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ID

39433

Beschreibung

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Stichworte

Versionen (2)
  1. 17.12.19 17.12.19 -
  2. 09.01.20 09.01.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. Januar 2020

DOI

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Creative Commons BY-NC 3.0
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    Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532)

    Englisch

    Adverse Events

    1 Formulare  
    1. StudyEvent: ODM
      1. Adverse Events
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Study Name
    Beschreibung

    Study Name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348560
    Subject ID
    Beschreibung

    Subject ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Study Site
    Beschreibung

    Study Site

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2825164
    Adverse Events
    Beschreibung

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Event
    Beschreibung

    Diagnosis only, otherwise sign/symptom

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0877248
    Adverse Event start date - Complete Date Unknown
    Beschreibung

    Adverse Event start date - Complete Date Unknown

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2697888
    UMLS CUI [1,2]
    C0439673
    Adverse Event - Start date and time
    Beschreibung

    Adverse Event - Start date and time

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C2826806
    Adverse Event - Outcome, End date and time
    Beschreibung

    Adverse Event - Outcome, End date and time

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1705586
    UMLS CUI [2]
    C2826793
    Adverse Event end date - Complete Date Unknown
    Beschreibung

    Adverse Event end date - Complete Date Unknown

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2826793
    UMLS CUI [1,2]
    C0439673
    Adverse Event - End date/ time
    Beschreibung

    Adverse Event - End date/ time

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C2826793
    Adverse Event - Frequency
    Beschreibung

    Adverse Event - Frequency

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0439603
    Adverse Event - Maximum Intensity
    Beschreibung

    Record maximum intensity throughout duration of event

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1710066
    Action taken with Investigational Product(s) as a result of the AE
    Beschreibung

    Action taken with Investigational Product(s) as a result of the AE

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C0877248
    Did the subject withdraw from study as a result of this AE?
    Beschreibung

    Please complete the Study Completion Form and Early Withdrawal forms if applicable.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C0877248
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Beschreibung

    Use best judgement at initial entry. May be amended when additional information becomes available.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    Adverse Event - Intensity Changes
    Beschreibung

    Adverse Event - Intensity Changes

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C0518690
    UMLS CUI-3
    C0392747
    Start date and time of event segment change
    Beschreibung

    Start date and time of event segment change

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C2826806
    UMLS CUI [1,2]
    C0443172
    Intensity of event segment
    Beschreibung

    Intensity of event segment

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0518690
    Was this event serious?
    Beschreibung

    Was this event serious?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Was this event determined by the investigator to be possibly suicidality-related?
    Beschreibung

    Please complete a Possible Suicidality-Related Adverse Event Form

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C3166387
    UMLS CUI [1,3]
    C0332149
    Serious Adverse Event
    Beschreibung

    Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255
    SAE number
    Beschreibung

    SAE number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    Randomisation
    Beschreibung

    Randomisation

    Alias
    UMLS CUI-1
    C0034656
    Did SAE occur after initiation of study medication?
    Beschreibung

    Did SAE occur after initiation of study medication?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0304229
    Intensity at onset of event
    Beschreibung

    Record intensity at the onset of event

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0332162
    Action taken with Investigational Product(s) as a result of the SAE
    Beschreibung

    Action taken with Investigational Product(s) as a result of the SAE

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C1519255
    Did the subject withdraw from study as a result of this SAE?
    Beschreibung

    Please complete the Study Completion Form and Early Withdrawal forms if applicable

    Datentyp

    boolean

    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?
    Beschreibung

    Use best judgement at initial entry. May be amended when additional information becomes available

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    Duration of AE if <24 hours
    Beschreibung

    Duration of AE if <24 hours

    Datentyp

    integer

    Maßeinheiten
    • hr(s)
    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C0877248
    hr(s)
    Duration of AE if <24 hours
    Beschreibung

    Duration of AE if <24 hours

    Datentyp

    integer

    Maßeinheiten
    • min(s)
    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C0877248
    min(s)
    Time to onset since last dose
    Beschreibung

    Time to onset since last dose

    Datentyp

    integer

    Maßeinheiten
    • hr(s)
    Alias
    UMLS CUI [1,1]
    C0332162
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C3174092
    UMLS CUI [1,4]
    C1517741
    hr(s)
    Time to onset since last dose
    Beschreibung

