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ID

34914

Beskrivning

Study ID: 101198 Clinical Study ID: 101198 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 The purpose of this form is to document any serious adverse events. A serious adverse event is defined as follows: 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. • Check that either ’Yes’ or ’no’ box at the top of the page has been completed. • Start dates must be provided for the reporting of serious adverse event data. If the exact date is not known, liaise with the investigator to ensure that a best estimate is provided. • Ensure that no medical or investigational procedures are captured on Serious Adverse Events pages. • Death should not be recorded as an SAE but should be recorded as the outcome of an SAE. The condition that resulted in the death should be recorded as the SAE. • Confirm that any SAEs marked as Recovering/Resolving or Not recovered/Not resolved have been followed up for details of resolution. • If the subject was withdrawn from the study due to an SAE, confirm that the following variables are consistent for the SAE which resulted in withdrawal: • If investigational product was permanently withdrawn due to an adverse event ... • ’Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ’Adverse Event’ • If the subject was withdrawn from the study for an adverse event ... • ’Withdrawal’ on the SAE page is recorded as ’Yes’. • ’Action Taken with Investigational Product(s) as a Result of the SAE’ on the SAE page is recorded as ’Investigational Product Withdrawn’. SECTION 4: If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s)Were Administered? If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur? SECTION 9: Details of Investigational Product Complete this section using the information in the Investigational Product page. Details of all investigational product(s) taken until the time of the SAE should be included. Provide specific details in Section 11 Narrative Remarks if the subject has taken an overdose of investigational product(s), including whether it was accidental or intentional. SECTION 12: SAE Additional/Follow-up Information On receipt of follow-up information, the appropriate section(s) on the SAE form must be amended/updated with any changes (i.e., diagnosis, end date or death, change in intensity, or causality). These changes must be initialled and dated with confirmation by the investigator with his/her re-signing the form and forwarded to GSK within 24 hours. The investigator and others responsible for subject care should institute any supplementary investigations of SAEs based on their clinical judgement of the likely causative factors. This may include seeking a further opinion from a specialist in the field of the AE. GSK may also request extra tests or extra follow-up information. If a subject dies, any post-mortem/autopsy findings, including histopathology, must be provided to GSK.

Nyckelord

Versioner (4)
  1. 24/01/2019 24/01/2019 -
  2. 28/01/2019 28/01/2019 -
  3. 01/02/2019 01/02/2019 -
  4. 04/02/2019 04/02/2019 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 de fevereiro de 2019

DOI

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Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

    Engelsk

    Serious Adverse Event Notification Form

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Beskrivning

    Centre Number

    Datatyp

    integer

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

    Randomisation Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    SECTION 1: Serious Adverse Event
    Beskrivning

    SECTION 1: Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255
    Did the subject experience any serious adverse events during the study?
    Beskrivning

    If YES, record details below

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519255
    SECTION 1: Serious Adverse Events Record
    Beskrivning

    SECTION 1: Serious Adverse Events Record

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-3
    C1828479
    Serious adverse events: Diagnosis only (if known) or signs / symptoms
    Beskrivning

    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. If this was recorded previously as a non-serious event but has progressed to serious, put a line through the Non-Serious AE record and transcribe the details onto the SAE form.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519255
    Start Date
    Beskrivning

    Day Month Year Record the start date and time of the first occurrence of the event or signs/symptoms of the serious event, not the date and time the event became serious.

    Datatyp

    text

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

    Hr : Min 00:00-23:59 Record the start date and time of the first occurrence of the event or signs/symptoms of the serious event, not the date and time the event became serious.

    Datatyp

    time

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

    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.

    Datatyp

    integer

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

    If fatal, record date of death 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’. Record the end time of the SAE.

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [2]
    C1148348
    End Time
    Beskrivning

    Hr : Min 00:00-23:59 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’. Record the end time of the SAE.

    Datatyp

    time

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

    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).

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1710056
    UMLS CUI [1,2]
    C1519255
    Action taken with investigational product(s) as a result of the non-serious AE
    Beskrivning

    Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = 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).

