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

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  5. 08.10.18 08.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

8. Oktober 2018

DOI

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Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040

Englisch

Laboratory comments, Clinical laboratory examination and Plasma/ Urine Samples - Baseline Week 8 and Baseline mean AED Concentrations and Range Calculations

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Beschreibung

Study Site; Numbers

Datentyp

text

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Patient's initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient's trial number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date sample collected
Beschreibung

Specimen collection date

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Laboratory finding
Beschreibung

Laboratory finding

Alias
UMLS CUI-1
C0587081
Do you consider any of the laboratory values at this clinic visit to be of potential OR actual clinical significance AND unexpected in this patient population?
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
Laboratory results that are of potential or actual clinical significance and unexpected
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
Laboratory parameter
Beschreibung

Laboratory; Parameter Value

Datentyp

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0549193
Comment (Laboratory parameter)
Beschreibung

Comment | Laboratory; Parameter Value

Datentyp

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2,1]
C0022877
UMLS CUI [2,2]
C0549193
Clinical laboratory examination - Hematology
Beschreibung

Clinical laboratory examination - Hematology

Alias
UMLS CUI-1
C0260877
UMLS CUI-2
C0205210
UMLS CUI-4
C0018943
Hemoglobin
Beschreibung

Hemoglobin

Datentyp

text

Alias
UMLS CUI [1]
C0019046
MCV
Beschreibung

Erythrocyte Mean Corpuscular Volume Measurement

Datentyp

text

Alias
UMLS CUI [1]
C1948043
Quantitative platelet count
Beschreibung

Platelet Count measurement

Datentyp

text

Alias
UMLS CUI [1]
C0032181
WBC
Beschreibung

White Blood Cell Count procedure

Datentyp

text

Alias
UMLS CUI [1]
C0023508
Differential WBC
Beschreibung

Differential white blood cell count procedure

Datentyp

text

Alias
UMLS CUI [1]
C0162401
Clinical laboratory examination - Clinical chemistry
Beschreibung

Clinical laboratory examination - Clinical chemistry

Alias
UMLS CUI-1
C0260877
UMLS CUI-2
C0205210
UMLS CUI-3
C0008000
Sodium
Beschreibung

Sodium measurement

Datentyp

text

Alias
UMLS CUI [1]
C0337443
Potassium
Beschreibung

Potassium measurement

Datentyp

text

Alias
UMLS CUI [1]
C0202194
Bicarbonate
Beschreibung

Bicarbonate measurement

Datentyp

text

Alias
UMLS CUI [1]
C0202059
Creatinine
Beschreibung

Creatinine measurement, serum (procedure)

Datentyp

text

Alias
UMLS CUI [1]
C0201976
Total Bilirubin
Beschreibung

Bilirubin, total measurement

Datentyp

text

Alias
UMLS CUI [1]
C0201913
Alkaline Phosphatase
Beschreibung

Alkaline phosphatase measurement

Datentyp

text

Alias
UMLS CUI [1]
C0201850
AST (SGOT)
Beschreibung

Aspartate aminotransferase measurement

Datentyp

text

Alias
UMLS CUI [1]
C0201899
ALT (SGTP)
Beschreibung

Alanine aminotransferase measurement

Datentyp

text

Alias
UMLS CUI [1]
C0201836
Albumin
Beschreibung

Albumin measurement

Datentyp

text

Alias
UMLS CUI [1]
C0201838
Glucose
Beschreibung

Plasma Glucose Measurement

Datentyp

text

Alias
UMLS CUI [1]
C0202042
Dipstick Urinalysis
Beschreibung

Dipstick Urinalysis

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
Urine Protein
Beschreibung

Urine total protein measurement

Datentyp

text

Alias
UMLS CUI [1]
C0428541
Urine Blood
Beschreibung

Urine dipstick for blood

Datentyp

text

Alias
UMLS CUI [1]
C0430372
Serum pregnancy (for females of childbearing potential only)
Beschreibung

Serum pregnancy (for females of childbearing potential only)

