0 Bedömningar
ID

29728

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-04-05 2018-04-05 -
  2. 2018-04-16 2018-04-16 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

16 april 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects GSK102587

    Engelsk

    Follow-up

    1 Formulär  
    1. StudyEvent: ODM
      1. Follow-up
    Vital Signs
    Beskrivning

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Vital Signs Date
    Beskrivning

    Vital Signs Date

    Datatyp

    date

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

    Actual Time Vital Signs

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C2826762
    Blood Pressure systolic
    Beskrivning

    Blood Pressure systolic

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood Pressure diastolic
    Beskrivning

    Blood Pressure diastolic

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart Rate
    Beskrivning

    Heart Rate

    Datatyp

    integer

    Måttenheter
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Drug and Alcohol Screen
    Beskrivning

    Drug and Alcohol Screen

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

    Date sample taken

    Datatyp

    date

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

    Time sample taken

    Datatyp

    time

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

    Cocaine

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0009170
    Amphetamines
    Beskrivning

    Amphetamines

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0002667
    Benzodiazepines
    Beskrivning

    Benzodiazepines

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0005064
    Cannabis metabolites
    Beskrivning

    Cannabis metabolites

    Datatyp

    integer

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

    Opiates

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0376196
    Barbiturates
    Beskrivning

    Barbiturates

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0004745
    PCP
    Beskrivning

    PCP

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0031381
    Alcohol
    Beskrivning

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

    Datatyp

    integer

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

    Local Laboratory - Haematology

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

    Lab ID

    Datatyp

    text

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

    Date Sample taken Haematology

    Datatyp

    date

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

    Time sample taken Haematology

    Datatyp

    time

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

    Planned Relative Time Haematology

    Datatyp

    integer

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

    Haemoglobin (Hb)

    Datatyp

    text

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

    Haematocrit (HCT)

    Datatyp

    text

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

    Platelet count (absolute)

    Datatyp

    text

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

    White blood cell count (WBC) (Absolute)

    Datatyp

    text

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

    Neutrophil count (absolute)

    Datatyp

    text

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

    Lymphocyte count (absolute)

    Datatyp

    text

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

    Monocyte count (absolute)

    Datatyp

    text

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

    Eosinophil count (absolute)

    Datatyp

    text

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

    Basophil count (absolute)

    Datatyp

    text

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

    Local Laboratory - Clinical Chemistry

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

    Lab ID

    Datatyp

    integer

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

    Date sample taken

    Datatyp

    date

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

    Time Sample Taken

    Datatyp

    time

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

    Planned Relative Time

    Datatyp

    integer

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

    Sodium

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0337443
    Potassium
    Beskrivning

    Potassium

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0202194
    Calcium
    Beskrivning

    Calcium

    Datatyp

    float

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

    Glucose (fasting)

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0583513
    Total Protein
    Beskrivning

    Total Protein

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0555903
    Albumin
    Beskrivning

    Albumin

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201838
    Total bilirubin
    Beskrivning

    Total bilirubin

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201913
    Alkaline phosphatase
    Beskrivning

    Alkaline phosphatase

    Datatyp

    float

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

    AST (SGOT)

    Datatyp

    float

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

    ALT (SGPT)

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201836
    Serum Creatinine
    Beskrivning

    Serum Creatinine

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201976
    Blood Urea Nitrogen
    Beskrivning

    BUN

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0005845
    LDH
    Beskrivning

    LDH

    Datatyp

    float

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

    Creatine Phosphokinase (CPK)

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0201973
    Urinalysis
    Beskrivning

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Lab ID
    Beskrivning

    Lab ID

    Datatyp

    text

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

    Date sample taken Urinalysis

    Datatyp

    date

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

    Time sample taken Urinalysis

    Datatyp

    time

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

    Urine Specific Gravity

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0202517
    pH
    Beskrivning

    Urine pH

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0042044
    Glucose
    Beskrivning

    Urine Glucose

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0004076
    Protein
    Beskrivning

    Urine Protein

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0262923
    Blood
    Beskrivning

    Hematuria

    Datatyp

    float

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

    Urine Ketones

    Datatyp

    float

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

    sedimentary microscopy

    Datatyp

    boolean

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

    RBC

    Datatyp

    float

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

    White blood cells

    Datatyp

    float

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

    Hyaline casts

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0427894
    Granular casts
    Beskrivning

    Granular casts

    Datatyp

    float

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

    Cellular casts

    Datatyp

    float

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

    Crystals

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C1287304
    Tillbaka till toppen

    Similar models

    Follow-up

    1 Formulär
    1. StudyEvent: ODM
      1. Follow-up
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial