Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Time vital signs
Item
Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C1303019 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Item
Has the subject had any changes in medication since the last study visit?
integer
C0580105 (UMLS CUI [1])
Code List
Has the subject had any changes in medication since the last study visit?
Item
Have the subject's smoking habits remained unchanged?
integer
C0543414 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Code List
Have the subject's smoking habits remained unchanged?
Item
Has the subject been reminded to comply with suggested dietary restrictions?
integer
C0425422 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Code List
Has the subject been reminded to comply with suggested dietary restrictions?
Item
Has the subject continued to refrain from alcohol consumption as instructed?
integer
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Code List
Has the subject continued to refrain from alcohol consumption as instructed?
Item
Has the subject experienced any Adverse Events since the last study contact?
integer
C0877248 (UMLS CUI [1])
Code List
Has the subject experienced any Adverse Events since the last study contact?
Patient diary
Item
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
text
C3890583 (UMLS CUI [1])
Breakfast started
Item
Breakfast started
time
C2698559 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Breakfast ended
Item
Breakfast ended
time
C2698559 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
Breakfast completed
Item
Did the subject complete the breakfast?
boolean
C0814440 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Breakfast not completed comment
Item
If no, please comment:
text
C0947611 (UMLS CUI [1,1])
C0814440 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Pharmacokinetics
Item
PK specimen drawn
time
C0031327 (UMLS CUI [1,1])
C0807979 (UMLS CUI [1,2])
Dosage given
Item
Dosage given
float
C0678766 (UMLS CUI [1])
Item
Dosage
integer
C0178602 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Time of Dosing
Item
Time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Was study medication dispensed to the subject?
integer
C3854006 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Code List
Was study medication dispensed to the subject?
Witness 1
Item
Witness 1
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date
Item
Witness date
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Discharge Time
Item
Time of discharge from study site
time
C3864299 (UMLS CUI [1])