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ID

26095

Beskrivning

Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.

Nyckelord

Versioner (3)
  1. 2017-10-02 2017-10-02 -
  2. 2017-10-02 2017-10-02 -
  3. 2017-10-09 2017-10-09 -
Rättsinnehavare

Glaxo Smith Kline

Uppladdad den

9 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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    GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. SAE Form and Investigator comment (Screening Visit)

    Engelsk

    SAE Form and Investigator comment (Screening Visit)

    1 Formulär  
    Serious Adverse Event
    Beskrivning

    Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255
    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. The investigator must inform GSK of serious adverse events by fax or telephone (fax preferred) within 24 hours of becoming aware of the event.
    Beskrivning

    Serious Adverse Event report

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3897642
    The investigator and others responsible for subject care should institute any supplementary investigations of SAEs based on their clinical judgment of the likely causative factors. This may include seeking a further opinion from a specialist in the field of the adverse event. GlaxoSmithKline may also request extra tests or extra follow-up information. If a subject dies, any postmortem findings, including histopathology, must be provided to GlaxoSmithKline. On receipt of follow-up information (e.g., diagnosis, dates of resolution, changes in intensity or causality) the appropriate SAE pages must be amended/updated. These changes must be initialed and dated by the investigator. A copy of the full set of SAE pages must always be faxed or mailed to GlaxoSmithKline within 24 hours of the investigator becoming aware of the new information.
    Beskrivning

    Follow-up information SAE

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0807975
    UMLS CUI [1,2]
    C1519255
    A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening NOTE:The tenn '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 hospitalization or prolongation of existing hospitalization NOTE:ln 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. d) results in disability/incapacity NOTE:The term disability means a substantial disruption of a person's ability to conduct nonnal 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. e) 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 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.
    Beskrivning

    Serious Adverse Event Definition

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1704788
    Investigator number
    Beskrivning

    Investigator Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2826689
    Treatment Number
    Beskrivning

    Treatment Number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1522541
    Subject number
    Beskrivning

    Subject number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Did the subject experience any serious adverse events during the study?
    Beskrivning

    If YES, indicate below

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519255
    Date of Birth
    Beskrivning

    Date of Birth

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Beskrivning

    Gender

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Beskrivning

    Race

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0034510
    Weight
    Beskrivning

    Patient Weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Height
    Beskrivning

    Patient Height

    Datatyp

    float

    Måttenheter
    • cm
    Alias
    UMLS CUI [1]
    C0489786
    cm
    Event Diagnose only (if known) otherwise Sign/Symptom
    Beskrivning

    Serious Adverse Events

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519255
    Date of onset
    Beskrivning

    Serious Adverse Event Onset Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0011008
    Time of onset
    Beskrivning

    SAE onset time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449244
    Maximum Intensity
    Beskrivning

    Maximum Intensity

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0877248
    Outcome
    Beskrivning

    Outcome SAE

    Datatyp

    text

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

    Date of resolution or death

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1519255
    Time of resolution or death
    Beskrivning

    Time of resolution or death

    Datatyp

    time

    Måttenheter
    • hh:mm
    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C2699488
    UMLS CUI [1,3]
    C1519255
    UMLS CUI [1,4]
    C1301931
    hh:mm
    Action Taken with Respect to Investigational Drug
    Beskrivning

    Action Taken

    Datatyp

    text

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

    Withdrawal

    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?
    Beskrivning

    Relationship to investigational products

    Datatyp

    text

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

    Seriousness

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1710056
    UMLS CUI [1,2]
    C1518404
    Possible Causes of SAE Other Than lnvestigational Product(s)
    Beskrivning

    check all that apply

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0015127
    Seriousness
    Beskrivning

    check all that apply

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1710056
    If fatal was an autopsy done/to be performed?
    Beskrivning

    Send autopsy report when available.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004398
    UMLS CUI [1,2]
    C0884358
    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 [1,1]
    C0012634
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C1519255
    Date of Onset
    Beskrivning

    Serious Adverse Event Onset Date

    Datatyp

    date

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

    Current Condition while SAE

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3827351
    UMLS CUI [1,2]
    C1519255
    Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
    Beskrivning

    Other relevant risk factors

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0035648
    UMLS CUI [1,2]
    C1519255
    Details of lnvestigational Product(s)
    Beskrivning

    Not Applicable At Screening

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1522508
    RELEVANT Concomitant Medications
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1519255
    Drug name (Trade name preferred)
    Beskrivning

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

    Datatyp

    text

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

    Medication Dose

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3174092
    Unit
    Beskrivning

    e.g.: G=Gram L=Litre MCG=Microgram MCL=Microlitre MG=Milligram ML=Millilitre TAB=Tablet

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519795
    Frequency (e.g. BID)
    Beskrivning

    Frequency

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Beskrivning

    Administration Route

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0013153
    Date Started
    Beskrivning

    Medication Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2826734
    Started Pre-Study
    Beskrivning

    Started Pre-Study

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0451613
    Date Stopped
    Beskrivning