    Time to onset since last dose

    Datentyp

    integer

    Maßeinheiten
    • min(s)
    Alias
    UMLS CUI [1,1]
    C0332162
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C3174092
    UMLS CUI [1,4]
    C1517741
    min(s)
    Was the SAE caused by activities related to study participation other than investigational product e.g. procedures, blood draws, washout, etc.?
    Beschreibung

    Was the SAE caused by activities related to study participation other than investigational product e.g. procedures, blood draws, washout, etc.?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C2348568
    UMLS CUI [3]
    C0304229
    UMLS CUI [4]
    C2700391
    UMLS CUI [5]
    C0005834
    UMLS CUI [6]
    C1710661
    UMLS CUI [7]
    C0439849
    Adverse Event - Seriousness
    Beschreibung

    Adverse Event - Seriousness

    Alias
    UMLS CUI-1
    C1710056
    Specify the reason for considering this an SAE
    Beschreibung

    Check all that apply

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1710056
    UMLS CUI [1,2]
    C0392360
    Specify reason for considering this an SAE with general narrative comment
    Beschreibung

    Specify reason for considering this an SAE with general narrative comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1710056
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C2348235
    UMLS CUI [2]
    C0947611
    Relevant Concomitant/Treatment Medications
    Beschreibung

    Relevant Concomitant/Treatment Medications

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C2347946
    UMLS CUI-3
    C0013227
    Relevant Concomitant/Treatment Medications - Drug Name
    Beschreibung

    (Trade name preferred)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2347946
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C2347946
    Relevant Concomitant/Treatment Medications - Total daily dose
    Beschreibung

    Relevant Concomitant/Treatment Medications - Total daily dose

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2347946
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C2347946
    UMLS CUI [3,1]
    C2348070
    UMLS CUI [3,2]
    C0439810
    Relevant Concomitant/Treatment Medications - Unit
    Beschreibung

    Relevant Concomitant/Treatment Medications - Unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2347946
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C2347946
    UMLS CUI [3]
    C0439148
    Relevant Concomitant/Treatment Medications - Indication
    Beschreibung

    Relevant Concomitant/Treatment Medications - Indication

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2347946
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C2347946
    UMLS CUI [3]
    C3146298
    Relevant Concomitant/Treatment Medications - Start date/time
    Beschreibung

    Relevant Concomitant/Treatment Medications - Start date/time

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C2826734
    UMLS CUI [2,1]
    C1301880
    UMLS CUI [2,2]
    C2347852
    UMLS CUI [3,1]
    C0013227
    UMLS CUI [3,2]
    C0808070
    UMLS CUI [4,1]
    C0013227
    UMLS CUI [4,2]
    C1301880
    Relevant Concomitant/Treatment Medications - Drug type
    Beschreibung

    Relevant Concomitant/Treatment Medications - Drug type

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2347946
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C2347946
    UMLS CUI [3]
    C0457591
    Lab Sequence Number
    Beschreibung

    Lab Sequence Number

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C2348184
    Lab Sequence Number
    Beschreibung

    Lab Sequence Number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C2348184
    Relevant Diagnostic Results
    Beschreibung

    Relevant Diagnostic Results

    Alias
    UMLS CUI-1
    C2347946
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0456984
    Test name
    Beschreibung

    Test name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0022885
    Test date
    Beschreibung

    Test date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826247
    Test results
    Beschreibung

    Test results

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0456984
    Test units
    Beschreibung

    Test units

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C0587081
    Normal low range
    Beschreibung

    Normal low range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0086715
    UMLS CUI [1,2]
    C0205251
    Normal high range
    Beschreibung

    Normal high range

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0086715
    UMLS CUI [1,2]
    C0205250
    Relevant diagnostic results not noted above
    Beschreibung

    Relevant diagnostic results not noted above

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0430022
    UMLS CUI [1,2]
    C0456984
    UMLS CUI [1,3]
    C0205394
    Adverse Events - Rechallenge
    Beschreibung

    Adverse Events - Rechallenge

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2347900
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    Beschreibung

    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1444662
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C0034897
    UMLS CUI [2,3]
    C0580673
    General Narrative Comments
    Beschreibung

