ID
31779
Descripción
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
Palabras clave
Versiones (5)
- 22/9/18 22/9/18 -
- 22/9/18 22/9/18 -
- 23/9/18 23/9/18 -
- 27/9/18 27/9/18 -
- 8/10/18 8/10/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
27 de septiembre de 2018
DOI
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Licencia
Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients (Clinical Study ID: 105-040)
Laboratory comments, Clinical laboratory examination and Plasma/ Urine Samples - Baseline Week 8 and Baseline mean AED Concentrations and Range Calculations
Descripción
Laboratory finding
Alias
- UMLS CUI-1
- C0587081
Descripción
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Descripción
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
Descripción
Laboratory; Parameter Value
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Descripción
Comment | Laboratory; Parameter Value
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Descripción
Clinical laboratory examination - Hematology
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-4
- C0018943
Descripción
Hemoglobin
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0019046
Descripción
Erythrocyte Mean Corpuscular Volume Measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1948043
Descripción
Platelet Count measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0032181
Descripción
White Blood Cell Count procedure
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0023508
Descripción
Differential white blood cell count procedure
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0162401
Descripción
Clinical laboratory examination - Clinical chemistry
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Descripción
Sodium measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0337443
Descripción
Potassium measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0202194
Descripción
Bicarbonate measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0202059
Descripción
Creatinine measurement, serum (procedure)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0201976
Descripción
Bilirubin, total measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0201913
Descripción
Alkaline phosphatase measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0201850
Descripción
Aspartate aminotransferase measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0201899
Descripción
Alanine aminotransferase measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0201836
Descripción
Albumin measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0201838
Descripción
Plasma Glucose Measurement
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0202042
Descripción
Dipstick Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Descripción
Serum pregnancy (for females of childbearing potential only)
Alias
- UMLS CUI-1
- C0430060
Descripción
AED plasma concentration
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Descripción
Urine Creatinine
Alias
- UMLS CUI-1
- C1318439
Descripción
Plasma Samples
Alias
- UMLS CUI-1
- C0444263
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Descripción
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.
Tipo de datos
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
Descripción
Urine Samples
Alias
- UMLS CUI-1
- C0200354
Descripción
Review collection procedures with patient/ parent. Obtain urine samples from a 24-hour collection.
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3897500
Descripción
Review collection procedures with patient/ parent. Obtain urine samples from a 24-hour collection.
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3899266
Descripción
Urine specimen collection, 24 hours; Volume Measurement
Tipo de datos
integer
Unidades de medida
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Descripción
Collection (action); Complete
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0205197
Descripción
AED Concentrations and Range (+/- 50%) Calculcations
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C1446561
- UMLS CUI-3
- C0003299
- UMLS CUI-4
- C1514721
Descripción
Antiepileptic Agents; Medication name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C2360065
Descripción
Range
Tipo de datos
float
Unidades de medida
- ug/mL
Alias
- UMLS CUI [1]
- C1514721
Descripción
Range
Tipo de datos
float
Unidades de medida
- ug/mL
Alias
- UMLS CUI [1]
- C1514721
Descripción
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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C2360065 (UMLS CUI [1,2])
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