ID
31943
Beschreibung
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
Stichworte
Versionen (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 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
8. Oktober 2018
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
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
Beschreibung
Laboratory finding
Alias
- UMLS CUI-1
- C0587081
Beschreibung
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Beschreibung
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
Beschreibung
Laboratory; Parameter Value
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Beschreibung
Comment | Laboratory; Parameter Value
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Beschreibung
Clinical laboratory examination - Hematology
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-4
- C0018943
Beschreibung
Hemoglobin
Datentyp
text
Alias
- UMLS CUI [1]
- C0019046
Beschreibung
Erythrocyte Mean Corpuscular Volume Measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C1948043
Beschreibung
Platelet Count measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0032181
Beschreibung
White Blood Cell Count procedure
Datentyp
text
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
Differential white blood cell count procedure
Datentyp
text
Alias
- UMLS CUI [1]
- C0162401
Beschreibung
Clinical laboratory examination - Clinical chemistry
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Beschreibung
Sodium measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0337443
Beschreibung
Potassium measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0202194
Beschreibung
Bicarbonate measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0202059
Beschreibung
Creatinine measurement, serum (procedure)
Datentyp
text
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
Bilirubin, total measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201913
Beschreibung
Alkaline phosphatase measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201850
Beschreibung
Aspartate aminotransferase measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201899
Beschreibung
Alanine aminotransferase measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
Albumin measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201838
Beschreibung
Plasma Glucose Measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0202042
Beschreibung
Dipstick Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Beschreibung
Serum pregnancy (for females of childbearing potential only)
Alias
- UMLS CUI-1
- C0430060
Beschreibung
AED plasma concentration
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Beschreibung
Urine Creatinine
Alias
- UMLS CUI-1
- C1318439
Beschreibung
Plasma Samples
Alias
- UMLS CUI-1
- C0444263
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Beschreibung
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.
Datentyp
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
Beschreibung
Urine Samples
Alias
- UMLS CUI-1
- C0200354
Beschreibung
Review collection procedures with patient/ parent. Obtain urine samples from a 24-hour collection.
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3897500
Beschreibung
Review collection procedures with patient/ parent. Obtain urine samples from a 24-hour collection.
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3899266
Beschreibung
Urine specimen collection, 24 hours; Volume Measurement
Datentyp
integer
Maßeinheiten
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Beschreibung
Collection (action); Complete
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0205197
Beschreibung
AED Concentrations and Range (+/- 50%) Calculcations
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C1446561
- UMLS CUI-3
- C0003299
- UMLS CUI-4
- C1514721
Beschreibung
Antiepileptic Agents; Medication name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C2360065
Beschreibung
Range
Datentyp
float
Maßeinheiten
- ug/mL
Alias
- UMLS CUI [1]
- C1514721
Beschreibung
Range
Datentyp
float
Maßeinheiten
- ug/mL
Alias
- UMLS CUI [1]
- C1514721
Beschreibung
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
Ähnliche Modelle
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])