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21020

Beschreibung

Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA (PRODAST) permission granted by Prof. Dr. Christian Weimar, University Hospital Essen The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. This is the (serious) Adverse Events form. https://clinicaltrials.gov/ct2/show/NCT02507856

Link

https://clinicaltrials.gov/ct2/show/NCT02507856

Stichworte

Versionen (1)
  1. 03/04/17 03/04/17 -
Hochgeladen am

3 aprile 2017

DOI

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    Prodast Dabigatran NCT02507856 Serious Adverse Events

    Deutsch ( localization.languageCode.DE )

    Prodast Dabigatran NCT02507856 Serious Adverse Events

    1 Formulare  
    Adverse Events
    Beschreibung

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Datum des Studieneinschlusses
    Beschreibung

    inclusion_date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0011008
    Patient Characteristics
    Beschreibung

    Patient Characteristics

    Alias
    UMLS CUI-1
    C0815172
    Patient No.
    Beschreibung

    Patient No.

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Sex
    Beschreibung

    tblAE.SEX

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Year of birth
    Beschreibung

    tblAE.BRTHYR

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2826771
    Height
    Beschreibung

    tblAE.HEIGHT

    Datentyp

    text

    Maßeinheiten
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Beschreibung

    tblAE.WEIGHT

    Datentyp

    integer

    Maßeinheiten
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Site address
    Beschreibung

    Site address

    Alias
    UMLS CUI-1
    C0421449
    Site
    Beschreibung

    tblAE.location

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0450429
    Street
    Beschreibung

    tblAE.Site_Street

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1301826
    City
    Beschreibung

    tblAE.city

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0008848
    Phone
    Beschreibung

    tblAE.phone

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1550483
    UMLS CUI [1,2]
    C1515258
    Fax
    Beschreibung

    tblAE.fax

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1549619
    Adverse Event
    Beschreibung

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    Event Number
    Beschreibung

    If not yet done, remember to document patient characteristics: Weight and Height. Sex and Year of Birth.

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2826275
    Age of the patient at time of event
    Beschreibung

    tblAE.AGE

    Datentyp

    integer

    Maßeinheiten
    • years
    Alias
    UMLS CUI [1,1]
    C0150907
    UMLS CUI [1,2]
    C0877248
    years
    Type of reportable event
    Beschreibung

    tblAE.reporttype

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C3641180
    Event
    Beschreibung

    If possible, record diagnosis of the event and mention the symptoms in the "description of the event" below. If there is no diagnosis associated with the symptom, record the symptom as the adverse event.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C3641180
    Start Date
    Beschreibung

    tblAE.AESTDAT

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2697889
    Start Time
    Beschreibung

    tblAE.AESTTIM

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C1301880
    Ongoing? Remember to document Follow-up report with the end date as soon as the event ended.
    Beschreibung

    undefined item

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2826663
    End Date
    Beschreibung

    tblAE.AEENDAT

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2697886
    End Time
    Beschreibung

    tblAE.AEENTIM

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C2826658
    Did the patient receive therapy/treatment due to the adverse event?
    Beschreibung

    If the answer is "yes", specify in the description below.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2981656
    Outcome of adverse event
    Beschreibung

    tblAE.AEOUT

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1705586
    Description of the event: If necessary (i.e. the received therapy due to event; cause of death; cause of seriousness is classified "other").
    Beschreibung

    tblAE.aedescr

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2699044
    Intensity
    Beschreibung

    mild (leicht) = Leichte Beschwerden ohne Beeinträchtigung der normalen täglichen Aktivitäten moderate (mäßig) = Unannehmlichkeiten mit Behinderung bei normalen täglichen Aktivitäten severe (schwer) = Unfähigkeit zur Arbeit oder zur Ausübung der normalen täglichen Aktivitäten

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1710066
    Was an antithrombotic medication taken within 7 days prior to the onset of the event?
    Beschreibung