    General Narrative Comments

    Alias
    UMLS CUI-1
    C0947611
    UMLS CUI-2
    C1135957
    General Narrative Comments
    Beschreibung

    Provide a brief narrative description of SAE, possible other causes of the event e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions and details of the treatment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1135957
    Possible suicidality-related adverse event - Section 1
    Beschreibung

    Possible suicidality-related adverse event - Section 1

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2732635
    UMLS CUI-3
    C3166387
    Start Date
    Beschreibung

    Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0808070
    Event
    Beschreibung

    Event

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0877248
    Possible suicidality-related adverse event - Section 2
    Beschreibung

    Possible suicidality-related adverse event - Section 2

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2732635
    UMLS CUI-3
    C3166387
    Provide a brief description of the possible suicidality-related AE/SAE
    Beschreibung

    Provide a brief description of the possible suicidality-related AE/SAE

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C3166387
    UMLS CUI [1,3]
    C0678257
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C3166387
    UMLS CUI [2,3]
    C0678257
    Possible suicidality-related adverse event - Section 3
    Beschreibung

    Possible suicidality-related adverse event - Section 3

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2732635
    UMLS CUI-3
    C3166387
    Disease under study
    Beschreibung

    Disease under study

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008976
    Concomitant medication(s)
    Beschreibung

    Record in Section 8

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Comorbid psychiatric condition(s)
    Beschreibung

    Record in Section 8

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C0009488
    Medical condition(s)
    Beschreibung

    Record in Section 8

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    Psycho-social stressors
    Beschreibung

    Record in Section 8

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0748073
    Withdrawal of investigational product(s)
    Beschreibung

    Withdrawal of investigational product(s)

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0013227
    Investigational product dose change
    Beschreibung

    Investigational product dose change

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707811
    Lack of efficacy
    Beschreibung

    Lack of efficacy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0235828
    Investigational product(s)
    Beschreibung

    Investigational product(s)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0304229
    Other cause
    Beschreibung

    Other cause

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0205394
    Specify other cause
    Beschreibung

    Specify other cause

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Possible suicidality-related adverse event - Section 4
    Beschreibung

    Possible suicidality-related adverse event - Section 4

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2732635
    UMLS CUI-3
    C3166387
    Has the subject had any psychiatric conditions in the past (other than the one under study)?
    Beschreibung

    Has the subject had any psychiatric conditions in the past (other than the one under study)?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C0205394
    If subject has had any psychiatric conditions in the past, provide informations
    Beschreibung

    If subject has had any psychiatric conditions in the past, provide informations

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C1533716
    Has the subject had any suicidal ideation, behaviour or self-harm in the past?
    Beschreibung

    Has the subject had any suicidal ideation, behaviour or self-harm in the past?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0424000
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [1,3]
    C1760428
    UMLS CUI [1,4]
    C0424366
    If the subject had any suicidal ideation, behaviour or self-harm in the past, provide information
    Beschreibung

    If the subject had any suicidal ideation, behaviour or self-harm in the past, provide information

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0424000
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [1,3]
    C1760428
    UMLS CUI [1,4]
    C0424366
    UMLS CUI [2]
    C1533716
    Subject's current use of illicit drugs?
    Beschreibung

    Subject's current use of illicit drugs?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0281875
    UMLS CUI [1,2]
    C0521116
    If current use of illicit drugs, provide information, including results of a drug screen test if one has been obtained
    Beschreibung

    If current use of illicit drugs, provide information, including results of a drug screen test if one has been obtained

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0281875
    UMLS CUI [1,2]
    C0521116
    UMLS CUI [2]
    C1533716
    UMLS CUI [3,1]
    C0373483
    UMLS CUI [3,2]
    C1274040
    Subject's current use of alcohol?
    Beschreibung

    Subject's current use of alcohol?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0521116
    If current use of alcohol, provide information, including results of an alcohol level test if one has been obtained.
    Beschreibung

    If current use of alcohol, provide information, including results of an alcohol level test if one has been obtained.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0521116
    UMLS CUI [2]
    C1533716
    UMLS CUI [3,1]
    C0202304
    UMLS CUI [3,2]
    C1274040
    Family history of suicidality?
    Beschreibung

    Family history of suicidality?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C3166387
    If family history of suicidality, provide information
    Beschreibung

