0 Beoordelingen
ID

17029

Beschrijving

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Cumulative

Trefwoorden

Versies (2)
  1. 22-08-16 22-08-16 -
  2. 28-09-16 28-09-16 -
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22 augustus 2016

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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    DM-ASP1941-1941-CL-0004 NCT01071850

    Engels

    Cumulative DM-ASP1941-1941-CL-0004 NCT01071850

    1 Formulieren  
    Targeted Medical History
    Beschrijving

    Targeted Medical History

    Mecial Condition
    Beschrijving

    Medical Condition

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0012634
    History
    Beschrijving

    Medical History Occurrence

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0262926
    Onset Date
    Beschrijving

    Onset Date Medical History

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C0262926
    Is Medical Condition ongoing?
    Beschrijving

    Medical Condition

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    Currently treated with medication?
    Beschrijving

    Medication

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    Medical History
    Beschrijving

    Medical History

    Alias
    UMLS CUI-1
    C0262926
    Is there any past or present Medical Condition?
    Beschrijving

    medical Condition, past or present

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0332119
    Medical Condition, specify:
    Beschrijving

    Medical Condition

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0012634
    Onset date Medical Condition
    Beschrijving

    Onset Date Medical Condition

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C0012634
    Is Medical Condition ongoing? If no, please provide Recovered Date.
    Beschrijving

    Medical Condition Ongoing

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    Recovered Date
    Beschrijving

    Recovery

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2004454
    Currently treated with medication?
    Beschrijving

    Medication

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    Concomitant Medication
    Beschrijving

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Is there any previous medication and/or concomitant medication to record?
    Beschrijving

    Concomitant Medication

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Medication
    Beschrijving

    Medication

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2347852
    UMLS CUI [2]
    C0013227
    Route of administration
    Beschrijving

    Route of administration

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0013153
    UMLS CUI [2]
    C2347852
    Start date
    Beschrijving

    Start date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0808070
    Stop Date
    Beschrijving

    StopDate

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0011008
    Ongoing
    Beschrijving

    Ongoing

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Dose
    Beschrijving

    Dose

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3174092
    UMLS CUI [2]
    C2347852
    Dose Units
    Beschrijving

    Dose Units

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3174092
    UMLS CUI [2]
    C2347852
    Frequency
    Beschrijving

    Frequency

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3476109
    UMLS CUI [2]
    C2347852
    Indication
    Beschrijving

    Indication

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3146298
    UMLS CUI [2]
    C2347852
    Reason for Use
    Beschrijving

    Reason

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0392360
    UMLS CUI [2]
    C2347852
    Adverse Events
    Beschrijving

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Was any adverse event reported or observed?
    Beschrijving

    Adverse Events

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Adverse Events
    Beschrijving

    Adverse Event

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0877248
    Onset Date
    Beschrijving

    Adverse Event Onset Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2985916
    If the AE onset date is the same day as the First Date of Randomized Study Drug, please select one:
    Beschrijving

    Adverse Event Onset Date

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2985916
    Adverse Event End Date
    Beschrijving

    Adverse Event End Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2697886
    Adverse Event Outcome
    Beschrijving

    Adverse Event Outcome

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1705586
    Adverse Event Course
    Beschrijving

    Adverse Event Course

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0877248
    Adverse Event Severity
    Beschrijving

    Adverse Event Severity

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1710066
    Serious AE? If seriousness is "yes", tick all that apply
    Beschrijving

    Serious Adverse Event

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Serious AE Number
    Beschrijving

    Serious Adverse Event

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1519255
    Death?
    Beschrijving

    AE Death

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C0011065
    Requires or prolongs hospitalization?
    Beschrijving

    AE Hospital

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C0019993
    Congenital Anomaly
    Beschrijving

    AE Congenital

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C2826727
    Life Threatening?
    Beschrijving

    AE Life threatening

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1517874
    Persistent or significant disability / incapacity
    Beschrijving

    AE persistent

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C0231170
    Other medical importance?
    Beschrijving