    Hinweise zur Dokumentation: In diesem Abschnitt ist es möglich, 2 verschiedene antithrombotische Therapien innerhalb der letzten 7 Tage vor dem unerwünschten Ereignis zu erfassen. - Bei nicht schwerwiegenden AEs: - Erfassen Sie hier wenn vorhanden die beiden Therapien innerhalb von 7 Tagen, bei denen ein Kausalzusammenhang zum AE besteht oder die zum Zeitpunkt des AEs oder zeitlich am nächsten zum AE eingenommen wurden. - Bei SAEs: - Erfassen Sie hier wenn vorhanden die beiden Therapien innerhalb von 7 Tagen, bei denen ein Kausalzusammenhang zum SAE besteht oder die zum Zeitpunkt des SAEs oder zeitlich am nächsten zum SAE eingenommen wurden. - Fallen mehr als 2 Therapien in den 7-Tage-Zeitraum, dokumentieren Sie weitere Therapien bitte unter „Report Details“ und dort unter „Concomitant therapies“.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0003281
    Causal relationship with the application of the antithrombotic product
    Beschreibung

    tblAE.AEREL

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0003281
    Action taken with suspect antithrombotic drug due to event [please answer independently of causal relationship]
    Beschreibung

    tblAE.AEACN2

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0003281
    Was the event an study outcome event (Endpunktereignis)? Document and link outcome event and check for completeness
    Beschreibung

    Study Outcomes are: - Stroke or TIA - Systemic embolism - Pulmonary (lung) embolism - Myocardial infarction - Major/Life threatening bleeding/gastrointestinal bleeding

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1624730
    Was the event serious?
    Beschreibung

    tblAE.AESER

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1705586
    UMLS CUI [1,2]
    C1519255
    SAE reason
    Beschreibung

    Include any further non-serious events that are associated with this serious event (occurence at the same time) and check for completeness

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1519255
    Associated AEs
    Beschreibung

    tblAE.assocAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0877248
    Is this non-serious event associated with a serious event (occurence at the same time)?
    Beschreibung

    Link this AE in the corresponding SAE report and report the SAE within 24 h the event was detected!

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C1519255
    Pregnancy
    Beschreibung

    Pregnancy

    Alias
    UMLS CUI-1
    C0032961
    Is patient pregnant?
    Beschreibung

    tblAE.pregnant

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0032961
    Week
    Beschreibung

    If yes, please complete pregnancy report part A. You will find this document in the investigator site file (Prüfarztordner).

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1135241
    Details Antithrombotic Product
    Beschreibung

    Details Antithrombotic Product

    Alias
    UMLS CUI-1
    C0003280
    Medication (Handelsbezeichnung bevorzugt, sonst Inhaltsstoff)
    Beschreibung

    tblAE.drugterm

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0003280
    UMLS CUI [1,2]
    C0919189
    Formulation
    Beschreibung

    tblAE.drugform

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1705957
    Please specify
    Beschreibung

    tblAE.drugformoth

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1705957
    Total daily dose at onset
    Beschreibung

    tblAE.drugdose

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0003280
    UMLS CUI [1,2]
    C0178602
    Total daily dose at onset
    Beschreibung

    tblAE.drugdose

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0003280
    UMLS CUI [1,2]
    C0869039
    Please specify unit
    Beschreibung

    tblAE.drugunitoth

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0003280
    UMLS CUI [1,2]
    C0869039
    Route of administration
    Beschreibung

    tblAE.drugroute

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0013153
    Please specify
    Beschreibung

    tblAE.drugrouteoth

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start date
    Beschreibung

    tblAE.drugstda

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0304229
    Ongoing?
    Beschreibung

    tblAE.drugongo

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0549178
    UMLS CUI [1,2]
    C0013216
    End date
    Beschreibung

    tblAE.drugendat

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1531784
    Indication for use
    Beschreibung

    tblAE.drugind

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1283828
    UMLS CUI [1,2]
    C1707479
    UMLS CUI [1,3]
    C0003281
    Details Further Antithrombotic Product
    Beschreibung

