0 Ratings
ID

29247

Description

A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Keywords

Versions (3)
  1. 1/31/18 1/31/18 -
  2. 2/22/18 2/22/18 -
  3. 3/11/18 3/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 11, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497

    English

    Visit 1 (Screening)

    1 forms  
    1. StudyEvent: ODM
      1. Visit 1 (Screening)
    Demography
    Description

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of Birth
    Description

    Date of Birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Description

    Gender

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Description

    White: Origins in the original peoples of Europe, the Middle East, Western Russia, Afghanistan, or the white racial groups of Africa Black: Origins in any of the black racial groups of Africa Asian: Origins in the original peoples of the Indian subcontinent, the Far East, Southeast Asia, or the Pacific Islands American Hispanic: Hispanics of North, Central or South American origin American Hispanic Other: People whose racial group is not represented above, or whose predominant origin cannot be determined

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034510
    Childbearing potential
    Description

    Childbearing potential

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    Contraceptive Methods
    Description

    Contraceptive Methods

    Alias
    UMLS CUI-1
    C0700589
    Contraceptive method
    Description

    Check all that apply

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0700589
    Other
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C0205394
    Psychiatric History
    Description

    Psychiatric History

    Alias
    UMLS CUI-1
    C0748059
    Psychiatric Condition
    Description

    Psychiatric Condition

    Data type

    text

    Alias
    UMLS CUI [1]
    C0004936
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    Continuing?
    Description

    Continuing psychiatric condition

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0439598
    UMLS CUI [1,2]
    C0004936
    Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Psychiatric History (cont.)
    Description

    Psychiatric History (cont.)

    Alias
    UMLS CUI-1
    C0748061
    UMLS CUI-2
    C0205394
    Are there any relevant additional psychiatric conditions not identified by the MINI but by the full Psychiatric Interview?
    Description

    If 'Yes' please record the full condition below

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0748061
    UMLS CUI [1,2]
    C0205394
    Psychiatric History_Other_List
    Description

    Psychiatric History_Other_List

    Alias
    UMLS CUI-1
    C0748061
    UMLS CUI-2
    C0205394
    Specify Condition
    Description

    Psychiatric Condition

    Data type

    text

    Alias
    UMLS CUI [1]
    C0004936
    Specify DSM-IV code:
    Description

    DSM-IV code

    Data type

    text

    Alias
    UMLS CUI [1]
    C0220952
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    Continuing?
    Description

    Continuing psychiatric condition

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0439598
    UMLS CUI [1,2]
    C0004936
    Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    History of Major Depression
    Description

    History of Major Depression

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C1269683
    1. Has the subject had any prior episodes of Major Depression?
    Description

    If yes, continue with questions 2-4.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1269683
    2. Month and year of first previous episode of Major Depression.
    Description

    Date of first previous episode of Major Depression

    Data type

    partialDate

    Alias
    UMLS CUI [1,1]
    C0024517
    UMLS CUI [1,2]
    C0205435
    3. Number of previous episodes of depressive illness in the past (do not include present episode).
    Description

    Number of previous episodes of depressive illness

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0349217
    UMLS CUI [1,2]
    C4086638
    4. Has the subject received any medication for past episodes of Major Depression which was stopped more than one month prior to the screening visit?
    Description

    If 'Yes' please record details in the Depression Medication History panel.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1269683
    Depresison medication history
    Description

    Depresison medication history

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0013227
    UMLS CUI-3
    C1269683
    Drug Name (trade name preferred)
    Description

    Record the details of any medication that the subject has received for past episodes of Major Depression. Only record medication that was stopped more than one month prior to the screening visit. Note: Medication received for Major Depression within one month prior to the screening visit should be recorded on the Prior and Concomitant Medications panel.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    HAM-D 17 IVRS prompt
    Description

    HAM-D 17 IVRS prompt

    Alias
    UMLS CUI-1
    C3639712
    Did the subject complete the HAM-D assessment at this visit via the Interactive Voice Response System (IVRS)?
    Description

    ----> If 'Yes', continue below ----> If 'No', the subject is not eligible to continue in this study.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3639712
    If 'Yes', was the subject's HAM-D total score >=18 at this visit?
    Description

    If 'No', the subject is not eligible to continue in this study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3639712
    UMLS CUI [1,2]
    C0449820
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Heart Rate
    Description

    Vital signs should be measured after the subject has been seated for at least 5 minutes. Heart Rate will be measured for 30 seconds.

