Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Item
Study Visit
text
C0545082 (UMLS CUI [1])
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
CL Item
Treatment Period 3 (Treatment Period 3)
CL Item
Follow-Up Visit (Follow-Up Visit)
Item
Protocol Time
text
C0040223 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
CL Item
Pre Dose (Pre Dose)
CL Item
Day 1 1h30 post dose (Day 1 1h30 post dose)
CL Item
Day 3 48h00 post dose (Day 3 48h00 post dose)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Neurological Examination Performed
Item
Has a neurological examination been performed?
boolean
C0027853 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Dizziness
Item
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? Dizziness
boolean
C0012833 (UMLS CUI [1])
C0007760 (UMLS CUI [2])
Vertigo
Item
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? vertigo
boolean
C0042571 (UMLS CUI [1])
C0007760 (UMLS CUI [2])
Diplopia
Item
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? Diplopia
boolean
C0012569 (UMLS CUI [1])
C0007760 (UMLS CUI [2])
Nystagmus
Item
Does the subject display any signs/symptoms suggestive of cerebellar dysfunction? Nystagmus
boolean
C0028738 (UMLS CUI [1])
C0007760 (UMLS CUI [2])
Involuntary Muscle Twitching
Item
Has the subject experienced any involuntary muscle twitching?
boolean
C0221722 (UMLS CUI [1])
Physician's Signature
Item
Physician's Signature
text
C1519316 (UMLS CUI [1])