Study ID
Item
Study ID
integer
C2826693 (UMLS CUI [1])
Study site name
Item
Study site name
text
C2825164 (UMLS CUI [1])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item
1. Is the participant/subject having new neurologic symptom(s) or an acute worsening of preexisting neurologic symptoms?
text
C0235031 (UMLS CUI [1])
Code List
1. Is the participant/subject having new neurologic symptom(s) or an acute worsening of preexisting neurologic symptoms?
Date of onset
Item
a. If Yes, Date of onset:
date
C0574845 (UMLS CUI [1])
Item
i. Did the symptoms last more than 24 hours?
text
C0235031 (UMLS CUI [1])
Code List
i. Did the symptoms last more than 24 hours?
CL Item
no (Skip to Q8) (2)
Item
2. Did the participant/subject have a fever due to intercurrent illness?
text
C0015967 (UMLS CUI [1])
Code List
2. Did the participant/subject have a fever due to intercurrent illness?
CL Item
Yes (Skip to Q8) (1)
Item
3. Prior to the onset of this event, were the participant’s/subject’s MS symptom(s) stable or improving over the last 30 days?
text
C0026769 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Code List
3. Prior to the onset of this event, were the participant’s/subject’s MS symptom(s) stable or improving over the last 30 days?
Item
a. If Yes, was onset within the last 24 hours?
text
C0277793 (UMLS CUI [1])
Code List
a. If Yes, was onset within the last 24 hours?
Item
b. If No, was the onset within the last 7 days?
text
C0277793 (UMLS CUI [1])
Code List
b. If No, was the onset within the last 7 days?
Item
4. Are the symptom(s) associated with new neurologic findings?
text
C0422837 (UMLS CUI [1])
Code List
4. Are the symptom(s) associated with new neurologic findings?
CL Item
yes [If Yes, in which system(s) was/is the deficit present? (Choose all that apply)] (1)
Pyramidal system
Item
Pyramidal system
boolean
C0228060 (UMLS CUI [1])
Sensory system
Item
Sensory system
boolean
C0682648 (UMLS CUI [1])
Cerebellar
Item
Cerebellar
boolean
C0007765 (UMLS CUI [1])
Bladder and bowel
Item
Bowel and/or Bladder
boolean
C2707247 (UMLS CUI [1])
Brainstem
Item
Brainstem
boolean
C0006121 (UMLS CUI [1])
Mental
Item
Mental
boolean
C0004936 (UMLS CUI [1])
Visual
Item
Visual
boolean
C0042789 (UMLS CUI [1])
Item
5. Are the participant’s/subject’s symptom(s) ongoing?
text
C2826680 (UMLS CUI [1])
Code List
5. Are the participant’s/subject’s symptom(s) ongoing?
End Date
Item
a. If No, End Date:
date
C0806020 (UMLS CUI [1])
symptom; treatment
Item
6. Please describe event, symptom(s) and treatment that occured with the participant/subject:
text
C1457887 (UMLS CUI [1])
C0039798 (UMLS CUI [2])
Item
7. If applicable, is this a protocol defined qualifying relapse according to the definition set in the study protocol?
text
C2348563 (UMLS CUI [1])
C0035020 (UMLS CUI [2])
Code List
7. If applicable, is this a protocol defined qualifying relapse according to the definition set in the study protocol?
relapse
Item
a. If No, please indicate why the event is not a qualifying relapse as defined in the protocol:
text
C0277556 (UMLS CUI [1])