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C1519255
    Did subject withdraw from study as a result of this serious AE?
    Beskrivning

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

    Datatyp

    text

    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(s)?
    Beskrivning

    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.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C1519255
    If fatal, was a post-mortem/autopsy performed?
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0004398
    UMLS CUI [2]
    C1519255
    SECTION 2: Seriousness
    Beskrivning

    SECTION 2: Seriousness

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C1710056
    SAE: Results in Death
    Beskrivning

    SAE: Results in Death

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1705232
    UMLS CUI [1,2]
    C1519255
    SAE: Is Life-Threatening
    Beskrivning

    SAE: Is Life-Threatening

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1517874
    UMLS CUI [1,2]
    C1519255
    SAE: Requires hospitalisation or prolongation of existing hospitalisation
    Beskrivning

    SAE: Requires hospitalisation or prolongation of existing hospitalisation

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0019993
    UMLS CUI [1,3]
    C0745041
    SAE: Results in disability/incapacity
    Beskrivning

    SAE: Results in disability/incapacity

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0231170
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C3176592
    SAE: Congenital anomaly/birth defect
    Beskrivning

    SAE: Congenital anomaly/birth defect

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C1519255
    Seriousness, if other please specify
    Beskrivning

    Seriousness Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1710056
    UMLS CUI [1,2]
    C2348235
    SECTION 3: Demography Data
    Beskrivning

    SECTION 3: Demography Data

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

    Date of birth

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Beskrivning

    Sex

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Weight
    Beskrivning

    Weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    SECTION 4: Serious Adverse Event Recurrence
    Beskrivning

    SECTION 4: Serious Adverse Event Recurrence

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0034897
    UMLS CUI-3
    C1828479
    If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
    Beskrivning

    SAE Recurrence

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0034897
    SECTION 5: Causes of SAE
    Beskrivning

    SECTION 5: Causes of SAE

    Alias
    UMLS CUI-1
    C3828190
    UMLS CUI-2
    C1519255
    UMLS CUI-4
    C1828479
    Disease under Study
    Beskrivning

    Disease under Study

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008976
    Medical Condition(s)
    Beskrivning

    Medical Condition(s)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    Medical Condition(s), specify
    Beskrivning

    Medical Condition(s) Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348235
    Lack of Efficacy
    Beskrivning

    Lack of Efficacy

    Datatyp

    boolean

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

    Withdrawal of investigational product(s)

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0013227
    Concomitant medication(s)
    Beskrivning

    Concomitant medication(s)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Concomitant medication(s), specify
    Beskrivning

    Concomitant medication(s) Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2348235
    Activity related to study participation (e.g., procedures)
    Beskrivning

    Activity Related to Study Participation

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C1519255
    UMLS CUI [2]
    C0199171
    Other
    Beskrivning

    Other

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0205394
    Other, specify
    Beskrivning

    Other Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    SECTION 6: Relevant Medical Conditions
    Beskrivning

    SECTION 6: Relevant Medical Conditions

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C0262926
    UMLS CUI-3
    C1519255
    UMLS CUI-4
    C1828479
    Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
    Beskrivning

    Relevant Medical Conditions

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0262926
    UMLS CUI [2]
    C1519255
    UMLS CUI [3]
    C0020517
    UMLS CUI [4]
    C0543467
    Date of onset
    Beskrivning

    Day Month Year

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C1519255
    Condition present at time of the SAE?
    Beskrivning

    Condition present at time of the SAE

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3827351
    UMLS CUI [1,2]
    C1519255
    If NO, date of last occurrence
    Beskrivning

    Day Month Year

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2745955
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [2]
    C1519255
    SECTION 7: Other Relevant Risk Factors
    Beskrivning

    SECTION 7: Other Relevant Risk Factors

    Alias
    UMLS CUI-1
    C0035648
    UMLS CUI-2
    C1519255
    UMLS CUI-3
    C0205394
    UMLS CUI-4
    C1828479
    Other Relevant Risk Factors
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0035648
    UMLS CUI [2]
    C1519255
    SECTION 8: Relevant Concomitant Medications
    Beskrivning

    SECTION 8: Relevant Concomitant Medications

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C2347852
    Drug, Trade name preferred
    Beskrivning

    Include any concomitant medications that may contribute to the occurrence of the SAE Trade name preferred

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2360065
    UMLS CUI [2]
    C1519255
    Dose
    Beskrivning

    Dose

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [2]
    C1519255
    Unit
    Beskrivning

    Unit

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [2]
    C1519255
    Frequency
    Beskrivning

    Frequency

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519255
    Route
    Beskrivning

    Route

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [2]
    C1519255
    Taken Prior to Study?
    Beskrivning

    Taken Prior to Study

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2347852
    UMLS CUI [2]
    C1519255
    Start Date
    Beskrivning

    Day Month Year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [2]
    C1519255
    Stop date
    Beskrivning

    Day Month Year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [2]
    C1519255
    Ongoing Medication?
    Beskrivning

    Ongoing Medication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3494713
    UMLS CUI [2]
    C1519255
    Reason for Medication
    Beskrivning

    Indication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [2]
    C1519255
    SECTION 9: Details of Investigational Product(s)
    Beskrivning

    SECTION 9: Details of Investigational Product(s)

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C0013230
    UMLS CUI-3
    C1522508
    Details of Investigational Product
    Beskrivning

    Details of Investigational Product

    Datatyp

    text

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

    Treatment Blind Broken

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3897431
    SECTION 10: Details of Relevant Assessments
    Beskrivning

    SECTION 10: Details of Relevant Assessments

    Alias
    UMLS CUI-1
    C1261322
    UMLS CUI-2
    C1519255
    Details of Relevant Assessments
    Beskrivning

    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

    Datatyp

    text

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

    SECTION 11: Narrative Remarks

    Alias
    UMLS CUI-1
    C1828479
    UMLS CUI-2
    C0947611
    Narrative Remarks
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1519255
    Conclusion
    Beskrivning

    Conclusion

    Alias
    UMLS CUI-1
    C1707478
    Investigator's Signature
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's name
    Beskrivning

    print

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Beskrivning

    Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    SECTION 12: Additional/Follow-Up Information
    Beskrivning

    SECTION 12: Additional/Follow-Up Information

    Alias
    UMLS CUI-1
    C1524062
    UMLS CUI-2
    C1533716
    UMLS CUI-3
    C1519255
    UMLS CUI-4
    C1522577
    SAE Additional/Follow-up Information
    Beskrivning

    use this page to provide any additional details on the SAE not already captured on the previous pages

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1524062
    UMLS CUI [1,2]
    C1533716
    UMLS CUI [1,3]
    C1519255
    UMLS CUI [1,4]
    C1522577
    Investigator's Signature
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's name
    Beskrivning

    print

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Beskrivning

    Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
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    Similar models

