ID
31710
Beschrijving
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 Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial
Trefwoorden
Versies (5)
- 22-09-18 22-09-18 -
- 22-09-18 22-09-18 -
- 23-09-18 23-09-18 -
- 27-09-18 27-09-18 -
- 08-10-18 08-10-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
22 september 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients
Laboratory comments, Clinical laboratory examination and Plasma/ Urine Samples - Baseline Week 8
Beschrijving
Laboratory finding
Alias
- UMLS CUI-1
- C0587081
Beschrijving
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Beschrijving
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
Beschrijving
Laboratory; Parameter Value
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Beschrijving
Comment | Laboratory; Parameter Value
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Beschrijving
Clinical laboratory examination - Hematology
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-4
- C0018943
Beschrijving
Hemoglobin
Datatype
text
Alias
- UMLS CUI [1]
- C0019046
Beschrijving
Erythrocyte Mean Corpuscular Volume Measurement
Datatype
text
Alias
- UMLS CUI [1]
- C1948043
Beschrijving
Platelet Count measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0032181
Beschrijving
White Blood Cell Count procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Differential white blood cell count procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0162401
Beschrijving
Clinical laboratory examination - Clinical chemistry
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Beschrijving
Sodium measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0337443
Beschrijving
Potassium measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
Bicarbonate measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0202059
Beschrijving
Creatinine measurement, serum (procedure)
Datatype
text
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Bilirubin, total measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Alkaline phosphatase measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Aspartate aminotransferase measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
Alanine aminotransferase measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
Albumin measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0201838
Beschrijving
Plasma Glucose Measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0202042
Beschrijving
Dipstick Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Beschrijving
Serum pregnancy (for females of childbearing potential only)
Alias
- UMLS CUI-1
- C0430060
Beschrijving
AED plasma concentration
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Beschrijving
Urine Creatinine
Alias
- UMLS CUI-1
- C1318439
Beschrijving
Plasma Samples
Alias
- UMLS CUI-1
- C0444263
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Beschrijving
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.
Datatype
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
Beschrijving
Urine Samples
Alias
- UMLS CUI-1
- C0200354
Beschrijving
Review collection procedures with patient/ parent. Obtain urine samples from a 24-hour collection.
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3897500
Beschrijving
Review collection procedures with patient/ parent. Obtain urine samples from a 24-hour collection.
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3899266
Beschrijving
Urine specimen collection, 24 hours; Volume Measurement
Datatype
integer
Maateenheden
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Beschrijving
Collection (action); Complete
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0205197
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Laboratory comments, Clinical laboratory examination and Plasma/ Urine Samples - Baseline Week 8
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C0549193 (UMLS CUI [1,2])
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