0 Evaluaciones
ID

41304

Descripción

Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Palabras clave

Versiones (1)
  1. 2020-08-13 2020-08-13 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

13 augusti 2020

DOI

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Licencia

Creative Commons BY 4.0
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    Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275

    Inglés

    Logs/Repeats

    1 formularios  
    1. StudyEvent: ODM
      1. Logs/Repeats
    Logs and Repeats
    Descripción

    Logs and Repeats

    Alias
    UMLS CUI-1
    C1708728
    UMLS CUI-2
    C0205341
    Date of visit/assessment
    Descripción

    Event Log, Repeat, Date of visit, Assessment Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1708728
    UMLS CUI [1,2]
    C0205341
    UMLS CUI [1,3]
    C1320303
    UMLS CUI [1,4]
    C2985720
    Were there any concomitant medications taken by the subject during the study?
    Descripción

    Concomitant Agent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Did the subject experience any adverse events during the study?
    Descripción

    Adverse event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Did the subject experience any serious adverse events during the study?
    Descripción

    Serious Adverse Event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Were any repeat or unscheduled vital signs recorded?
    Descripción

    Vital signs, Repeat; Vital signs, Unscheduled

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0205341
    UMLS CUI [2,1]
    C0518766
    UMLS CUI [2,2]
    C3854240
    Was any unscheduled study medication taken?
    Descripción

    Experimental drug, Unscheduled

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C3854240
    Were any repeat or unscheduled PK blood samples taken?
    Descripción

    Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Repeat; Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Unscheduled

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0205341
    UMLS CUI [2,1]
    C0031328
    UMLS CUI [2,2]
    C0005834
    UMLS CUI [2,3]
    C3854240
    Were there an unscheduled or repeat ECHO/MUGA examinations performed?
    Descripción

    Echocardiography, Multiple gated acquisition scanning, Repeat; Echocardiography, Multiple gated acquisition scanning, Unscheduled

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013516
    UMLS CUI [1,2]
    C0521317
    UMLS CUI [1,3]
    C0205341
    UMLS CUI [2,1]
    C0013516
    UMLS CUI [2,2]
    C0521317
    UMLS CUI [2,3]
    C3854240
    Were any unscheduled or repeat ECGs performed?
    Descripción

    Electrocardiography, Repeat; Electrocardiography, Unscheduled

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0205341
    UMLS CUI [2,1]
    C1623258
    UMLS CUI [2,2]
    C3854240
    Were the liver event criteria met for this subject as defined by the protocol?
    Descripción

    Liver, Adverse Event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0023884
    UMLS CUI [1,2]
    C0877248
    ECHO/MUGA
    Descripción

    ECHO/MUGA

    Alias
    UMLS CUI-1
    C0013516
    UMLS CUI-2
    C0521317
    Ejection fraction range lower limit
    Descripción

    Echocardiography, Multiple gated acquisition scanning, Ejection fraction (finding), Lower Limit of Normal

    Tipo de datos

    integer

    Unidades de medida
    • %
    Alias
    UMLS CUI [1,1]
    C0013516
    UMLS CUI [1,2]
    C0521317
    UMLS CUI [1,3]
    C2700378
    UMLS CUI [1,4]
    C1518030
    %
    Scan Type
    Descripción

    Echocardiography, Multiple gated acquisition scanning

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013516
    UMLS CUI [1,2]
    C0521317
    Date and Time of Scan
    Descripción

    Echocardiography, Multiple gated acquisition scanning, Date in time, Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0013516
    UMLS CUI [1,2]
    C0521317
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Left ventricular ejection fraction (LVEF)
    Descripción

    Echocardiography, Multiple gated acquisition scanning, Left ventricular ejection fraction

    Tipo de datos

    integer

    Unidades de medida
    • %
    Alias
    UMLS CUI [1,1]
    C0013516
    UMLS CUI [1,2]
    C0521317
    UMLS CUI [1,3]
    C0428772
    %
    Left ventricular ejection fraction (LVEF)
    Descripción

    Echocardiography, Multiple gated acquisition scanning, Left ventricular ejection fraction

    Tipo de datos

    integer

    Unidades de medida
    • %
    Alias
    UMLS CUI [1,1]
    C0013516
    UMLS CUI [1,2]
    C0521317
    UMLS CUI [1,3]
    C0428772
    %
    Scan results
    Descripción

    Echocardiography, Multiple gated acquisition scanning, Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013516
    UMLS CUI [1,2]
    C0521317
    UMLS CUI [1,3]
    C1274040
    Describe abnormality
    Descripción

    Echocardiography, Multiple gated acquisition scanning, Abnormality

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013516
    UMLS CUI [1,2]
    C0521317
    UMLS CUI [1,3]
    C1704258
    Vital Signs - Repeating Form
    Descripción

    Vital Signs - Repeating Form

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0205341
    Actual date/time
    Descripción

    Vital signs, Date in time, Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Weight
    Descripción

    Body Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Sitting heart rate
    Descripción

    Heart rate while sitting

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C2029904
    Sitting blood pressure measurement - Systolic
    Descripción

    Systolic Pressure, Sitting position

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    mmHg
    Sitting blood pressure measurement - Diastolic
    Descripción

    Diastolic blood pressure, Sitting position

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    mmHg
    Unscheduled 12-Lead ECG - Repeating Form
    Descripción

    Unscheduled 12-Lead ECG - Repeating Form

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C3854240
    UMLS CUI-3
    C0205341
    Date and Time of ECG
    Descripción

    12 lead ECG, Date in time, Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Heart rate
    Descripción

    12 lead ECG, Heart rate

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0018810
    bpm
    PR Interval
    Descripción

    12 lead ECG, Electrocardiogram: P-R interval

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429087
    msec
    QRS Duration
    Descripción

    12 lead ECG, QRS complex duration

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429025
    msec
    Uncorrected QT Interval
    Descripción

    12 lead ECG, QT interval - finding

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1287082
    msec
    QTc Interval
    Descripción

    12 lead ECG, Electrocardiogram QT corrected interval

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    Result of the ECG
    Descripción

    12 lead ECG, Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1274040
    12-Lead ECG Abnormalities
    Descripción

    12-Lead ECG Abnormalities

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C1704258
    Date and Time of ECG
    Descripción

    12 lead ECG, Abnormality, Date in time, Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Record clinically significant abnormalities
    Descripción

    12 lead ECG, Abnormality

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    Unscheduled Pharmacokinetics Samples (PK) - Repeating Form
    Descripción

    Unscheduled Pharmacokinetics Samples (PK) - Repeating Form

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C3854240
    UMLS CUI-3
    C0205341
    PK Sample ID
    Descripción

    Pharmacokinetic aspects, Sample identification number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C1299222
    Actual date/time
    Descripción

    Pharmacokinetic aspects, Date in time, Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Investigational Product - GSK1120212 Unscheduled (Study Drug) - Repeating Form
    Descripción

