0 Avaliações
ID

33115

Descrição

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the form of SAE. It has to be filled in if the subject has experienced an SAE.

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Versões (1)
  1. 28/11/2018 28/11/2018 -
Titular dos direitos

GlaxoSmithKline

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28 de novembro de 2018

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Creative Commons BY-NC 3.0
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    Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

    Inglês

    Serious Adverse Event (SAE)

    1 Formulários  
    Administrative data
    Descrição

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Descrição

    Subject Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Investigator Number
    Descrição

    Investigator Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826689
    Treatment number
    Descrição

    Treatment number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1522541
    Session Number
    Descrição

    Session Number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1883017
    UMLS CUI [1,2]
    C0750480
    Serious Adverse Event (SAE)
    Descrição

    Serious Adverse Event (SAE)

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

    If YES, indicate following sections. A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening c) requires hospitalization or prolongation of existing hospitalization d) results in disability/incapacity e) a congenital anomaly/birth defect f) other 1) Complete the Serious Adverse Event pages: A separate set of SAE pages should be used for each SAE. However, if at the time of initial reporting, multiple SAEs are apparent that are temporally and/or clinically related, then they can be reported on the same page. 2) Inform GlaxoSmithKline: The investigator must inform GSK of serious adverse events by fax or telephone (fax preferred) within 24 hours of becoming aware of the event.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C2347804
    SECTION 1 Demography
    Descrição

    SECTION 1 Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Descrição

    Sex

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Descrição

    Race

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0034510
    Weight
    Descrição

    Weight

    Tipo de dados

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Height
    Descrição

    Height

    Tipo de dados

    integer

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Serious Adverse Events
    Descrição

    Serious Adverse Events

    Alias
    UMLS CUI-1
    C1519255
    Serious adverse events, Diagnosis
    Descrição

    Diagnosis only (if known) OR Serious signs / symptoms (list one per line). Enter only the diagnosis (if known); otherwise each serious sign and symptom should be entered on a separate line. If a diagnosis subsequently becomes available, then this should be entered and the signs and symptoms crossed out.

    Tipo de dados

    text

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

    day month year. Record the date of onset of the first occurrence of the SAE.

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C1519255
    Time of onset
    Descrição

    00:00-23:59. Record the exact time of onset of the SAE.

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0449244
    UMLS CUI [1,2]
    C1519255
    Maximum intensity
    Descrição

    Record the maximum intensity that occurred over the duration of the SAE. Amend the intensity if it increases.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1710066
    Outcome of SAE
    Descrição

    All SAEs must be followed until the events are resolved, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Resolved", "Resolved with sequelae", or was "Fatal". 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 resolved" Also enter "Not resolved" if the SAE was ongoing at the time of death, but was not the cause of death.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1705586
    Date of resolution or death
    Descrição

    day month year. Record the date of resolution or the date of death. If the event resolved with sequelae, enter the date the subject's medical condition stabilized. Leave blank if the event is "Not resolved".

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2985918
    UMLS CUI [1,2]
    C1148348
    Time of resolution or death
    Descrição

    00:00-23:59. Record the exact time of resolution of the SAE or the time of death.

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C2699488
    UMLS CUI [1,3]
    C1519255
    UMLS CUI [2]
    C1301931
    Action taken with investigational product(s) as a result of the SAE
    Descrição

    Indicate only for the specific event(s) that were directly responsible for the action taken with investigational product(s)· None: lnvestigational product(s) continue(s) even though an adverse event has occurred. Dose adjusted: Dose is increased or decreased for one or more investigational product(s). Temporarily interrupted: Administration of one or more investigational product(s) was stopped temporarily but then restarted. Permanently discontinued: Administration of one or more investigational product(s) was stopped permanently and not restarted. Not applicable: Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or postdosing) or the subject died and there was no prior decision to discontinue investigational product(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?
    Descrição

    Indicate only the event(s) directly responsible for the subject's withdrawal as indicated on the End of Study Record page.

