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ID

32650

Descrição

This ODM file contains the form to document all serious events that are temporally associated with the use of the study medication. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Palavras-chave

Versões (2)
  1. 06/11/2018 06/11/2018 -
  2. 09/11/2018 09/11/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

9 de novembro de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

    Inglês

    Serious Adverse Event

    1 Formulários  
    1. StudyEvent: ODM
      1. Serious Adverse Event
    Administrative Data
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descrição

    Subject Identifier

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Descrição

    Centre Number

    Tipo de dados

    text

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

    Randomisation Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Serious Adverse Event
    Descrição

    Serious Adverse Event

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

    DEFINITION OF A SERIOUS ADVERSE EVENT (SAE) (Page 1 of 5) A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death. b) is life-threatening. Note: The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c) requires hospitalisation or prolongation of existing hospitalisation. Note: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is ’serious’. When in doubt as to whether ’hospitalisation’ occurred or was necessary, the AE should be considered ’serious’. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity, or Note: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e) is a congenital anomaly/birth defect. f) other. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519255
    If fatal, was a post-mortem/autopsy performed If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
    Descrição

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

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0004398
    UMLS CUI [1,2]
    C1519255
    SECTION 1
    Descrição

    SECTION 1

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C1519255
    Diagnosis Only (if known) Otherwise Sign/Symptom
    Descrição

    Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE. However, if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C1519255
    Start Date
    Descrição

    Record the start date of the first occurrence of the SAE.

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1519255
    Start Time
    Descrição

    Start Time of Serious Adverse Event

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C1519255
    Outcome
    Descrição

    All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1705586
    UMLS CUI [1,2]
    C1519255
    End Date
    Descrição

    Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/ Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1519255
    End Time
    Descrição

    End Time of Serious Adverse Event

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C1519255
    Maximum Intensity
    Descrição

    Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1710056
    UMLS CUI [1,2]
    C1519255
    Actions taken with Investigational Product(s) as a Result of the SAE
    Descrição

    Investigational product(s) withdrawn = Dose reduced = Dose increased = Dose not changed = Dose interrupted = Not applicable = Administration of investigational product(s) was permanently discontinued. Dose is reduced for one or more investigational product(s). Dose increased for one or more investigational product(s). Investigational product(s) continues even though an adverse event has occurred. Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C1519255
    Did the subject withdraw from study as a result of this SAE? If yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.
    Descrição

    Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’. If yes: Complete Study Conclusion page and check Adverse event as reason for withdrawal.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1519255
    Is there a reasonable possibility the SAE may have been caused by the investigational product?
    Descrição

    It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0085978
    UMLS CUI [1,2]
    C1519255
    SECTION 2: Seriousness
    Descrição

    SECTION 2: Seriousness

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C1710056
    [A] Results in death
    Descrição

    SAE results in death

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1705232
    UMLS CUI [1,2]
    C1519255
    [B] Is life-threatening
    Descrição

    SAE is life-threatening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1517874
    UMLS CUI [1,2]
    C1519255
    [C] Requires hospitalisation or prolongation of existing hospitalisation
    Descrição

    SAE requires hospitalisation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2826664
    UMLS CUI [1,2]
    C1519255
    [D] Results in disability/incapacity
    Descrição

    SAE results in disability/incapacity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0231170
    [E] Congenital anomaly/birth defect
    Descrição

    Congenital anomaly/birth defect

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C1519255
    [F] Other
    Descrição

    SAE, other

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1880177
    Other, specify
    Descrição

    (see definition of SAE)

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3845569
    UMLS CUI [1,2]
    C1519255
    SECTION 3 Demography Data
    Descrição

    SECTION 3 Demography Data

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

    Date of birth

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Descrição

    Sex

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0079399
    Weight
    Descrição

    Weight

    Tipo de dados

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
    Descrição

    SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C0034897
    If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
    Descrição

    Recurrence of the reported SAE in case of discontinuation of the investigational product

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0034897
    UMLS CUI [1,3]
    C0304229
    UMLS CUI [1,4]
    C0457454
    SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)
    Descrição

    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
    Descrição

    Disease under study

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008976
    Medical condition(s) (record in Section 6)
    Descrição

    Medical condition(s)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    Lack of efficacy
    Descrição

    Lack of efficacy

    Tipo de dados

    boolean

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

    Withdrawal of investigational product(s)

    Tipo de dados

    boolean

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

    Concomitant medication(s)