    Investigational Product - GSK1120212 Unscheduled (Study Drug) - Repeating Form

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C3854240
    UMLS CUI-3
    C0205341
    Unscheduled Dose - Date/Time
    Descripción

    Experimental drug, Unscheduled, Date in time, Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C3854240
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Adverse Event (AE) - Repeating Form
    Descripción

    Adverse Event (AE) - Repeating Form

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C0205341
    Sequence number
    Descripción

    Adverse event, Sequence Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2348184
    Was the event serious?
    Descripción

    Serious Adverse Event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Yes, Seriousness Reason(s)
    Descripción

    Serious Adverse Event, Reason and justification

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0566251
    Event
    Descripción

    Adverse event

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0877248
    Modified term
    Descripción

    Adverse Event Modified Reported Term

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826798
    MedDRA synonym
    Descripción

    Adverse event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1140263
    MedDRA lower level term code
    Descripción

    Adverse event, MedDRA Low Level Term Code

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C3898442
    Failed coding
    Descripción

    Adverse event, Code, Failed

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0805701
    UMLS CUI [1,3]
    C0231175
    Start date
    Descripción

    Adverse Event Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2697888
    Did the event occur prior to rollover?
    Descripción

    Adverse event, Before

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0332152
    Outcome/End date
    Descripción

    Adverse Event Outcome, Adverse Event End Date

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1705586
    UMLS CUI [1,2]
    C2697886
    End Date and Time
    Descripción

    Adverse Event End Date Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C2826793
    Date and Time of Death
    Descripción

    Adverse event, Date of death, Time of death

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1148348
    UMLS CUI [1,3]
    C1301931
    Frequency
    Descripción

    Adverse event, Frequencies

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0439603
    Intensity at onset of event
    Descripción

    Adverse event, Symptom intensity, Onset

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0332162
    Maximum intensity
    Descripción

    Adverse event, Symptom intensity, Maximum

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0806909
    Grade at onset of event
    Descripción

    Adverse event, Grade, Onset

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0332162
    Maximum grade
    Descripción

    Adverse event, Grade, Maximum

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0806909
    Grade or intensity at onset of event
    Descripción

    Adverse event, Grade, Symptom intensity, Onset

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0518690
    UMLS CUI [1,4]
    C0332162
    Maximum Grade or intensity
    Descripción

    Adverse event, Grade, Symptom intensity, Maximum

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0518690
    UMLS CUI [1,4]
    C0806909
    Were any actions taken with investigational product(s) as a result of the AE?
    Descripción

    Adverse event, Action Taken with Study Treatment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1704758
    Yes, tick all that apply
    Descripción

    Adverse event, Action Taken with Study Treatment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1704758
    Most clinically significant action taken with investigational product(s) as a Result of the AE
    Descripción

    Adverse Event, Action Taken with Study Treatment, Clinical Significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1704758
    UMLS CUI [1,3]
    C2826293
    Did the subject withdraw from study as a result of this AE?
    Descripción

    Adverse event, Withdraw

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2349954
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Descripción

    Adverse event, Causations, Experimental drug

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C0304229
    Yes, Check all that apply
    Descripción

    Adverse event, Causations, Experimental drug

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C0304229
    Duration of AE if < 24 hours
    Descripción

    Adverse event, Duration

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2926735
    Time to onset since last dose
    Descripción

    Adverse event, Time of onset, Date last dose

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449244
    UMLS CUI [1,3]
    C1762893
    Is this adverse event a dose-limiting toxicity during the determinative period?
    Descripción

    Adverse event, dose-limiting, Drug toxicity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1512043
    UMLS CUI [1,3]
    C0013221
    Were concomitant medications taken to treat this adverse event?
    Descripción

    Adverse event, Therapeutic procedure, Concomitant Agent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C2347852
    Start Date of Event Segment
    Descripción

    Adverse event, Part, Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449719
    UMLS CUI [1,3]
    C0808070
    Intensity of event segment
    Descripción

    Adverse event, Part, Symptom intensity

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449719
    UMLS CUI [1,3]
    C0518690
    Grade of event segment
    Descripción

    Adverse event, Part, Grade

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449719
    UMLS CUI [1,3]
    C0441800
    Grade or Intensity of event segment
    Descripción

    Adverse event, Part, Grade, Symptom intensity

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449719
    UMLS CUI [1,3]
    C0441800
    UMLS CUI [1,4]
    C0518690
    Start Date of Action(s)
    Descripción

    Adverse event, Therapeutic procedure, Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0808070
    Action taken with investigational product
    Descripción

    Adverse event, Action Taken with Study Treatment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1704758
    Investigational product action is taken with
    Descripción

    Adverse event, Action Taken with Study Treatment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1704758
    Date event became serious (Date event met serious criteria)
    Descripción

    Serious Adverse Event, Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0808070
    Date event ceased to be serious
    Descripción

    Serious Adverse Event, End date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0806020
    Serious Adverse Events (SAE)
    Descripción

    Serious Adverse Events (SAE)

    Alias
    UMLS CUI-1
    C1519255
    SAE Sequence Number
    Descripción

    Serious Adverse Event, Sequence Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348184
    Report
    Descripción

    Serious Adverse Event Report

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3897642
    SAE form started
    Descripción

    Serious Adverse Event, Report, Start Date, Start time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0684224
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [1,4]
    C1301880
    Seriousness Reason(s)
    Descripción

    Serious Adverse Event, Reason and justification

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0566251
    Was SAE caused by activities related to study participation (e.g. procedures)?
    Descripción

    Serious Adverse Event, Causations, Activities, Study Subject Participation Status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C0441655
    UMLS CUI [1,4]
    C2348568
    Serious Adverse Event
    Descripción

    Serious Adverse Event

    Tipo de datos

    text

    Modified term copied from adverse event form
    Descripción

    Serious Adverse Event, Adverse Event Modified Reported Term

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826798
    Start date
    Descripción

    Serious Adverse Event, Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0808070
    Outcome / End date
    Descripción

    Serious Adverse Event, Adverse Event Outcome

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1705586
    End Date and Time
    Descripción

    Serious Adverse Event, End date, End Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [1,3]
    C1522314
    Date and Time of Death
    Descripción

    Serious Adverse Event, Date of death, Time of death

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1302234
    UMLS CUI [1,3]
    C1148348
    UMLS CUI [1,4]
    C1301931
    Frequency
    Descripción

    Serious Adverse Event, Frequencies

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0439603
    Maximum Intensity
    Descripción

    Serious Adverse Event, Symptom intensity, Maximum

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0806909
    Maximum grade
    Descripción

    Serious Adverse Event, Grade, Maximum

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0806909
    Maximum Grade or Intensity
    Descripción

    Serious Adverse Event, Grade, Symptom intensity, Maximum

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0518690
    UMLS CUI [1,4]
    C0806909
    Toxicity/Intensity History
    Descripción

    Serious Adverse Event, Toxicity aspects, Patient History

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0040539
    UMLS CUI [1,3]
    C0679831
    Most clinically significant action taken with investigational product(s) as a Result of the AE
    Descripción

    Serious Adverse Event, Action Taken with Study Treatment, Clinical Significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1704758
    UMLS CUI [1,3]
    C2826293
    Action(s) taken with Investigational Product
    Descripción

    Serious Adverse Event, Action Taken with Study Treatment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1704758
    Did the subject withdraw from study as a result of this AE?
    Descripción

    Serious Adverse Event, Withdraw

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2349954
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Descripción

    Serious Adverse Event, Investigational New Drugs, Relationships

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    Duration of AE if < 24 hours
    Descripción

    Serious Adverse Event, Duration

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2926735
    Time to onset since last dose
    Descripción

    Serious Adverse Event, Time of onset, Time last dose

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449244
    UMLS CUI [1,3]
    C0946444
    Is this adverse event a dose-limiting toxicity during the determinative period?
    Descripción

    Serious Adverse Event, Dose-limiting, Drug toxicity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1512043
    UMLS CUI [1,3]
    C0013221
    Date segments adverse event was serious
    Descripción

    Serious Adverse Event, Part

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449719
    Are there any relevant concomitant medications associated with this serious adverse event?
    Descripción

    Serious Adverse Event, Concomitant Agent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    Concomitant Medication - Sequence Number
    Descripción

    Serious Adverse Event, Concomitant Agent, Sequence Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C2348184
    Concomitant Medication - Drug Name
    Descripción

    Serious Adverse Event, Concomitant Agent, Medication name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C2360065
    Concomitant Medication - Modified reported term
    Descripción

    Serious Adverse Event, Concomitant Agent, Concomitant Medication Modified Reported Term

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C2826819
    Concomitant Medication - Drug Name
    Descripción

    Serious Adverse Event, Concomitant Agent, Medication name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C2360065
    Concomitant Medication - Unit Dose
    Descripción

    Serious Adverse Event, Concomitant Agent, Dosage

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0178602
    Concomitant Medication - Units
    Descripción

    Serious Adverse Event, Concomitant Agent, Unit of Measure

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C1519795
    Concomitant Medication - Frequency
    Descripción

    Serious Adverse Event, Concomitant Agent, Frequencies

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0439603
    Concomitant Medication - Route
    Descripción

    Serious Adverse Event, Concomitant Agent, Drug Administration Routes

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0013153
    Concomitant Medication - Reason for Medication
    Descripción

    Serious Adverse Event, Concomitant Agent, Reason and justification

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0566251
    Concomitant Medication - Reason for Medication Modified Report Term
    Descripción

    Serious Adverse Event, Concomitant Agent, Concomitant Medication Modified Reported Term, Reason and justification

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C2826819
    UMLS CUI [1,4]
    C0566251
    Concomitant Medication - Start Date
    Descripción

    Serious Adverse Event, Concomitant Agent, Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0808070
    Concomitant Medication - Ongoing?
    Descripción

    Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C2826666
    Concomitant Medication - No, End Date
    Descripción

    Serious Adverse Event, Concomitant Agent, End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0806020
    Concomitant Medication - Total Duration
    Descripción

    Serious Adverse Event, Concomitant Agent, Duration

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0449238
    Concomitant Medication - Duration Unit
    Descripción

    Serious Adverse Event, Concomitant Agent, Duration, Unit of Measure

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0449238
    UMLS CUI [1,4]
    C1519795
    Did SAE occur after initiation of study medication?
    Descripción

    Serious Adverse Event, Experimental drug, Initiation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C1704686
    Randomization Number
    Descripción

    Serious Adverse Event, Randomization, Numbers

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0034656
    UMLS CUI [1,3]
    C0237753
    Relevant Medical Conditions - MHx Sequence Number
    Descripción

    Serious Adverse Event, Disease, Sequence Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C2348184
    Relevant Medical Conditions - Specific Condition Name
    Descripción

    Serious Adverse Event, Disease

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C2348184
    Relevant Medical Conditions - Modified reported term
    Descripción

    Serious Adverse Event, Disease, Adverse Event Modified Reported Term

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C2826798
    Relevant Medical Conditions - Date of onset
    Descripción

    Serious Adverse Event, Disease, Date of onset

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C0574845
    Relevant Medical Conditions - Continuing?
    Descripción

    Serious Adverse Event, Disease, Continuous

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C0549178
    Relevant Medical Conditions - No, specify date of last occurrence
    Descripción

    Serious Adverse Event, Disease, End date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C0806020
    Relevant Diagnostic Results - Lab Sequence Number
    Descripción

    Serious Adverse Event, diagnostic procedure, Sequence Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C2348184
    Relevant Diagnostic Results - Test Name
    Descripción

    Serious Adverse Event, diagnostic procedure, Test Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C2826273
    Relevant Diagnostic Results - Test Date
    Descripción

    Serious Adverse Event, diagnostic procedure, Date in time

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0011008
    Relevant Diagnostic Results - Test Result
    Descripción

    Serious Adverse Event, diagnostic procedure, Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C1274040
    Relevant Diagnostic Results - Test Units
    Descripción

    Serious Adverse Event, diagnostic procedure, Unit of Measure

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C1519795
    Relevant Diagnostic Results - Normal Low Range
    Descripción

    Serious Adverse Event, diagnostic procedure, Normal Range, Low

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0086715
    UMLS CUI [1,4]
    C0205251
    Relevant Diagnostic Results - Normal High Range
    Descripción

    Serious Adverse Event, diagnostic procedure, Normal Range, High

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0086715
    UMLS CUI [1,4]
    C0205250
    Relevant Diagnostic Results - Relevant diagnostic results not noted above
    Descripción

    Serious Adverse Event, diagnostic procedure, Result, Other

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C0205394
    Rechallenge - If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    Descripción

    Serious Adverse Event, Relationships, Experimental drug

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0304229
    Investigational Product - Study Drug
    Descripción

    Serious Adverse Event, Experimental drug

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0808070
    Investigational Product - Start Date
    Descripción

    Serious Adverse Event, Experimental drug, Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0808070
    Investigational Product - Stop Date
    Descripción

    Serious Adverse Event, Experimental drug, End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0806020
    Investigational Product - Dose
    Descripción

    Serious Adverse Event, Experimental drug, Dosage

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0178602
    Investigational Product - Cumulative Dose
    Descripción

    Serious Adverse Event, Experimental drug, Cumulative Dose

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C2986497
    General Narrative Comments
    Descripción

    Serious Adverse Event, Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0947611
    Concomitant Medications - Repeating Form
    Descripción

    Concomitant Medications - Repeating Form

    Alias
    UMLS CUI-1
    C2347852
    Sequence Number
    Descripción

    Concomitant Agent, Sequence Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2348184
    Drug Name
    Descripción

    Concomitant Agent, Medication name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2360065
    Modified reported term
    Descripción

    Concomitant Agent, Concomitant Medication Modified Reported Term

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2826819
    Failed coding
    Descripción

