ID
31943
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 (5)
- 9/22/18 9/22/18 -
- 9/22/18 9/22/18 -
- 9/23/18 9/23/18 -
- 9/27/18 9/27/18 -
- 10/8/18 10/8/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 8, 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
Laboratory comments, Clinical laboratory examination and Plasma/ Urine Samples - Baseline Week 8 and Baseline mean AED Concentrations and Range Calculations
Description
Laboratory finding
Alias
- UMLS CUI-1
- C0587081
Description
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Description
Laboratory results that are of potential or actual clinical significance and unexpected
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C2826293
- UMLS CUI-3
- C4055646
Description
Laboratory; Parameter Value
Data type
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Description
Comment | Laboratory; Parameter Value
Data type
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Description
Clinical laboratory examination - Hematology
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-4
- C0018943
Description
Hemoglobin
Data type
text
Alias
- UMLS CUI [1]
- C0019046
Description
Erythrocyte Mean Corpuscular Volume Measurement
Data type
text
Alias
- UMLS CUI [1]
- C1948043
Description
Platelet Count measurement
Data type
text
Alias
- UMLS CUI [1]
- C0032181
Description
White Blood Cell Count procedure
Data type
text
Alias
- UMLS CUI [1]
- C0023508
Description
Differential white blood cell count procedure
Data type
text
Alias
- UMLS CUI [1]
- C0162401
Description
Clinical laboratory examination - Clinical chemistry
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Description
Sodium measurement
Data type
text
Alias
- UMLS CUI [1]
- C0337443
Description
Potassium measurement
Data type
text
Alias
- UMLS CUI [1]
- C0202194
Description
Bicarbonate measurement
Data type
text
Alias
- UMLS CUI [1]
- C0202059
Description
Creatinine measurement, serum (procedure)
Data type
text
Alias
- UMLS CUI [1]
- C0201976
Description
Bilirubin, total measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201913
Description
Alkaline phosphatase measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201850
Description
Aspartate aminotransferase measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201899
Description
Alanine aminotransferase measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201836
Description
Albumin measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201838
Description
Plasma Glucose Measurement
Data type
text
Alias
- UMLS CUI [1]
- C0202042
Description
Dipstick Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Description
Serum pregnancy (for females of childbearing potential only)
Alias
- UMLS CUI-1
- C0430060
Description
AED plasma concentration
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Description
Urine Creatinine
Alias
- UMLS CUI-1
- C1318439
Description
Plasma Samples
Alias
- UMLS CUI-1
- C0444263
Description
Draw blood samples at a time that is constant for the patient throughout the study (+/- 30 minutes) and prior to the next scheduled AED dose, as close to the dose as is reasonably possible.
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Description
Draw blood samples at a time that is constant for the patient throughout the study (+/- 30 minutes) and prior to the next scheduled anticipated study medication dose, as close to the dose as is reasonably possible.
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0444506
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0040223
- UMLS CUI [2,3]
- C0200345
Description
Urine Samples
Alias
- UMLS CUI-1
- C0200354
Description
Review collection procedures with patient/ parent. Obtain urine samples from a 24-hour collection.
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3897500
Description
Review collection procedures with patient/ parent. Obtain urine samples from a 24-hour collection.
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3899266
Description
Urine specimen collection, 24 hours; Volume Measurement
Data type
integer
Measurement units
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Description
Collection (action); Complete
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0205197
Description
AED Concentrations and Range (+/- 50%) Calculcations
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C1446561
- UMLS CUI-3
- C0003299
- UMLS CUI-4
- C1514721
Description
Antiepileptic Agents; Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C2360065
Description
Range
Data type
float
Measurement units
- ug/mL
Alias
- UMLS CUI [1]
- C1514721
Description
Range
Data type
float
Measurement units
- ug/mL
Alias
- UMLS CUI [1]
- C1514721
Description
Date of mean AED Concentrations and Range Calculations
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C1446561
- UMLS CUI-3
- C0011008
- UMLS CUI-5
- C0003299
- UMLS CUI-6
- C1514721
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Laboratory comments, Clinical laboratory examination and Plasma/ Urine Samples - Baseline Week 8 and Baseline mean AED Concentrations and Range Calculations
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C0003299 (UMLS CUI-3)
C1514721 (UMLS CUI-4)
C2360065 (UMLS CUI [1,2])
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