ID
32006
Description
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
Keywords
Versions (6)
- 9/21/18 9/21/18 -
- 9/22/18 9/22/18 -
- 9/22/18 9/22/18 -
- 9/27/18 9/27/18 -
- 10/8/18 10/8/18 -
- 10/11/18 10/11/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 11, 2018
DOI
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License
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
Concomitant Medications - Study Week 1 Through Taper and Follow- up, AED Prescription and Compliance - Week 2 through Taper and Follow- Up, Study Medication Prescription and Compliance Record - Study Week 9 Through Taper and Follow- Up
Description
Additional medications
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1706712
Description
Pharmaceutical Preparations; Additional Therapy; Taken; Clinical Trials; During
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1706712
- UMLS CUI [1,3]
- C1883727
- UMLS CUI [1,4]
- C0008976
- UMLS CUI [1,5]
- C0347984
Description
Record Additional medications
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1706712
- UMLS CUI-3
- C0034869
Description
Date in time; Pharmaceutical Preparations; Taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1883727
Description
Medication name | Generic drug name
Data type
text
Alias
- UMLS CUI [1]
- C2360065
- UMLS CUI [2]
- C0592502
Description
AED Prescription Record
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C1521941
Description
Antiepileptic Agents; Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C2360065
Description
Antiepileptic Agents; Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0808070
Description
Antiepileptic Agents; End date
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0806020
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Antiepileptic drugs Compliance Record
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0525058
Description
Antiepileptic Agents; Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C2360065
Description
Antiepileptic Agents; Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0808070
Description
Antiepileptic Agents; End date
Data type
date
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0806020
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
AED entire day's dosing information
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C1533716
- UMLS CUI-4
- C0439228
- UMLS CUI-5
- C0439751
Description
Antiepileptic Agents; Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C2360065
Description
Antiepileptic Agents; Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0808070
Description
Antiepileptic Agents; End date
Data type
date
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0806020
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosage
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0178602
Description
Study Medication Prescription Record
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1521941
Description
Experimental drug; Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
Experimental drug; End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Dosage; Schedule (document type); Study Protocol; Requirement
Data type
float
Measurement units
- mg/kg/day
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0086960
- UMLS CUI [1,3]
- C2348563
- UMLS CUI [1,4]
- C1514873
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Medication dose; Calculated
Data type
text
Measurement units
- mg/day
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0444686
Description
Drug dose; prescribed; Clinical Investigators; |Experimental drug; Time; a.m.
Data type
time
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0278329
- UMLS CUI [1,3]
- C0008961
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0040223
- UMLS CUI [2,3]
- C4331833
Description
Drug dose; prescribed; Clinical Investigators; |Experimental drug; Dosage; a.m.
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0278329
- UMLS CUI [1,3]
- C0008961
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0178602
- UMLS CUI [2,3]
- C4331833
Description
Drug dose; prescribed; Clinical Investigators; |Experimental drug; Time; post meridiem
Data type
time
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0278329
- UMLS CUI [1,3]
- C0008961
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0040223
- UMLS CUI [2,3]
- C1509133
Description
Drug dose; prescribed; Clinical Investigators; |Experimental drug; Dosage; post meridiem
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0278329
- UMLS CUI [1,3]
- C0008961
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0178602
- UMLS CUI [2,3]
- C1509133
Description
Study Medication Compliance Record
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3714738
- UMLS CUI-3
- C0034869
Description
Experimental drug; Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
Experimental drug; End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Experimental drug; Dosage; a.m.
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C4331833
Description
Experimental drug; Time; a.m.
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C4331833
Description
Experimental drug; Dosage; post meridiem
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1509133
Description
Experimental drug; Time; post meridiem
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C1509133
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C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0086960 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
C0444686 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
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C0278329 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C4331833 (UMLS CUI [2,3])
C0278329 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1509133 (UMLS CUI [2,3])
C0278329 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
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C1509133 (UMLS CUI [2,3])
C3714738 (UMLS CUI-2)
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C0178602 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
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C1509133 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
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