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Blood Pressure Systolic
    Description

    Vital signs should be measured after the subject has been seated for at least 5 minutes. Average Blood Pressure from 2 readings is recorded.

    Data type

    integer

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

    Vital signs should be measured after the subject has been seated for at least 5 minutes. Average Blood Pressure from 2 readings is recorded.

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Physical Examination Prompt
    Description

    Physical Examination Prompt

    Alias
    UMLS CUI-1
    C0031809
    Was a physical examination completed for this visit?
    Description

    Physical Examination

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031809
    Were any abnormalities detected?
    Description

    If 'Yes', please record the appropriate details in the Current Medical Conditions panel which is the next panel.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1704258
    Current Medical Conditions
    Description

    Current Medical Conditions

    Alias
    UMLS CUI-1
    C3899485
    Body System
    Description

    Record any current medical condition. Enter a separate record for each condition, selecting the appropriate body system. Psychiatric history should NOT be recorded here, but in the Psychiatric History panel. Allergic conditions should be recorded on the Allergic History panel.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0460002
    Condition
    Description

    Record any current medical condition. Enter a separate record for each condition, selecting the appropriate body system. Psychiatric history should NOT be recorded here, but in the Psychiatric History panel. Allergic conditions should be recorded on the Allergic History panel.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0012634
    Allergic History
    Description

    Allergic History

    Alias
    UMLS CUI-1
    C0020517
    Medical History (past or current)
    Description

    Medical History

    Data type

    text

    Alias
    UMLS CUI [1]
    C0262926
    Asthma
    Description

    Asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    Environmental Allergy
    Description

    ie.hayfever, seasonal rhinitis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0282504
    Food Allergy
    Description

    Food Allergy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0016470
    Specify Food
    Description

    Food Allergy - Specify Food

    Data type

    text

    Alias
    UMLS CUI [1]
    C0016452
    Drug Hypersensitivity / Allergy
    Description

    Drug Hypersensitivity / Allergy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013182
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0015237
    Specify Drug
    Description

    Drug Hypersensitivity / Allergy - Specify Drug

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    Bronchospasm
    Description

    Bronchospasm

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006266
    Rash
    Description

    Rash

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015230
    Urticaria
    Description

    Urticaria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042109
    Pruritis
    Description

    Pruritis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0033774
    Angioedema
    Description

    Angioedema

    Data type

    text

    Alias
    UMLS CUI [1]
    C0002994
    Serum Sickness
    Description

    ie. myalgia, fatigue

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0036830
    Stevens-Johnson Syndrome
    Description

    (severe rash with fever, fatigue, lymphedema)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038325
    Anaphylaxis
    Description

    Anaphylaxis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002792
    OTHER
    Description

    OTHER allergy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0205394
    Specify other:
    Description

    OTHER allergy - specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0205394
    Prior and Concomitant Medication Prompt
    Description

    Prior and Concomitant Medication Prompt

    Alias
    UMLS CUI-1
    C2826257
    UMLS CUI-3
    C2347852
    Has the subject taken any medication (including prescribed, non-prescribed and herbal) within one month of the screening visit, including those that are still ongoing?
    Description

    If 'Yes', please record on the Prior and Concomitant Medications panel.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826257
    UMLS CUI [2]
    C2347852
    12-lead Electrocardiogram
    Description

    12-lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456
    Was the ECG trace completed at this visit?
    Description

    If 'Yes': Ensure the trace is sent to the Central ECG Reader. Refer to the Investigator Guidelines. Please enter the ECG result below AFTER the Central ECG Reader provides the result.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1623258
    Date of ECG
    Description

    Date of ECG

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826640
    Result of ECG
    Description

    If 'Abnormal - clinically significant', please record on the Current Medical Conditions panel.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Laboratory tests
    Description

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885
    Date of blood sample
    Description

    Date of blood sample

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Date of urine samples
    Description

    Date of urine samples

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2371162
    UMLS CUI [1,2]
    C0011008
    After reviewing the laboratory results, are there any clinically significant abnormalities?
    Description

    Please answer the questions AFTER the laboratory results are back. If 'Yes' please record the appropriate details in the Current Medical Conditions panel. Saving this panel after selecting 'Yes' will take you to the Current Medical Conditions panel.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1853129
    Did the subject have a blood alcohol level of >=15 mg/dl (0.015%) at Screening?
    Description

    Please answer the question AFTER the laboratory results are back. If "Yes", the subject is not eligible for the study. A positive blood alcohol level test may not be repeated

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0202304
    Result of urine drug screen?
    Description

    Please answer the question AFTER the laboratory results are back. If "Positive", the subject is not eligible for the study. A positive urine drug screen test may not be repeated.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0202274
    Serum hCG
    Description

    Serum hCG

    Alias
    UMLS CUI-1
    C2348195
    Was a serum HCG performed?
    Description

    If "Yes", please record result below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348195
    Sample Date
    Description

    Sample Date hCG

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C2348195
    Result
    Description

    If "Positive", withdraw the subject and complete the paper Pregnancy Notification form. Also complete the End of Study Record panels

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348195
    Eligibility Criteria and Comments
    Description

    Eligibility Criteria and Comments

    Alias
    UMLS CUI-1
    C1516637
    UMLS CUI-3
    C0947611
    Did the subject meet all of the inclusion criteria?
    Description

    see seperate form If 'No', check all boxes corresponding to violations of any of the Screening Visit inclusion criteria. Note that the numbering of the criteria is as in the protocol but those criteria that can only be assessed at the Screening Visit are listed. If the subject passed all of the Screening Visit inclusion and exclusion criteria, schedule the Baseline Visit for when the laboratory and ECG results are due back but no more than 14 days time.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    Did the subject meet any of the exclusion criteria?
    Description

    If 'Yes', check all boxes corresponding to the Screening Visit exclusion criteria that disqualified the subject from entry. Note that the numbering of the criteria is as in the protocol but those criteria that can only be assessed at the Screening Visit are listed. If the subject passed all of the Screening Visit inclusion and exclusion criteria, schedule the Baseline Visit for when the laboratory and ECG results are due back but no more than 14 days time.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    Record any additional comments related to this visit
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
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    Similar models

    Visit 1 (Screening)

