Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Baseline Signs and Symptoms - Onset Date and Time
Item
Baseline Signs and Symptoms - Onset Date and Time
datetime
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0574845 (UMLS CUI [2,1])
C0449244 (UMLS CUI [2,2])
Baseline Signs and Symptoms - End Date and Time
Item
Baseline Signs and Symptoms - End Date and Time
datetime
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
Baseline Signs and Symptoms - Outcome
integer
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1547647 (UMLS CUI [2])
Code List
Baseline Signs and Symptoms - Outcome
Item
Baseline Signs and Symptoms - Event Course
integer
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C0441471 (UMLS CUI [2,2])
Code List
Baseline Signs and Symptoms - Event Course
Baseline Signs and Symptoms - Intermittent Course - number of episodes
Item
Baseline Signs and Symptoms - Intermittent Course - number of episodes
integer
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C0205267 (UMLS CUI [2,2])
C4086638 (UMLS CUI [3])
Item
Baseline Signs and Symptoms - Intensity (maximum)
integer
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Code List
Baseline Signs and Symptoms - Intensity (maximum)
Item
Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation
integer
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1510821 (UMLS CUI [2])
C0034656 (UMLS CUI [3])
Code List
Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation
CL Item
Suspected (reasonable possibility) (3)
Baseline Signs and Symptoms - Corrective Therapy
Item
Baseline Signs and Symptoms - Corrective Therapy
boolean
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
Baseline Signs and Symptoms - Was subject withdrawn due to this event?
Item
Baseline Signs and Symptoms - Was subject withdrawn due to this event?
boolean
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
Baseline Signs and Symptoms - Investigator's Signature
Item
Baseline Signs and Symptoms - Investigator's Signature
text
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C2346576 (UMLS CUI [2])
Baseline Signs and Symptoms - Investigator's Signature Date
Item
Baseline Signs and Symptoms - Investigator's Signature Date
date
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C2346576 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Was evening meal eaten before dosing?
Item
Was evening meal eaten before dosing?
boolean
C0439550 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Meal finish date and time
Item
Meal finish date and time
datetime
C1998602 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Date and time of dosing
Item
Date and time of dosing
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Number of Tablets Dispensed
Item
Number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Dosing Details - Comments
Item
Dosing Details - Comments
text
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Dose Level
Item
Dose Level
text
C0178602 (UMLS CUI [1])
Dose checked and administered by
Item
Dose checked and administered by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2348343 (UMLS CUI [2])
Dose checked and witnessed by
Item
Dose checked and witnessed by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0682356 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Was evening meal eaten before dosing?
Item
Was evening meal eaten before dosing?
boolean
C0439550 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Meal finish date and time
Item
Meal finish date and time
datetime
C1998602 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Date and time of dosing
Item
Date and time of dosing
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Number of Tablets Dispensed
Item
Number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Dosing Details - Comments
Item
Dosing Details - Comments
text
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Dose Level
Item
Dose Level
text
C0178602 (UMLS CUI [1])
Dose checked and administered by
Item
Dose checked and administered by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2348343 (UMLS CUI [2])
Dose checked and witnessed by
Item
Dose checked and witnessed by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0682356 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Was evening meal eaten before dosing?
Item
Was evening meal eaten before dosing?
boolean
C0439550 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Meal finish date and time
Item
Meal finish date and time
datetime
C1998602 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Date and time of dosing
Item
Date and time of dosing
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Number of Tablets Dispensed
Item
Number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Number of Tablets Returned
Item
Number of Tablets Returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Dosing Details - Comments
Item
Dosing Details - Comments
text
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Dose Level
Item
Dose Level
text
C0178602 (UMLS CUI [1])
Dose checked and administered by
Item
Dose checked and administered by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2348343 (UMLS CUI [2])
Dose checked and witnessed by
Item
Dose checked and witnessed by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0682356 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])