ID
31779
Beskrivning
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
Nyckelord
Versioner (5)
- 2018-09-22 2018-09-22 -
- 2018-09-22 2018-09-22 -
- 2018-09-23 2018-09-23 -
- 2018-09-27 2018-09-27 -
- 2018-10-08 2018-10-08 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
27 september 2018
DOI
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Licens
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
Beskrivning
Laboratory finding
Alias
- UMLS CUI-1
- C0587081
Beskrivning
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Beskrivning
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
Beskrivning
Clinical laboratory examination - Hematology
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-4
- C0018943
Beskrivning
Hemoglobin
Datatyp
text
Alias
- UMLS CUI [1]
- C0019046
Beskrivning
Erythrocyte Mean Corpuscular Volume Measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C1948043
Beskrivning
Platelet Count measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0032181
Beskrivning
White Blood Cell Count procedure
Datatyp
text
Alias
- UMLS CUI [1]
- C0023508
Beskrivning
Differential white blood cell count procedure
Datatyp
text
Alias
- UMLS CUI [1]
- C0162401
Beskrivning
Clinical laboratory examination - Clinical chemistry
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Beskrivning
Sodium measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0337443
Beskrivning
Potassium measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0202194
Beskrivning
Bicarbonate measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0202059
Beskrivning
Creatinine measurement, serum (procedure)
Datatyp
text
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
Bilirubin, total measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0201913
Beskrivning
Alkaline phosphatase measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0201850
Beskrivning
Aspartate aminotransferase measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0201899
Beskrivning
Alanine aminotransferase measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0201836
Beskrivning
Albumin measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0201838
Beskrivning
Plasma Glucose Measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0202042
Beskrivning
Dipstick Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Beskrivning
Serum pregnancy (for females of childbearing potential only)
Alias
- UMLS CUI-1
- C0430060
Beskrivning
AED plasma concentration
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Beskrivning
Urine Creatinine
Alias
- UMLS CUI-1
- C1318439
Beskrivning
Plasma Samples
Alias
- UMLS CUI-1
- C0444263
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Beskrivning
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.
Datatyp
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
Beskrivning
Urine Samples
Alias
- UMLS CUI-1
- C0200354
Beskrivning
Review collection procedures with patient/ parent. Obtain urine samples from a 24-hour collection.
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3897500
Beskrivning
Review collection procedures with patient/ parent. Obtain urine samples from a 24-hour collection.
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3899266
Beskrivning
Urine specimen collection, 24 hours; Volume Measurement
Datatyp
integer
Måttenheter
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Beskrivning
Collection (action); Complete
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0205197
Beskrivning
AED Concentrations and Range (+/- 50%) Calculcations
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C1446561
- UMLS CUI-3
- C0003299
- UMLS CUI-4
- C1514721
Beskrivning
Antiepileptic Agents; Medication name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C2360065
Beskrivning
Range
Datatyp
float
Måttenheter
- ug/mL
Alias
- UMLS CUI [1]
- C1514721
Beskrivning
Range
Datatyp
float
Måttenheter
- ug/mL
Alias
- UMLS CUI [1]
- C1514721
Beskrivning
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
Similar models
Laboratory comments, Clinical laboratory examination and Plasma/ Urine Samples - Baseline Week 8 and Baseline mean AED Concentrations and Range Calculations
C0237753 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
C2826293 (UMLS CUI-2)
C4055646 (UMLS CUI-3)
C0549193 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2,1])
C0549193 (UMLS CUI [2,2])
C0205210 (UMLS CUI-2)
C0018943 (UMLS CUI-4)
C0205210 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
C0430370 (UMLS CUI-2)
C0003299 (UMLS CUI-2)
C0003299 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,3])
C0444506 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
C3897500 (UMLS CUI [1,2])
C3899266 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C1446561 (UMLS CUI-2)
C0003299 (UMLS CUI-3)
C1514721 (UMLS CUI-4)
C2360065 (UMLS CUI [1,2])
C1446561 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0003299 (UMLS CUI-5)
C1514721 (UMLS CUI-6)
C0011008 (UMLS CUI [1,2])