    If family history of suicidality, provide information

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C3166387
    UMLS CUI [2]
    C1533716
    Family history of psychiatric disorders?
    Beschreibung

    Family history of psychiatric disorders?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0004936
    If family history of psychiatric disorders, provide information
    Beschreibung

    If family history of psychiatric disorders, provide information

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0004936
    Possible suicidality-related adverse event - Section 5
    Beschreibung

    Possible suicidality-related adverse event - Section 5

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2732635
    UMLS CUI-3
    C3166387
    Provide information on the subject's current psycho-social stressors. For example, isolation, problems with family, relationships, work, finances, stress, etc.
    Beschreibung

    Provide information on the subject's current psycho-social stressors

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0748073
    UMLS CUI [2]
    C0205409
    UMLS CUI [3]
    C0424960
    UMLS CUI [4]
    C0439849
    UMLS CUI [5]
    C0043227
    UMLS CUI [6]
    C0557159
    UMLS CUI [7]
    C0038435
    Possible suicidality-related adverse event - Section 6
    Beschreibung

    Possible suicidality-related adverse event - Section 6

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2732635
    UMLS CUI-3
    C3166387
    Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event. For example, suicidal thoughts, associated frequency, severity and duration as well as likelihood of the subject acting upon these thoughts.
    Beschreibung

    Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0424000
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [2]
    C1760428
    UMLS CUI [3]
    C0439603
    UMLS CUI [4]
    C0439793
    UMLS CUI [5]
    C0449238
    UMLS CUI [6]
    C0033204
    Possible suicidality-related adverse event - Section 7
    Beschreibung

    Possible suicidality-related adverse event - Section 7

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2732635
    UMLS CUI-3
    C3166387
    Provide information on any suicidal behavior present during the study, as assessed by the investigator, for this index event.
    Beschreibung

    For example: Details of any suicidal behaviour, including any plan, preparations, and/or attempt Description of the associated frequencs, severity and duration of these behaviours Likelihood of the subject action upon plans and preparations If possible, description of the subject's intent (or evidence of attention seeking behaviour) Description of the degree of impulsivity or premeditation Description on the subject's mood and thoughts before and after the behaviour

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1760428
    UMLS CUI [1,2]
    C1533716
    UMLS CUI [2,1]
    C0347984
    UMLS CUI [2,2]
    C0008976
    Possible suicidality-related adverse event - Section 8
    Beschreibung

    Possible suicidality-related adverse event - Section 8

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2732635
    UMLS CUI-3
    C3166387
    Provide any additional comments or explanation, including but not limited to, both medical and psychiatric treatment, outcome and follow-up.
    Beschreibung

    Provide any additional comments or explanation, including but not limited to, both medical and psychiatric treatment, outcome and follow-up.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1830770
    UMLS CUI [2,1]
    C0681841
    UMLS CUI [2,2]
    C1524062
    UMLS CUI [3]
    C0237726
    UMLS CUI [4]
    C0204523
    UMLS CUI [5]
    C1547647
    UMLS CUI [6]
    C1522577
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Adverse Events