    Serious Adverse Event Notification Form

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Randomisation Number
    Item
    Randomisation Number
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    SECTION 1: Serious Adverse Event
    C1519255 (UMLS CUI-1)
    Item
    Did the subject experience any serious adverse events during the study?
    text
    C1519255 (UMLS CUI [1])
    serious adverse events
    Code List
    Did the subject experience any serious adverse events during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    SECTION 1: Serious Adverse Events Record
    C1519255 (UMLS CUI-1)
    C1828479 (UMLS CUI-3)
    Serious adverse event
    Item
    Serious adverse events: Diagnosis only (if known) or signs / symptoms
    text
    C1519255 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    text
    C0808070 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Start Time
    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])
    Sex
    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 [1,1])
    C1519255 (UMLS CUI [1,2])
    C1148348 (UMLS CUI [2])
    End Time
    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])
    Seriousness
    Code List
    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])
    C1519255 (UMLS CUI [1,2])
    Withdrawal
    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)
    Item
    Did subject withdraw from study as a result of this serious AE?
    text
    C1710677 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Seriousness
    Code List
    Did subject withdraw from study as a result of this serious AE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
    text
    C0304229 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Cause of SAE
    Code List
    Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If fatal, was a post-mortem/autopsy performed?
    text
    C0004398 (UMLS CUI [1])
    C1519255 (UMLS CUI [2])
    Withdrawal
    Code List
    If fatal, was a post-mortem/autopsy performed?
    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
    SAE: Results in Death
    boolean
    C1705232 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE: Is Life-Threatening
    Item
    SAE: Is Life-Threatening
    boolean
    C1517874 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE: Requires hospitalisation or prolongation of existing hospitalisation
    Item
    SAE: Requires hospitalisation or prolongation of existing hospitalisation
    boolean
    C1519255 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    C0745041 (UMLS CUI [1,3])
    SAE: Results in disability/incapacity
    Item
    SAE: Results in disability/incapacity
    boolean
    C1519255 (UMLS CUI [1,1])
    C0231170 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2,1])
    C3176592 (UMLS CUI [2,2])
    SAE: Congenital anomaly/birth defect
    Item
    SAE: Congenital anomaly/birth defect
    boolean
    C0000768 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Seriousness Specification
    Item
    Seriousness, if other please specify
    text
    C1710056 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    SECTION 3: Demography Data
    C0011298 (UMLS CUI-1)
    C1828479 (UMLS CUI-2)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Seriousness
    Code List
    Sex
    CL Item
    Male (Male)
    CL Item
    Female (Female)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    SECTION 4: Serious Adverse Event Recurrence
    C1519255 (UMLS CUI-1)
    C0034897 (UMLS CUI-2)
    C1828479 (UMLS CUI-3)
    Item
    If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
    text
    C1519255 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    Cause of SAE
    Code List
    If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational 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: Causes of SAE
    C3828190 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    C1828479 (UMLS CUI-4)
    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)
    boolean
    C0012634 (UMLS CUI [1])
    Medical Condition(s) Specification
    Item
    Medical Condition(s), specify
    text
    C0012634 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    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)
    boolean
    C2347852 (UMLS CUI [1])
    Concomitant medication(s) Specification
    Item
    Concomitant medication(s), specify
    text
    C2347852 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Activity Related to Study Participation
    Item
    Activity related to study participation (e.g., procedures)
    boolean
    C2348568 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    C0199171 (UMLS CUI [2])
    Other
    Item
    Other
    boolean
    C0205394 (UMLS CUI [1])
    Other Specification
    Item
    Other, specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    SECTION 6: Relevant Medical Conditions
    C0012634 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    C1828479 (UMLS CUI-4)
    Relevant Medical Conditions
    Item
    Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
    text
    C0262926 (UMLS CUI [1])
    C1519255 (UMLS CUI [2])
    C0020517 (UMLS CUI [3])
    C0543467 (UMLS CUI [4])
    Date of onset
    Item
    Date of onset
    text
    C0574845 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Condition present at time of the SAE?
    text
    C3827351 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Seriousness
    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
    text
    C2745955 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C1519255 (UMLS CUI [2])
    Item Group
    SECTION 7: Other Relevant Risk Factors
    C0035648 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    C1828479 (UMLS CUI-4)
    Other relevant risk factors
    Item
    Other Relevant Risk Factors
    text
    C0035648 (UMLS CUI [1])
    C1519255 (UMLS CUI [2])
    Item Group
    SECTION 8: Relevant Concomitant Medications
    C1828479 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Drug
    Item
    Drug, Trade name preferred
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2])
    Dose
    Item
    Dose
    text
    C3174092 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2])
    Unit
    Item
    Unit
    text
    C1519795 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2])
    Frequency
    Item
    Frequency
    text
    C1519255 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2])
    Item
    Taken Prior to Study?
    text
    C2347852 (UMLS CUI [1])
    C1519255 (UMLS CUI [2])
    Seriousness
    Code List
    Taken Prior to Study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2])
    Stop date
    Item
    Stop date
    date
    C0806020 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2])
    Item
    Ongoing Medication?
    text
    C2347852 (UMLS CUI [1,1])
    C3494713 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2])
    Sex
    Code List
    Ongoing Medication?
    CL Item
    Male (M)
    CL Item
    Female (F)
    Indication
    Item
    Reason for Medication
    text
    C3146298 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2])
    Item Group
    SECTION 9: Details of Investigational Product(s)
    C1828479 (UMLS CUI-1)
    C0013230 (UMLS CUI-2)
    C1522508 (UMLS CUI-3)
    Details of Investigational Product
    Item
    Details of Investigational Product
    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])
    Treatment Blind Broken
    Code List
    Was treatment blind 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
    C1261322 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Details of Relevant Assessments
    Item
    Details of Relevant Assessments
    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
    text
    C0947611 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    Conclusion
    C1707478 (UMLS CUI-1)
    Investigator's Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator's name
    Item
    Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    SECTION 12: Additional/Follow-Up Information
    C1524062 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    C1522577 (UMLS CUI-4)
    SAE Additional/Follow-up Information
    Item
    SAE Additional/Follow-up Information
    text
    C1524062 (UMLS CUI [1,1])
    C1533716 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    C1522577 (UMLS CUI [1,4])
    Investigator's Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator's name
    Item
    Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
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