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])
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Epilepsy
Item
Is this patient diagnosed as having epilepsy?
boolean
C0014544 (UMLS CUI [1])
Partial; Seizures; Manifestation of; Clinical
Item
Has the investigator judged that this patient has only partial seizure (simple, complex, or those that evolve to secondarily generalized seizures) with a definable, reliable, and consistent clinical manifestation that can be identified and counted by the patient or recorder?
boolean
C0728938 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C1280464 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
Seizures; Records; Daily; Complete; Accurate (qualifier)
Item
Has the investigator judged that a complete and accurate daily record of the patient's seizures can be maintained throughout the study?
boolean
C0036572 (UMLS CUI [1,1])
C0034869 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0443131 (UMLS CUI [1,5])
Seizures; Frequencies (time pattern) | Baseline | Seizures; Interval; Free of (attribute)
Item
Has the investigator judged that the patient's seizures frequency is such that the patient is likely to experience during Baseline at least four seizures during each of the two consecutive 4-week intervals and the patient's maximum seizure- free interval during the entire Baseline Pahse is not likely to exceed 4 weeks?
boolean
C0036572 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C1442488 (UMLS CUI [2])
C0036572 (UMLS CUI [3,1])
C1272706 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Antiepileptic Agents | Pharmaceutical Preparations; chronic | Medication regimen; Stable status
Item
Do current antiepileptic drugs consist of one or two chronically- used drugs (excluding felbamate or gabapentin), that will be at a stable regimen within2 weeks prior to initiation of the Baseline Phase?
boolean
C0003299 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0237125 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Age
Item
Will this patient be between the ages of 2- 12 years, inclusive, at initiation of the Baseline Phase?
boolean
C0001779 (UMLS CUI [1])
Antiepileptic Agents; Therapeutic procedure | Enzymes; Pharmaceutical Preparations
Item
Does this patient's concurrent antiepileptic drugs therpay consist of enzyme- inducing drugs only?
boolean
C0003299 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0014442 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Body Weight
Item
If AED therapy does not consist of enzyme- including drugs only, does this patient weigh at least 10 kg?
boolean
C0005910 (UMLS CUI [1])
Gender | Childbearing Potential
Item
Is this patient a female of childbearing potential (i.e. menarcheal and not surgically sterelized)?
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Childbearing Potential | Pregnancy | Serum pregnancy test (B-HCG) | Breast Feeding
Item
If patient is female and of childbearing potential, is this patient not currently pregnant (the result of s serum pregnancy test conducted at Screen is negative) or breastfeeding?
boolean
C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0430060 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Childbearing Potential | Contraceptive methods; Pharmaceutical Preparations | Contraceptive methods; Devices | Abstinence
Item
If patient is female and of childbearing potential, does this patient employ a contraceptive method (whether a drug, device or abstinence) acceptable to the investigator?
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C0699733 (UMLS CUI [3,2])
C3843422 (UMLS CUI [4])
Screening procedure; Evaluation; Acceptable | Medical contraindication; Clinical Trials; participation
Item
Are the results of all Screen assessments judged to be clinically acceptable to the investigator and do not indicate any reasons why entry into the study would be contraindicated?
boolean
C0220908 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Lamictal
Item
Is this patient either currently receiving LAMICTAL (lamotrigine) or has received it in the past?
boolean
C0678180 (UMLS CUI [1])
Generalized seizures
Item
Is this patient diagnosed with generalized seizures?
boolean
C0234533 (UMLS CUI [1])
Nonepileptic Seizures | Antiepileptic Agents; Indication | Seizures; False | Metabolic Diseases | Drug abuse | Alcohol abuse
Item
Does this patient have non- epileptic seizures for which treatment with antiepileptic drugs is not indicated (e.g., pseudo seizures or seizures solely due to metabolic disorders, or drug or alcohol abuse)?