    1 Formulare
    1. StudyEvent: ODM
      1. Adverse Events
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Study Name
    Item
    Study Name
    text
    C2348560 (UMLS CUI [1])
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Study Site
    Item
    Study Site
    text
    C2825164 (UMLS CUI [1])
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    Event
    Item
    Event
    text
    C0877248 (UMLS CUI [1])
    Item
    Adverse Event start date - Complete Date Unknown
    integer
    C2697888 (UMLS CUI [1,1])
    C0439673 (UMLS CUI [1,2])
    Adverse event start date - Complete Date Unknown
    Code List
    Adverse Event start date - Complete Date Unknown
    CL Item
    Complete Date Unknown (1)
    Adverse Event - Start date and time
    Item
    Adverse Event - Start date and time
    datetime
    C2826806 (UMLS CUI [1])
    Item
    Adverse Event - Outcome, End date and time
    integer
    C1705586 (UMLS CUI [1])
    C2826793 (UMLS CUI [2])
    Adverse Event - Outcome, End date and time
    Code List
    Adverse Event - Outcome, End date and time
    CL Item
    Recovered/Resolved (1)
    CL Item
    Recovering/Resolving (2)
    CL Item
    Not Recovered/Not Resolved (3)
    CL Item
    Recovered/Resolved with sequelae (4)
    Item
    Adverse Event end date - Complete Date Unknown
    text
    C2826793 (UMLS CUI [1,1])
    C0439673 (UMLS CUI [1,2])
    Adverse event end date - Complete Date Unknown
    Code List
    Adverse Event end date - Complete Date Unknown
    CL Item
    Complete Date Unknown (1)
    Adverse Event - End date/ time
    Item
    Adverse Event - End date/ time
    datetime
    C2826793 (UMLS CUI [1])
    Item
    Adverse Event - Frequency
    integer
    C0877248 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Adverse Event - Frequency
    Code List
    Adverse Event - Frequency
    CL Item
    Single Episode (1)
    CL Item
    Intermittent (2)
    Item
    Adverse Event - Maximum Intensity
    integer
    C1710066 (UMLS CUI [1])
    Adverse Event - Maximum Intensity
    Code List
    Adverse Event - Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (4)
    Item
    Action taken with Investigational Product(s) as a result of the AE
    integer
    C1704758 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Action taken with Investigational Product(s) as a result of the AE
    Code List
    Action taken with Investigational Product(s) as a result of the 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 (6)
    Did the subject withdraw from study as a result of this AE?
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C1710677 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C0877248 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Item Group
    Adverse Event - Intensity Changes
    C0877248 (UMLS CUI-1)
    C0518690 (UMLS CUI-2)
    C0392747 (UMLS CUI-3)
    Start date and time of event segment change
    Item
    Start date and time of event segment change
    datetime
    C2826806 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    Item
    Intensity of event segment
    integer
    C0877248 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Intensity of event segment
    Code List
    Intensity of event segment
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Was this event serious?
    Item
    Was this event serious?
    boolean
    C1519255 (UMLS CUI [1])
    Was this event determined by the investigator to be possibly suicidality-related?
    Item
    Was this event determined by the investigator to be possibly suicidality-related?
    boolean
    C0877248 (UMLS CUI [1,1])
    C3166387 (UMLS CUI [1,2])
    C0332149 (UMLS CUI [1,3])
    Item Group
    Serious Adverse Event
    C1519255 (UMLS CUI-1)
    SAE number
    Item
    SAE number
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    Randomisation
    C0034656 (UMLS CUI-1)
    Did SAE occur after initiation of study medication?
    Item
    Did SAE occur after initiation of study medication?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item
    Intensity at onset of event
    integer
    C0518690 (UMLS CUI [1,1])
    C0332162 (UMLS CUI [1,2])
    Randomisation - Intensity at onset of event
    Code List
    Intensity at onset of event
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (4)
    Item
    Action taken with Investigational Product(s) as a result of the SAE
    integer
    C1704758 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Action taken with 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
    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 (6)
    Did the subject withdraw from study as a result of this SAE?
    Item
    Did the subject withdraw from study as a result of this SAE?