    Details Further Antithrombotic Product

    Alias
    UMLS CUI-1
    C0003281
    Medication (Handelsbezeichnung bevorzugt, sonst Inhaltsstoff)
    Beschreibung

    tblAE.drugterm2

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0003280
    UMLS CUI [1,2]
    C0919189
    Formulation
    Beschreibung

    tblAE.drugform2

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1705957
    Please specify
    Beschreibung

    tblAE.drugformoth2

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1705957
    Total daily dose at onset
    Beschreibung

    tblAE.drugdose2

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0003280
    UMLS CUI [1,2]
    C0178602
    Please specify unit
    Beschreibung

    tblAE.drugunitoth2

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0003280
    UMLS CUI [1,2]
    C0869039
    Total daily dose at onset
    Beschreibung

    tblAE.drugdose2

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0003280
    UMLS CUI [1,2]
    C0869039
    Route of administration
    Beschreibung

    tblAE.drugroute2

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0013153
    Please specify
    Beschreibung

    tblAE.drugrouteoth2

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start date
    Beschreibung

    tblAE.drugstda2

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0304229
    Ongoing?
    Beschreibung

    tblAE.drugongo2

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0549178
    UMLS CUI [1,2]
    C0013216
    End date
    Beschreibung

    tblAE.drugendat2

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1531784
    Indication for use
    Beschreibung

    tblAE.drugind2

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1283828
    UMLS CUI [1,2]
    C1707479
    UMLS CUI [1,3]
    C0003281
    Concomitant Therapies
    Beschreibung

    Concomitant Therapies

    Alias
    UMLS CUI-1
    C1707479
    Concomitant diagnoses
    Beschreibung

    Concomitant diagnoses

    Alias
    UMLS CUI-1
    C0243086
    ID
    Beschreibung

    tblSAE_CDiag.cdiagid

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C1300638
    Concomitant diagnose
    Beschreibung

    tblSAE_CDiag.concdiag

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C0011900
    ID
    Beschreibung

    tblSAE_CDiag.cdiagid

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C1300638
    Concomitant diagnose
    Beschreibung

    tblSAE_CDiag.concdiag

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C0011900
    ID
    Beschreibung

    tblSAE_CDiag.cdiagid

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C1300638
    Concomitant diagnose
    Beschreibung

    tblSAE_CDiag.concdiag

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C0011900
    ID
    Beschreibung

    tblSAE_CDiag.cdiagid

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C1300638
    Concomitant diagnose
    Beschreibung

    tblSAE_CDiag.concdiag

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C0011900
    ID
    Beschreibung

    tblSAE_CDiag.cdiagid

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C1300638
    Concomitant diagnose
    Beschreibung

    tblSAE_CDiag.concdiag

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C0011900
    ID
    Beschreibung

    tblSAE_CDiag.cdiagid

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C1300638
    Concomitant diagnose
    Beschreibung

    tblSAE_CDiag.concdiag

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C0011900
    ID
    Beschreibung

    tblSAE_CDiag.cdiagid

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C1300638
    Concomitant diagnose
    Beschreibung

    ttblSAE_CDiag.concdiag

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C0011900
    ID
    Beschreibung

    tblSAE_CDiag.cdiagid

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C1300638
    Concomitant diagnose
    Beschreibung

    tblSAE_CDiag.concdiag

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C0011900
    ID
    Beschreibung

    tblSAE_CDiag.cdiagid

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C1300638
    Concomitant diagnose
    Beschreibung

    tblSAE_CDiag.concdiag

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C0011900
    ID
    Beschreibung

    tblSAE_CDiag.cdiagid

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C1300638
    Concomitant diagnose
    Beschreibung

    tblSAE_CDiag.concdiag

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0243086
    UMLS CUI [1,2]
    C0011900
    Comments
    Beschreibung

