ID
31710
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 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
Mots-clés
Versions (5)
- 22/09/2018 22/09/2018 -
- 22/09/2018 22/09/2018 -
- 23/09/2018 23/09/2018 -
- 27/09/2018 27/09/2018 -
- 08/10/2018 08/10/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
22 septembre 2018
DOI
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Licence
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
Description
Laboratory finding
Alias
- UMLS CUI-1
- C0587081
Description
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Type de données
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
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Description
Comment | Laboratory; Parameter Value
Type de données
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
Type de données
text
Alias
- UMLS CUI [1]
- C0019046
Description
Erythrocyte Mean Corpuscular Volume Measurement
Type de données
text
Alias
- UMLS CUI [1]
- C1948043
Description
Platelet Count measurement
Type de données
text
Alias
- UMLS CUI [1]
- C0032181
Description
White Blood Cell Count procedure
Type de données
text
Alias
- UMLS CUI [1]
- C0023508
Description
Differential white blood cell count procedure
Type de données
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
Type de données
text
Alias
- UMLS CUI [1]
- C0337443
Description
Potassium measurement
Type de données
text
Alias
- UMLS CUI [1]
- C0202194
Description
Bicarbonate measurement
Type de données
text
Alias
- UMLS CUI [1]
- C0202059
Description
Creatinine measurement, serum (procedure)
Type de données
text
Alias
- UMLS CUI [1]
- C0201976
Description
Bilirubin, total measurement
Type de données
text
Alias
- UMLS CUI [1]
- C0201913
Description
Alkaline phosphatase measurement
Type de données
text
Alias
- UMLS CUI [1]
- C0201850
Description
Aspartate aminotransferase measurement
Type de données
text
Alias
- UMLS CUI [1]
- C0201899
Description
Alanine aminotransferase measurement
Type de données
text
Alias
- UMLS CUI [1]
- C0201836
Description
Albumin measurement
Type de données
text
Alias
- UMLS CUI [1]
- C0201838
Description
Plasma Glucose Measurement
Type de données
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.
Type de données
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.
Type de données
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.
Type de données
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.
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3899266
Description
Urine specimen collection, 24 hours; Volume Measurement
Type de données
integer
Unités de mesure
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Description
Collection (action); Complete
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0205197
Similar models
Laboratory comments, Clinical laboratory examination and Plasma/ Urine Samples - Baseline Week 8
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])