    boolean
    C1710677 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    Item
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Duration of AE if <24 hours
    Item
    Duration of AE if <24 hours
    integer
    C0449238 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Duration of AE if <24 hours
    Item
    Duration of AE if <24 hours
    integer
    C0449238 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Time to onset since last dose
    Item
    Time to onset since last dose
    integer
    C0332162 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    C1517741 (UMLS CUI [1,4])
    Time to onset since last dose
    Item
    Time to onset since last dose
    integer
    C0332162 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [1,3])
    C1517741 (UMLS CUI [1,4])
    Was the SAE caused by activities related to study participation other than investigational product e.g. procedures, blood draws, washout, etc.?
    Item
    Was the SAE caused by activities related to study participation other than investigational product e.g. procedures, blood draws, washout, etc.?
    boolean
    C1519255 (UMLS CUI [1])
    C2348568 (UMLS CUI [2])
    C0304229 (UMLS CUI [3])
    C2700391 (UMLS CUI [4])
    C0005834 (UMLS CUI [5])
    C1710661 (UMLS CUI [6])
    C0439849 (UMLS CUI [7])
    Item Group
    Adverse Event - Seriousness
    C1710056 (UMLS CUI-1)
    Item
    Specify the reason for considering this an SAE
    integer
    C1710056 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Specify the reason for considering this an SAE
    Code List
    Specify the reason for considering this an SAE
    CL Item
    Results in death (1)
    CL Item
    Is life-threatening (2)
    CL Item
    Requires hospitalisation or prolongation of existing hospitalisation (3)
    CL Item
    Results in disability/incapacity (4)
    CL Item
    Congenital anomaly/birth defect (5)
    CL Item
    Other (6)
    CL Item
    Possible drug-induced liver injury (see definition in SAE section of protocol) (7)
    Specify reason for considering this an SAE with general narrative comment
    Item
    Specify reason for considering this an SAE with general narrative comment
    text
    C1710056 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [2])
    Item Group
    Relevant Concomitant/Treatment Medications
    C2347852 (UMLS CUI-1)
    C2347946 (UMLS CUI-2)
    C0013227 (UMLS CUI-3)
    Relevant Concomitant/Treatment Medications - Drug Name
    Item
    Relevant Concomitant/Treatment Medications - Drug Name
    text
    C2347852 (UMLS CUI [1,1])
    C2347946 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [2,1])
    C2347946 (UMLS CUI [2,2])
    Relevant Concomitant/Treatment Medications - Total daily dose
    Item
    Relevant Concomitant/Treatment Medications - Total daily dose
    float
    C2347852 (UMLS CUI [1,1])
    C2347946 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [2,1])
    C2347946 (UMLS CUI [2,2])
    C2348070 (UMLS CUI [3,1])
    C0439810 (UMLS CUI [3,2])
    Relevant Concomitant/Treatment Medications - Unit
    Item
    Relevant Concomitant/Treatment Medications - Unit
    text
    C2347852 (UMLS CUI [1,1])
    C2347946 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [2,1])
    C2347946 (UMLS CUI [2,2])
    C0439148 (UMLS CUI [3])
    Relevant Concomitant/Treatment Medications - Indication
    Item
    Relevant Concomitant/Treatment Medications - Indication
    text
    C2347852 (UMLS CUI [1,1])
    C2347946 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [2,1])
    C2347946 (UMLS CUI [2,2])
    C3146298 (UMLS CUI [3])
    Relevant Concomitant/Treatment Medications - Start date/time
    Item
    Relevant Concomitant/Treatment Medications - Start date/time
    datetime
    C2826734 (UMLS CUI [1])
    C1301880 (UMLS CUI [2,1])
    C2347852 (UMLS CUI [2,2])
    C0013227 (UMLS CUI [3,1])
    C0808070 (UMLS CUI [3,2])
    C0013227 (UMLS CUI [4,1])
    C1301880 (UMLS CUI [4,2])
    Item
    Relevant Concomitant/Treatment Medications - Drug type
    integer
    C2347852 (UMLS CUI [1,1])
    C2347946 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [2,1])
    C2347946 (UMLS CUI [2,2])
    C0457591 (UMLS CUI [3])
    Relevant Concomitant/Treatment Medications - Drug type
    Code List
    Relevant Concomitant/Treatment Medications - Drug type
    CL Item
    Concomitant (1)
    CL Item
    Treatment (2)
    CL Item
    Cause of SAE (3)
    Item Group
    Lab Sequence Number
    C0022885 (UMLS CUI-1)
    C2348184 (UMLS CUI-2)
    Lab Sequence Number
    Item
    Lab Sequence Number
    text
    C0022885 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Item Group
    Relevant Diagnostic Results
    C2347946 (UMLS CUI-1)
    C0430022 (UMLS CUI-2)