    AE Other

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C0205394
    Action taken with study treatment
    Beschrijving

    Study treatment

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C0949266
    Treatment required?
    Beschrijving

    Treatment required

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0332307
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [1,4]
    C1521801
    Drug Treatment required?
    Beschrijving

    Drug Treatment required

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C0013216
    Non Medication Therapy
    Beschrijving

    Non Medication Therapy

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    Relationship to Study Drug
    Beschrijving

    AE Relation to study drug

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C0304229
    Was the infection symptomatic? (Only UTI/Genital Infection)
    Beschrijving

    AE UTI/Genital

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2]
    C0729552
    UMLS CUI [3]
    C0042029
    Was the infection confirmed by a laboratory? (Only UTI/Genital Infection)
    Beschrijving

    AE UTI/Genital

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2]
    C0729552
    UMLS CUI [3]
    C0042029
    UMLS CUI [4]
    C3244125
    Hypoglycemic Event Classification
    Beschrijving

    AE hypoglycemia

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2]
    C0020615
    Was a glucometer reading taken prior to treating the Hypoglycemic Event?
    Beschrijving

    AE hypoglycemia glucometer

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2]
    C0020615
    UMLS CUI [3]
    C0472226
    glucometer reading
    Beschrijving

    AE hypoglycemia glucometer

    Datatype

    text

    Maateenheden
    • mmol/L
    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2]
    C0020615
    UMLS CUI [3]
    C0472226
    UMLS CUI [4]
    C0005802
    mmol/L
    Number of hours since the last meal/ snack?
    Beschrijving

    AE hypoglycemia last meal

    Datatype

    text

    Maateenheden
    • hours
    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2]
    C0020615
    hours
    Number of hours since the last dose of ASP1941 study medication.
    Beschrijving

    AE hypoglycemia last meal

    Datatype

    text

    Maateenheden
    • hours
    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2]
    C0020615
    UMLS CUI [3]
    C0013216
    hours
    Number of hours since the last dose of Metformin study medication.
    Beschrijving

    AE hypoglycemia last meal

    Datatype

    text

    Maateenheden
    • hours
    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2]
    C0020615
    UMLS CUI [3]
    C0013216
    hours
    Serious Adverse Event reconciled?
    Beschrijving

    Serious Adverse Event

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    Adjudication Reference ID
    Beschrijving

    Adjudication Reference ID

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0680730
    Hospitalization Records
    Beschrijving

    Hospitalization Records

    Alias
    UMLS CUI-1
    C0019993
    Was the subject hospitalized from the time of First Dose of Randomized Study Drug through Visit 11?
    Beschrijving

    Hospitalization

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019993
    Date of admission:
    Beschrijving

    Date of admission

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0019993
    Ongoing?
    Beschrijving

    Ongoing

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0549178
    UMLS CUI [1,2]
    C0019993
    Date of discharge:
    Beschrijving

    Date of Discharge

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C2361123
    UMLS CUI [1,2]
    C0019993
    Type of Hospitalization
    Beschrijving

    Type of Hospitalization

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0019993
    Reason for Hospitalization
    Beschrijving

    Reason for Hospitalization

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C0019993
    If Other, specify
    Beschrijving

    Reason for Hospitalization, Other

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0019993
    UMLS CUI [2]
    C0205394
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    Similar models

    Cumulative DM-ASP1941-1941-CL-0004 NCT01071850

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Targeted Medical History
    Medical Condition
    Item
    Mecial Condition
    text
    C0012634 (UMLS CUI [1])
    Medical History Occurrence
    Item
    History
    boolean
    C0262926 (UMLS CUI [1])
    Onset Date Medical History
    Item
    Onset Date
    date
    C0574845 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    Medical Condition
    Item
    Is Medical Condition ongoing?
    boolean
    C0012634 (UMLS CUI [1])
    Medication
    Item
    Currently treated with medication?
    boolean
    C0013227 (UMLS CUI [1])
    Item Group
    Medical History
    C0262926 (UMLS CUI-1)
    medical Condition, past or present
    Item
    Is there any past or present Medical Condition?
    boolean
    C0012634 (UMLS CUI [1,1])
    C0332119 (UMLS CUI [1,2])
    Medical Condition
    Item
    Medical Condition, specify:
    text
    C0012634 (UMLS CUI [1])
    Onset Date Medical Condition
    Item
    Onset date Medical Condition
    date
    C0574845 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Medical Condition Ongoing
    Item
    Is Medical Condition ongoing? If no, please provide Recovered Date.
    boolean
    C0012634 (UMLS CUI [1])
    Recovery
    Item
    Recovered Date
    date
    C2004454 (UMLS CUI [1])
    Medication
    Item
    Currently treated with medication?
    boolean
    C0013227 (UMLS CUI [1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant Medication
    Item
    Is there any previous medication and/or concomitant medication to record?
    boolean
    C2347852 (UMLS CUI [1])
    Medication
    Item
    Medication
    text
    C2347852 (UMLS CUI [1])
    C0013227 (UMLS CUI [2])
    Item
    Route of administration
    integer
    C0013153 (UMLS CUI [1])
    C2347852 (UMLS CUI [2])
    Route of administration
    Code List
    Route of administration
    CL Item
    oral (1)
    CL Item
    intravenous (2)
    CL Item
    topical (3)
    CL Item
    nasogastric (4)
    CL Item
    subcutaneous (5)
    CL Item
    intramuscular (6)
    CL Item
    ear/auricular (7)
    CL Item
    ophthalmic (8)
    CL Item
    sublingual (9)
    CL Item
    inhaled (10)
    CL Item
    continuous inhalation (11)
    CL Item
    swish & spit/swallow (12)
    CL Item
    intranasal (13)
    CL Item
    transdermal (14)
    CL Item
    vaginal (15)
    CL Item
    rectal (16)
    CL Item
    epidural (17)
    CL Item
    intrathecal (18)
    CL Item
    peri-articular (19)
    CL Item
    intraperitoneal (20)
    CL Item
    intradermal (21)
    CL Item
    intra-arterial (22)
    CL Item
    intra-urethral (23)
    CL Item
    unknown (24)
    CL Item
    other (25)
    Start date
    Item
    Start date
    date
    C2347852 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    StopDate
    Item
    Stop Date
    date
    C2347852 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Ongoing
    Item
    Ongoing
    boolean
    C2347852 (UMLS CUI [1])
    Dose
    Item
    Dose
    text
    C3174092 (UMLS CUI [1])
    C2347852 (UMLS CUI [2])
    Dose Units
    Item
    Dose Units
    text
    C3174092 (UMLS CUI [1])
    C2347852 (UMLS CUI [2])
    Frequency
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    C2347852 (UMLS CUI [2])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1])
    C2347852 (UMLS CUI [2])
    Item
    Reason for Use
    integer
    C0392360 (UMLS CUI [1])
    C2347852 (UMLS CUI [2])
    Reason
    Code List
    Reason for Use
    CL Item
    Primary Diagnosis (1)
    CL Item
    For Medical History (2)
    CL Item
    For AE (3)
    CL Item
    Prophylaxis (4)
    CL Item
    Other (5)
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    Adverse Events
    Item
    Was any adverse event reported or observed?
    boolean
