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ID

29728

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

Keywords

Versions (2)
  1. 4/5/18 4/5/18 -
  2. 4/16/18 4/16/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 16, 2018

DOI

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License

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

    English

    Follow-up

    1 forms  
    1. StudyEvent: ODM
      1. Follow-up
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Vital Signs Date
    Description

    Vital Signs Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644
    Actual Time Vital Signs
    Description

    Actual Time Vital Signs

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826762
    Blood Pressure systolic
    Description

    Blood Pressure systolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood Pressure diastolic
    Description

    Blood Pressure diastolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart Rate
    Description

    Heart Rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Drug and Alcohol Screen
    Description

    Drug and Alcohol Screen

    Alias
    UMLS CUI-1
    C0373483
    UMLS CUI-2
    C0038586
    UMLS CUI-3
    C0948726
    Date sample taken Drug and Alcohol Screen
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C1302413
    Time sample taken Drug and Alcohol Screen
    Description

    Time sample taken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0040223
    Cocaine
    Description

    Cocaine

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0009170
    Amphetamines
    Description

    Amphetamines

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0002667
    Benzodiazepines
    Description

    Benzodiazepines

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0005064
    Cannabis metabolites
    Description

    Cannabis metabolites

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0936079
    UMLS CUI [1,2]
    C0870883
    Opiates
    Description

    Opiates

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0376196
    Barbiturates
    Description

    Barbiturates

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0004745
    PCP
    Description

    PCP

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031381
    Alcohol
    Description

    If any of the above are positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0202304
    UMLS CUI [2]
    C0001948
    Local Laboratory - Haematology
    Description

    Local Laboratory - Haematology

    Alias
    UMLS CUI-1
    C0474523
    UMLS CUI-2
    C0022885
    Lab ID
    Description

    Lab ID

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0600091
    Date Sample taken Haematology
    Description

    Date Sample taken Haematology

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0018941
    UMLS CUI [1,3]
    C1302413
    Time sample taken Haematology
    Description

    Time sample taken Haematology

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0018941
    UMLS CUI [1,3]
    C0040223
    Planned Relative Time Haematology
    Description

    Planned Relative Time Haematology

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0018941
    UMLS CUI [1,3]
    C0439564
    Haemoglobin (Hb)
    Description

    Haemoglobin (Hb)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0518015
    Haematocrit (HCT)
    Description

    Haematocrit (HCT)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0018935
    Platelet count (absolute)
    Description

    Platelet count (absolute)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032181
    White blood cell count (WBC) (Absolute)
    Description

    White blood cell count (WBC) (Absolute)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0023508
    Neutrophil count (absolute)
    Description

    Neutrophil count (absolute)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0948762
    Lymphocyte count (absolute)
    Description

    Lymphocyte count (absolute)

    Data type

    text

    Alias
    UMLS CUI [1]
    C3544087
    Monocyte count (absolute)
    Description

    Monocyte count (absolute)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0200637
    Eosinophil count (absolute)
    Description

    Eosinophil count (absolute)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0200638
    Basophil count (absolute)
    Description

    Basophil count (absolute)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0200641
    Local Laboratory - Clinical Chemistry
    Description

    Local Laboratory - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0022885
    Lab ID
    Description

    Lab ID

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0600091
    Date sample taken clinical chemistry
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C1302413
    Time Sample Taken Clinical Chemistry
    Description

    Time Sample Taken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0040223
    Planned Relative Time Clinical Chemistry
    Description

    Planned Relative Time

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0439564
    Sodium
    Description

    Sodium

    Data type

    float

    Alias
    UMLS CUI [1]
    C0337443
    Potassium
    Description

    Potassium

    Data type

    float

    Alias
    UMLS CUI [1]
    C0202194
    Calcium
    Description

    Calcium

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201925
    Glucose (fasting)
    Description

    Glucose (fasting)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0583513
    Total Protein
    Description

    Total Protein

    Data type

    float

    Alias
    UMLS CUI [1]
    C0555903
    Albumin
    Description

    Albumin

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201838
    Total bilirubin
    Description

    Total bilirubin

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201913
    Alkaline phosphatase
    Description

    Alkaline phosphatase

    Data type

    float

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

    AST (SGOT)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201899
    ALT (SGPT)
    Description

    ALT (SGPT)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201836
    Serum Creatinine
    Description

    Serum Creatinine

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201976
    Blood Urea Nitrogen
    Description

    BUN

    Data type

    float

    Alias
    UMLS CUI [1]
    C0005845
    LDH
    Description

    LDH

    Data type

    float

    Alias
    UMLS CUI [1]
    C0202113
    Creatine Phosphokinase (CPK)
    Description

    Creatine Phosphokinase (CPK)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201973
    Urinalysis
    Description