    1 forms
    1. StudyEvent: ODM
      1. Visit 1 (Screening)
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Demography
    C0011298 (UMLS CUI-1)
    Date of Birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Female (FEMALE)
    CL Item
    Male (MALE)
    Item
    Race
    text
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    White (WHITE)
    CL Item
    Black (BLACK)
    CL Item
    Asian (ASIAN)
    CL Item
    American Hispanic (AMERICAN HISPANIC)
    CL Item
    Other (OTHER)
    Childbearing potential
    Item
    Childbearing potential
    boolean
    C3831118 (UMLS CUI [1])
    Item Group
    Contraceptive Methods
    C0700589 (UMLS CUI-1)
    Item
    Contraceptive method
    integer
    C0700589 (UMLS CUI [1])
    Contraceptive method
    Code List
    Contraceptive method
    CL Item
    Oral contraceptive (1)
    C0009905 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Intrauterine contraceptive device (2)
    C0021900 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Depot contraceptive (implants, injectables) (3)
    C0700589 (UMLS CUI-1)
    C2585377 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Double barrier (condom, diaphragm) (4)
    C0042241 (UMLS CUI-1)
    C3873750 (UMLS CUI-3)
    (Comment:en)
    CL Item
    Sterilisation of male partner (5)
    C0024559 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Abstinence (6)
    C3843422 (UMLS CUI-1)
    (Comment:en)
    Other contraceptive method
    Item
    Other
    text
    C0700589 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Psychiatric History
    C0748059 (UMLS CUI-1)
    Item
    Psychiatric Condition
    text
    C0004936 (UMLS CUI [1])
    Psychiatric Condition
    Code List
    Psychiatric Condition
    CL Item
    Major Depressive Episode (A)
    C0024517 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Dysthymia (B)
    C0013415 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Suicidality (C)
    C0438696 (UMLS CUI-1)
    (Comment:en)
    CL Item
    (Hypo) Manic Episode (D)
    C0349208 (UMLS CUI-1)
    C1396834 (UMLS CUI-3)
    (Comment:en)
    CL Item
    Panic Disorder (E)
    C0030319 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Agoraphobia (F)
    C0001818 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Social Phobia (G)
    C0031572 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Obsessive Compulsive Disorder (H)
    C0028768 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Alcohol (Dependence/Abuse) (J)
    C0085762 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Drug (Dependence/Abuse) (Non-alcohol) (K)
    C1510472 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Psychotic Disorders (L)
    CL Item
    Anorexia Nervosa (M)
    CL Item
    Bulimia Nervosa (N)
    CL Item
    Generalised Anxiety Disorder (O)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Continuing psychiatric condition
    Item
    Continuing?
    boolean
    C0439598 (UMLS CUI [1,1])
    C0004936 (UMLS CUI [1,2])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Item Group
    Psychiatric History (cont.)
    C0748061 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Psychiatric History_Other
    Item
    Are there any relevant additional psychiatric conditions not identified by the MINI but by the full Psychiatric Interview?
    boolean
    C0748061 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Psychiatric History_Other_List
    C0748061 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Psychiatric Condition
    Item
    Specify Condition
    text
    C0004936 (UMLS CUI [1])
    DSM-IV code
    Item
    Specify DSM-IV code:
    text
    C0220952 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Continuing psychiatric condition
    Item
    Continuing?
    boolean
    C0439598 (UMLS CUI [1,1])
    C0004936 (UMLS CUI [1,2])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Item Group
    History of Major Depression
    C0262926 (UMLS CUI-1)
    C1269683 (UMLS CUI-2)
    Previous episodes of Major Depression
    Item
    1. Has the subject had any prior episodes of Major Depression?
    boolean
    C1269683 (UMLS CUI [1])
    Date of first previous episode of Major Depression
    Item
    2. Month and year of first previous episode of Major Depression.
    partialDate
    C0024517 (UMLS CUI [1,1])
    C0205435 (UMLS CUI [1,2])
    Number of previous episodes of depressive illness
    Item
    3. Number of previous episodes of depressive illness in the past (do not include present episode).
    integer
    C0349217 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Previous medication for Major Depression
    Item
    4. Has the subject received any medication for past episodes of Major Depression which was stopped more than one month prior to the screening visit?
    boolean
    C0013227 (UMLS CUI [1,1])
    C1269683 (UMLS CUI [1,2])
    Item Group
    C0262926 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    C1269683 (UMLS CUI-3)
    Drug name
    Item
    Drug Name (trade name preferred)
    text
    C0013227 (UMLS CUI [1])
    Item Group
    HAM-D 17 IVRS prompt
    C3639712 (UMLS CUI-1)
    HAM-D 17
    Item
    Did the subject complete the HAM-D assessment at this visit via the Interactive Voice Response System (IVRS)?