    Concomitant Agent, Code, Failed

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0805701
    UMLS CUI [1,3]
    C0231175
    Unit Dose
    Descripción

    Concomitant Agent, Dosage

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0178602
    Units
    Descripción

    Concomitant Agent, Unit of Measure

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1519795
    Frequency
    Descripción

    Concomitant Agent, Frequencies

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0439603
    Route
    Descripción

    Concomitant Agent, Drug Administration Routes

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0013153
    Reason for Medication
    Descripción

    Concomitant Agent, Reason and justification

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0566251
    Start Date
    Descripción

    Concomitant Medication Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826734
    Taken Prior to Study?
    Descripción

    Concomitant Medication Previous Occurrence

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Ongoing?
    Descripción

    Concomitant Medication Ongoing

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    No, specify End Date
    Descripción

    Concomitant Medication End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826744
    Device Used to Administer Medication
    Descripción

    Concomitant Agent, Devices, Medication administered

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0699733
    UMLS CUI [1,3]
    C0806914
    Total Daily Dose
    Descripción

    Concomitant Agent, Daily Dose, Total

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2348070
    UMLS CUI [1,3]
    C0439810
    Was drug administered for an exacerbation?
    Descripción

    Concomitant Agent, Disease Exacerbation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0235874
    Was drug administered as a rescue medication?
    Descripción

    Concomitant Agent, Rescue remedy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0884980
    Cumulative Dose Used?
    Descripción

    Concomitant Agent, Cumulative Dose

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2986497
    Was drug ever used?
    Descripción

    Concomitant Agent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Total Duration
    Descripción

    Concomitant Agent, Duration, Total

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0449238
    UMLS CUI [1,3]
    C0439810
    Duration Unit
    Descripción

    Concomitant Agent, Duration, Unit of Measure

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0449238
    UMLS CUI [1,3]
    C1519795
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    Similar models

