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Informations:
Erreur:
ID
29563
Description
Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Follow-up
Mots-clés
Versions (2)
- 05/04/2018 05/04/2018 -
- 16/04/2018 16/04/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
5 avril 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects GSK102587
Similar models
Follow-up
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Actual Time Vital Signs
Item
Actual Time Vital Signs
time
C2826762 (UMLS CUI [1])
Blood Pressure systolic
Item
Blood Pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure diastolic
Item
Blood Pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Drug and Alcohol Screen
C0373483 (UMLS CUI-1)
C0038586 (UMLS CUI-2)
C0948726 (UMLS CUI-3)
C0038586 (UMLS CUI-2)
C0948726 (UMLS CUI-3)
Date sample taken
Item
Date sample taken Drug and Alcohol Screen
date
C0005834 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken Drug and Alcohol Screen
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
Item
Cannabis metabolites
integer
C0936079 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
C0870883 (UMLS CUI [1,2])
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
Item Group
Local Laboratory - Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date Sample taken Haematology
Item
Date Sample taken Haematology
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time sample taken Haematology
Item
Time sample taken Haematology
time
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Haematology
integer
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
CL Item
Check-in (Result 1) (1)
CL Item
24 hours post-dose (Result 2) (2)
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
text
C0518015 (UMLS CUI [1])
Haematocrit (HCT)
Item
Haematocrit (HCT)
text
C0018935 (UMLS CUI [1])
Platelet count (absolute)
Item
Platelet count (absolute)
text
C0032181 (UMLS CUI [1])
White blood cell count (WBC) (Absolute)
Item
White blood cell count (WBC) (Absolute)
text
C0023508 (UMLS CUI [1])
Neutrophil count (absolute)
Item
Neutrophil count (absolute)
text
C0948762 (UMLS CUI [1])
Lymphocyte count (absolute)
Item
Lymphocyte count (absolute)
text
C3544087 (UMLS CUI [1])
Monocyte count (absolute)
Item
Monocyte count (absolute)
text
C0200637 (UMLS CUI [1])
Eosinophil count (absolute)
Item
Eosinophil count (absolute)
text
C0200638 (UMLS CUI [1])
Basophil count (absolute)
Item
Basophil count (absolute)
text
C0200641 (UMLS CUI [1])
Item Group
Local Laboratory - Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken clinical chemistry
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time Sample Taken
Item
Time Sample Taken Clinical Chemistry
time
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Clinical Chemistry
integer
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
CL Item
Check-in (Result 1) (1)
CL Item
24 hours post-dose (Result 2) (2)
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Glucose (fasting)
Item
Glucose (fasting)
float
C0583513 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
BUN
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Creatine Phosphokinase (CPK)
Item
Creatine Phosphokinase (CPK)
float
C0201973 (UMLS CUI [1])
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
C0600091 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
Date sample taken Urinalysis
Item
Date sample taken Urinalysis
date
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time sample taken Urinalysis
Item
Time sample taken Urinalysis
time
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Urine Specific Gravity
Item
Specific gravity
float
C0202517 (UMLS CUI [1])
Urine pH
Item
pH
float
C0042044 (UMLS CUI [1])
Urine Glucose
Item
Glucose
float
C0004076 (UMLS CUI [1])
Urine Protein
Item
Protein
float
C0262923 (UMLS CUI [1])
Hematuria
Item
Blood
float
C0018965 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
Urine Ketones
Item
Ketones
float
C1991100 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
sedimentary microscopy
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
RBC
Item
Red Blood Cells
float
C0014772 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
White blood cells
Item
White blood cells
float
C0023508 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
Hyaline casts
Item
Hyaline casts
float
C0427894 (UMLS CUI [1])
Granular casts
Item
Granular casts
float
C2697521 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
Cellular casts
Item
Cellular casts
float
C2699157 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
Crystals
Item
Crystals
float
C1287304 (UMLS CUI [1])
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