Item
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.)
text
C0545082 (UMLS CUI [1])
Code List
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.)
CL Item
Not Done (Not Done)
Date of visit
Item
If Yes, please provide the Date of Visit.
date
Item
Form Not Done
text
C0005477 (UMLS CUI [1])
CL Item
Not Done (Not Done)
Samples Taken
Item
Were samples taken?
boolean
C1277698 (UMLS CUI [1])
Date of Samples Taken
Item
Date of Sample Taken
date
C0460065 (UMLS CUI [1])
Item
Laboratory Interpretation (If LAB interpretetation is abnormal, please select assessment items below and report the interpretation for each.)
text
C0262707 (UMLS CUI [1])
Code List
Laboratory Interpretation (If LAB interpretetation is abnormal, please select assessment items below and report the interpretation for each.)
CL Item
Abnormal (Abnormal)
Item
Laboratory Tests
text
C1655775 (UMLS CUI [1])
Code List
Laboratory Tests
CL Item
Alkaline Phosphatase (Alkaline Phosphatase)
CL Item
Creatinine (Creatinine)
CL Item
Potassium (Potassium)
Item
Laboratory Interpretation: Specification
text
C0262707 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
Laboratory Interpretation: Specification
CL Item
Abnormal-not clinically significant (Abnormal-not clinically significant)
CL Item
Abnormal-clinically significant (Abnormal-clinically significant)
Biochemistry: Comment
Item
Record any clinically significant abnormal findings/conditions identified during the exam on Medical and Surgical History and/or Adverse Event form.
text
C0005477 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
text
C2936719 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
CL Item
Not Done (Not Done)
Item
Intensity of dynamic mechanical allodynia (0=No Pain; 10=Pain as bad as patient can imagine)
integer
C0522510 (UMLS CUI [1])
Code List
Intensity of dynamic mechanical allodynia (0=No Pain; 10=Pain as bad as patient can imagine)
Dynamic Mechanical Allodynia: Size
Item
Total surface area size of area of dynamic mechanical allodynia
float
C0522510 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
text
C1704738 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
CL Item
Not Done (Not Done)
Number of contacts for Neuropathic Pains
Item
Number of contacts with a healthcare professional related to neuropathic pain, since the last visit
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
Number of contacts: Specification
Item
Number of contacts with a healthcare professional for other causes, since the last visit
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
text
C3274448 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
CL Item
Not Done (Not Done)
Adverse Event
Item
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
boolean
C0877248 (UMLS CUI [1])
Date of Last Evaluation
Item
Date of Last Evaluation
date
C0805839 (UMLS CUI [1])
Item
Primary End of Treatment/Study Reason (Primary End of Treatment/Study Reason: For any randomized/registered subject that did not receive any study drug please select RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG.) (If primary "End of Treatment/Study Reason" is "Adverse Event" or "Death", please provide details on "Adverse Events" form.)
text
C0444496 (UMLS CUI [1])
Code List
Primary End of Treatment/Study Reason (Primary End of Treatment/Study Reason: For any randomized/registered subject that did not receive any study drug please select RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG.) (If primary "End of Treatment/Study Reason" is "Adverse Event" or "Death", please provide details on "Adverse Events" form.)
CL Item
Completed (Completed)
CL Item
Randomized/Registered but never received/dispensed study drug (Randomized/Registered but never received/dispensed study drug)
CL Item
Adverse Event (Adverse Event)
CL Item
Lack of efficacy (Lack of efficacy)
CL Item
Lost to Follow-Up (Lost to Follow-Up)
CL Item
Progressive Disease (Progressive Disease)
CL Item
Protocol Violation (Protocol Violation)
CL Item
Withdrawal by Subject (Withdrawal by Subject)
CL Item
Study terminated by sponsor (Study terminated by sponsor)
Date of Withdrawal
Item
Date of Withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Protocol Violation
Item
If "Protocol Viiolation", specify:
text
C1709750 (UMLS CUI [1])
End of Study: Reason Specification
Item
If primary reason is "Other", specify:
text
C0444496 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Continuation status
Item
Ask the patient: Are you willing to continue treatment with the study medication
boolean
C0805733 (UMLS CUI [1])