Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item
Date of Visit
integer
C1320303 (UMLS CUI [1])
Item
Which Cohort is the subject enrolled in?
text
C0599755 (UMLS CUI [1])
Code List
Which Cohort is the subject enrolled in?
CL Item
Cohort 1 (3mg/Placebo IV / 4hrs) (C1)
CL Item
Cohort 2 (7.5mg/Placebo IV / 24hrs) (C2)
CL Item
Cohort 3 (7.5mg/Placebo IV / 4hrs) (C3)
CL Item
Cohort 4 (10mg/Placebo IV / 24hrs) (C4)
Date/Time of Cohort Assignment
Item
Date/Time of Cohort Assignment
datetime
C0599755 (UMLS CUI [1,1])
C1516050 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Dosage Duration (per Protocol)
integer
C0449238 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Dosage Duration (per Protocol)
Start Date and Time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
Stop Date and Time
Item
Stop Date and Time
datetime
C3899266 (UMLS CUI [1])
Volume administered
Item
Volume administered (mL)
float
C2349139 (UMLS CUI [1])
Item
Dosage Duration (per Protocol)
integer
C0449238 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Dosage Duration (per Protocol)
Start Date and Time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
Stop Date and Time
Item
Stop Date and Time
datetime
C3899266 (UMLS CUI [1])
Volume administered
Item
Volume administered (mL)
float
C2349139 (UMLS CUI [1])
Investigational Product Container Number
Item
Investigational Product Container Number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Correct treatment received
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Reason incorrect treatment
Item
Reason incorrect treatment
text
C0566251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Randomisation possible
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomisation Date/Time
Item
Date/time of randomisation
datetime
C0034656 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])