    Comments

    Alias
    UMLS CUI-1
    C0947611
    Comments
    Beschreibung

    tblAE.saecomm

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Prodast Dabigatran NCT02507856 Serious Adverse Events

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    inclusion_date
    Item
    Datum des Studieneinschlusses
    date
    C1512693 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Patient Characteristics
    C0815172 (UMLS CUI-1)
    Patient No.
    Item
    Patient No.
    integer
    C2348585 (UMLS CUI [1])
    Item
    Sex
    integer
    C0079399 (UMLS CUI [1])
    tblAE.SEX
    Code List
    Sex
    CL Item
    male (1)
    CL Item
    female (2)
    tblAE.BRTHYR
    Item
    Year of birth
    integer
    C2826771 (UMLS CUI [1])
    tblAE.HEIGHT
    Item
    Height
    text
    C0005890 (UMLS CUI [1])
    tblAE.WEIGHT
    Item
    Weight
    integer
    C0005910 (UMLS CUI [1])
    Item Group
    Site address
    C0421449 (UMLS CUI-1)
    tblAE.location
    Item
    Site
    text
    C0450429 (UMLS CUI [1])
    tblAE.Site_Street
    Item
    Street
    text
    C1301826 (UMLS CUI [1])
    tblAE.city
    Item
    City
    text
    C0008848 (UMLS CUI [1])
    tblAE.phone
    Item
    Phone
    text
    C1550483 (UMLS CUI [1,1])
    C1515258 (UMLS CUI [1,2])
    tblAE.fax
    Item
    Fax
    text
    C1549619 (UMLS CUI [1])
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    tblAE.AESPID
    Item
    Event Number
    integer
    C2826275 (UMLS CUI [1])
    tblAE.AGE
    Item
    Age of the patient at time of event
    integer
    C0150907 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    Type of reportable event
    integer
    C0877248 (UMLS CUI [1,1])
    C3641180 (UMLS CUI [1,2])
    tblAE.reporttype
    Code List
    Type of reportable event
    CL Item
    Initial report (1)
    CL Item
    Follow-up report (2)
    tblAE.AETERM
    Item
    Event
    text
    C0877248 (UMLS CUI [1,1])
    C3641180 (UMLS CUI [1,2])
    tblAE.AESTDAT
    Item
    Start Date
    date
    C2697889 (UMLS CUI [1])
    tblAE.AESTTIM
    Item
    Start Time
    time
    C1301880 (UMLS CUI [1])
    Item
    Ongoing? Remember to document Follow-up report with the end date as soon as the event ended.
    integer
    C2826663 (UMLS CUI [1])
    undefined item
    Code List
    Ongoing? Remember to document Follow-up report with the end date as soon as the event ended.
    CL Item
    Yes (1)
    tblAE.AEENDAT
    Item
    End Date
    date
    C2697886 (UMLS CUI [1])
    tblAE.AEENTIM
    Item
    End Time
    time
    C2826658 (UMLS CUI [1])
    Item
    Did the patient receive therapy/treatment due to the adverse event?
    text
    C2981656 (UMLS CUI [1])
    tblAE.aethpy
    Code List
    Did the patient receive therapy/treatment due to the adverse event?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Outcome of adverse event
    integer
    C1705586 (UMLS CUI [1])
    tblAE.AEOUT
    Code List
    Outcome of adverse event
    CL Item
    recovered (1)
    CL Item
    not yet recovered (2)
    CL Item
    sequelae (3)
    CL Item
    fatal (4)
    CL Item
    unknown (5)
    tblAE.aedescr
    Item
    Description of the event: If necessary (i.e. the received therapy due to event; cause of death; cause of seriousness is classified "other").
    text
    C0877248 (UMLS CUI [1,1])
    C2699044 (UMLS CUI [1,2])
    Item
    Intensity
    integer
    C1710066 (UMLS CUI [1])
    tblAE.AESEV
    Code List
    Intensity
    CL Item
    mild, 2=moderate, 3=severe (1)
    Item
    Was an antithrombotic medication taken within 7 days prior to the onset of the event?
    integer
    C0877248 (UMLS CUI [1,1])
