Study Site; Numbers
Item
Site number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Person Initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Comment; Date in time
Item
Comment Date
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Page (document); Numbers
Item
Page number
integer
C1704732 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Project; Identification number
Item
Project number
integer
C1709701 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Study Protocol; Numbers
Item
Protocol number
integer
C2348563 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Study Site; Numbers
Item
Site number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Discharge date
Item
Date discharged
date
C2361123 (UMLS CUI [1])
Person Initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Experimental drug; Discontinuation (procedure) | Completion Status; Therapeutic procedure
Item
Was study drug stopped permanently before completion of all 18 weeks of treatment and taper?
boolean
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0805732 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Item
If study drug stopped, check the primary reason drug was stopped
integer
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
If study drug stopped, check the primary reason drug was stopped
CL Item
Adverse Experience (record details on ADVERSEnEXPERIENCES pages) (1)
CL Item
Death (Check only, if death is NOT an outcome of an adverse experience) (2)
CL Item
Inadequate response to study drug (including seizure exacerbation) (3)
CL Item
Consent withdrawn (4)
CL Item
Lost to follow-up (5)
CL Item
Protocol violation (non- compliance or pregnancy) (6)
Date last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Baseline; Complete | Screening procedure; Complete | treatment phases; Complete | Tapering - action; Complete
Item
Did the patient complete the Screen, Baseline, Treatment Phases and Taper?
boolean
C1442488 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0220908 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0815181 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0441640 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
Item
If patient did not complete Screen, Baseline, Treatment Phases and Taper, check primary reason.
integer
C1442488 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0220908 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0566251 (UMLS CUI [2,3])
C0815181 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0566251 (UMLS CUI [3,3])
C0441640 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0566251 (UMLS CUI [4,3])
Code List
If patient did not complete Screen, Baseline, Treatment Phases and Taper, check primary reason.
CL Item
Adverse Experience (record details on ADVERSEnEXPERIENCES pages) (1)
CL Item
Death (Check only, if death is NOT an outcome of an adverse experience) (2)
CL Item
Inadequate response to study drug (including seizure exacerbation) (3)
CL Item
Consent withdrawn (4)
CL Item
Lost to follow-up (5)
CL Item
Protocol violation (non- compliance or pregnancy) (6)
Discharge date; Study
Item
Date patient discharged from the study
date
C2361123 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Cessation of life; Clinical Trials; During
Item
Did the patient die anytime during the study (Baseline Day 1 through Taper and Folllow-Up Phases?)
boolean
C0011065 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1442488 (UMLS CUI [2])
C0441640 (UMLS CUI [3])
C1522577 (UMLS CUI [4])
Death Related to Adverse Event; Date of onset
Item
If patient died, onset date of the event wich led to death
date
C1705232 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Characterize the cause of death
integer
C0007465 (UMLS CUI [1])
Code List
Characterize the cause of death
CL Item
Seizure- related (If seizure- related, check one) (2)
CL Item
Status epilepticus (4)
CL Item
Other (specify) (6)
Cause of Death; Other; Specification
Item
If other cause of death, specify.
text
C0007465 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Check attribution of death to study medication
integer
C0011065 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0596130 (UMLS CUI [1,3])
Code List
Check attribution of death to study medication
CL Item
Not a reasonable possibility (1)
CL Item
A resonable possibility (2)
Autopsy
Item
Was an autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Randomization; Code; Blinded Clinical Study Unit
Item
Was the blind on the randomization code for this patient broken?
boolean
C0034656 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C2347038 (UMLS CUI [1,3])
C3846158 (UMLS CUI [1,4])
Date in time; Blinded Clinical Study
Item
Date of blind was broken
date
C0011008 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
Date in time; Blinded Clinical Study
Item
Reason for breaking blind
text
C0011008 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
Investigator Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature; Date in time
Item
Date of Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Laboratory Results; Clinical Significance; Unexpected
Item
Do you consider any of the laboratory values at this clinic visit to be of potential OR actual clinical significance AND unexpected in this patient population?
boolean
C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
Laboratory; Parameter Value
Item
Laboratory parameter
text
C0022877 (UMLS CUI [1,1])
C0549193 (UMLS CUI [1,2])
Comment | Laboratory; Parameter Value
Item
Comment (Laboratory parameter)
text
C0947611 (UMLS CUI [1])
C0022877 (UMLS CUI [2,1])
C0549193 (UMLS CUI [2,2])