    Tipo de dados

    boolean

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

    Activity related to study participation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    Other, specify
    Descrição

    Other, specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1521902
    SECTION 6 RELEVANT Medical Conditions
    Descrição

    SECTION 6 RELEVANT Medical Conditions

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C1828479
    Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
    Descrição

    Relevant Medical Conditions

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C1519255
    Date of onset
    Descrição

    Date of onset

    Tipo de dados

    date

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

    Continuation SAE

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C1519255
    If No, Date of Last Occurrence
    Descrição

    Date of Last Occurrence

    Tipo de dados

    date

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

    SECTION 7 Other RELEVANT Risk Factors

    Alias
    UMLS CUI-1
    C0035648
    UMLS CUI-2
    C1519255
    UMLS CUI-3
    C0205394
    Other RELEVANT Risk Factors
    Descrição

    (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0035648
    SECTION 8 RELEVANT Concomitant Medications
    Descrição

    SECTION 8 RELEVANT Concomitant Medications

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

    (Trade Name preferred)

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0013227
    Dose
    Descrição

    Dose

    Tipo de dados

    float

    Alias
    UMLS CUI [1]
    C3174092
    Unit
    Descrição

    Unit

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519795
    Frequency
    Descrição

    Frequency

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Descrição

    Route

    Tipo de dados

    text

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

    Taken Prior to Study?

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826667
    Start Date
    Descrição

    Start Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0808070
    Stop Date
    Descrição

    Stop Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0806020
    Ongoing Medication?
    Descrição

    Ongoing Medication?

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826666
    Reason for Medication
    Descrição

    Reason for Medication

    Tipo de dados

    text

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

    SECTION 9 Details of Investigational Product(s)

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C0013230
    UMLS CUI-3
    C1522508
    Date study medication taken
    Descrição

    Date study medication taken

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0011008
    Time study medication taken
    Descrição

    Time study medication taken

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0040223
    Was randomisation code broken at investigational site?
    Descrição

    Randomisation code broken at investigational site

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C3899531
    SECTION 10 Details of relevant Assessments
    Descrição

    SECTION 10 Details of relevant Assessments

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C0011900
    UMLS CUI-3
    C1519255
    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)
    Descrição

    Details of relevant assessments

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1261322
    UMLS CUI [1,2]
    C1519255
    SECTION 11 Narrative Remarks
    Descrição

    SECTION 11 Narrative Remarks

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C0947611
    Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
    Descrição

    Narrative Remarks

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1519255
    Investigator's name and signature
    Descrição

    Investigator's name and signature

    Alias
    UMLS CUI-1
    C2826892
    UMLS CUI-3
    C2346576
    Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
    Descrição

    Investigator's signature

    Tipo de dados

    text

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

    Investigator’s name

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Descrição

    Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0011008
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    Serious Adverse Event

    1 Formulários
    1. StudyEvent: ODM
      1. Serious Adverse Event
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative Data
    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
    Serious Adverse Event
    C1519255 (UMLS CUI-1)
    Item
    Did the subject experience a serious adverse event during the study?
    text
    C1519255 (UMLS CUI [1])
    Did the subject experience a serious adverse event during the study?
    Code List
    Did the subject experience a serious adverse event during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If fatal, was a post-mortem/autopsy performed If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
    text
    C0004398 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Autopsy after serious event
    Code List
    If fatal, was a post-mortem/autopsy performed If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    SECTION 1
    C1828479 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Event
    Item
    Diagnosis Only (if known) Otherwise Sign/Symptom
    text
    C0011900 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Start Date of the Serious Adverse Event
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Start Time of Serious Adverse Event
    Item
    Start Time
    time
    C1301880 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    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 of Serious Adverse Event
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    End Time of Serious Adverse Event
    Item
    End Time
    time
    C1522314 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Maximum Intensity
    text
    C1710056 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Maximum Intensity
    Code List
    Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (X)
    Item
    Actions taken with Investigational Product(s) as a Result of the SAE
    text
    C1704758 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Actions taken with Investigational Product(s) as a Result of the SAE
    Code List
    Actions 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
    Doce increased (3)
    CL Item
    Dose not changed (4)
    CL Item
    Dose interrupted (5)
    CL Item
    Not applicable (X)
    Item
    Did the subject withdraw from study as a result of this SAE? If yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.
    text
    C0422727 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Did the subject withdraw from study as a result of this SAE?
    Code List
    Did the subject withdraw from study as a result of this SAE? If yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Is there a reasonable possibility the SAE may have been caused by the investigational product?
    text
    C0085978 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Is there a reasonable possibility the SAE may have been caused by the investigational product?
    Code List
    Is there a reasonable possibility the SAE may have been caused by the investigational product?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    SECTION 2: Seriousness
    C1828479 (UMLS CUI-1)
    C1710056 (UMLS CUI-2)
    SAE results in death
    Item
    [A] Results in death
    boolean
    C1705232 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE is life-threatening
    Item
    [B] Is life-threatening
    boolean
    C1517874 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE requires hospitalisation
    Item
    [C] Requires hospitalisation or prolongation of existing hospitalisation
    boolean
    C2826664 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE results in disability/incapacity
    Item
    [D] Results in disability/incapacity
    boolean
    C1519255 (UMLS CUI [1,1])
    C0231170 (UMLS CUI [1,2])
    Congenital anomaly/birth defect
    Item
    [E] Congenital anomaly/birth defect
    boolean
    C0000768 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE, other
    Item
    [F] Other
    boolean
    C1519255 (UMLS CUI [1,1])
    C1880177 (UMLS CUI [1,2])
    SAE, other: specification
    Item
    Other, specify
    text
    C3845569 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    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
    C0005910 (UMLS CUI [1])
    Item Group
    SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
    C0877248 (UMLS CUI-1)
    C0034897 (UMLS CUI-2)
    Item
    If Investigational Product(s) 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(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
    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 under study
    Item
    Disease under study
    boolean
    C0012634 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Medical condition(s)
    Item
    Medical condition(s) (record in Section 6)
    boolean
    C0012634 (UMLS CUI [1])
    Lack of efficacy
    Item
    Lack of efficacy
    boolean
    C0235828 (UMLS CUI [1])
    Withdrawal of investigational product(s)
    Item
    Withdrawal of investigational product(s)
    boolean
    C2349954 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Concomitant medication(s)
    Item
    Concomitant medication(s) (record in Section 8)
    boolean
    C2347852 (UMLS CUI [1])
    Activity related to study participation
    Item
    Activity related to study participation (e.g., procedures)
    boolean
    C2348568 (UMLS CUI [1])
    Other, specify
    Item
    Other, specify
    text
    C0205394 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Item Group
    SECTION 6 RELEVANT Medical Conditions
    C0262926 (UMLS CUI-1)
    C1828479 (UMLS CUI-2)
    Relevant Medical Conditions
    Item
    Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
    text
    C0012634 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Date of onset
    Item
    Date of onset
    date
    C0574845 (UMLS CUI [1])
    Item
    Condition Present at Time of the SAE?
    text
    C0805733 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Condition Present at Time of the SAE
    Code List
    Condition Present at Time of the SAE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of Last Occurrence
    Item
    If No, Date of Last Occurrence
    date
    C0011008 (UMLS CUI [1,1])
    C2745955 (UMLS CUI [1,2])
    Item Group
    SECTION 7 Other RELEVANT Risk Factors
    C0035648 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Other RELEVANT Risk Factors
    Item
    Other RELEVANT Risk Factors
    text
    C0035648 (UMLS CUI [1])
    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
    float
    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])
    Item
    Taken Prior to Study?
    text
    C2826667 (UMLS CUI [1])
    Taken Prior to Study?
    Code List
    Taken Prior to Study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Item
    Ongoing Medication?
    text
    C2826666 (UMLS CUI [1])
    Ongoing Medication?
    Code List
    Ongoing Medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    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)
    C0013230 (UMLS CUI-2)
    C1522508 (UMLS CUI-3)
    Date study medication taken
    Item
    Date study medication taken
    date
    C0304229 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time study medication taken
    Item
    Time study medication taken
    time
    C0304229 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Was randomisation code broken at investigational site?
    text
    C0034656 (UMLS CUI [1,1])
    C3899531 (UMLS CUI [1,2])
    Randomisation code broken at investigational site
    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)
    C0011900 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    Details of relevant assessments
    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
    C1261322 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    SECTION 11 Narrative Remarks
    C1828479 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    Narrative Remarks
    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])
    Item Group
    Investigator's name and signature
    C2826892 (UMLS CUI-1)
    C2346576 (UMLS CUI-3)
    Investigator's signature
    Item
    Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
    text
    C2346576 (UMLS CUI [1])
    Investigator’s name
    Item
    Investigator’s name (print)
    text
    C2826892 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
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