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Lab ID
    Description

    Lab ID

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0600091
    UMLS CUI [2]
    C0042014
    Date sample taken Urinalysis
    Description

    Date sample taken Urinalysis

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0011008
    Time sample taken Urinalysis
    Description

    Time sample taken Urinalysis

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0040223
    Specific gravity
    Description

    Urine Specific Gravity

    Data type

    float

    Alias
    UMLS CUI [1]
    C0202517
    pH
    Description

    Urine pH

    Data type

    float

    Alias
    UMLS CUI [1]
    C0042044
    Glucose
    Description

    Urine Glucose

    Data type

    float

    Alias
    UMLS CUI [1]
    C0004076
    Protein
    Description

    Urine Protein

    Data type

    float

    Alias
    UMLS CUI [1]
    C0262923
    Blood
    Description

    Hematuria

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0018965
    UMLS CUI [1,2]
    C0042014
    Ketones
    Description

    Urine Ketones

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C1991100
    UMLS CUI [1,2]
    C0042014
    Was sedimentary microscopy performed?
    Description

    sedimentary microscopy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0430397
    UMLS CUI [1,2]
    C2700128
    Red Blood Cells
    Description

    RBC

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0014772
    UMLS CUI [1,2]
    C2700128
    White blood cells
    Description

    White blood cells

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C2700128
    Hyaline casts
    Description

    Hyaline casts

    Data type

    float

    Alias
    UMLS CUI [1]
    C0427894
    Granular casts
    Description

    Granular casts

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C2697521
    UMLS CUI [1,2]
    C2700128
    Cellular casts
    Description

    Cellular casts

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C2699157
    UMLS CUI [1,2]
    C2700128
    Crystals
    Description

    Crystals

    Data type

    float

    Alias
    UMLS CUI [1]
    C1287304
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    Follow-up

    1 forms
    1. StudyEvent: ODM
      1. Follow-up
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    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)
    Date sample taken
    Item
    Date sample taken Drug and Alcohol Screen
    date
    C0005834 (UMLS CUI [1,1])
    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])
    Item
    Cocaine
    integer
    C0009170 (UMLS CUI [1])
    Cocaine
    Code List
    Cocaine
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Amphetamines
    integer
    C0002667 (UMLS CUI [1])
    Cocaine
    Code List
    Amphetamines
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Benzodiazepines
    integer
    C0005064 (UMLS CUI [1])
    Cocaine
    Code List
    Benzodiazepines
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Cannabis metabolites
    integer
    C0936079 (UMLS CUI [1,1])
    C0870883 (UMLS CUI [1,2])
    Cocaine
    Code List
    Cannabis metabolites
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Opiates
    integer
    C0376196 (UMLS CUI [1])
    Cocaine
    Code List
    Opiates
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Barbiturates
    integer
    C0004745 (UMLS CUI [1])
    Cocaine
    Code List
    Barbiturates
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    PCP
    integer
    C0031381 (UMLS CUI [1])
    Cocaine
    Code List
    PCP
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Alcohol
    integer
    C0202304 (UMLS CUI [1])
    C0001948 (UMLS CUI [2])
    Cocaine
    Code List
    Alcohol
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item Group
    Local Laboratory - Haematology
    C0474523 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    Lab ID
    Item
    Lab ID
    text
    C0022877 (UMLS CUI [1,1])
    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])
    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])
    Item
    Planned Relative Time Haematology
    integer
    C0005834 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    Planned Relative Time Haematology
    Code List
    Planned Relative Time Haematology
    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)
    Lab ID
    Item
    Lab ID
    integer
    C0022877 (UMLS CUI [1,1])
    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])
    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])
    Item
    Planned Relative Time Clinical Chemistry
    integer
    C0005834 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    Planned Relative Time Haematology
    Code List
    Planned Relative Time Clinical Chemistry
    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])
    Item Group
    Urinalysis
    C0042014 (UMLS CUI-1)
    Lab ID
    Item
    Lab ID
    text
    C0022877 (UMLS CUI [1,1])
    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])
    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])
    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])
    Urine Ketones
    Item
    Ketones
    float
    C1991100 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    sedimentary microscopy
    Item
    Was sedimentary microscopy performed?
    boolean
    C0430397 (UMLS CUI [1,1])
    C2700128 (UMLS CUI [1,2])
    RBC
    Item
    Red Blood Cells
    float
    C0014772 (UMLS CUI [1,1])
    C2700128 (UMLS CUI [1,2])
    White blood cells
    Item
    White blood cells
    float
    C0023508 (UMLS CUI [1,1])
    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])
    Cellular casts
    Item
    Cellular casts
    float
    C2699157 (UMLS CUI [1,1])
    C2700128 (UMLS CUI [1,2])
    Crystals
    Item
    Crystals
    float
    C1287304 (UMLS CUI [1])
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