ID

38958

Description

Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Keywords

Versions (1)
  1. 11/15/19 11/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597

    English

    Concomitant Medications; Non-serious Adverse Events; Serious Adverse Events

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Description

    Centre Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Randomisation Number
    Description

    Randomisation Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Were any concomitant medications taken by the subject during the study?
    Description

    If Yes, record each medication on a separate line using Trade Names where possible.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008976
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Drug Name
    Description

    (Trade Name preferred)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    Concomitant Medication - Unit Dose
    Description

    Concomitant Medication - Unit Dose

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0869039
    Concomitant Medications - Units
    Description

    Concomitant Medications - Units

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1519795
    Concomitant Medication - Frequency
    Description

    Concomitant Medication - Frequency

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3476109
    Concomitant Medication - Route
    Description

    Concomitant Medication - Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0013153
    Concomitant Medication - Reason for Medication
    Description

    Concomitant Medication - Reason for Medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0013227
    Conocmitant Medication - Start Date
    Description

    Conocmitant Medication - Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734
    Conocmitant Medication - Start Time
    Description

    Conocmitant Medication - Start Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C2347852
    Concomitant Medication - Taken prior to Study?
    Description

    Concomitant Medication - Taken prior to Study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Conocmitant Medication - Stop Date
    Description

    Conocmitant Medication - Stop Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744
    Concomitant Medication - Stop Time
    Description

    Concomitant Medication - Stop Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1522314
    Concomitant Medication - Ongoing Medication?
    Description

    Concomitant Medication - Ongoing Medication?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Non-Serious adverse Events
    Description

    Non-Serious adverse Events

    Alias
    UMLS CUI-1
    C1518404
    Did the subject experience any non-serious adverse events during the study?
    Description

    If Yes, record details below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1518404
    Non-Serious adverse Events
    Description

    Non-Serious adverse Events

    Alias
    UMLS CUI-1
    C1518404
    Non-serious Adverse Event
    Description

    Diagnosis Only (if known) Otherwise Sign/Symptom

    Data type

    text

    Alias
    UMLS CUI [1]
    C1518404
    Non-serious Adverse Event Start Date
    Description

    Non-serious Adverse Event Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2697888
    UMLS CUI [1,2]
    C1518404
    Non-serious Adverse Event Start Time
    Description

    Non-serious Adverse Event Start Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1301880
    Non-serious Adverse Event Outcome
    Description

    Non-serious Adverse Event Outcome

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1705586
    Non-serious Adverse Event End Date
    Description

    Non-serious Adverse Event End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2697886
    UMLS CUI [1,2]
    C1518404
    Non-serious Adverse Event End Time
    Description

    Non-serious Adverse Event End Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1522314
    Non-serious Adverse Event Frequency
    Description

    Non-serious Adverse Event Frequency

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0439603
    Non-serious Adverse Event Maximum Intensity
    Description

    Non-serious Adverse Event Maximum Intensity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0806909
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    Description

    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C1518404
    Did the subject withdraw from study as a result of this AE?
    Description

    Did the subject withdraw from study as a result of this AE?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C1518404
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Is there a reasonable possibility that the AE may have been caused by the investigational product?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    Serious Adverse Event
    Description

    Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255
    Did the subject experience a serious adverse event during the study?
    Description

    If Yes, record details below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Serious Adverse Event - Section 1
    Description

    Serious Adverse Event - Section 1

    Alias
    UMLS CUI-1
    C1519255
    Serious Adverse Event
    Description

    Diagnosis Only (if known ) Otherwise Sign/Symptom

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519255
    Serious Adverse Event Start Date
    Description

    Serious Adverse Event Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2697888
    UMLS CUI [1,2]
    C1519255
    Serious Adverse Event Start Time
    Description

    Serious Adverse Event Start Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1301880
    Serious Adverse Event Outcome
    Description

    Serious Adverse Event Outcome

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1705586
    Serious Adverse Event End Date
    Description

    Serious Adverse Event End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2697886
    UMLS CUI [1,2]
    C1519255
    Serious Adverse Event End Time
    Description

    Serious Adverse Event End Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1522314
    Serious Adverse Event Maximum Intensity
    Description

    Serious Adverse Event Maximum Intensity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0806909
    Action Taken with Investigational Product(s) as a Result of the SAE
    Description

    Action Taken with Investigational Product(s) as a Result of the SAE

    Data type

    text

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

    Did the subject withdraw from study as a result of this SAE?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C1519255
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    Description

    Is there a reasonable possibility that the SAE may have been caused by the investigational product?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    If fatal, was a post-mortem/autopsy performed
    Description

    If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1302234
    UMLS CUI [1,3]
    C0004398
    Serious Adverse Event - Section 2 Seriousness
    Description

    Serious Adverse Event - Section 2 Seriousness

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C1710056
    Specify reason(s) for considering this a SAE
    Description

    Check all that apply:

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1710056
    UMLS CUI [1,2]
    C0392360
    If other reason for considering this a SAE, specify
    Description

    If other reason for considering this a SAE, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1710056
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Serious Adverse Event - Section 3 Demography Data
    Description

    Serious Adverse Event - Section 3 Demography Data

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0011298
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Description

    Sex

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Serious Adverse Event - Section 4
    Description

    Serious Adverse Event - Section 4

    Alias
    UMLS CUI-1
    C1519255
    If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?
    Description

    If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0034897
    UMLS CUI [1,3]
    C0304229
    UMLS CUI [1,4]
    C0457454
    Serious Adverse Event - Section 5 Possible Causes of SAE Other Than Investigational Product(s)
    Description

    Serious Adverse Event - Section 5 Possible Causes of SAE Other Than Investigational Product(s)

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0085978
    UMLS CUI-3
    C0304229
    UMLS CUI-4
    C0205394
    Possible Causes of SAE Other Than Investigational Product(s)
    Description

    Check all that apply:

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C0304229
    UMLS CUI [1,4]
    C0205394
    Specify medical conditions
    Description

    Specify medical conditions

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348235
    Specify concomitant medication(s)
    Description

    Specify concomitant medication(s)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2348235
    If other cause of SAE, specify
    Description

    If other cause of SAE, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0085978
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Serious Adverse Event - Section 6 Relevant medical Conditions
    Description

    Serious Adverse Event - Section 6 Relevant medical Conditions

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0012634
    UMLS CUI-3
    C2347946
    Specify any RELEVANT past or current medical disorders, allergies, surgeries that can help explain the SAE.
    Description

    Ensure each medical condition recorded in this section is also recorded in the appropriate Medical Conditions form

    Data type

    text

    Alias
    UMLS CUI [1]
    C0012634
    UMLS CUI [2]
    C0020517
    UMLS CUI [3]
    C0543467
    UMLS CUI [4]
    C1519255
    Medical condition - Date of Onset
    Description

    Medical condition - Date of Onset

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0574845
    Medical condition - Condition Present at Time of the SAE?
    Description

    Medical condition - Condition Present at Time of the SAE?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0150312
    UMLS CUI [1,3]
    C1519255
    If Condition is Present at Time of the SAE, Date of Last Occurence
    Description

    If Condition is Present at Time of the SAE, Date of Last Occurence

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0150312
    UMLS CUI [1,3]
    C1519255
    UMLS CUI [2,1]
    C1517741
    UMLS CUI [2,2]
    C2745955
    UMLS CUI [2,3]
    C0011008
    Serious Adverse Event - Section 7 Other relevant Risk Factors
    Description

    Serious Adverse Event - Section 7 Other relevant Risk Factors

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0035648
    UMLS CUI-3
    C0205394
    Include details of any concomitant medication(s) that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
    Description

    Ensure each concomitant medication recorded in this section is also recorded in the Concomitant Medication form.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1522508
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C0681841
    UMLS CUI [3,1]
    C0085978
    UMLS CUI [3,2]
    C1519255
    UMLS CUI [4,1]
    C2981656
    UMLS CUI [4,2]
    C1519255
    Serious Adverse Event - Section 8 Relevant Concomitant Medications
    Description

    Serious Adverse Event - Section 8 Relevant Concomitant Medications

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C2347852
    SAE Concomitant Medication - Drug Name
    Description

    (Trade Name preferred)

    Data type

    text

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

    SAE Concomitant Medication - Dose

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C3174092
    SAE Concomitant Medication - Unit
    Description

    SAE Concomitant Medication - Unit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0439148
    SAE Concomitant Medication - Frequency
    Description