    Medication End Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1521826
    UMLS CUI [1,2]
    C0806020
    Medication continued post-SAE
    Beskrivning

    Ongoing Medication

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2826666
    UMLS CUI [1,2]
    C1519255
    Conditions treated/indication
    Beskrivning

    Reason for Medication

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826696
    Narrative/Comments
    Beskrivning

    Provide a textual description of the serious adverse event (including treatment of the event)

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1519255
    Details of RELEVANT Assessments
    Beskrivning

    Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C1519255
    To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
    Beskrivning

    Reporting Investigator

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C1533716
    Name (print)
    Beskrivning

    Investigator Name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Address
    Beskrivning

    Investigator Address

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1442065
    UMLS CUI [1,2]
    C0008961
    Signature
    Beskrivning

    Investigator Signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Beskrivning

    Date of completion

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0850287
    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.
    Beskrivning

    Additional or follow-up information

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1533716
    UMLS CUI [1,2]
    C1519255
    Name (print)
    Beskrivning

    Investigator Name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Address
    Beskrivning

    Investigator Address

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1442065
    UMLS CUI [1,2]
    C0008961
    Signature
    Beskrivning

    Investigator Signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Beskrivning

    Date of completion

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0850287
    Investigator Comment Log
    Beskrivning

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C0947611
    If CRF page numbers are listed, check that they correspond to the documented comment.
    Beskrivning

    Monitor Data Validation Checks

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519941
    Use this form to document any other relevant information that is not noted elsewhere in the CRF.
    Beskrivning

    Investigator Comment Log

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0947611
    Date of comment
    Beskrivning

    Date of comment

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0011008
    CRF page number if applicable
    Beskrivning

    CRF page number if applicable

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C1516308
    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All infom,ation entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
    Beskrivning

    Investigators Statement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C1710187
    Investigator signature
    Beskrivning

    Investigator signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator Name - print
    Beskrivning

    Investigator Name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Beskrivning

    Date of completion

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0850287
    Tillbaka till toppen

    Similar models

    SAE Form and Investigator comment (Screening Visit)

