Description

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment; ODM derived from: https://clinicaltrials.gov/show/NCT02016911

Lien

https://clinicaltrials.gov/show/NCT02016911

Mots-clés

  1. 21/12/2018 21/12/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

21 décembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Diabetes NCT02016911

Eligibility Diabetes NCT02016911

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02016911
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
Description

Liver function | Hepatic impairment Mild | Hepatic impairment Moderate | Hepatic impairment Severe

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C2945599
UMLS CUI [3,1]
C0948807
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C0948807
UMLS CUI [4,2]
C0205082
body mass index (bmi) 18.5-40.0 kg/m^2 (both inclusive)
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease
Description

Crohn Disease | Ulcerative Colitis | Inflammatory Bowel Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0010346
UMLS CUI [2]
C0009324
UMLS CUI [3]
C0021390
uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg)
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
any donation of blood or plasma in excess of 400 ml within the 3 months preceding screening
Description

Blood Donation Excessive Amount | Plasma Donation Excessive Amount

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0005794
UMLS CUI [2,3]
C0442802
UMLS CUI [2,4]
C1265611
history of significant drug abuse, or a positive drug test at the screening visit (visit 2)
Description

Drug abuse | Drug screening test Positive

Type de données

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2,1]
C0373483
UMLS CUI [2,2]
C1514241

Similar models

Eligibility Diabetes NCT02016911

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02016911
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Liver function | Hepatic impairment Mild | Hepatic impairment Moderate | Hepatic impairment Severe
Item
subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
boolean
C0232741 (UMLS CUI [1])
C0948807 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0948807 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0948807 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) 18.5-40.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Crohn Disease | Ulcerative Colitis | Inflammatory Bowel Disease
Item
history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease
boolean
C0010346 (UMLS CUI [1])
C0009324 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Blood Donation Excessive Amount | Plasma Donation Excessive Amount
Item
any donation of blood or plasma in excess of 400 ml within the 3 months preceding screening
boolean
C0005794 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0442802 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Drug abuse | Drug screening test Positive
Item
history of significant drug abuse, or a positive drug test at the screening visit (visit 2)
boolean
C0013146 (UMLS CUI [1])
C0373483 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial