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22474

Beschreibung

Study part: .A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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  1. 05.06.17 05.06.17 -
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GlaxoSmithKline

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5. Juni 2017

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    Serious Adverse Events Mepolizumab HES NCT00086658

    Englisch

    Serious Adverse Events

    1 Formulare  
    1. StudyEvent: ODM
      1. Serious Adverse Events
    SERIOUS ADVERSE EVENT (SAE)
    Beschreibung

    SERIOUS ADVERSE EVENT (SAE)

    Alias
    UMLS CUI-1
    C1519255
    Subject ID
    Beschreibung

    Subject ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Beschreibung

    Centre Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0475309
    UMLS CUI [1,2]
    C0019994
    Randomisation Number
    Beschreibung

    Randomisation Number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Did the subject experience a serious adverse event during the study?
    Beschreibung

    Serious Adverse Events

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    SECTION 1
    Beschreibung

    SECTION 1

    Alias
    UMLS CUI-1
    C1828479
    Event
    Beschreibung

    Event

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0877248
    Start Date
    Beschreibung

    Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0808070
    Outcome
    Beschreibung

    Outcome

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1705586
    End date
    Beschreibung

    End date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0806020
    Maximum Intensity
    Beschreibung

    Maximum Intensity

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0877248
    Action Taken with Investigational Product(s) as a Result of the SAE
    Beschreibung

    Action Taken

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826626
    Did the subject withdraw from study as a result of this SAE?
    Beschreibung

    Complete Study Conclusion page and Adverse event as reason for withdrawal.

    Datentyp

    boolean

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

    causations adverse events

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0085978
    UMLS CUI [1,2]
    C0877248
    If fatal, was a post-mortem/autopsy performed?
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004398
    SECTION 2 Seriousness
    Beschreibung

    SECTION 2 Seriousness

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C1710056
    Results in death
    Beschreibung

    Death

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0011065
    Is life-threatening
    Beschreibung

    life-threatening

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826244
    Requires hospitalisation or prolongation of existing hospitalisation
    Beschreibung

    hospitalisation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019993
    Results in disability/incapacity
    Beschreibung

    disability

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0231170
    Congenital anomaly/birth defect
    Beschreibung

    Congenital anomaly

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826727
    Other, specify
    Beschreibung

    Other

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0205394
    SECTION 3 Demography Data
    Beschreibung

    SECTION 3 Demography Data

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C0011298
    Date of birth
    Beschreibung

    Date of birth

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Beschreibung

    Sex

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Weight
    Beschreibung

    Weight

    Datentyp

    float

    Maßeinheiten
    • kg
    kg
    SECTION 4
    Beschreibung

    SECTION 4

    Alias
    UMLS CUI-1
    C1828479
    If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
    Beschreibung

    Adverse event Recurrence

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0034897
    SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)
    Beschreibung

    SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C0085978
    UMLS CUI-3
    C1710056
    Disease under study
    Beschreibung

    Disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    Medical condition(s) (record in Section 6)
    Beschreibung

    Medical condition

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1699700
    Lack of efficacy
    Beschreibung

    Lack of efficacy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0235828
    Withdrawal of investigational product(s)
    Beschreibung

    Withdrawal of investigational product

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0013227
    Concomitant medication (record in Section 8)
    Beschreibung

    Concomitant medication

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Activity related to study participation (e.g., procedures)
    Beschreibung

    study participation status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    Other, specify
    Beschreibung

    other

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0205394
    SECTION 6 RELEVANT Medical Conditions
    Beschreibung

    SECTION 6 RELEVANT Medical Conditions

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C0012634
    Specify any RELEVANT past or current medical disorders, allergies,surgeries, etc. that can help explain the SAE
    Beschreibung

    Medical Conditions Hypersensitivity surgeries

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0020517
    UMLS CUI [1,3]
    C0543467
    Date of Onset
    Beschreibung

    Date of Onset

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0574845
    Condition Present at Time of the SAE?
    Beschreibung

    Medical Conditions SAE

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1519255
    If No, Date of Last Occurrence
    Beschreibung

    Date of Last Occurrence

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2745955
    UMLS CUI [1,2]
    C0011008
    SECTION 7 Other RELEVANT Risk Factors
    Beschreibung

    SECTION 7 Other RELEVANT Risk Factors

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C0035648
    Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
    Beschreibung

    Risk Factors substance use disorder occupational hazard

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0035648
    UMLS CUI [1,2]
    C0038586
    UMLS CUI [1,3]
    C0337074
    SECTION 8 RELEVANT Concomitant Medications
    Beschreibung

    SECTION 8 RELEVANT Concomitant Medications

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C2347852
    Drug Name
    Beschreibung

    Drug Name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013227
    Dose
    Beschreibung

    Dose

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3174092
    Unit
    Beschreibung

    Unit

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1519795
    Frequency
    Beschreibung

    Frequency

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Beschreibung

    Route

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013153
    Taken Prior to Study?
    Beschreibung

    Taken Prior to Study?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Start Date
    Beschreibung

    Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0808070
    Stop Date
    Beschreibung

    Stop Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0806020
    Ongoing Medication?
    Beschreibung

    Ongoing Medication?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Reason for Medication
    Beschreibung

    Reason for Medication

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    SECTION 9 Details of Investigational Product(s)
    Beschreibung

    SECTION 9 Details of Investigational Product(s)

    Alias
    UMLS CUI-1
    C1828479
    Did the SAE occur during the Screening Period?
    Beschreibung

    SAE Screening Study

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348164
    Date of First Dose
    Beschreibung

    Date of First Dose

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C3173309
    Date of Most Recent Dose
    Beschreibung

    Date of Most Recent Dose

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C3854006
    UMLS CUI [1,3]
    C1513491
    UMLS CUI [1,4]
    C0178602
    Number of Doses Completed to Date
    Beschreibung

    Number of Doses

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0750480
    Was randomisation code broken at investigational site?
    Beschreibung

    randomisation

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0034656
    SECTION 10 Details of RELEVANT Assessments
    Beschreibung

    SECTION 10 Details of RELEVANT Assessments

    Alias
    UMLS CUI-1
    C1828479
    Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g.,laboratory data with units and normal range)
    Beschreibung

    Procedures related to diagnosis SAE laboratory

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2939431
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C0022885
    SECTION 11 Narrative Remarks
    Beschreibung

    SECTION 11 Narrative Remarks

    Alias
    UMLS CUI-1
    C1828479
    Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
    Beschreibung

    comment SAE

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1519255
    Investigator’s signature
    Beschreibung

    Investigator signature

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator’s name
    Beschreibung

    Investigator name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Beschreibung

    Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Serious Adverse Events

    1 Formulare
    1. StudyEvent: ODM
      1. Serious Adverse Events
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    SERIOUS ADVERSE EVENT (SAE)
    C1519255 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    integer
    C0475309 (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])
    Serious Adverse Events
    Item
    Did the subject experience a serious adverse event during the study?
    boolean
    C1519255 (UMLS CUI [1])
    Item Group
    SECTION 1
    C1828479 (UMLS CUI-1)
    Event
    Item
    Event
    text
    C0877248 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1])
    Outcome
    Code List
    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)
    End date
    Item
    End date
    date
    C0806020 (UMLS CUI [1])
    Item
    Maximum Intensity
    text
    C0518690 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Maximum Intensity
    Code List
    Maximum Intensity
    CL Item
    Mild (Mild)
    CL Item
    Moderate (Moderate)
    CL Item
    Severe (Severe)
    CL Item
    Not applicable (Not applicable)
    Item
    Action Taken with Investigational Product(s) as a Result of the SAE
    text
    C2826626 (UMLS CUI [1])
    Action Taken
    Code List
    Action Taken with Investigational Product(s) as a Result of the SAE
    CL Item
    Investigational product(s) withdrawn (Investigational product(s) withdrawn)
    CL Item
    Dose reduced (Dose reduced)
    CL Item
    Dose increased (Dose increased)
    CL Item
    Dose not changed (Dose not changed)
    CL Item
    Dose interrupted (Dose interrupted)
    CL Item
    Not applicable (Not applicable)
    subject withdraw from study as a result of SAE
    Item
    Did the subject withdraw from study as a result of this SAE?
    boolean
    C2349954 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    causations adverse events
    Item
    Is there a reasonable possibility the SAE may have been caused by the investigational product?
    boolean
    C0085978 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    autopsy
    Item
    If fatal, was a post-mortem/autopsy performed?
    boolean
    C0004398 (UMLS CUI [1])
    Item Group
    SECTION 2 Seriousness
    C1828479 (UMLS CUI-1)
    C1710056 (UMLS CUI-2)
    Death
    Item
    Results in death
    boolean
    C0011065 (UMLS CUI [1])
    life-threatening
    Item
    Is life-threatening
    boolean
    C2826244 (UMLS CUI [1])
    hospitalisation
    Item
    Requires hospitalisation or prolongation of existing hospitalisation
    boolean
    C0019993 (UMLS CUI [1])
    disability
    Item
    Results in disability/incapacity
    boolean
    C0231170 (UMLS CUI [1])
    Congenital anomaly
    Item
    Congenital anomaly/birth defect
    boolean
    C2826727 (UMLS CUI [1])
    Other
    Item
    Other, specify
    text
    C0205394 (UMLS CUI [1])
    Item Group
    SECTION 3 Demography Data
    C1828479 (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
    Male (Male)
    CL Item
    Female (Female)
    Weight
    Item
    Weight
    float
    Item Group
    SECTION 4
    C1828479 (UMLS CUI-1)
    Item
    If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
    text
    C0877248 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    Adverse event Recurrence
    Code List
    If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown at this time (Unknown at this time)
    CL Item
    Not applicable (Not applicable)
    Item Group
    SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)
    C1828479 (UMLS CUI-1)
    C0085978 (UMLS CUI-2)
    C1710056 (UMLS CUI-3)
    Disease
    Item
    Disease under study
    boolean
    C0012634 (UMLS CUI [1])
    Medical condition
    Item
    Medical condition(s) (record in Section 6)
    boolean
    C1699700 (UMLS CUI [1])
    Lack of efficacy
    Item
    Lack of efficacy
    boolean
    C0235828 (UMLS CUI [1])
    Withdrawal of investigational product
    Item
    Withdrawal of investigational product(s)
    boolean
    C2349954 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Concomitant medication
    Item
    Concomitant medication (record in Section 8)
    boolean
    C2347852 (UMLS CUI [1])
    study participation status
    Item
    Activity related to study participation (e.g., procedures)
    boolean
    C2348568 (UMLS CUI [1])
    other
    Item
    Other, specify
    text
    C0205394 (UMLS CUI [1])
    Item Group
    SECTION 6 RELEVANT Medical Conditions
    C1828479 (UMLS CUI-1)
    C0012634 (UMLS CUI-2)
    Medical Conditions Hypersensitivity surgeries
    Item
    Specify any RELEVANT past or current medical disorders, allergies,surgeries, etc. that can help explain the SAE
    text
    C0012634 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [1,3])
    Date of Onset
    Item
    Date of Onset
    date
    C0574845 (UMLS CUI [1])
    Medical Conditions SAE
    Item
    Condition Present at Time of the SAE?
    boolean
    C0012634 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Date of Last Occurrence
    Item
    If No, Date of Last Occurrence
    date
    C2745955 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    SECTION 7 Other RELEVANT Risk Factors
    C1828479 (UMLS CUI-1)
    C0035648 (UMLS CUI-2)
    Risk Factors substance use disorder occupational hazard
    Item
    Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
    text
    C0035648 (UMLS CUI [1,1])
    C0038586 (UMLS CUI [1,2])
    C0337074 (UMLS CUI [1,3])
    Item Group
    SECTION 8 RELEVANT Concomitant Medications
    C1828479 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Drug Name
    Item
    Drug Name
    text
    C0013227 (UMLS CUI [1])
    Dose
    Item
    Dose
    integer
    C3174092 (UMLS CUI [1])
    Unit
    Item
    Unit
    text
    C1519795 (UMLS CUI [1])
    Frequency
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Taken Prior to Study?
    Item
    Taken Prior to Study?
    boolean
    C2826667 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Ongoing Medication?
    Item
    Ongoing Medication?
    boolean
    C2826666 (UMLS CUI [1])
    Reason for Medication
    Item
    Reason for Medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Item Group
    SECTION 9 Details of Investigational Product(s)
    C1828479 (UMLS CUI-1)
    SAE Screening Study
    Item
    Did the SAE occur during the Screening Period?
    boolean
    C1519255 (UMLS CUI [1,1])
    C2348164 (UMLS CUI [1,2])
    Date of First Dose
    Item
    Date of First Dose
    date
    C3173309 (UMLS CUI [1])
    Date of Most Recent Dose
    Item
    Date of Most Recent Dose
    date
    C0011008 (UMLS CUI [1,1])
    C3854006 (UMLS CUI [1,2])
    C1513491 (UMLS CUI [1,3])
    C0178602 (UMLS CUI [1,4])
    Number of Doses
    Item
    Number of Doses Completed to Date
    integer
    C0178602 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Item
    Was randomisation code broken at investigational site?
    text
    C0034656 (UMLS CUI [1])
    randomisation
    Code List
    Was randomisation code broken at investigational site?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Not applicable (Not applicable)
    Item Group
    SECTION 10 Details of RELEVANT Assessments
    C1828479 (UMLS CUI-1)
    Procedures related to diagnosis SAE laboratory
    Item
    Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g.,laboratory data with units and normal range)
    text
    C2939431 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0022885 (UMLS CUI [1,3])
    Item Group
    SECTION 11 Narrative Remarks
    C1828479 (UMLS CUI-1)
    comment SAE
    Item
    Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
    text
    C0947611 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Investigator signature
    Item
    Investigator’s signature
    text
    C2346576 (UMLS CUI [1])
    Investigator name
    Item
    Investigator’s name
    text
    C2826892 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
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