    Tipo de dados

    text

    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(s)?
    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 easonable possibility" is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence/arguments that may support "A reasonable possibility'' include, for example, a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concomitant illness, or relevant medical history, should also be considered.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C1519255
    Does the AE meet the definition of serious?
    Descrição

    If you tick No, please fill in the non-serious AE form and not the SAE form! A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening c) requires hospitalization or prolongation of existing hospitalization d) results in disability/incapacity e) a congenital anomaly/birth defect f) other

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1710056
    SECTION 3 Possible Causes of SAE other than Investigational Product(s)
    Descrição

    SECTION 3 Possible Causes of SAE other than Investigational Product(s)

    Alias
    UMLS CUI-1
    C0015127
    UMLS CUI-2
    C1519255
    Disease under study
    Descrição

    Disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1519255
    Treatment failure
    Descrição

    Treatment failure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0162643
    UMLS CUI [1,2]
    C1519255
    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]
    C0304229
    UMLS CUI [1,3]
    C1519255
    Concomitant disorder
    Descrição

    Concomitant disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C1519255
    If Concomitant disorder, please specify
    Descrição

    Concomitant disorder, specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0009488
    Concomitant medication
    Descrição

    Concomitant medication

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1519255
    If Concomitant medication, please specify
    Descrição

    Concomitant medication, specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2347852
    Activity related to study participation
    Descrição

    (e.g., procedures)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    If Activity related to study participation, please specify
    Descrição

    Activity related to study participation, specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348568
    Other causation
    Descrição

    Other causation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0015127
    UMLS CUI [1,3]
    C1519255
    If Other, please specify
    Descrição

    Other, specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0015127
    SECTION 4 Seriousness of SAE
    Descrição

    SECTION 4 Seriousness of SAE

    Alias
    UMLS CUI-1
    C1710056
    Death
    Descrição

    Death

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0011065
    UMLS CUI [1,2]
    C1519255
    If fatal, was an autopsy done/to be performed?
    Descrição

    Send autopsy report when available.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0004398
    UMLS CUI [1,2]
    C1518965
    Life threatening
    Descrição

    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.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1517874
    UMLS CUI [1,2]
    C1519255
    Hospitalization required or prolonged
    Descrição

    NOTE: In general, hospitalization 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 outpatient setting. Complications that occur during hospitalization are AEs. If a complication prolongs hospitalization or fulfills any other serious criteria, the event is serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE should be considered serious. Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2348993
    UMLS CUI [1,2]
    C1519255
    Disabling or incapacitating
    Descrição

    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, diarrhea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3830477
    UMLS CUI [1,2]
    C1519255
    Congenital anomaly
    Descrição

    Congenital anomaly

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2826727
    UMLS CUI [1,2]
    C1519255
    Other seriousness
    Descrição

    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 hospitalization but may jeopardize 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 hospitalization, or development of drug dependency or drug abuse.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1710056
    UMLS CUI [1,2]
    C0205394
    If Other, please specify
    Descrição

    Other, specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0205394
    SECTION 5 Relevant Medical Conditions
    Descrição

    SECTION 5 Relevant Medical Conditions

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

    Past/Current disease, allergies, surgeries

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1444637
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [2,1]
    C0521116
    UMLS CUI [2,2]
    C0012634
    UMLS CUI [3]
    C0020517
    UMLS CUI [4]
    C0543467
    Date of onset
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0574845
    Condition present at time of the SAE
    Descrição

    Condition present at time of the SAE

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1519255
    If you tick NO in "Condition present at time of the SAE", date of last occurrence
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2745955
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C1519255
    SECTION 6 Other Relevant Risk Factors
    Descrição

    SECTION 6 Other Relevant Risk Factors

    Alias
    UMLS CUI-1
    C0205394
    UMLS CUI-2
    C0035648
    UMLS CUI-3
    C1519255
    Specify any family history or any social history relevant to the SAE.
    Descrição