    SAE Concomitant Medication - Frequency

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C3476109
    SAE Concomitant Medication - Route
    Description

    SAE Concomitant Medication - Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C0013153
    SAE Concomitant Medication - Taken Prior to Study?
    Description

    SAE Concomitant Medication - Taken Prior to Study?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826667
    SAE Concomitant Medication - Start Date
    Description

    SAE Concomitant Medication - Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826734
    SAE Concomitant Medication - Stop Date
    Description

    SAE Concomitant Medication - Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826744
    SAE Concomitant Medication - Ongoing Medication?
    Description

    SAE Concomitant Medication - Ongoing Medication?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826666
    SAE Concomitant Medication - Reason for Medication
    Description

    SAE Concomitant Medication - Reason for Medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826696
    Serious Adverse Event - Section 9 Details of Investigational Product(s)
    Description

    Serious Adverse Event - Section 9 Details of Investigational Product(s)

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0304229
    UMLS CUI-3
    C1522508
    Details of Investigational Product(s)
    Description

    Details of Investigational Product(s)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C1522508
    Was treatment blind broken at investigational site?
    Description

    Was treatment blind broken at investigational site?

    Data type

    text

    Alias
    UMLS CUI [1]
    C3897431
    Serious Adverse Event - Section 10 Details of relevant Assessments
    Description

    Serious Adverse Event - Section 10 Details of relevant Assessments

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0220825
    UMLS CUI-3
    C1522508
    Details of relevant Assessments
    Description

    Provide details of any tests or procedures carried out to diagnose or confirm the SAE (e.g., laboratory data with units and normal range) if data for this SAE have not been previously entered, and the CRF includes a page for the test, ensure the data is also entered on the page.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C1522508
    Serious Adverse Event - Section 11 Narrative Remarks
    Description

    Serious Adverse Event - Section 11 Narrative Remarks

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0947611
    Serious Adverse Event - Narrative Remarks
    Description

    (provide a brief narrative description of the SAE and details of treatment given)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0947611
    Investigator's signature
    Description

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Description

    (confirming that the data on the SAE pages are accurate and complete)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator’s name (print)
    Description

    Investigator’s name (print)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Investigator's signature - Date
    Description

    Investigator's signature - Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Concomitant Medications; Non-serious Adverse Events; Serious Adverse Events

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Randomisation Number
    Item
    Randomisation Number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Were any concomitant medications taken by the subject during the study?
    Item
    Were any concomitant medications taken by the subject during the study?
    boolean
    C2347852 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Drug Name
    Item
    Drug Name
    text
    C0013227 (UMLS CUI [1])
    Concomitant Medication - Unit Dose
    Item
    Concomitant Medication - Unit Dose
    float
    C2347852 (UMLS CUI [1,1])
    C0869039 (UMLS CUI [1,2])
    Item
    Concomitant Medications - Units
    text
    C2347852 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Concomitant Medications - Units
    Code List
    Concomitant Medications - Units
    CL Item
    Tablet (TAB)
    CL Item
    Microlitre (MCL)
    CL Item
    Millilitre (ML)
    CL Item
    Litre (L)
    CL Item
    Microgram (MCG)
    CL Item
    Milligram (MG)
    CL Item
    Gram (G)
    Item
    Concomitant Medication - Frequency
    text
    C2347852 (UMLS CUI [1,1])
    C3476109 (UMLS CUI [1,2])
    Concomitant Medication - Frequency
    Code List
    Concomitant Medication - Frequency
    CL Item
    1 x Daily (OD/QD)
    CL Item
    2 x Daily (BID)
    CL Item
    3 x Daily (TID)
    CL Item
    4 x Daily (QID)
    CL Item
    As required (PRN)
    Item
    Concomitant Medication - Route
    text
    C2347852 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Concomitant Medication - Route
    Code List
    Concomitant Medication - Route
    CL Item
    Intramuscular (IM)
    CL Item
    Inhalation (IH)
    CL Item
    Intravenous (IV)
    CL Item
    Nasal (NS)
    CL Item
    Topical (TP)
    CL Item
    Oral (PO)
    CL Item
    Vaginal (VG)
    Concomitant Medication - Reason for Medication
    Item
    Concomitant Medication - Reason for Medication
    text
    C2347852 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    Conocmitant Medication - Start Date
    Item
    Conocmitant Medication - Start Date
    date
    C2826734 (UMLS CUI [1])
    Conocmitant Medication - Start Time
    Item
    Conocmitant Medication - Start Time
    time
    C1301880 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Concomitant Medication - Taken prior to Study?
    Item
    Concomitant Medication - Taken prior to Study?
    boolean
    C2826667 (UMLS CUI [1])
    Conocmitant Medication - Stop Date
    Item
    Conocmitant Medication - Stop Date
    date
    C2826744 (UMLS CUI [1])
    Concomitant Medication - Stop Time
    Item
    Concomitant Medication - Stop Time
    time
    C2347852 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Concomitant Medication - Ongoing Medication?
    Item
    Concomitant Medication - Ongoing Medication?
    boolean
    C2826666 (UMLS CUI [1])
    Item Group
    Non-Serious adverse Events
    C1518404 (UMLS CUI-1)
    Did the subject experience any non-serious adverse events during the study?
    Item
    Did the subject experience any non-serious adverse events during the study?
    boolean
    C1518404 (UMLS CUI [1])
    Item Group
    Non-Serious adverse Events
    C1518404 (UMLS CUI-1)
    Non-serious Adverse Event
    Item
    Non-serious Adverse Event
    text
    C1518404 (UMLS CUI [1])
    Non-serious Adverse Event Start Date
    Item
    Non-serious Adverse Event Start Date
    date
    C2697888 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Non-serious Adverse Event Start Time
    Item
    Non-serious Adverse Event Start Time
    time
    C1518404 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Item
    Non-serious Adverse Event Outcome
    integer
    C1518404 (UMLS CUI [1,1])
    C1705586 (UMLS CUI [1,2])
    Non-serious Adverse Event Outcome
    Code List
    Non-serious Adverse Event Outcome
    CL Item
    Recovered/ Resolved (1)
    CL Item
    Recovering/ Resolving (2)
    CL Item
    Not recovered/ Not resolved (3)
    CL Item
    Recovered/ Resolvedmwith sequelae (4)
    Non-serious Adverse Event End Date
    Item
    Non-serious Adverse Event End Date
    date
    C2697886 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Non-serious Adverse Event End Time
    Item
    Non-serious Adverse Event End Time
    time
    C1518404 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Non-serious Adverse Event Frequency
    integer
    C1518404 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Non-serious Adverse Event Frequency
    Code List
    Non-serious Adverse Event Frequency
    CL Item
    Single episode (1)
    CL Item
    Intermittent (2)
    Item
    Non-serious Adverse Event Maximum Intensity
    text
    C1518404 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    Non-serious Adverse Event Maximum Intensity
    Code List
    Non-serious Adverse Event Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (X)
    Item
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    text
    C1704758 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    Code List
    Action Taken with Investigational Product(s) as a Result of the Non-Serious 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 (X)
    Did the subject withdraw from study as a result of this AE?
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C1710677 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C1518404 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Item Group
    Serious Adverse Event