    Logs/Repeats

    1 formularios
    1. StudyEvent: ODM
      1. Logs/Repeats
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Logs and Repeats
    C1708728 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Event Log, Repeat, Date of visit, Assessment Date
    Item
    Date of visit/assessment
    date
    C1708728 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    C1320303 (UMLS CUI [1,3])
    C2985720 (UMLS CUI [1,4])
    Concomitant Agent
    Item
    Were there any concomitant medications taken by the subject during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Adverse event
    Item
    Did the subject experience any adverse events during the study?
    boolean
    C0877248 (UMLS CUI [1])
    Serious Adverse Event
    Item
    Did the subject experience any serious adverse events during the study?
    boolean
    C1519255 (UMLS CUI [1])
    Vital signs, Repeat; Vital signs, Unscheduled
    Item
    Were any repeat or unscheduled vital signs recorded?
    boolean
    C0518766 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    C0518766 (UMLS CUI [2,1])
    C3854240 (UMLS CUI [2,2])
    Experimental drug, Unscheduled
    Item
    Was any unscheduled study medication taken?
    boolean
    C0304229 (UMLS CUI [1,1])
    C3854240 (UMLS CUI [1,2])
    Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Repeat; Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Unscheduled
    Item
    Were any repeat or unscheduled PK blood samples taken?
    boolean
    C0031328 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0205341 (UMLS CUI [1,3])
    C0031328 (UMLS CUI [2,1])
    C0005834 (UMLS CUI [2,2])
    C3854240 (UMLS CUI [2,3])
    Echocardiography, Multiple gated acquisition scanning, Repeat; Echocardiography, Multiple gated acquisition scanning, Unscheduled
    Item
    Were there an unscheduled or repeat ECHO/MUGA examinations performed?
    boolean
    C0013516 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    C0205341 (UMLS CUI [1,3])
    C0013516 (UMLS CUI [2,1])
    C0521317 (UMLS CUI [2,2])
    C3854240 (UMLS CUI [2,3])
    Electrocardiography, Repeat; Electrocardiography, Unscheduled
    Item
    Were any unscheduled or repeat ECGs performed?
    boolean
    C1623258 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    C1623258 (UMLS CUI [2,1])
    C3854240 (UMLS CUI [2,2])
    Liver, Adverse Event
    Item
    Were the liver event criteria met for this subject as defined by the protocol?
    boolean
    C0023884 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item Group
    ECHO/MUGA
    C0013516 (UMLS CUI-1)
    C0521317 (UMLS CUI-2)
    Echocardiography, Multiple gated acquisition scanning, Ejection fraction (finding), Lower Limit of Normal
    Item
    Ejection fraction range lower limit
    integer
    C0013516 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    C2700378 (UMLS CUI [1,3])
    C1518030 (UMLS CUI [1,4])
    Item
    Scan Type
    text
    C0013516 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    Echocardiography, Multiple gated acquisition scanning
    Code List
    Scan Type
    CL Item
    ECHO (1)
    CL Item
    MUGA (2)
    Echocardiography, Multiple gated acquisition scanning, Date in time, Time
    Item
    Date and Time of Scan
    datetime
    C0013516 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Echocardiography, Multiple gated acquisition scanning, Left ventricular ejection fraction
    Item
    Left ventricular ejection fraction (LVEF)
    integer
    C0013516 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    C0428772 (UMLS CUI [1,3])
    Echocardiography, Multiple gated acquisition scanning, Left ventricular ejection fraction
    Item
    Left ventricular ejection fraction (LVEF)
    integer
    C0013516 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    C0428772 (UMLS CUI [1,3])
    Item
    Scan results
    text
    C0013516 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Echocardiography, Multiple gated acquisition scanning, Result
    Code List
    Scan results
    CL Item
    Normal (1)
    CL Item
    Abnormal, describe abnormality (2)
    Echocardiography, Multiple gated acquisition scanning, Abnormality
    Item
    Describe abnormality
    text
    C0013516 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Item Group
    Vital Signs - Repeating Form
    C0518766 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Vital signs, Date in time, Time
    Item
    Actual date/time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item
    Sitting heart rate
    integer
    C2029904 (UMLS CUI [1])
    Gender
    Code List
    Sitting heart rate
    Systolic Pressure, Sitting position
    Item
    Sitting blood pressure measurement - Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Diastolic blood pressure, Sitting position
    Item
    Sitting blood pressure measurement - Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Item Group
    Unscheduled 12-Lead ECG - Repeating Form
    C0430456 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    C0205341 (UMLS CUI-3)
    12 lead ECG, Date in time, Time
    Item
    Date and Time of ECG
    datetime
    C0430456 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    12 lead ECG, Heart rate
    Item
    Heart rate
    integer
    C0430456 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    12 lead ECG, Electrocardiogram: P-R interval
    Item
    PR Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0429087 (UMLS CUI [1,2])
    12 lead ECG, QRS complex duration
    Item
    QRS Duration
    integer
    C0430456 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    12 lead ECG, QT interval - finding
    Item
    Uncorrected QT Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    Item
    QTc Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method
    Code List
    QTc Interval
    Item
    Result of the ECG
    text
    C0430456 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    CL Item
    No result (not available) (4)
    Item Group
    12-Lead ECG Abnormalities
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    12 lead ECG, Abnormality, Date in time, Time
    Item
    Date and Time of ECG
    datetime
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Record clinically significant abnormalities
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    12 lead ECG, Abnormality
    Code List
    Record clinically significant abnormalities
    CL Item
    No abnormalities (1)
    CL Item
    Sinus bradycardia (50-59 beats/min) (2)
    CL Item
    Sinus bradycardia (40-49 beats/min) (3)
    CL Item
    Sinus bradycardia (30-39 beats/min) (4)
    CL Item
    Sinus bradycardia (<30 beats/min) (5)
    CL Item
    Sinus pause (6)
    CL Item
    Sinus tachycardia (>100 beats/min) (7)
    CL Item
    Ectopic supraventricular beats (8)
    CL Item
    Ectopic supraventricular rhythm (9)
    CL Item
    Wandering atrial pacemaker (10)
    CL Item
    Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (11)
    CL Item
    Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (12)
    CL Item
    Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (13)
    CL Item
    Atrial flutter (14)
    CL Item
    Atrial fibrillation (15)
    CL Item
    Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (16)
    CL Item
    Junctional tachycardia (>100 beats/min) (17)
    CL Item
    Ventricular premature deplorisation (18)
    CL Item
    Ventricular couplets (19)
    CL Item
    Bigeminy (20)
    CL Item
    Trigeminy (21)
    CL Item
    Electrical alternans (22)
    CL Item
    R on T phenomenon (23)
    CL Item
    Ventricular fibrillation (24)
    CL Item
    Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (25)
    CL Item
    Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (26)
    CL Item
    Sustained ventricular tachycardia (>100 beats/min, >30 beats) (27)
    CL Item
    Wide QRS tachycardia (diagnosis unknown (28)
    CL Item
    Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (29)
    CL Item
    Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (30)
    CL Item
    Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (31)
    CL Item
    Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (32)
    CL Item
    Torsades de Pointes (TdP) (33)
    CL Item
    Pacemaker (34)
    CL Item
    First degree AV block (PR interval >200msec) (35)
    CL Item
    Short PR Intervak (36)
    CL Item
    Second degree AV block (Mobitz type 1) (37)
    CL Item
    Second degree AV block (Mobitz type 2) (38)
    CL Item
    2:1 AV block (39)
    CL Item
    Third degree AV block (40)
    CL Item
    Left axis deviation (QRS axis more negative than -30 degrees) (41)
    CL Item
    Right axis deviation (QRS axis more positive than +100 degrees) (42)
    CL Item
    Incomplete left bundle branch block (43)
    CL Item
    Incomplete left bundle branch block (44)
    CL Item
    Right bundle branch block (45)
    CL Item
    Left anterior hemiblock (46)
    CL Item
    Left posterior hemiblock (47)
    CL Item
    Left bundle branch block (48)
    CL Item
    Bifascicular block (49)
    CL Item
    Non-specific intraventricular conduction delay (QRS >=120 msec) (50)
    CL Item
    Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine (51)
    CL Item
    QTc prolongation >=500 msec (52)