    C0877248 (UMLS CUI [1])
    Adverse Event
    Item
    Adverse Events
    text
    C0877248 (UMLS CUI [1])
    Adverse Event Onset Date
    Item
    Onset Date
    date
    C2985916 (UMLS CUI [1])
    Item
    If the AE onset date is the same day as the First Date of Randomized Study Drug, please select one:
    integer
    C2985916 (UMLS CUI [1])
    Adverse Event Onset Date
    Code List
    If the AE onset date is the same day as the First Date of Randomized Study Drug, please select one:
    CL Item
    Onset before first dose of study drug (1)
    CL Item
    Onset after first dose of study drug (2)
    Adverse Event End Date
    Item
    Adverse Event End Date
    date
    C2697886 (UMLS CUI [1])
    Item
    Adverse Event Outcome
    integer
    C1705586 (UMLS CUI [1])
    Adverse Event Outcome
    Code List
    Adverse Event Outcome
    CL Item
    Recovered / Resolved (1)
    CL Item
    Recovering / Resolving (2)
    CL Item
    Not Recovered / Not Resolved (3)
    CL Item
    Recovered / Resolved with Sequelae (4)
    CL Item
    Fatal (5)
    CL Item
    Unknown (6)
    Item
    Adverse Event Course
    integer
    C0877248 (UMLS CUI [1])
    Adverse Event Course
    Code List
    Adverse Event Course
    CL Item
    Single Episode (1)
    CL Item
    Intermittent (2)
    CL Item
    Continuous (3)
    Item
    Adverse Event Severity
    integer
    C1710066 (UMLS CUI [1])
    Adverse Event Severity
    Code List
    Adverse Event Severity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Serious Adverse Event
    Item
    Serious AE? If seriousness is "yes", tick all that apply
    boolean
    C1519255 (UMLS CUI [1])
    Serious Adverse Event
    Item
    Serious AE Number
    text
    C1519255 (UMLS CUI [1])
    Item
    Death?
    integer
    C1519255 (UMLS CUI [1])
    C0011065 (UMLS CUI [2])
    AE Death
    Code List
    Death?
    CL Item
    Yes (1)
    Item
    Requires or prolongs hospitalization?
    integer
    C1519255 (UMLS CUI [1])
    C0019993 (UMLS CUI [2])
    AE Hospital
    Code List
    Requires or prolongs hospitalization?
    CL Item
    Yes (1)
    Item
    Congenital Anomaly
    integer
    C1519255 (UMLS CUI [1])
    C2826727 (UMLS CUI [2])
    AE Congenital
    Code List
    Congenital Anomaly
    CL Item
    Yes (1)
    Item
    Life Threatening?
    integer
    C1517874 (UMLS CUI [1])
    AE Life threatening
    Code List
    Life Threatening?
    CL Item
    Yes (1)
    Item
    Persistent or significant disability / incapacity
    integer
    C1519255 (UMLS CUI [1])
    C0231170 (UMLS CUI [2])
    AE persistent
    Code List
    Persistent or significant disability / incapacity
    CL Item
    Yes (1)
    Item
    Other medical importance?
    integer
    C1519255 (UMLS CUI [1])
    C0205394 (UMLS CUI [2])
    AE Other
    Code List
    Other medical importance?
    CL Item
    Yes (1)
    Item
    Action taken with study treatment
    integer
    C1519255 (UMLS CUI [1])
    C0949266 (UMLS CUI [2])
    Study treatment
    Code List
    Action taken with study treatment
    CL Item
    Dose not changed (1)
    CL Item
    drup interrupted (2)
    CL Item
    drug withdrawn (3)
    CL Item
    Not Applicable (4)
    CL Item
    Unknown (5)
    Treatment required
    Item
    Treatment required?
    boolean
    C0332307 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C1521801 (UMLS CUI [1,4])
    Item
    Drug Treatment required?
    integer
    C1519255 (UMLS CUI [1])
    C0013216 (UMLS CUI [2])
    Drug Treatment required?
    Code List
    Drug Treatment required?
    CL Item
    Yes (1)
    Item
    Non Medication Therapy
    integer
    C1519255 (UMLS CUI [1])
    Non Medication Therapy
    Code List
    Non Medication Therapy
    CL Item
    Yes (1)
    Item
    Relationship to Study Drug
    integer
    C1519255 (UMLS CUI [1])
    C0877248 (UMLS CUI [2,1])