    C1519255 (UMLS CUI-1)
    Did the subject experience a serious adverse event during the study?
    Item
    Did the subject experience a serious adverse event during the study?
    boolean
    C1519255 (UMLS CUI [1])
    Item Group
    Serious Adverse Event - Section 1
    C1519255 (UMLS CUI-1)
    Serious Adverse Event
    Item
    Serious Adverse Event
    text
    C1519255 (UMLS CUI [1])
    Serious Adverse Event Start Date
    Item
    Serious Adverse Event Start Date
    date
    C2697888 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Serious Adverse Event Start Time
    Item
    Serious Adverse Event Start Time
    time
    C1519255 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Item
    Serious Adverse Event Outcome
    integer
    C1519255 (UMLS CUI [1,1])
    C1705586 (UMLS CUI [1,2])
    Serious Adverse Event Outcome
    Code List
    Serious Adverse Event Outcome
    CL Item
    Recovered/ Resolved  (1)
    CL Item
    Recovering/ Resolving  (2)
    CL Item
    Not recovered/ Not resolved  (3)
    CL Item
    Recovered/ Resolvedmwith sequelae  (4)
    CL Item
    Fatal (5)
    Serious Adverse Event End Date
    Item
    Serious Adverse Event End Date
    date
    C2697886 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Serious Adverse Event End Time
    Item
    Serious Adverse Event End Time
    time
    C1519255 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Serious Adverse Event Maximum Intensity
    text
    C1519255 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    Serious Adverse Event Maximum Intensity
    Code List
    Serious Adverse Event Maximum Intensity
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe  (3)
    CL Item
    Not applicable (X)
    Item
    Action Taken with Investigational Product(s) as a Result of the SAE
    text
    C1704758 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Action Taken with Investigational Product(s) as a Result of the SAE
    Code List
    Action Taken with Investigational Product(s) as a Result of the SAE
    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 (X)
    Did the subject withdraw from study as a result of this SAE?
    Item
    Did the subject withdraw from study as a result of this SAE?
    boolean
    C1710677 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    Item
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    If fatal, was a post-mortem/autopsy performed
    Item
    If fatal, was a post-mortem/autopsy performed
    boolean
    C1519255 (UMLS CUI [1,1])
    C1302234 (UMLS CUI [1,2])
    C0004398 (UMLS CUI [1,3])
    Item Group
    Serious Adverse Event - Section 2 Seriousness
    C1519255 (UMLS CUI-1)
    C1710056 (UMLS CUI-2)
    Item
    Specify reason(s) for considering this a SAE
    text
    C1710056 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Serious Adverse Event - Section 2 Seriousness
    Code List
    Specify reason(s) for considering this a SAE
    CL Item
    Results in death  (A)
    CL Item
    Is life-threatening  (B)
    CL Item
    Requires hospitalisation or prolongation of existing hospitalisation ( see definition of SAE ) (C)
    CL Item
    Results in disability/incapacity (D)
    CL Item
    Congenital anomaly/birth defect (E)
    CL Item
    Other, specify (F)
    CL Item
    Is associated with liver injury and impaired liver function (G)
    If other reason for considering this a SAE, specify
    Item
    If other reason for considering this a SAE, specify
    text
    C1710056 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item Group
    Serious Adverse Event - Section 3 Demography Data
    C1519255 (UMLS CUI-1)
    C0011298 (UMLS CUI-2)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Sex
    Code List
    Sex
    CL Item
    Female (F)
    CL Item
    Male (M)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Serious Adverse Event - Section 4
    C1519255 (UMLS CUI-1)
    Item
    If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?
    text
    C1519255 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    C0457454 (UMLS CUI [1,4])
    If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?
    Code List
    If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown at this time (U)
    CL Item
    Not applicable (X)
    Item Group
    Serious Adverse Event - Section 5 Possible Causes of SAE Other Than Investigational Product(s)
    C1519255 (UMLS CUI-1)
    C0085978 (UMLS CUI-2)
    C0304229 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Item
    Possible Causes of SAE Other Than Investigational Product(s)
    integer
    C1519255 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Possible Causes of SAE Other Than Investigational Product(s)
    Code List
    Possible Causes of SAE Other Than Investigational Product(s)
    CL Item
    Disease under study (1)
    CL Item
    Medical condition(s) specify (2)
    CL Item
    Lack of efficacy (3)
    CL Item
    Withdrawal of investigational product(s) (4)
    CL Item
    Concomitant medication(s) s pecify  (5)
    CL Item
    Activity related to study participation (e.g., procedures) (6)
    CL Item
    Other, specify (7)
    Specify medical conditions
    Item
    Specify medical conditions
    text
    C0012634 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Specify concomitant medication(s)
    Item
    Specify concomitant medication(s)
    text
    C2347852 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    If other cause of SAE, specify