boolean
C3495874 (UMLS CUI [1])
C0003299 (UMLS CUI [2,1])
C3146298 (UMLS CUI [2,2])
C0036572 (UMLS CUI [3,1])
C0205237 (UMLS CUI [3,2])
C0025517 (UMLS CUI [4])
C0013146 (UMLS CUI [5])
C0085762 (UMLS CUI [6])
Lesion; Intracerebral
Item
Are this patient's seizures due to a currently active, known, and identifiable intracerebral lesion?
boolean
C0221198 (UMLS CUI [1,1])
C0442111 (UMLS CUI [1,2])
Compliance behavior | Pharmaceutical Preparations | Records; Seizures | Records; Adverse event | Records; Pharmaceutical Preparations; Dosage
Item
Is this patient either poorly or not compliant (i.e. is judged to be unable to take or be given medication or is unwilling to take or be given medication as prescribed, or a complete and accurate record of daily seizures, adverse experiences, and dosing deviations cannot be maintained)?
boolean
C1321605 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
C0034869 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
C0034869 (UMLS CUI [4,1])
C0877248 (UMLS CUI [4,2])
C0034869 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
Drug abuser
Item
Is this patient a misuser of any medication (prescription or non prescription)?
boolean
C0338666 (UMLS CUI [1])
Drug abuser | Alcohol abuse
Item
Is this patient a drug or alcohol abuser?
boolean
C0338666 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
nervous system disorder; Progress
Item
Does this patient have a progressive neurologic disorder?
boolean
C0027765 (UMLS CUI [1,1])
C1280477 (UMLS CUI [1,2])
Asthma | Steroid therapy; chronic | Steroid therapy; Intermittent
Item
Does this patient have asthma requiring either chronic or intermittent steroid therapy?
boolean
C0004096 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3,1])
C0205267 (UMLS CUI [3,2])
Mental disorders; Severe (severity modifier) | Pharmaceutical Preparations; Requirement | Hospitalization
Item
Does this patient have a psychiatric disorder requiring medication or has had a past psychiatric condition that was both judged to be severe and required hospitalization?
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0019993 (UMLS CUI [3])
Heart Diseases; chronic | Kidney Diseases; chronic | Liver diseases; chronic
Item
Does this patient have a clinically significant chronic cardiac, renal, or hepatic medical condition?
boolean
C0018799 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
Condition; Affecting; drug absorption | Disease; Effect; Pharmaceutical Preparations; Distribution | Disease; Effect; Pharmaceutical Preparations; Metabolism | Disease; Effect; Pharmaceutical Preparations; Excretory function Unit
Item
Does this patient have a condition which affects the absorption, distribution, metabolism, or excretion of drugs?
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C1704711 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C1280500 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0025519 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C1280500 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0221102 (UMLS CUI [4,4])
Psychotropic Drugs | Antiepileptic Agents | Preparations; Attention deficit hyperactivity disorder | Methylphenidate | Clonidine | Attention deficit hyperactivity disorder
Item
Is this patient currently taking any psychoactive drugs other than those used to treat his or her epilepsy or hyperactivity, or methylphenidate, dextroamphetamine and clonidine used to treat his or her Attention Deficit Disorder (ADD)?
boolean
C0033978 (UMLS CUI [1])
C0003299 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1263846 (UMLS CUI [3,2])
C0025810 (UMLS CUI [4])
C0009014 (UMLS CUI [5])
C1263846 (UMLS CUI [6])
Status Epilepticus | Baseline; Before
Item
Has this patient experienced status epilepticus within 12 weeks prior to initiation of the Baseline Phase?
boolean
C0038220 (UMLS CUI [1])
C1442488 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Investigational New Drugs; Other | Baseline; Before
Item
Has this patient taken any other investigational medication within4 weeks prior to initiation of the Baseline Phase?
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1442488 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Vagus Nerve Stimulation | Diet; Other Coding | Operative Surgical Procedures; Planned; Seizure Control
Item
Is this patient currently undergoing vagal stimulation or is on the ketonic diet, or will undergo surgery to control seizures during the study?
boolean
C2350432 (UMLS CUI [1])
C0012155 (UMLS CUI [2,1])
C3846158 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C1821609 (UMLS CUI [3,3])