    (e.g., smoking, alcohol, diet, drug abuse, occupational hazard)

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C3714536
    SECTION 7 Details of Investigational Product(s)
    Descrição

    SECTION 7 Details of Investigational Product(s)

    Alias
    UMLS CUI-1
    C0013230
    UMLS CUI-2
    C1522508
    lnvestigational product
    Descrição

    lnvestigational product

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1522508
    Treatment period
    Descrição

    Treatment period

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2347804
    Date of dose
    Descrição

    Date of dose

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    SECTION 8 Relevant Concomitant Medications
    Descrição

    SECTION 8 Relevant Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Drug
    Descrição

    (Trade name preferred)

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0013227
    Drug Dose
    Descrição

    Drug Dose

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0678766
    Dose unit
    Descrição

    Dose unit

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0869039
    Frequency
    Descrição

    Frequency

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Descrição

    Route

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0013153
    Date started
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0808070
    Started pre-study
    Descrição

    Started pre-study

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C2347804
    Date stopped
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0806020
    Tick if continued Post-SAE
    Descrição

    Post-SAE, continuing

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0549178
    UMLS CUI [1,2]
    C0032756
    UMLS CUI [1,3]
    C1519255
    Conditions treated / indication
    Descrição

    Conditions treated / indication

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826696
    SECTION 9 Narrative / Comments
    Descrição

    SECTION 9 Narrative / Comments

    Alias
    UMLS CUI-1
    C0947611
    UMLS CUI-2
    C1519255
    Description of SAE
    Descrição

    This should include but not be limited to the following: • Any previous occurrences of this type of event • Any relevant non-serious adverse events that occurred prior to the SAE • The full clinical presentation and sequelae/evolution of the SAE • Any associated signs and symptoms of the SAE • Explain any possible causes of the SAE • Treatment for the SAE (including any specific medications administered or non-drug treatment) • Any other action taken for the management of the SAE or the subject • Duration and outcome of the SAE • If the SAE is associated with an overdose of investigational product(s), details of the amount of overdose and whether it was intentional or accidental.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0678257
    SECTION 10 Details of Relevant Assessments
    Descrição

    SECTION 10 Details of Relevant Assessments

    Alias
    UMLS CUI-1
    C1261322
    UMLS CUI-2
    C1519255
    Details of assessment
    Descrição

    Provide details of any other assessments or supplementary investigations/examinations that were conducted as part of the subject’s care and/or based on clinical judgment of the likely causative factors of the SAE. This may include, but not be limited to: • Laboratory data. Always provide the reference range and baseline values (fax or mail pages if extensive supporting data) • Findings of ECGs, X-rays, etc. • Results of other diagnostic tests or assays • Key findings from hospital discharge or pathology reports

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1522508
    UMLS CUI [1,2]
    C0220825
    SECTION 11 Reporting Investigator
    Descrição

    SECTION 11 Reporting Investigator

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C1533716
    Reporting investigator - Name (print)
    Descrição

    The reporting investigator (not the study nurse or study monitor) must sign and date the SAE page.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826892
    Address
    Descrição

    Address

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1442065
    UMLS CUI [1,2]
    C0008961
    Invetigator Signature
    Descrição

    Invetigator Signature

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0011008
    Additional or follow-up information
    Descrição

    Additional or follow-up information

    Alias
    UMLS CUI-1
    C1533716
    UMLS CUI-2
    C1519255
    Additional details of SAE
    Descrição

    Use this page to provide any additional details on the serious adverse event not already captured on the previous pages. The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1546922
    UMLS CUI [1,2]
    C1519255
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    Serious Adverse Event (SAE)

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Investigator Number
    Item
    Investigator Number
    text
    C2826689 (UMLS CUI [1])
    Treatment number
    Item
    Treatment number
    text
    C1522541 (UMLS CUI [1])
    Item
    Session Number
    integer
    C1883017 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Session Number
    Code List
    Session Number
    CL Item
    Session 1 (1)
    CL Item
    Session 2 (2)
    CL Item
    Session 3 (3)
    CL Item
    Session 4 (4)
    CL Item
    Session 5 (5)
    CL Item
    Session 6 (6)
    Item Group
    Serious Adverse Event (SAE)
    C1519255 (UMLS CUI-1)
    Item
    Did the subject experience any serious adverse events during the study?
    text
    C1519255 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    SAE during study
    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 Demography
    C0011298 (UMLS CUI-1)
    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 (M)
    CL Item
    Female (F)
    Item
    Race
    integer
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    White (1)
    CL Item
    Black (2)
    CL Item
    Asian (3)
    CL Item
    Other (4)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Item Group
    Serious Adverse Events
    C1519255 (UMLS CUI-1)
    Serious adverse events, Diagnosis
    Item
    Serious adverse events, Diagnosis
    text
    C1519255 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Date of onset
    Item
    Date of onset
    date
    C0574845 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Time of onset
    Item
    Time of onset
    time
    C0449244 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Maximum intensity
    text
    C1710066 (UMLS CUI [1])
    Maximum intensity
    Code List
    Maximum intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (X)
    Item
    Outcome of SAE
    text
    C1705586 (UMLS CUI [1])
    Outcome of SAE
    Code List
    Outcome of SAE
    CL Item
    Resolved (R)
    CL Item
    Resolved with Sequelae (S)
    CL Item
    Fatal (F)
    CL Item
    Not Resolved (N)
    Date of resolution or death
    Item
    Date of resolution or death
    date
    C2985918 (UMLS CUI [1,1])
    C1148348 (UMLS CUI [1,2])
    Time of resolution or death
    Item
    Time of resolution or death
    time
    C0040223 (UMLS CUI [1,1])
    C2699488 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    C1301931 (UMLS CUI [2])
    Item
    Action taken with investigational product(s) as a result of the SAE
    text
    C1704758 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    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
    None (0)
    CL Item
    Dose adjusted (1)
    CL Item
    Temporarily interrupted (2)
    CL Item
    Permanently discontinued (3)
    CL Item
    Not applicable (X)
    Item
    Did the subject withdraw from study as a result of this SAE?
    text
    C2349954 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Withdrawal
    Code List
    Did the subject withdraw from study as a result of this SAE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Is there a reasonable possibility 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])
    Relationship to investigational product(s)
    Code List
    Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Does the AE meet the definition of serious?
    text
    C1710056 (UMLS CUI [1])
    Seriousness
    Code List
    Does the AE meet the definition of serious?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    SECTION 3 Possible Causes of SAE other than Investigational Product(s)
    C0015127 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Disease
    Item
    Disease under study
    boolean
    C0012634 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Treatment failure
    Item
    Treatment failure
    boolean
    C0162643 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Withdrawal of investigational product(s)
    Item
    Withdrawal of investigational product(s)
    boolean
    C2349954 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Concomitant disorder
    Item
    Concomitant disorder
    boolean
    C0009488 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Concomitant disorder, specify
    Item
    If Concomitant disorder, please specify
    text
    C0009488 (UMLS CUI [1])
    Concomitant medication
    Item
    Concomitant medication
    boolean
    C2347852 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Concomitant medication, specify
    Item
    If Concomitant medication, please specify
    text
    C2347852 (UMLS CUI [1])
    Activity related to study participation
    Item
    Activity related to study participation
    boolean
    C2348568 (UMLS CUI [1])
    Activity related to study participation, specify
    Item
    If Activity related to study participation, please specify
    text
    C2348568 (UMLS CUI [1])
    Other causation
    Item
    Other causation
    boolean
    C0205394 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Other, specify
    Item