    Item
    If other cause of SAE, specify
    text
    C0085978 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item Group
    Serious Adverse Event - Section 6 Relevant medical Conditions
    C1519255 (UMLS CUI-1)
    C0012634 (UMLS CUI-2)
    C2347946 (UMLS CUI-3)
    Specify any RELEVANT past or current medical disorders, allergies, surgeries that can help explain the SAE.
    Item
    Specify any RELEVANT past or current medical disorders, allergies, surgeries that can help explain the SAE.
    text
    C0012634 (UMLS CUI [1])
    C0020517 (UMLS CUI [2])
    C0543467 (UMLS CUI [3])
    C1519255 (UMLS CUI [4])
    Medical condition - Date of Onset
    Item
    Medical condition - Date of Onset
    date
    C0012634 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Medical condition - Condition Present at Time of the SAE?
    Item
    Medical condition - Condition Present at Time of the SAE?
    boolean
    C0012634 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    If Condition is Present at Time of the SAE, Date of Last Occurence
    Item
    If Condition is Present at Time of the SAE, Date of Last Occurence
    date
    C0012634 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    C1517741 (UMLS CUI [2,1])
    C2745955 (UMLS CUI [2,2])
    C0011008 (UMLS CUI [2,3])
    Item Group
    Serious Adverse Event - Section 7 Other relevant Risk Factors
    C1519255 (UMLS CUI-1)
    C0035648 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Include details of any concomitant medication(s) that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
    Item
    Include details of any concomitant medication(s) that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
    text
    C2347852 (UMLS CUI [1,1])
    C1522508 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2,1])
    C0681841 (UMLS CUI [2,2])
    C0085978 (UMLS CUI [3,1])
    C1519255 (UMLS CUI [3,2])
    C2981656 (UMLS CUI [4,1])
    C1519255 (UMLS CUI [4,2])
    Item Group
    Serious Adverse Event - Section 8 Relevant Concomitant Medications
    C1519255 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    SAE Concomitant Medication - Drug Name
    Item
    SAE Concomitant Medication - Drug Name
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C2360065 (UMLS CUI [1,3])
    SAE Concomitant Medication - Dose
    Item
    SAE Concomitant Medication - Dose
    float
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    SAE Concomitant Medication - Unit
    Item
    SAE Concomitant Medication - Unit
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0439148 (UMLS CUI [1,3])
    SAE Concomitant Medication - Frequency
    Item
    SAE Concomitant Medication - Frequency
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C3476109 (UMLS CUI [1,3])
    SAE Concomitant Medication - Route
    Item
    SAE Concomitant Medication - Route
    text
    C1519255 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    SAE Concomitant Medication - Taken Prior to Study?
    Item
    SAE Concomitant Medication - Taken Prior to Study?
    boolean
    C1519255 (UMLS CUI [1,1])
    C2826667 (UMLS CUI [1,2])
    SAE Concomitant Medication - Start Date
    Item
    SAE Concomitant Medication - Start Date
    date
    C1519255 (UMLS CUI [1,1])
    C2826734 (UMLS CUI [1,2])
    SAE Concomitant Medication - Stop Date
    Item
    SAE Concomitant Medication - Stop Date
    date
    C1519255 (UMLS CUI [1,1])
    C2826744 (UMLS CUI [1,2])
    SAE Concomitant Medication - Ongoing Medication?
    Item
    SAE Concomitant Medication - Ongoing Medication?
    boolean
    C1519255 (UMLS CUI [1,1])
    C2826666 (UMLS CUI [1,2])
    SAE Concomitant Medication - Reason for Medication
    Item
    SAE Concomitant Medication - Reason for Medication
    text
    C1519255 (UMLS CUI [1,1])
    C2826696 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Event - Section 9 Details of Investigational Product(s)
    C1519255 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    C1522508 (UMLS CUI-3)
    Details of Investigational Product(s)
    Item
    Details of Investigational Product(s)
    text
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C1522508 (UMLS CUI [1,3])
    Item
    Was treatment blind broken at investigational site?
    text
    C3897431 (UMLS CUI [1])
    Was treatment blind broken at investigational site?
    Code List
    Was treatment blind broken at investigational site?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not applicable (X)
    Item Group
    Serious Adverse Event - Section 10 Details of relevant Assessments
    C1519255 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    C1522508 (UMLS CUI-3)
    Details of relevant Assessments
    Item
    Details of relevant Assessments
    text
    C0220825 (UMLS CUI [1,1])
    C1522508 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Event - Section 11 Narrative Remarks
    C1519255 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    Serious Adverse Event - Narrative Remarks
    Item
    Serious Adverse Event - Narrative Remarks
    text
    C1519255 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Investigator’s name (print)
    Item
    Investigator’s name (print)
    text
    C2826892 (UMLS CUI [1])
    Investigator's signature - Date
    Item
    Investigator's signature - Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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