    C0456984 (UMLS CUI-3)
    Test name
    Item
    Test name
    text
    C0022885 (UMLS CUI [1])
    Test date
    Item
    Test date
    date
    C2826247 (UMLS CUI [1])
    Test results
    Item
    Test results
    text
    C0456984 (UMLS CUI [1])
    Test units
    Item
    Test units
    text
    C1519795 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Normal low range
    Item
    Normal low range
    text
    C0086715 (UMLS CUI [1,1])
    C0205251 (UMLS CUI [1,2])
    Normal high range
    Item
    Normal high range
    text
    C0086715 (UMLS CUI [1,1])
    C0205250 (UMLS CUI [1,2])
    Relevant diagnostic results not noted above
    Item
    Relevant diagnostic results not noted above
    text
    C0430022 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item Group
    Adverse Events - Rechallenge
    C0877248 (UMLS CUI-1)
    C2347900 (UMLS CUI-2)
    Item
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    integer
    C0304229 (UMLS CUI [1,1])
    C1444662 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [2,1])
    C0034897 (UMLS CUI [2,2])
    C0580673 (UMLS CUI [2,3])
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    Code List
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Unknown at this time (3)
    CL Item
    Not applicable (4)
    Item Group
    General Narrative Comments
    C0947611 (UMLS CUI-1)
    C1135957 (UMLS CUI-2)
    General Narrative Comments
    Item
    General Narrative Comments
    text
    C0947611 (UMLS CUI [1,1])
    C1135957 (UMLS CUI [1,2])
    Item Group
    Possible suicidality-related adverse event - Section 1
    C0877248 (UMLS CUI-1)
    C2732635 (UMLS CUI-2)
    C3166387 (UMLS CUI-3)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Event
    Item
    Event
    text
    C0877248 (UMLS CUI [1])
    Item Group
    Possible suicidality-related adverse event - Section 2
    C0877248 (UMLS CUI-1)
    C2732635 (UMLS CUI-2)
    C3166387 (UMLS CUI-3)
    Provide a brief description of the possible suicidality-related AE/SAE
    Item
    Provide a brief description of the possible suicidality-related AE/SAE
    text
    C0877248 (UMLS CUI [1,1])
    C3166387 (UMLS CUI [1,2])
    C0678257 (UMLS CUI [1,3])
    C1519255 (UMLS CUI [2,1])
    C3166387 (UMLS CUI [2,2])
    C0678257 (UMLS CUI [2,3])
    Item Group
    Possible suicidality-related adverse event - Section 3
    C0877248 (UMLS CUI-1)
    C2732635 (UMLS CUI-2)
    C3166387 (UMLS CUI-3)
    Disease under study
    Item
    Disease under study
    boolean
    C0012634 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Concomitant medication(s)
    Item
    Concomitant medication(s)
    boolean
    C2347852 (UMLS CUI [1])
    Comorbid psychiatric condition(s)
    Item
    Comorbid psychiatric condition(s)
    boolean
    C0004936 (UMLS CUI [1,1])
    C0009488 (UMLS CUI [1,2])
    Medical condition(s)
    Item
    Medical condition(s)
    boolean
    C0012634 (UMLS CUI [1])
    Psycho-social stressors
    Item
    Psycho-social stressors
    boolean
    C0748073 (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])
    Investigational product dose change
    Item
    Investigational product dose change
    boolean
    C0304229 (UMLS CUI [1,1])
    C1707811 (UMLS CUI [1,2])
    Lack of efficacy
    Item
    Lack of efficacy
    boolean
    C0235828 (UMLS CUI [1])
    Investigational product(s)
    Item
    Investigational product(s)
    boolean
    C0304229 (UMLS CUI [1])
    Other cause
    Item
    Other cause
    boolean
    C0392360 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Specify other cause
    Item
    Specify other cause
    text
    C0392360 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Possible suicidality-related adverse event - Section 4
    C0877248 (UMLS CUI-1)
    C2732635 (UMLS CUI-2)
    C3166387 (UMLS CUI-3)
    Has the subject had any psychiatric conditions in the past (other than the one under study)?
    Item
    Has the subject had any psychiatric conditions in the past (other than the one under study)?
    boolean
    C0004936 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    If subject has had any psychiatric conditions in the past, provide informations
    Item
    If subject has had any psychiatric conditions in the past, provide informations
    text
    C0004936 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1533716 (UMLS CUI [2])
    Has the subject had any suicidal ideation, behaviour or self-harm in the past?
    Item
    Has the subject had any suicidal ideation, behaviour or self-harm in the past?
    boolean
    C0424000 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C1760428 (UMLS CUI [1,3])
    C0424366 (UMLS CUI [1,4])
    If the subject had any suicidal ideation, behaviour or self-harm in the past, provide information
