Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
ABNORMAL FINDINGS
Item
ONLY COMPLETE THE FOLLOWING IF THERE WERE ABNORMAL FINDINGS AT THE SCREENING VISIT
boolean
C1704258 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C0522055 (UMLS CUI [1])
Code List
Were any clinically significant abnormalities detected?
CL Item
Yes - If ’Yes’, please record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study. (2)
abnormal findings
Item
If any abnormality was present at screening please perform a physical examination. If there are any significant abnormal findings record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study.
boolean
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Date of sample
Item
Date of sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Were any clinically significant abnormalities detected?
integer
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Were any clinically significant abnormalities detected?
CL Item
Yes - If ‘Yes’, please record the findings and/or diagnosis in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study. (2)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Positive - If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and send a sample to Quest Diagnostics for further evaluation. (2)