ID

31916

Beschreibung

Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Stichworte

Versionen (2)
  1. 30.09.18 30.09.18 -
  2. 08.10.18 08.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

8. Oktober 2018

DOI

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Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040

Englisch

Inclusion and Exclusion Criteria Source Worksheet - Screen

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Beschreibung

Study Site; Numbers

Datentyp

text

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Patient's initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient's trial number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Date of assessment
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Is this patient diagnosed as having epilepsy?
Beschreibung

The diagnosis must be definitive and must include specification of all of the patient's seizure types according to the International Classification of Epileptic Seizures.

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
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?
Beschreibung

Partial; Seizures; Manifestation of; Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0728938
UMLS CUI [1,2]
C0036572
UMLS CUI [1,3]
C1280464
UMLS CUI [1,4]
C0205210
Has the investigator judged that a complete and accurate daily record of the patient's seizures can be maintained throughout the study?
Beschreibung

Seizures; Records; Daily; Complete; Accurate (qualifier)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0034869
UMLS CUI [1,3]
C0332173
UMLS CUI [1,4]
C0205197
UMLS CUI [1,5]
C0443131
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?
Beschreibung

Seizures; Frequencies (time pattern) | Baseline | Seizures; Interval; Free of (attribute)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0439603
UMLS CUI [2]
C1442488
UMLS CUI [3,1]
C0036572
UMLS CUI [3,2]
C1272706
UMLS CUI [3,3]
C0332296
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?
Beschreibung

Antiepileptic Agents | Pharmaceutical Preparations; chronic | Medication regimen; Stable status

Datentyp

boolean

Alias
UMLS CUI [1]
C0003299
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0237125
UMLS CUI [3,2]
C0205360
Will this patient be between the ages of 2- 12 years, inclusive, at initiation of the Baseline Phase?
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Does this patient's concurrent antiepileptic drugs therpay consist of enzyme- inducing drugs only?
Beschreibung

Antiepileptic Agents; Therapeutic procedure | Enzymes; Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0014442
UMLS CUI [2,2]
C0013227
If AED therapy does not consist of enzyme- including drugs only, does this patient weigh at least 10 kg?
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
Is this patient a female of childbearing potential (i.e. menarcheal and not surgically sterelized)?
Beschreibung

Gender | Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3831118
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?
Beschreibung

Childbearing Potential | Pregnancy | Serum pregnancy test (B-HCG) | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0430060
UMLS CUI [4]
C0006147
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?
Beschreibung

Childbearing Potential | Contraceptive methods; Pharmaceutical Preparations | Contraceptive methods; Devices | Abstinence

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0013227
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0699733
UMLS CUI [4]
C3843422
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?
Beschreibung

Screening procedure; Evaluation; Acceptable | Medical contraindication; Clinical Trials; participation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1879533
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0679823
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Date of assessment
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Is this patient either currently receiving LAMICTAL (lamotrigine) or has received it in the past?
Beschreibung

Lamictal

Datentyp

boolean

Alias
UMLS CUI [1]
C0678180
Is this patient diagnosed with generalized seizures?
Beschreibung

Generalized seizures

Datentyp

boolean

Alias
UMLS CUI [1]
C0234533
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)?
Beschreibung

Nonepileptic Seizures | Antiepileptic Agents; Indication | Seizures; False | Metabolic Diseases | Drug abuse | Alcohol abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C3495874
UMLS CUI [2,1]
C0003299
UMLS CUI [2,2]
C3146298
UMLS CUI [3,1]
C0036572
UMLS CUI [3,2]
C0205237
UMLS CUI [4]
C0025517
UMLS CUI [5]
C0013146
UMLS CUI [6]
C0085762
Are this patient's seizures due to a currently active, known, and identifiable intracerebral lesion?
Beschreibung

Lesion; Intracerebral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0442111
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)?
Beschreibung

Compliance behavior | Pharmaceutical Preparations | Records; Seizures | Records; Adverse event | Records; Pharmaceutical Preparations; Dosage

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0013227
UMLS CUI [3,1]
C0034869
UMLS CUI [3,2]
C0036572
UMLS CUI [4,1]
C0034869
UMLS CUI [4,2]
C0877248
UMLS CUI [5,1]
C0034869
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C0178602
Is this patient a misuser of any medication (prescription or non prescription)?
Beschreibung

Drug abuser

Datentyp

boolean

Alias
UMLS CUI [1]
C0338666
Is this patient a drug or alcohol abuser?
Beschreibung

Drug abuser | Alcohol abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0338666
UMLS CUI [2]
C0085762
Does this patient have a progressive neurologic disorder?
Beschreibung

nervous system disorder; Progress

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C1280477
Does this patient have asthma requiring either chronic or intermittent steroid therapy?
Beschreibung

Asthma | Steroid therapy; chronic | Steroid therapy; Intermittent

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C0205267
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?
Beschreibung

Mental disorders; Severe (severity modifier) | Pharmaceutical Preparations; Requirement | Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1514873
UMLS CUI [3]
C0019993
Does this patient have a clinically significant chronic cardiac, renal, or hepatic medical condition?
Beschreibung

Heart Diseases; chronic | Kidney Diseases; chronic | Liver diseases; chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205191
Does this patient have a condition which affects the absorption, distribution, metabolism, or excretion of drugs?
Beschreibung

Condition; Affecting; drug absorption | Disease; Effect; Pharmaceutical Preparations; Distribution | Disease; Effect; Pharmaceutical Preparations; Metabolism | Disease; Effect; Pharmaceutical Preparations; Excretory function Unit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C0013227
UMLS CUI [2,4]
C1704711
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1280500
UMLS CUI [3,3]
C0013227
UMLS CUI [3,4]
C0025519
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1280500
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0221102
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)?
Beschreibung

Psychotropic Drugs | Antiepileptic Agents | Preparations; Attention deficit hyperactivity disorder | Methylphenidate | Clonidine | Attention deficit hyperactivity disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0003299
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1263846
UMLS CUI [4]
C0025810
UMLS CUI [5]
C0009014
UMLS CUI [6]
C1263846
Has this patient experienced status epilepticus within 12 weeks prior to initiation of the Baseline Phase?
Beschreibung

Status Epilepticus | Baseline; Before

Datentyp

boolean

Alias
UMLS CUI [1]
C0038220
UMLS CUI [2,1]
C1442488
UMLS CUI [2,2]
C0332152
Has this patient taken any other investigational medication within4 weeks prior to initiation of the Baseline Phase?
Beschreibung

Investigational New Drugs; Other | Baseline; Before

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1442488
UMLS CUI [2,2]
C0332152
Is this patient currently undergoing vagal stimulation or is on the ketonic diet, or will undergo surgery to control seizures during the study?
Beschreibung

Vagus Nerve Stimulation | Diet; Other Coding | Operative Surgical Procedures; Planned; Seizure Control

Datentyp

boolean

Alias
UMLS CUI [1]
C2350432
UMLS CUI [2,1]
C0012155
UMLS CUI [2,2]
C3846158
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1301732
UMLS CUI [3,3]
C1821609
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Inclusion and Exclusion Criteria Source Worksheet - Screen

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
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])
Item Group
Inclusion Criteria
C1512693 (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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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])
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