    CL Item
    AV dissociation (53)
    CL Item
    Myocardial infarction, old (54)
    CL Item
    Myocardial infarction, non Q-wave (55)
    CL Item
    Non-specific ST-T changes (56)
    CL Item
    J point elevation (57)
    CL Item
    ST elevation (58)
    CL Item
    ST depression (59)
    CL Item
    ST segment abnormality (60)
    CL Item
    U waves (61)
    CL Item
    T wave inversion (62)
    CL Item
    T wave peaked (63)
    CL Item
    T waves biphasic (64)
    CL Item
    T waves flat (65)
    CL Item
    66)Notched T-waves (66)Notched T-waves)
    CL Item
    Low QRS voltage (67)
    CL Item
    T wave abnormality (68)
    CL Item
    Other abnormal rhythm (69)
    CL Item
    Other morphology (70)
    CL Item
    Other conduction (71)
    CL Item
    Other myocardial infarction (72)
    CL Item
    Other depolarization/repolarisation (73)
    CL Item
    Other abnormality/Cardiologist comments (74)
    Item Group
    Unscheduled Pharmacokinetics Samples (PK) - Repeating Form
    C0031328 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    C0205341 (UMLS CUI-3)
    Pharmacokinetic aspects, Sample identification number
    Item
    PK Sample ID
    integer
    C0031328 (UMLS CUI [1,1])
    C1299222 (UMLS CUI [1,2])
    Pharmacokinetic aspects, Date in time, Time
    Item
    Actual date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item Group
    Investigational Product - GSK1120212 Unscheduled (Study Drug) - Repeating Form
    C0304229 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    C0205341 (UMLS CUI-3)
    Experimental drug, Unscheduled, Date in time, Time
    Item
    Unscheduled Dose - Date/Time
    datetime
    C0304229 (UMLS CUI [1,1])
    C3854240 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item Group
    Adverse Event (AE) - Repeating Form
    C0877248 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Adverse event, Sequence Number
    Item
    Sequence number
    integer
    C0877248 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Serious Adverse Event
    Item
    Was the event serious?
    boolean
    C1519255 (UMLS CUI [1])
    Item
    Yes, Seriousness Reason(s)
    text
    C1519255 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Serious Adverse Event, Reason and justification
    Code List
    Yes, Seriousness Reason(s)
    CL Item
    Results in death (1)
    CL Item
    Is life-threatening (2)
    CL Item
    Requires hospitalization or prolongation of existing hospitalization (3)
    CL Item
    Results in disability/incapacity (4)
    CL Item
    Congenital anomaly/birth defect (5)
    CL Item
    Other, specify within general narrative comment (6)
    CL Item
    Serious Protocol Defined Liver Chemistry Stopping/Interruption Criteria Met (7)
    Adverse event
    Item
    Event
    text
    C0877248 (UMLS CUI [1])
    Adverse Event Modified Reported Term
    Item
    Modified term
    text
    C2826798 (UMLS CUI [1])
    Adverse event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
    Item
    MedDRA synonym
    text
    C0877248 (UMLS CUI [1,1])
    C1140263 (UMLS CUI [1,2])
    Adverse event, MedDRA Low Level Term Code
    Item
    MedDRA lower level term code
    text
    C0877248 (UMLS CUI [1,1])
    C3898442 (UMLS CUI [1,2])
    Adverse event, Code, Failed
    Item
    Failed coding
    text
    C0877248 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    Adverse Event Start Date
    Item
    Start date
    date
    C2697888 (UMLS CUI [1])
    Adverse event, Before
    Item
    Did the event occur prior to rollover?
    boolean
    C0877248 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    Item
    Outcome/End date
    text
    C1705586 (UMLS CUI [1,1])
    C2697886 (UMLS CUI [1,2])
    Adverse Event Outcome, Adverse Event End Date
    Code List
    Outcome/End date
    CL Item
    Recovered/Resolved, prove End Date and Time (1)
    CL Item
    Recovering/Resolving (2)
    CL Item
    Not recovered/Not resolved (3)
    CL Item
    Recovered/Recovered with sequelae, prove End Date and Time (4)
    CL Item
    Fatal, record Date and Time of Death (5)
    Adverse Event End Date Time
    Item
    End Date and Time
    datetime
    C2826793 (UMLS CUI [1])
    Adverse event, Date of death, Time of death
    Item
    Date and Time of Death
    datetime
    C0877248 (UMLS CUI [1,1])
    C1148348 (UMLS CUI [1,2])
    C1301931 (UMLS CUI [1,3])
    Item
    Frequency
    text
    C0877248 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Adverse event, Frequencies
    Code List
    Frequency
    CL Item
    Single Episode (1)
    CL Item
    Intermittent (2)
    Item
    Intensity at onset of event
    text
    C0877248 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0332162 (UMLS CUI [1,3])
    Adverse event, Symptom intensity, Onset
    Code List
    Intensity at onset of event
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (4)
    Item
    Maximum intensity
    text
    C0877248 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    Adverse event, Symptom intensity, Onset
    Code List
    Maximum intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (4)
    Item
    Grade at onset of event
    text
    C0877248 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0332162 (UMLS CUI [1,3])
    Adverse event, Grade, Onset
    Code List
    Grade at onset of event
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Maximum grade
    text
    C0877248 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    Adverse event, Grade, Onset
    Code List
    Maximum grade
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Grade or intensity at onset of event
    text
    C0877248 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [1,3])
    C0332162 (UMLS CUI [1,4])
    Adverse event, Grade, Symptom intensity, Onset
    Code List
    Grade or intensity at onset of event
    CL Item
    Mild or Grade 1 (1)
    CL Item
    Moderate or Grade 2 (2)
    CL Item
    Severe or Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    CL Item
    Not applicable (6)
    Item
    Maximum Grade or intensity
    text
    C0877248 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [1,3])
    C0806909 (UMLS CUI [1,4])
    Adverse event, Grade, Symptom intensity, Onset
    Code List
    Maximum Grade or intensity
    CL Item
    Mild or Grade 1 (1)
    CL Item
    Moderate or Grade 2 (2)
    CL Item
    Severe or Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    CL Item
    Not applicable (6)
    Item
    Were any actions taken with investigational product(s) as a result of the AE?
    text
    C0877248 (UMLS CUI [1,1])
    C1704758 (UMLS CUI [1,2])
    Adverse event, Action Taken with Study Treatment
    Code List
    Were any actions taken with investigational product(s) as a result of the AE?
    CL Item
    No action taken with investigational product(s) (1)
    CL Item
    Yes, actions were taken with investigational product(s) (2)
    CL Item
    Not applicable, AE occurred when not receiving investigational product(s) (3)
    Item
    Yes, tick all that apply
    text
    C0877248 (UMLS CUI [1,1])
    C1704758 (UMLS CUI [1,2])
    Adverse event, Action Taken with Study Treatment
    Code List
    Yes, tick all that apply
    CL Item
    Investigational product(s) withdrawn (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose interrupted (3)
    CL Item
    Dose delayed (4)
    CL Item
    Cycle interrupted (5)
    CL Item
    Cycle delayed (6)
    CL Item
    Infusion interrupted (7)
    CL Item
    Infusion delayed (8)
    Item
    Most clinically significant action taken with investigational product(s) as a Result of the AE
    text
    C0877248 (UMLS CUI [1,1])
    C1704758 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Adverse Event, Action Taken with Study Treatment, Clinical Significance
    Code List
    Most clinically significant action taken with investigational product(s) as a Result of the AE
    CL Item
    Investigational product(s) withdrawn (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose increased (3)
    CL Item
    Dose not changed (4)
    CL Item
    Dose interrupted (5)
    CL Item
    Not applicable (6)
    Adverse event, Withdraw
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C0877248 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Adverse event, Causations, Experimental drug
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C0877248 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Item
    Yes, Check all that apply
    text
    C0877248 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Adverse event, Causations, Experimental drug
    Code List
    Yes, Check all that apply
    CL Item
    Lapatinib (1)
    CL Item
    Esomeprazole (2)
    Adverse event, Duration
    Item
    Duration of AE if < 24 hours
    time
    C0877248 (UMLS CUI [1,1])
    C2926735 (UMLS CUI [1,2])
    Adverse event, Time of onset, Date last dose
    Item
    Time to onset since last dose
    time
    C0877248 (UMLS CUI [1,1])
    C0449244 (UMLS CUI [1,2])
    C1762893 (UMLS CUI [1,3])
    Adverse event, dose-limiting, Drug toxicity
    Item
    Is this adverse event a dose-limiting toxicity during the determinative period?
    boolean
    C0877248 (UMLS CUI [1,1])
    C1512043 (UMLS CUI [1,2])
    C0013221 (UMLS CUI [1,3])
    Adverse event, Therapeutic procedure, Concomitant Agent
