Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Randomisation Number
Item
If subject was randomised, provide Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
If subject was randomised, provide Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date/time of dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Code List
Investigational Product
CL Item
10 mg Sumaptriptan/ 60 mg Naproxen Sodium (422)
CL Item
30 mg Sumaptriptan/ 180 mg Naproxen Sodium (423)
CL Item
85 mg Sumaptriptan/ soomg Naproxen Sodium (424)
Did the subject receive the correct treatment
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C1272706 (UMLS CUI [2,2])
If subject did not receive the correct treatment, record reason(s)
Item
If subject did not receive the correct treatment, record reason(s)
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])