    C0304229 (UMLS CUI [2,2])
    AE Relation to study drug
    Code List
    Relationship to Study Drug
    CL Item
    Not related (1)
    CL Item
    possible (2)
    CL Item
    probable (3)
    Item
    Was the infection symptomatic? (Only UTI/Genital Infection)
    integer
    C0877248 (UMLS CUI [1])
    C0729552 (UMLS CUI [2])
    C0042029 (UMLS CUI [3])
    AE UTI/Genital
    Code List
    Was the infection symptomatic? (Only UTI/Genital Infection)
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Unknown (3)
    Item
    Was the infection confirmed by a laboratory? (Only UTI/Genital Infection)
    integer
    C0877248 (UMLS CUI [1])
    C0729552 (UMLS CUI [2])
    C0042029 (UMLS CUI [3])
    C3244125 (UMLS CUI [4])
    AE UTI/Genital
    Code List
    Was the infection confirmed by a laboratory? (Only UTI/Genital Infection)
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Unknown (3)
    Item
    Hypoglycemic Event Classification
    integer
    C0877248 (UMLS CUI [1])
    C0020615 (UMLS CUI [2])
    hypoglycemia
    Code List
    Hypoglycemic Event Classification
    CL Item
    Severe Hypoglycemia (1)
    CL Item
    Documented symptomatic Hypoglycemia (2)
    CL Item
    Asymptomatic Hypoglycemia (3)
    CL Item
    Probable symptomatic Hypoglycemia (4)
    CL Item
    Relative Hypoglycemia (5)
    AE hypoglycemia glucometer
    Item
    Was a glucometer reading taken prior to treating the Hypoglycemic Event?
    boolean
    C0877248 (UMLS CUI [1])
    C0020615 (UMLS CUI [2])
    C0472226 (UMLS CUI [3])
    AE hypoglycemia glucometer
    Item
    glucometer reading
    text
    C0877248 (UMLS CUI [1])
    C0020615 (UMLS CUI [2])
    C0472226 (UMLS CUI [3])
    C0005802 (UMLS CUI [4])
    AE hypoglycemia last meal
    Item
    Number of hours since the last meal/ snack?
    text
    C0877248 (UMLS CUI [1])
    C0020615 (UMLS CUI [2])
    AE hypoglycemia last meal
    Item
    Number of hours since the last dose of ASP1941 study medication.
    text
    C0877248 (UMLS CUI [1])
    C0020615 (UMLS CUI [2])
    C0013216 (UMLS CUI [3])
    AE hypoglycemia last meal
    Item
    Number of hours since the last dose of Metformin study medication.
    text
    C0877248 (UMLS CUI [1])
    C0020615 (UMLS CUI [2])
    C0013216 (UMLS CUI [3])
    Item
    Serious Adverse Event reconciled?
    integer
    C1519255 (UMLS CUI [1])
    Serious Adverse Event
    Code List
    Serious Adverse Event reconciled?
    CL Item
    Yes (1)
    CL Item
    Reviewed (2)
    Adjudication Reference ID
    Item
    Adjudication Reference ID
    text
    C0680730 (UMLS CUI [1])
    Item Group
    Hospitalization Records
    C0019993 (UMLS CUI-1)
    Hospitalization
    Item
    Was the subject hospitalized from the time of First Dose of Randomized Study Drug through Visit 11?
    boolean
    C0019993 (UMLS CUI [1])
    Date of admission
    Item
    Date of admission:
    date
    C0011008 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    Ongoing
    Item
    Ongoing?
    boolean
    C0549178 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    Date of Discharge
    Item
    Date of discharge:
    date
    C2361123 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    Item
    Type of Hospitalization
    integer
    C0019993 (UMLS CUI [1])
    Type of Hospitalization
    Code List
    Type of Hospitalization
    CL Item
    Non ICU (1)
    CL Item
    ICU (2)
    Item
    Reason for Hospitalization
    integer
    C1519255 (UMLS CUI [1])
    C0019993 (UMLS CUI [2])
    Type of Hospitalization
    Code List
    Reason for Hospitalization
    CL Item
    Adverse Event (1)
    CL Item
    Other (2)
    Reason for Hospitalization, Other
    Item
    If Other, specify
    text
    C0019993 (UMLS CUI [1])
    C0205394 (UMLS CUI [2])
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