Informed Consent | Status pre- Clinical Trial Procedures
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
Age
Item
male or female, age 18 years or older at the time of signing inform consent
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) equal or above 30.0 kg/m^2 at the screening visit
boolean
C1305855 (UMLS CUI [1])
Weight loss Attempt Quantity Unsuccessful
Item
at least one unsuccessful weight loss attempt per investigator judgement
boolean
C1262477 (UMLS CUI [1,1])
C1516084 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
Hemoglobin A1c measurement | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
a hba1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
boolean
C0474680 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Hypoglycemic Agents
Item
treatment with glucose lowering agent(s) within 90 days before screening
boolean
C0020616 (UMLS CUI [1])
Calcitonin measurement
Item
screening calcitonin equal to or above 50 ng/l (pg/ml)
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Obesity of endocrine origin | Cushing Syndrome
Item
obesity induced by endocrine disorders (e.g. cushing syndrome)
boolean
C0267992 (UMLS CUI [1])
C0010481 (UMLS CUI [2])
Pharmaceutical Preparation Causing Body Weight Change
Item
treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0005911 (UMLS CUI [1,3])
Operative Surgical Procedures Obesity | Suction Lipectomy Previous allowed | Abdominoplasty Previous allowed
Item
previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed)
boolean
C0543467 (UMLS CUI [1,1])
C0028754 (UMLS CUI [1,2])
C0038640 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0198542 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Major Depressive Disorder
Item
history of major depressive disorder within 2 years before randomisation
boolean
C1269683 (UMLS CUI [1])
Suicide attempt
Item
any lifetime history of a suicidal attempt
boolean
C0038663 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])