    Item
    Were concomitant medications taken to treat this adverse event?
    boolean
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C2347852 (UMLS CUI [1,3])
    Adverse event, Part, Start Date
    Item
    Start Date of Event Segment
    date
    C0877248 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Item
    Intensity of event segment
    text
    C0877248 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [1,3])
    Adverse event, Part, Symptom intensity
    Code List
    Intensity of event segment
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Grade of event segment
    text
    C0877248 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    C0441800 (UMLS CUI [1,3])
    Adverse event, Part, Symptom intensity
    Code List
    Grade of event segment
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Grade or Intensity of event segment
    text
    C0877248 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    C0441800 (UMLS CUI [1,3])
    C0518690 (UMLS CUI [1,4])
    Adverse event, Part, Symptom intensity
    Code List
    Grade or Intensity of event segment
    CL Item
    Mild or Grade 1 (1)
    CL Item
    Moderate or Grade 2 (2)
    CL Item
    Severe or Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Adverse event, Therapeutic procedure, Start Date
    Item
    Start Date of Action(s)
    date
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Item
    Action taken with investigational product
    text
    C0877248 (UMLS CUI [1,1])
    C1704758 (UMLS CUI [1,2])
    Adverse event, Action Taken with Study Treatment
    Code List
    Action taken with investigational product
    CL Item
    Investigational product(s) withdrawn (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose interrupted (3)
    CL Item
    Dose delayed (4)
    Item
    Investigational product action is taken with
    text
    C0877248 (UMLS CUI [1,1])
    C1704758 (UMLS CUI [1,2])
    Adverse event, Action Taken with Study Treatment
    Code List
    Investigational product action is taken with
    CL Item
    Lapatinib (1)
    CL Item
    Esomeprazole (2)
    Serious Adverse Event, Start Date
    Item
    Date event became serious (Date event met serious criteria)
    date
    C1519255 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Serious Adverse Event, End date
    Item
    Date event ceased to be serious
    date
    C1519255 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Events (SAE)
    C1519255 (UMLS CUI-1)
    Serious Adverse Event, Sequence Number
    Item
    SAE Sequence Number
    integer
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Item
    Report
    text
    C3897642 (UMLS CUI [1])
    Serious Adverse Event Report
    Code List
    Report
    CL Item
    Initial (1)
    CL Item
    Follow-Up (2)
    Serious Adverse Event, Report, Start Date, Start time
    Item
    SAE form started
    datetime
    C1519255 (UMLS CUI [1,1])
    C0684224 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C1301880 (UMLS CUI [1,4])
    Item
    Seriousness Reason(s)
    text
    C1519255 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    undefined item
    Code List
    Seriousness Reason(s)
    CL Item
    Results in death  (1)
    CL Item
    Is life-threatening (2)
    CL Item
    Requires hospitalization or prolongation of existing hospitalization (3)
    CL Item
    Results in disability/incapacity (4)
    CL Item
    Congenital anomaly/birth defect  (5)
    CL Item
    Other, specify with general narrative comment (6)
    Serious Adverse Event, Causations, Activities, Study Subject Participation Status
    Item
    Was SAE caused by activities related to study participation (e.g. procedures)?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C0441655 (UMLS CUI [1,3])
    C2348568 (UMLS CUI [1,4])
    Serious Adverse Event
    Item
    Serious Adverse Event
    text
    Serious Adverse Event, Adverse Event Modified Reported Term
    Item
    Modified term copied from adverse event form
    text
    C1519255 (UMLS CUI [1,1])
    C2826798 (UMLS CUI [1,2])
    Serious Adverse Event, Start Date
    Item
    Start date
    date
    C1519255 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Outcome / End date
    text
    C1519255 (UMLS CUI [1,1])
    C1705586 (UMLS CUI [1,2])
    Serious Adverse Event, Adverse Event Outcome
    Code List
    Outcome / End date
    CL Item
    Recovered/Resolved, provide End Date and Time (1)
    CL Item
    Recovering/Resolving (2)
    CL Item
    Not recovered/Not resolved (3)
    CL Item
    Recovered/Resolved with sequelae, provide End Date and Time  (4)
    CL Item
    Fatal, record Date and Time of Death (5)
    Serious Adverse Event, End date, End Time
    Item
    End Date and Time
    datetime
    C1519255 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [1,3])
    Serious Adverse Event, Date of death, Time of death
    Item
    Date and Time of Death
    datetime
    C1519255 (UMLS CUI [1,1])
    C1302234 (UMLS CUI [1,2])
    C1148348 (UMLS CUI [1,3])
    C1301931 (UMLS CUI [1,4])
    Item
    Frequency
    text
    C1519255 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Serious Adverse Event, Frequencies
    Code List
    Frequency
    CL Item
    Single Episode (1)
    CL Item
    Intermittent (2)
    Item
    Maximum Intensity
    text
    C1519255 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    Serious Adverse Event, Symptom intensity, Maximum
    Code List
    Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe  (3)
    CL Item
    Not applicable (4)
    Item
    Maximum grade
    text
    C1519255 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    Serious Adverse Event, Grade, Maximum
    Code List
    Maximum grade
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Maximum Grade or Intensity
    text
    C1519255 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [1,3])
    C0806909 (UMLS CUI [1,4])
    Serious Adverse Event, Grade, Symptom intensity, Maximum
    Code List
    Maximum Grade or Intensity
    CL Item
    Mild or Grade 1 (1)
    CL Item
    Moderate or Grade 2 (2)
    CL Item
    Severe or Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    CL Item
    Not applicable (6)
    Serious Adverse Event, Toxicity aspects, Patient History
    Item
    Toxicity/Intensity History
    text
    C1519255 (UMLS CUI [1,1])
    C0040539 (UMLS CUI [1,2])
    C0679831 (UMLS CUI [1,3])
    Item
    Most clinically significant action taken with investigational product(s) as a Result of the AE
    text
    C1519255 (UMLS CUI [1,1])
    C1704758 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Serious Adverse Event, Action Taken with Study Treatment, Clinical Significance
    Code List
    Most clinically significant action taken with investigational product(s) as a Result of the AE
    CL Item
    Investigational product(s) withdrawn (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose increased (3)
    CL Item
    Dose not changed (4)
    CL Item
    Dose interrupted (5)
    CL Item
    Not applicable (6)
    Serious Adverse Event, Action Taken with Study Treatment
    Item
    Action(s) taken with Investigational Product
    text
    C1519255 (UMLS CUI [1,1])
    C1704758 (UMLS CUI [1,2])
    Serious Adverse Event, Withdraw
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C1519255 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Serious Adverse Event, Investigational New Drugs, Relationships
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    text
    C1519255 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Serious Adverse Event, Duration
    Item
    Duration of AE if < 24 hours
    time
    C1519255 (UMLS CUI [1,1])
    C2926735 (UMLS CUI [1,2])
    Serious Adverse Event, Time of onset, Time last dose
    Item
    Time to onset since last dose
    time
    C1519255 (UMLS CUI [1,1])
    C0449244 (UMLS CUI [1,2])
    C0946444 (UMLS CUI [1,3])
    Serious Adverse Event, Dose-limiting, Drug toxicity
    Item
    Is this adverse event a dose-limiting toxicity during the determinative period?
    boolean
    C1519255 (UMLS CUI [1,1])
    C1512043 (UMLS CUI [1,2])
    C0013221 (UMLS CUI [1,3])
    Serious Adverse Event, Part
    Item
    Date segments adverse event was serious
    date
    C1519255 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    Serious Adverse Event, Concomitant Agent
    Item
    Are there any relevant concomitant medications associated with this serious adverse event?
    boolean
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Serious Adverse Event, Concomitant Agent, Sequence Number
    Item
    Concomitant Medication - Sequence Number
    integer
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C2348184 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Medication name
    Item
    Concomitant Medication - Drug Name
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C2360065 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Concomitant Medication Modified Reported Term
    Item
    Concomitant Medication - Modified reported term
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C2826819 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Medication name
    Item
    Concomitant Medication - Drug Name
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C2360065 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Dosage