Alias
UMLS CUI-1
C0430060
Serum pregnancy
Beschreibung

Serum pregnancy test (B-HCG)

Datentyp

text

Alias
UMLS CUI [1]
C0430060
AED plasma concentration
Beschreibung

AED plasma concentration

Alias
UMLS CUI-1
C0683150
UMLS CUI-2
C0003299
AED plasma concentration (trough)
Beschreibung

plasma concentration; Antiepileptic Agents; Trough

Datentyp

text

Alias
UMLS CUI [1,1]
C0683150
UMLS CUI [1,2]
C0003299
UMLS CUI [1,3]
C0444506
Urine Creatinine
Beschreibung

Urine Creatinine

Alias
UMLS CUI-1
C1318439
Urine Creatinine
Beschreibung

Urine creatinine measurement

Datentyp

text

Alias
UMLS CUI [1]
C1318439
Plasma Samples
Beschreibung

Plasma Samples

Alias
UMLS CUI-1
C0444263
Antiepileptic drug (trough)
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
Study Medication (trough) - Date and Time sample drawn
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
Urine Samples
Beschreibung

Urine Samples

Alias
UMLS CUI-1
C0200354
Start date and time of 24- hour period
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
End date and time of 24- hour period
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
Total urine volume
Beschreibung

Urine specimen collection, 24 hours; Volume Measurement

Datentyp

integer

Maßeinheiten
  • ml
Alias
UMLS CUI [1,1]
C0455060
UMLS CUI [1,2]
C2700258
ml
Were all voids collected?
Beschreibung

Collection (action); Complete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C0205197
AED Concentrations and Range (+/- 50%) Calculcations
Beschreibung

AED Concentrations and Range (+/- 50%) Calculcations

Alias
UMLS CUI-1
C0003299
UMLS CUI-2
C1446561
UMLS CUI-3
C0003299
UMLS CUI-4
C1514721
Antiepileptic drug name
Beschreibung

Antiepileptic Agents; Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C2360065
Mean +50% (calculate by multiplying the mean plasma concentration by 1.5)
Beschreibung

Range

Datentyp

float

Maßeinheiten
  • ug/mL
Alias
UMLS CUI [1]
C1514721
ug/mL
Mean -50% (calculate by multiplying the mean plasma concentrations by 0.5)
Beschreibung

Range

Datentyp

float

Maßeinheiten
  • ug/mL
Alias
UMLS CUI [1]
C1514721
ug/mL
Date of mean AED Concentrations and Range Calculations
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
Date of calculation
Beschreibung

Calculation; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1441506
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Laboratory comments, Clinical laboratory examination and Plasma/ Urine Samples - Baseline Week 8 and Baseline mean AED Concentrations and Range Calculations