    Item
    If the subject had any suicidal ideation, behaviour or self-harm in the past, provide information
    text
    C0424000 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C1760428 (UMLS CUI [1,3])
    C0424366 (UMLS CUI [1,4])
    C1533716 (UMLS CUI [2])
    Subject's current use of illicit drugs?
    Item
    Subject's current use of illicit drugs?
    boolean
    C0281875 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    If current use of illicit drugs, provide information, including results of a drug screen test if one has been obtained
    Item
    If current use of illicit drugs, provide information, including results of a drug screen test if one has been obtained
    text
    C0281875 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    C1533716 (UMLS CUI [2])
    C0373483 (UMLS CUI [3,1])
    C1274040 (UMLS CUI [3,2])
    Subject's current use of alcohol?
    Item
    Subject's current use of alcohol?
    boolean
    C0001948 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    If current use of alcohol, provide information, including results of an alcohol level test if one has been obtained.
    Item
    If current use of alcohol, provide information, including results of an alcohol level test if one has been obtained.
    text
    C0001948 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    C1533716 (UMLS CUI [2])
    C0202304 (UMLS CUI [3,1])
    C1274040 (UMLS CUI [3,2])
    Family history of suicidality?
    Item
    Family history of suicidality?
    boolean
    C0241889 (UMLS CUI [1,1])
    C3166387 (UMLS CUI [1,2])
    If family history of suicidality, provide information
    Item
    If family history of suicidality, provide information
    text
    C0241889 (UMLS CUI [1,1])
    C3166387 (UMLS CUI [1,2])
    C1533716 (UMLS CUI [2])
    Family history of psychiatric disorders?
    Item
    Family history of psychiatric disorders?
    boolean
    C0241889 (UMLS CUI [1,1])
    C0004936 (UMLS CUI [1,2])
    If family history of psychiatric disorders, provide information
    Item
    If family history of psychiatric disorders, provide information
    text
    C0241889 (UMLS CUI [1,1])
    C0004936 (UMLS CUI [1,2])
    Item Group
    Possible suicidality-related adverse event - Section 5
    C0877248 (UMLS CUI-1)
    C2732635 (UMLS CUI-2)
    C3166387 (UMLS CUI-3)
    Provide information on the subject's current psycho-social stressors
    Item
    Provide information on the subject's current psycho-social stressors. For example, isolation, problems with family, relationships, work, finances, stress, etc.
    text
    C0748073 (UMLS CUI [1])
    C0205409 (UMLS CUI [2])
    C0424960 (UMLS CUI [3])
    C0439849 (UMLS CUI [4])
    C0043227 (UMLS CUI [5])
    C0557159 (UMLS CUI [6])
    C0038435 (UMLS CUI [7])
    Item Group
    Possible suicidality-related adverse event - Section 6
    C0877248 (UMLS CUI-1)
    C2732635 (UMLS CUI-2)
    C3166387 (UMLS CUI-3)
    Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event
    Item
    Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event. For example, suicidal thoughts, associated frequency, severity and duration as well as likelihood of the subject acting upon these thoughts.
    text
    C0424000 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C1760428 (UMLS CUI [2])
    C0439603 (UMLS CUI [3])
    C0439793 (UMLS CUI [4])
    C0449238 (UMLS CUI [5])
    C0033204 (UMLS CUI [6])
    Item Group
    Possible suicidality-related adverse event - Section 7
    C0877248 (UMLS CUI-1)
    C2732635 (UMLS CUI-2)
    C3166387 (UMLS CUI-3)
    Provide information on any suicidal behavior present during the study, as assessed by the investigator, for this index event.
    Item
    Provide information on any suicidal behavior present during the study, as assessed by the investigator, for this index event.
    text
    C1760428 (UMLS CUI [1,1])
    C1533716 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [2,1])
    C0008976 (UMLS CUI [2,2])
    Item Group
    Possible suicidality-related adverse event - Section 8
    C0877248 (UMLS CUI-1)
    C2732635 (UMLS CUI-2)
    C3166387 (UMLS CUI-3)
    Provide any additional comments or explanation, including but not limited to, both medical and psychiatric treatment, outcome and follow-up.
    Item
    Provide any additional comments or explanation, including but not limited to, both medical and psychiatric treatment, outcome and follow-up.
    text
    C1830770 (UMLS CUI [1])
    C0681841 (UMLS CUI [2,1])
    C1524062 (UMLS CUI [2,2])
    C0237726 (UMLS CUI [3])
    C0204523 (UMLS CUI [4])
    C1547647 (UMLS CUI [5])
    C1522577 (UMLS CUI [6])
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