Patient's Initials
Item
Patient's Initials
text
C2986440 (UMLS CUI [1])
Patient's trial number
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Will the patient be aged 3-25 years inclusive, at the start of treatment?
Item
Will the patient be aged 3-25 years inclusive, at the start of treatment?
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential | Pregnant During the Study | Contraceptive methods
Item
Is the patient male, or female and of childbearing potential, who in the judgement of the investigator has no reasonable chance of being/becoming pregnant during the course of the study, based on a review of birth control methods employed and other factors in their gynaecological history?
boolean
C3831118 (UMLS CUI [1])
C3828490 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Seizures | Drop Attack | Epilepsy, Atonic | Epilepsy, Tonic | Myoclonic Epilepsy | Tonic - clonic seizures
Item
Does the patient have more than one predominantly generalised seizure type including drop attacks (atonic, tonic, major myoclonic) and/or tonic-clonic seizures of at least one year duration?
boolean
C0036572 (UMLS CUI [1])
C0259813 (UMLS CUI [2])
C0086236 (UMLS CUI [3])
C0086241 (UMLS CUI [4])
C0014550 (UMLS CUI [5])
C0494475 (UMLS CUI [6])
Was the age of onset of epilepsy < 11 years?
Item
Was the age of onset of epilepsy < 11 years?
boolean
C0206132 (UMLS CUI [1])
Does the patient have observable seizures occuring at least every alternate day (or a similar average frequency).
Item
Does the patient have observable seizures occuring at least every alternate day (or a similar average frequency).
boolean
C1285626 (UMLS CUI [1])
C0558287 (UMLS CUI [2])
C0439603 (UMLS CUI [3])
Electroencephalogram abnormal | Background; Abnormality | electroencephalogram spike and slow waves; Abnormality | Abnormality; Brain; Focal | Abnormality; Brain; Unifocal | Child
Item
Does the patient have a recent EEG recording which demonstrates an abnormal background, some slow spike wave abnormality (<2.5Hz) and lacks predominantly focal or unifacal abnormalities, particularly in younger children?
boolean
C0151611 (UMLS CUI [1])
C1706907 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C2206302 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C1704258 (UMLS CUI [4,1])
C0006104 (UMLS CUI [4,2])
C0205234 (UMLS CUI [4,3])
C1704258 (UMLS CUI [5,1])
C0006104 (UMLS CUI [5,2])
C0443337 (UMLS CUI [5,3])
C0008059 (UMLS CUI [6])
Mental impairment | Mental deterioration | Normal intellectual function | Intellectual impairment, mild | Development; Evaluation | Intelligence quotient
Item
Does the patient have at least moderate intellectual impairment or is there a cIinicaI impression of intellectual deterioration in those patients with normal intellectual function or mild impairment based on results of developmental assessments or IQ tests as appropriate and feasible?
boolean
C0683322 (UMLS CUI [1])
C0234985 (UMLS CUI [2])
C3553690 (UMLS CUI [3])
C1836523 (UMLS CUI [4])
C1527148 (UMLS CUI [5,1])
C0220825 (UMLS CUI [5,2])
C0456149 (UMLS CUI [6])
Has the patient's antiepileptic medication dosing remained unchanged for one month before screen?
Item
Has the patient's antiepileptic medication dosing remained unchanged for one month before screen?
boolean
C0003299 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Are the patient and carer (parent or guardian) likely to comply with all study procedures?
Item
Are the patient and carer (parent or guardian) likely to comply with all study procedures?
boolean
C1321605 (UMLS CUI [1])
Has the carer (parent or guardian) given written informed consent?
Item
Has the carer (parent or guardian) given written informed consent?
boolean
C0021430 (UMLS CUI [1])
Is the patient suffering from any severe known organic disease e.g renal or hepatic impairment, which may interfere with drug evaluation?
Item
Is the patient suffering from any severe known organic disease e.g renal or hepatic impairment, which may interfere with drug evaluation?
boolean
C0683324 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2])
C0948807 (UMLS CUI [3])
C0013175 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
Neurodegenerative Disorders; Progressive | Lysosomal Storage Diseases | Neuronal Ceroid-Lipofuscinoses | Electrophysiological Processes; Evaluation procedure | Diagnostic service - neuroradiology lab | Metabolic; Evaluation procedure
Item
Is the patient suffering from any known definite progressive neurodegenerative disorder e.g. Iysosomal storage disorder, Batten's disease, as established by the appropriate electrophysiological, neuroradiological and metabolic investigations?
boolean
C0524851 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0085078 (UMLS CUI [2])
C0027877 (UMLS CUI [3])
C2350528 (UMLS CUI [4,1])
C1261322 (UMLS CUI [4,2])
C2183225 (UMLS CUI [5])
C0311400 (UMLS CUI [6,1])
C1261322 (UMLS CUI [6,2])
Is the patient receiving treatment with more than 2 antiepileptic drugs?
Item
Is the patient receiving treatment with more than 2 antiepileptic drugs?
boolean
C0003299 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Has the patient been previously exposed to lamotrigine?
Item
Has the patient been previously exposed to lamotrigine?
boolean
C0064636 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Has the patient been treated with an investigational (unmarketed) drug within 3 months before screen?
Item
Has the patient been treated with an investigational (unmarketed) drug within 3 months before screen?
boolean
C0013230 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
Has the patient had more than 2 episodes of major tonic-clonic status epilepticus in any one of the past 6 months?
Item
Has the patient had more than 2 episodes of major tonic-clonic status epilepticus in any one of the past 6 months?
boolean
C0038220 (UMLS CUI [1,1])
C0014549 (UMLS CUI [1,2])