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Site; Numbers
Item
Site number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Person Initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Specimen collection date
Item
Date sample collected
date
C1302413 (UMLS CUI [1])
Item Group
Laboratory finding
C0587081 (UMLS CUI-1)
Laboratory Results; Clinical Significance; Unexpected
Item
Do you consider any of the laboratory values at this clinic visit to be of potential OR actual clinical significance AND unexpected in this patient population?
boolean
C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
Item Group
Laboratory results that are of potential or actual clinical significance and unexpected
C1254595 (UMLS CUI-1)
C2826293 (UMLS CUI-2)
C4055646 (UMLS CUI-3)
Laboratory; Parameter Value
Item
Laboratory parameter
text
C0022877 (UMLS CUI [1,1])
C0549193 (UMLS CUI [1,2])
Comment | Laboratory; Parameter Value
Item
Comment (Laboratory parameter)
text
C0947611 (UMLS CUI [1])
C0022877 (UMLS CUI [2,1])
C0549193 (UMLS CUI [2,2])
Item Group
Clinical laboratory examination - Hematology
C0260877 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C0018943 (UMLS CUI-4)
Hemoglobin
Item
Hemoglobin
text
C0019046 (UMLS CUI [1])
Erythrocyte Mean Corpuscular Volume Measurement
Item
MCV
text
C1948043 (UMLS CUI [1])
Platelet Count measurement
Item
Quantitative platelet count
text
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
WBC
text
C0023508 (UMLS CUI [1])
Differential white blood cell count procedure
Item
Differential WBC
text
C0162401 (UMLS CUI [1])
Item Group
Clinical laboratory examination - Clinical chemistry
C0260877 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
Sodium measurement
Item
Sodium
text
C0337443 (UMLS CUI [1])
Potassium measurement
Item
Potassium
text
C0202194 (UMLS CUI [1])
Bicarbonate measurement
Item
Bicarbonate
text
C0202059 (UMLS CUI [1])
Creatinine measurement, serum (procedure)
Item
Creatinine
text
C0201976 (UMLS CUI [1])
Bilirubin, total measurement
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
Alkaline Phosphatase
text
C0201850 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
AST (SGOT)
text
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
ALT (SGTP)
text
C0201836 (UMLS CUI [1])
Albumin measurement
Item
Albumin
text
C0201838 (UMLS CUI [1])
Plasma Glucose Measurement
Item
Glucose
text
C0202042 (UMLS CUI [1])
Item Group
Dipstick Urinalysis
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Urine total protein measurement
Item
Urine Protein
text
C0428541 (UMLS CUI [1])
Urine dipstick for blood
Item
Urine Blood
text
C0430372 (UMLS CUI [1])
Item Group
Serum pregnancy (for females of childbearing potential only)
C0430060 (UMLS CUI-1)
Serum pregnancy test (B-HCG)
Item
Serum pregnancy
text
C0430060 (UMLS CUI [1])
Item Group
AED plasma concentration
C0683150 (UMLS CUI-1)
C0003299 (UMLS CUI-2)
plasma concentration; Antiepileptic Agents; Trough
Item
AED plasma concentration (trough)
text
C0683150 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,3])
Item Group
Urine Creatinine
C1318439 (UMLS CUI-1)
Urine creatinine measurement
Item
Urine Creatinine
text
C1318439 (UMLS CUI [1])
Item Group
Plasma Samples
C0444263 (UMLS CUI-1)
Plasma specimen | Antiepileptic Agents; Trough
Item
Antiepileptic drug (trough)
text
C0003299 (UMLS CUI [1,1])
C0444506 (UMLS CUI [1,2])
Experimental drug; Trough | Date in time; Time; Specimen Collection
Item
Study Medication (trough) - Date and Time sample drawn
datetime
C0304229 (UMLS CUI [1,1])
C0444506 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
Item Group
Urine Samples
C0200354 (UMLS CUI-1)
Urine specimen collection, 24 hours; Start Date and Time of Procedure
Item
Start date and time of 24- hour period
datetime
C0455060 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
Urine specimen collection, 24 hours; End Date and Time of Procedure
Item
End date and time of 24- hour period
datetime
C0455060 (UMLS CUI [1,1])
C3899266 (UMLS CUI [1,2])
Urine specimen collection, 24 hours; Volume Measurement
Item
Total urine volume
integer
C0455060 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
Collection (action); Complete
Item
Were all voids collected?
boolean
C1516698 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
AED Concentrations and Range (+/- 50%) Calculcations
C0003299 (UMLS CUI-1)
C1446561 (UMLS CUI-2)
C0003299 (UMLS CUI-3)
C1514721 (UMLS CUI-4)
Antiepileptic Agents; Medication name
Item
Antiepileptic drug name
text
C0003299 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Range
Item
Mean +50% (calculate by multiplying the mean plasma concentration by 1.5)
float
C1514721 (UMLS CUI [1])
Range
Item
Mean -50% (calculate by multiplying the mean plasma concentrations by 0.5)
float
C1514721 (UMLS CUI [1])
Item Group
Date of mean AED Concentrations and Range Calculations
C0003299 (UMLS CUI-1)
C1446561 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0003299 (UMLS CUI-5)
C1514721 (UMLS CUI-6)
Calculation; Date in time
Item
Date of calculation
date
C1441506 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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