    If Other, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    Item Group
    SECTION 4 Seriousness of SAE
    C1710056 (UMLS CUI-1)
    Death
    Item
    Death
    boolean
    C0011065 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    If fatal, was an autopsy done/to be performed?
    text
    C0004398 (UMLS CUI [1,1])
    C1518965 (UMLS CUI [1,2])
    Autopsy performance
    Code List
    If fatal, was an autopsy done/to be performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Life threatening
    Item
    Life threatening
    boolean
    C1517874 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Hospitalization required/prolonged
    Item
    Hospitalization required or prolonged
    boolean
    C2348993 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Disabling/incapacitating
    Item
    Disabling or incapacitating
    boolean
    C3830477 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Congenital anomaly
    Item
    Congenital anomaly
    boolean
    C2826727 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Other seriousness
    Item
    Other seriousness
    boolean
    C1710056 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other, specify
    Item
    If Other, please specify
    text
    C0205394 (UMLS CUI [1])
    Item Group
    SECTION 5 Relevant Medical Conditions
    C0012634 (UMLS CUI-1)
    Past/Current disease, allergies, surgeries
    Item
    Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
    text
    C1444637 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0521116 (UMLS CUI [2,1])
    C0012634 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3])
    C0543467 (UMLS CUI [4])
    Date of onset
    Item
    Date of onset
    date
    C0574845 (UMLS CUI [1])
    Item
    Condition present at time of the SAE
    text
    C0012634 (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 you tick NO in "Condition present at time of the SAE", date of last occurrence
    date
    C2745955 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C1519255 (UMLS CUI [1,4])
    Item Group
    SECTION 6 Other Relevant Risk Factors
    C0205394 (UMLS CUI-1)
    C0035648 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    Any family history/any social history relevant to the SAE.
    Item
    Specify any family history or any social history relevant to the SAE.
    text
    C0241889 (UMLS CUI [1,1])
    C3714536 (UMLS CUI [1,2])
    Item Group
    SECTION 7 Details of Investigational Product(s)
    C0013230 (UMLS CUI-1)
    C1522508 (UMLS CUI-2)
    lnvestigational product
    Item
    lnvestigational product
    text
    C0304229 (UMLS CUI [1,1])
    C1522508 (UMLS CUI [1,2])
    Treatment period
    Item
    Treatment period
    integer
    C2347804 (UMLS CUI [1])
    Date of dose
    Item
    Date of dose
    date
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    SECTION 8 Relevant Concomitant Medications
    C2347852 (UMLS CUI-1)
    Drug
    Item
    Drug
    text
    C0013227 (UMLS CUI [1])
    Drug Dose
    Item
    Drug Dose
    integer
    C0678766 (UMLS CUI [1])
    Dose unit
    Item
    Dose unit
    text
    C0869039 (UMLS CUI [1])
    Frequency
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Date started
    Item
    Date started
    date
    C0808070 (UMLS CUI [1])
    Started pre-study
    Item
    Started pre-study
    boolean
    C0808070 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Date stopped
    Item
    Date stopped
    date
    C0806020 (UMLS CUI [1])
    Post-SAE, continuing
    Item
    Tick if continued Post-SAE
    boolean
    C0549178 (UMLS CUI [1,1])
    C0032756 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Conditions treated / indication
    Item
    Conditions treated / indication
    text
    C2826696 (UMLS CUI [1])
    Item Group
    SECTION 9 Narrative / Comments
    C0947611 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Description of SAE
    Item
    Description of SAE
    text
    C1519255 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Item Group
    SECTION 10 Details of Relevant Assessments
    C1261322 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Details of assessment
    Item
    Details of assessment
    text
    C1522508 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    Item Group
    SECTION 11 Reporting Investigator
    C0008961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Reporting investigator - Name
    Item
    Reporting investigator - Name (print)
    text
    C2826892 (UMLS CUI [1])
    Address
    Item
    Address
    text
    C1442065 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Invetigator Signature
    Item
    Invetigator Signature
    text
    C2346576 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Additional or follow-up information
    C1533716 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Additional details SAE
    Item
    Additional details of SAE
    text
    C1546922 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
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