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])
Specimen collection date
Item
Date sample collected - Week 4
date
C1302413 (UMLS CUI [1])
Specimen collection date
Item
Date sample collected - Week 6
date
C1302413 (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])
Antiepileptic Agents; plasma concentration
Item
AED plasma concentration
text
C0003299 (UMLS CUI [1,1])
C0683150 (UMLS CUI [1,2])
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])
Antiepileptic Agents; plasma concentration
Item
AED plasma concentration
text
C0003299 (UMLS CUI [1,1])
C0683150 (UMLS CUI [1,2])
Inclusion; Exclusion Criteria
Item
Does the patient continue to meet the Inclusion and Exclusion Criteria?
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Seizures; Count; Interval ; During | Seizure free; Interval; Baseline; During
Item
Has the investigator judged that this patient had at least four seizures during each of the two consecutive 4- week intervals and the patient's maximum seizure- free interval during entire Baseline Phase did not exceed 4 weeks?
boolean
C0036572 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C1299590 (UMLS CUI [2,1])
C1272706 (UMLS CUI [2,2])
C1442488 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
Menarche; Visit; Last; Since
Item
Has this patient become menarcheal since the last clinic visit?
boolean
C0025274 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
Menarche | Pregnancy | Serum pregnancy test negative | Breast Feeding
Item
If patient become menarcheal since the last clinic visit, is this patient not currently pregnant (the result of a serum pregnancy test conducted at this visit is negative) or breastfeeding?
boolean
C0025274 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Contraceptive methods; Pharmaceutical Preparations | Contraceptive methods; Devices | Contraceptive methods; Abstinence
Item
Does this patient employ a contraceptive method (whether a drug, device or abstinence) acceptable to the investigator?
boolean
C0700589 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0699733 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C3843422 (UMLS CUI [3,2])
Statement; Signature; Pregnancy; avoidance
Item
Has this patient either signed or have had signed by a parent or guardian on their behalf, a statement of intent to avoid pregnancy?
boolean
C1710187 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0870186 (UMLS CUI [1,4])