    boolean
    C3639712 (UMLS CUI [1])
    HAM-D 17 total score
    Item
    If 'Yes', was the subject's HAM-D total score >=18 at this visit?
    boolean
    C3639712 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Blood Pressure Systolic
    Item
    Blood Pressure Systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood Pressure Diastolic
    Item
    Blood Pressure Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Item Group
    Physical Examination Prompt
    C0031809 (UMLS CUI-1)
    Physical Examination
    Item
    Was a physical examination completed for this visit?
    boolean
    C0031809 (UMLS CUI [1])
    Physical Examination, abnormalities detected
    Item
    Were any abnormalities detected?
    boolean
    C0031809 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Item Group
    Current Medical Conditions
    C3899485 (UMLS CUI-1)
    Body System
    Item
    Body System
    text
    C0460002 (UMLS CUI [1])
    Condition
    Item
    Condition
    text
    C0012634 (UMLS CUI [1])
    Item Group
    Allergic History
    C0020517 (UMLS CUI-1)
    Item
    Medical History (past or current)
    text
    C0262926 (UMLS CUI [1])
    Medical History
    Code List
    Medical History (past or current)
    CL Item
    past (PAST)
    CL Item
    current (CURRENT)
    Asthma
    Item
    Asthma
    boolean
    C0004096 (UMLS CUI [1])
    Environmental Illness
    Item
    Environmental Allergy
    boolean
    C0282504 (UMLS CUI [1])
    Food Allergy
    Item
    Food Allergy
    boolean
    C0016470 (UMLS CUI [1])
    Food Allergy - Specify Food
    Item
    Specify Food
    text
    C0016452 (UMLS CUI [1])
    Drug Hypersensitivity / Allergy
    Item
    Drug Hypersensitivity / Allergy
    boolean
    C0013182 (UMLS CUI [1])
    C0020517 (UMLS CUI [2,1])
    C0015237 (UMLS CUI [2,2])
    Drug Hypersensitivity / Allergy - Specify Drug
    Item
    Specify Drug
    text
    C0013227 (UMLS CUI [1])
    Bronchospasm
    Item
    Bronchospasm
    boolean
    C0006266 (UMLS CUI [1])
    Rash
    Item
    Rash
    boolean
    C0015230 (UMLS CUI [1])
    Urticaria
    Item
    Urticaria
    boolean
    C0042109 (UMLS CUI [1])
    Pruritis
    Item
    Pruritis
    boolean
    C0033774 (UMLS CUI [1])
    Angioedema
    Item
    Angioedema
    text
    C0002994 (UMLS CUI [1])
    Serum Sickness
    Item
    Serum Sickness
    boolean
    C0036830 (UMLS CUI [1])
    Stevens-Johnson Syndrome
    Item
    Stevens-Johnson Syndrome
    boolean
    C0038325 (UMLS CUI [1])
    Anaphylaxis
    Item
    Anaphylaxis
    boolean
    C0002792 (UMLS CUI [1])
    OTHER allergy
    Item
    OTHER
    boolean
    C0020517 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    OTHER allergy - specify
    Item
    Specify other:
    text
    C0020517 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Prior and Concomitant Medication Prompt
    C2826257 (UMLS CUI-1)
    C2347852 (UMLS CUI-3)
    Prior and concomitant medication
    Item
    Has the subject taken any medication (including prescribed, non-prescribed and herbal) within one month of the screening visit, including those that are still ongoing?
    boolean
    C2826257 (UMLS CUI [1])
    C2347852 (UMLS CUI [2])
    Item Group
    12-lead Electrocardiogram
    C0430456 (UMLS CUI-1)
    ECG completed
    Item
    Was the ECG trace completed at this visit?
    boolean
    C1623258 (UMLS CUI [1])
    Date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Item
    Result of ECG
    integer
    C0438154 (UMLS CUI [1])
    ECG Finding
    Code List
    Result of ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant (2)
    CL Item
    Abnormal - clinically significant (3)
    Item Group
    Laboratory tests
    C0022885 (UMLS CUI-1)
    Date of blood sample
    Item
    Date of blood sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Date of urine samples
    Item
    Date of urine samples
    date
    C2371162 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    laboratory abnormalities
    Item
    After reviewing the laboratory results, are there any clinically significant abnormalities?
    boolean
    C1853129 (UMLS CUI [1])
    Blood alcohol
    Item
    Did the subject have a blood alcohol level of >=15 mg/dl (0.015%) at Screening?
    boolean
    C0202304 (UMLS CUI [1])
    Urine drug screen
    Item
    Result of urine drug screen?
    boolean
    C0202274 (UMLS CUI [1])
    Item Group
    C2348195 (UMLS CUI-1)
    Serum hCG
    Item
    Was a serum HCG performed?
    boolean
    C2348195 (UMLS CUI [1])
    Sample Date hCG
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1,1])
    C2348195 (UMLS CUI [1,2])
    Serum hCG Result
    Item
    Result
    boolean
    C2348195 (UMLS CUI [1])
    Item Group
    C1516637 (UMLS CUI-1)
    C0947611 (UMLS CUI-3)
    Inclusion Criteria
    Item
    Did the subject meet all of the inclusion criteria?
    boolean
    C1512693 (UMLS CUI [1])
    Exclusion Criteria
    Item
    Did the subject meet any of the exclusion criteria?
    boolean
    C0680251 (UMLS CUI [1])
    Comments
    Item
    Record any additional comments related to this visit
    text
    C0947611 (UMLS CUI [1])
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