Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C0011008 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Item
Race
integer
C0034510 (UMLS CUI [1])
CL Item
American Hispanic (1)
CL Item
Arabic/North African (2)
CL Item
East and South East Asian (4)
CL Item
White/Caucasian (7)
Item
Blood and lymphatic system disorders
integer
C0851353 (UMLS CUI [1])
Code List
Blood and lymphatic system disorders
CL Item
No Medical Condition (2)
Item
Cardiac disorders
integer
C0018799 (UMLS CUI [1])
Code List
Cardiac disorders
CL Item
No Medical Condition (2)
Item
Ear and labyrinth disorders
integer
C0851354 (UMLS CUI [1])
Code List
Ear and labyrinth disorders
CL Item
No Medical Condition (2)
Item
Endocrine disorders
integer
C0014130 (UMLS CUI [1])
Code List
Endocrine disorders
CL Item
No Medical Condition (2)
Item
Eye disorders
integer
C0015397 (UMLS CUI [1])
CL Item
No Medical Condition (2)
Item
Gastrointestinal disorders
integer
C0017178 (UMLS CUI [1])
Code List
Gastrointestinal disorders
CL Item
No Medical Condition (2)
Item
Hepatobiliary disorders
integer
C0267792 (UMLS CUI [1])
Code List
Hepatobiliary disorders
CL Item
No Medical Condition (2)
Item
Immune system disorders
integer
C1334156 (UMLS CUI [1])
Code List
Immune system disorders
CL Item
No Medical Condition (2)
Item
Metabolism and nutrition disorders
integer
C0851358 (UMLS CUI [1])
Code List
Metabolism and nutrition disorders
CL Item
No Medical Condition (2)
Item
Musculoskeletal and connective tissue disorders
integer
C0263660 (UMLS CUI [1])
Code List
Musculoskeletal and connective tissue disorders
CL Item
No Medical Condition (2)
Item
Nervous system disorders
integer
C0810273 (UMLS CUI [1])
Code List
Nervous system disorders
CL Item
No Medical Condition (2)
Item
Psychiatric disorders
integer
C0004936 (UMLS CUI [1])
Code List
Psychiatric disorders
CL Item
No Medical Condition (2)
Item
Renal and urinary disorders
integer
C0042075 (UMLS CUI [1])
Code List
Renal and urinary disorders
CL Item
No Medical Condition (2)
Item
Reproductive system and breast disorders
integer
C0851366 (UMLS CUI [1])
Code List
Reproductive system and breast disorders
CL Item
No Medical Condition (2)
Item
Respiratory, thoracic and mediastinal disorders
integer
C0851355 (UMLS CUI [1])
Code List
Respiratory, thoracic and mediastinal disorders
CL Item
No Medical Condition (2)
Item
Skin and subcutaneous tissue disorders
integer
C0178301 (UMLS CUI [1])
Code List
Skin and subcutaneous tissue disorders
CL Item
No Medical Condition (2)
Item
Vascular disorders
integer
C0042373 (UMLS CUI [1])
Code List
Vascular disorders
CL Item
No Medical Condition (2)
Item
Infections and infestations
integer
C0009450 (UMLS CUI [1,1])
C0851565 (UMLS CUI [1,2])
Code List
Infections and infestations
CL Item
No Medical Condition (2)
Item
Congenital, familial and genetic disorders
integer
C0851352 (UMLS CUI [1])
Code List
Congenital, familial and genetic disorders
CL Item
No Medical Condition (2)
Item
General disorders and administration site conditions
integer
C0851362 (UMLS CUI [1])
Code List
General disorders and administration site conditions
CL Item
No Medical Condition (2)
Item
Injury, poisoning and procedural complications
integer
C0947733 (UMLS CUI [1])
Code List
Injury, poisoning and procedural complications
CL Item
No Medical Condition (2)
randomisation number
Item
Record randomisation number.
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
identifying number investigational product container
Item
Record the identifying number from the investigational product container dispensed at this visit.
integer
C0600091 (UMLS CUI [1])
Item
Was a genital examination performed on the subject?
text
C0849001 (UMLS CUI [1])
C0849002 (UMLS CUI [2])
Code List
Was a genital examination performed on the subject?
Item
Were any Herpes lesions present?
text
C0744883 (UMLS CUI [1])
Code List
Were any Herpes lesions present?
Item
Were any other abnormal findings present?
text
C2826636 (UMLS CUI [1])
C0849001 (UMLS CUI [2,1])
C0849002 (UMLS CUI [2,2])
Code List
Were any other abnormal findings present?
specify abnormal findings
Item
If Yes, specify:
text
C2826636 (UMLS CUI [1])
C0849001 (UMLS CUI [2,1])
C0849002 (UMLS CUI [2,2])