Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
Visit Investigational Product dispensed (double-blind nasal spray)
text
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Code List
Visit Investigational Product dispensed (double-blind nasal spray)
CL Item
Replacement 1 (if used) (Replacement 1 (if used))
CL Item
Replacement 2 (if used) (Replacement 2 (if used))
CL Item
Replacement 3 (if used) (Replacement 3 (if used))
Date Investigational Product Dispensed
Item
Date Investigational Product Dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Weight of Investigational Product when dispensed
Item
Weight of Investigational Product when dispensed
float
C0013227 (UMLS CUI [1,1])
C0805077 (UMLS CUI [1,2])
C0043100 (UMLS CUI [1,3])
Date investigational product returned
Item
Date investigational product returned
date
C0013230 (UMLS CUI [1,1])
C2826249 (UMLS CUI [1,2])
Weight of investigational Product when returned
Item
Weight of investigational Product when returned
float
C0304229 (UMLS CUI [1,1])
C2699071 (UMLS CUI [1,2])
C0043100 (UMLS CUI [1,3])
Item
Replacement Number (if used)
integer
C0559956 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0180098 (UMLS CUI [1,3])
Code List
Replacement Number (if used)
Investigational Prodcut Container Number
Item
Record the identifying number from the (replacement) investigational product container dispensed (if applicable) during the treatment period.
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Code List
Was the treatment blind broken during the study?
Date blind broken
Item
If Treatment Blind was broken during the study, when?
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If Treatment Blind was broken during the study, why?
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If Treatment Blind was broken during the study, why?
CL Item
Medical emergency requiring identification of investigational product for further treatment. (1)
Item
If other reason for breaking treatment blind, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Code List
If other reason for breaking treatment blind, specify