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Serious Adverse Event
    C1519255 (UMLS CUI-1)
    Serious Adverse Event report
    Item
    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. The investigator must inform GSK of serious adverse events by fax or telephone (fax preferred) within 24 hours of becoming aware of the event.
    text
    C3897642 (UMLS CUI [1])
    Follow-up information SAE
    Item
    The investigator and others responsible for subject care should institute any supplementary investigations of SAEs based on their clinical judgment of the likely causative factors. This may include seeking a further opinion from a specialist in the field of the adverse event. GlaxoSmithKline may also request extra tests or extra follow-up information. If a subject dies, any postmortem findings, including histopathology, must be provided to GlaxoSmithKline. On receipt of follow-up information (e.g., diagnosis, dates of resolution, changes in intensity or causality) the appropriate SAE pages must be amended/updated. These changes must be initialed and dated by the investigator. A copy of the full set of SAE pages must always be faxed or mailed to GlaxoSmithKline within 24 hours of the investigator becoming aware of the new information.
    text
    C0807975 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Serious Adverse Event Definition
    Item
    A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening NOTE:The tenn '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 hospitalization or prolongation of existing hospitalization NOTE:ln 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. d) results in disability/incapacity NOTE:The term disability means a substantial disruption of a person's ability to conduct nonnal 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. e) 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 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.
    text
    C1519255 (UMLS CUI [1,1])
    C1704788 (UMLS CUI [1,2])
    Investigator Identifier
    Item
    Investigator number
    integer
    C2826689 (UMLS CUI [1])
    Treatment Number
    Item
    Treatment Number
    text
    C1522541 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    integer
    C2348585 (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
    No (N)
    CL Item
    Yes (Y)
    Date of Birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Sex
    CL Item
    Male (1)
    CL Item
    Female (2)
    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)
    Patient Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Patient Height
    Item
    Height
    float
    C0489786 (UMLS CUI [1])
    Serious Adverse Events
    Item
    Event Diagnose only (if known) otherwise Sign/Symptom
    text
    C1519255 (UMLS CUI [1])
    Serious Adverse Event Onset Date
    Item
    Date of onset
    date
    C1519255 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    SAE onset time
    Item
    Time of onset
    time
    C1519255 (UMLS CUI [1,1])
    C0449244 (UMLS CUI [1,2])
    Item
    Maximum Intensity
    text
    C0518690 (UMLS CUI [1,1])
    C0877248 (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
    Outcome
    text
    C1705586 (UMLS CUI [1])
    Outcome SAE
    Code List
    Outcome
    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
    C0806020 (UMLS CUI [1,1])
    C1519255 (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 [1,4])
    Item
    Action Taken with Respect to Investigational Drug
    text
    C2826626 (UMLS CUI [1])
    Action Taken
    Code List
    Action Taken with Respect to Investigational Drug
    CL Item
    none (1)
    CL Item
    Dose adjusted (2)
    CL Item
    Temporarily interrupted (3)
    CL Item
    Permanently discontinued (4)
    CL Item
    Not applicable (x)
    Item
    Did subject withdraw from study as a result of this SAE?
    text
    C1710677 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    serious adverse events
    Code List
    Did subject withdraw from study as a result of this SAE?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    text
    C0085978 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    serious adverse events
    Code List
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Does the AE meet the definition of serious?
    text
    C1710056 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    serious adverse events
    Code List
    Does the AE meet the definition of serious?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Possible Causes of SAE Other Than lnvestigational Product(s)
    integer
    C1519255 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    SAE causes
    Code List
    Possible Causes of SAE Other Than lnvestigational Product(s)
    CL Item
    Disease under study (1)
    CL Item
    Concomitant disorder (specify) (2)
    CL Item
    Treatment failure (3)
    CL Item
    Withdrawal of investigational product(s) (4)
    CL Item
    Concomitant medication (specify) (5)
    CL Item
    Activity related to study participation (e.g. , procedures,specify) (6)
    CL Item
    Other, specify (7)
    Item
    Seriousness
    text
    C1710056 (UMLS CUI [1])
    Serious Adverse Event
    Code List
    Seriousness
    CL Item
    Results in death (A)
    CL Item
    Is life-threatening (B)
    CL Item
    Requires hospitalisation or prolongation of existing hospitalisation (C)
    CL Item
    Results in disability/incapacity (D)
    CL Item
    Congenital anomaly/birth defect (E)
    CL Item
    Other,please specify (F)
    autopsy done
    Item
    If fatal was an autopsy done/to be performed?
    boolean
    C0004398 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    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])
    Serious Adverse Event Onset Date
    Item
    Date of Onset
    date
    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])
    serious adverse events
    Code List
    Condition Present at Time of the SAE?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Other relevant risk factors
    Item
    Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
    text
    C0035648 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    lnvestigational Product
    Item
    Details of lnvestigational Product(s)
    text
    C0304229 (UMLS CUI [1,1])
    C1522508 (UMLS CUI [1,2])
    Relevant Concomitant Medications
    Item
    RELEVANT Concomitant Medications
    text
    C2347852 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Drug name
    Item
    Drug name (Trade name preferred)
    text
    C2347852 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Medication Dose
    Item
    Dose
    integer
    C3174092 (UMLS CUI [1])
    Unit
    Item
    Unit
    text
    C1519795 (UMLS CUI [1])
    Frequency
    Item
    Frequency (e.g. BID)
    text
    C3476109 (UMLS CUI [1])
    Administration Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Medication Start Date
    Item
    Date Started
    date
    C2826734 (UMLS CUI [1])
    Started Pre-Study
    Item
    Started Pre-Study
    boolean
    C0013227 (UMLS CUI [1,1])
    C0451613 (UMLS CUI [1,2])
    Medication End Date
    Item
    Date Stopped
    date
    C1521826 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Ongoing Medication
    Item
    Medication continued post-SAE
    boolean
    C2826666 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Reason for Medication
    Item
    Conditions treated/indication
    text
    C2826696 (UMLS CUI [1])
    Comments
    Item
    Narrative/Comments
    text
    C0947611 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Assessments
    Item
    Details of RELEVANT Assessments
    text
    C0220825 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Reporting Investigator
    Item
    To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
    boolean
    C0008961 (UMLS CUI [1,1])
    C1533716 (UMLS CUI [1,2])
    Investigator Name
    Item
    Name (print)
    text
    C2826892 (UMLS CUI [1])
    Investigator Address
    Item
    Address
    text
    C1442065 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Investigator Signature
    Item
    Signature
    text
    C2346576 (UMLS CUI [1])
    Date of completion
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0850287 (UMLS CUI [1,2])
    Additional or follow-up information
    Item
    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.
    text
    C1533716 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Investigator Name
    Item
    Name (print)
    text
    C2826892 (UMLS CUI [1])
    Investigator Address
    Item
    Address
    text
    C1442065 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Investigator Signature
    Item
    Signature
    text
    C2346576 (UMLS CUI [1])
    Date of completion
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0850287 (UMLS CUI [1,2])
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    Monitor Data Validation Checks
    Item
    If CRF page numbers are listed, check that they correspond to the documented comment.
    text
    C1519941 (UMLS CUI [1])
    Investigator Comment Log
    Item
    Use this form to document any other relevant information that is not noted elsewhere in the CRF.
    text
    C0008961 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Date of comment
    Item
    Date of comment
    date
    C0947611 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    CRF page number if applicable
    Item
    CRF page number if applicable
    integer
    C1704732 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Investigators Statement
    Item
    I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All infom,ation entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
    boolean
    C0008961 (UMLS CUI [1,1])
    C1710187 (UMLS CUI [1,2])
    Investigator signature
    Item
    Investigator signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Name
    Item
    Investigator Name - print
    text
    C2826892 (UMLS CUI [1])
    Date of completion
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0850287 (UMLS CUI [1,2])
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