    Item
    Concomitant Medication - Unit Dose
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Unit of Measure
    Item
    Concomitant Medication - Units
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Frequencies
    Item
    Concomitant Medication - Frequency
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0439603 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Drug Administration Routes
    Item
    Concomitant Medication - Route
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Reason and justification
    Item
    Concomitant Medication - Reason for Medication
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Concomitant Medication Modified Reported Term, Reason and justification
    Item
    Concomitant Medication - Reason for Medication Modified Report Term
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C2826819 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    Serious Adverse Event, Concomitant Agent, Start Date
    Item
    Concomitant Medication - Start Date
    date
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing
    Item
    Concomitant Medication - Ongoing?
    boolean
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C2826666 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, End Date
    Item
    Concomitant Medication - No, End Date
    date
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Duration
    Item
    Concomitant Medication - Total Duration
    time
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0449238 (UMLS CUI [1,3])
    Serious Adverse Event, Concomitant Agent, Duration, Unit of Measure
    Item
    Concomitant Medication - Duration Unit
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0449238 (UMLS CUI [1,3])
    C1519795 (UMLS CUI [1,4])
    Serious Adverse Event, Experimental drug, Initiation
    Item
    Did SAE occur after initiation of study medication?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C1704686 (UMLS CUI [1,3])
    Serious Adverse Event, Randomization, Numbers
    Item
    Randomization Number
    integer
    C1519255 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Serious Adverse Event, Disease, Sequence Number
    Item
    Relevant Medical Conditions - MHx Sequence Number
    integer
    C1519255 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C2348184 (UMLS CUI [1,3])
    Serious Adverse Event, Disease
    Item
    Relevant Medical Conditions - Specific Condition Name
    text
    C1519255 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C2348184 (UMLS CUI [1,3])
    Serious Adverse Event, Disease, Adverse Event Modified Reported Term
    Item
    Relevant Medical Conditions - Modified reported term
    text
    C1519255 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C2826798 (UMLS CUI [1,3])
    Serious Adverse Event, Disease, Date of onset
    Item
    Relevant Medical Conditions - Date of onset
    date
    C1519255 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0574845 (UMLS CUI [1,3])
    Serious Adverse Event, Disease, Continuous
    Item
    Relevant Medical Conditions - Continuing?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0549178 (UMLS CUI [1,3])
    Serious Adverse Event, Disease, End date
    Item
    Relevant Medical Conditions - No, specify date of last occurrence
    date
    C1519255 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    Serious Adverse Event, diagnostic procedure, Sequence Number
    Item
    Relevant Diagnostic Results - Lab Sequence Number
    integer
    C1519255 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C2348184 (UMLS CUI [1,3])
    Serious Adverse Event, diagnostic procedure, Test Name
    Item
    Relevant Diagnostic Results - Test Name
    text
    C1519255 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C2826273 (UMLS CUI [1,3])
    Serious Adverse Event, diagnostic procedure, Date in time
    Item
    Relevant Diagnostic Results - Test Date
    date
    C1519255 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Serious Adverse Event, diagnostic procedure, Result
    Item
    Relevant Diagnostic Results - Test Result
    text
    C1519255 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Serious Adverse Event, diagnostic procedure, Unit of Measure
    Item
    Relevant Diagnostic Results - Test Units
    text
    C1519255 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Serious Adverse Event, diagnostic procedure, Normal Range, Low
    Item
    Relevant Diagnostic Results - Normal Low Range
    text
    C1519255 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C0086715 (UMLS CUI [1,3])
    C0205251 (UMLS CUI [1,4])
    Serious Adverse Event, diagnostic procedure, Normal Range, High
    Item
    Relevant Diagnostic Results - Normal High Range
    text
    C1519255 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C0086715 (UMLS CUI [1,3])
    C0205250 (UMLS CUI [1,4])
    Serious Adverse Event, diagnostic procedure, Result, Other
    Item
    Relevant Diagnostic Results - Relevant diagnostic results not noted above
    text
    C1519255 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Serious Adverse Event, Relationships, Experimental drug
    Item
    Rechallenge - If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    text
    C1518404 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Serious Adverse Event, Experimental drug
    Item
    Investigational Product - Study Drug
    text
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Serious Adverse Event, Experimental drug, Start Date
    Item
    Investigational Product - Start Date
    date
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Serious Adverse Event, Experimental drug, End Date
    Item
    Investigational Product - Stop Date
    date
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    Serious Adverse Event, Experimental drug, Dosage
    Item
    Investigational Product - Dose
    text
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    Serious Adverse Event, Experimental drug, Cumulative Dose
    Item
    Investigational Product - Cumulative Dose
    text
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2986497 (UMLS CUI [1,3])
    Serious Adverse Event, Comment
    Item
    General Narrative Comments
    text
    C1519255 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Concomitant Medications - Repeating Form
    C2347852 (UMLS CUI-1)
    Concomitant Agent, Sequence Number
    Item
    Sequence Number
    integer
    C2347852 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Concomitant Agent, Medication name
    Item
    Drug Name
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Agent, Concomitant Medication Modified Reported Term
    Item
    Modified reported term
    text
    C2347852 (UMLS CUI [1,1])
    C2826819 (UMLS CUI [1,2])
    Concomitant Agent, Code, Failed
    Item
    Failed coding
    text
    C2347852 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    Concomitant Agent, Dosage
    Item
    Unit Dose
    text
    C2347852 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Concomitant Agent, Unit of Measure
    Item
    Units
    text
    C2347852 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Concomitant Agent, Frequencies
    Item
    Frequency
    text
    C2347852 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Concomitant Agent, Drug Administration Routes
    Item
    Route
    text
    C2347852 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Concomitant Agent, Reason and justification
    Item
    Reason for Medication
    text
    C2347852 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Concomitant Medication Start Date
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication Previous Occurrence
    Item
    Taken Prior to Study?
    boolean
    C2826667 (UMLS CUI [1])
    Concomitant Medication Ongoing
    Item
    Ongoing?
    boolean
    C2826666 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    No, specify End Date
    date
    C2826744 (UMLS CUI [1])
    Concomitant Agent, Devices, Medication administered
    Item
    Device Used to Administer Medication
    text
    C2347852 (UMLS CUI [1,1])
    C0699733 (UMLS CUI [1,2])
    C0806914 (UMLS CUI [1,3])
    Concomitant Agent, Daily Dose, Total
    Item
    Total Daily Dose
    text
    C2347852 (UMLS CUI [1,1])
    C2348070 (UMLS CUI [1,2])
    C0439810 (UMLS CUI [1,3])
    Concomitant Agent, Disease Exacerbation
    Item
    Was drug administered for an exacerbation?
    boolean
    C2347852 (UMLS CUI [1,1])
    C0235874 (UMLS CUI [1,2])
    Concomitant Agent, Rescue remedy
    Item
    Was drug administered as a rescue medication?
    boolean
    C2347852 (UMLS CUI [1,1])
    C0884980 (UMLS CUI [1,2])
    Concomitant Agent, Cumulative Dose
    Item
    Cumulative Dose Used?
    boolean
    C2347852 (UMLS CUI [1,1])
    C2986497 (UMLS CUI [1,2])
    Concomitant Agent
    Item
    Was drug ever used?
    boolean
    C2347852 (UMLS CUI [1])
    Concomitant Agent, Duration, Total
    Item
    Total Duration
    text
    C2347852 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    C0439810 (UMLS CUI [1,3])
    Concomitant Agent, Duration, Unit of Measure
    Item
    Duration Unit
    text
    C2347852 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
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