    C0003281 (UMLS CUI [1,2])
    tblAE.aethpy
    Code List
    Was an antithrombotic medication taken within 7 days prior to the onset of the event?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Causal relationship with the application of the antithrombotic product
    integer
    C0003281 (UMLS CUI [1])
    tblAE.aethpy
    Code List
    Causal relationship with the application of the antithrombotic product
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Action taken with suspect antithrombotic drug due to event [please answer independently of causal relationship]
    integer
    C0003281 (UMLS CUI [1])
    tblAE.AEACN2
    Code List
    Action taken with suspect antithrombotic drug due to event [please answer independently of causal relationship]
    CL Item
    continued (1)
    CL Item
    reduced (2)
    CL Item
    discontinued (3)
    CL Item
    increased (4)
    CL Item
    discontinued and reintroduced (6)
    CL Item
    not applicable (7)
    Item
    Was the event an study outcome event (Endpunktereignis)? Document and link outcome event and check for completeness
    integer
    C1624730 (UMLS CUI [1])
    tblAE.aethpy
    Code List
    Was the event an study outcome event (Endpunktereignis)? Document and link outcome event and check for completeness
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Was the event serious?
    integer
    C1705586 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    tblAE.aethpy
    Code List
    Was the event serious?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    SAE reason
    integer
    C1519255 (UMLS CUI [1])
    tblAE.saecat
    Code List
    SAE reason
    CL Item
    fatal (1)
    CL Item
    immediately life threatening (2)
    CL Item
    disabling (3)
    CL Item
    hospitalization (4)
    CL Item
    prolonged hospitalization (5)
    CL Item
    congenital anomaly (6)
    CL Item
    others (e.g. drug dependency/abuse, cancer) (7)
    tblAE.assocAE
    Item
    Associated AEs
    text
    C0877248 (UMLS CUI [1])
    Item
    Is this non-serious event associated with a serious event (occurence at the same time)?
    integer
    C0877248 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    tblAE.aethpy
    Code List
    Is this non-serious event associated with a serious event (occurence at the same time)?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Pregnancy
    C0032961 (UMLS CUI-1)
    Item
    Is patient pregnant?
    integer
    C0032961 (UMLS CUI [1])
    tblAE.aethpy
    Code List
    Is patient pregnant?
    CL Item
    Yes (1)
    CL Item
    No (2)
    tblAE.pregweek
    Item
    Week
    integer
    C1135241 (UMLS CUI [1])
    Item Group
    Details Antithrombotic Product
    C0003280 (UMLS CUI-1)
    tblAE.drugterm
    Item
    Medication (Handelsbezeichnung bevorzugt, sonst Inhaltsstoff)
    text
    C0003280 (UMLS CUI [1,1])
    C0919189 (UMLS CUI [1,2])
    Item
    Formulation
    integer
    C1705957 (UMLS CUI [1])
    tblAE.drugform
    Code List
    Formulation
    CL Item
    Tablet (1)
    CL Item
    Capsule (2)
    CL Item
    Ointment [Salbe] (3)
    CL Item
    Suppository [Zäpfchen] (4)
    CL Item
    Aerosol (5)
    CL Item
    Spray (6)
    CL Item
    Solution (7)
    CL Item
    Suspension (8)
    CL Item
    Patch [Pflaster] (9)
    CL Item
    Gas (10)
    CL Item
    Gel (11)
    CL Item
    Cream (12)
    CL Item
    Powder (13)
    CL Item
    Other (14)
    tblAE.drugformoth
    Item
    Please specify
    text
    C1705957 (UMLS CUI [1])
    tblAE.drugdose
    Item
    Total daily dose at onset
    text
    C0003280 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Item
    Total daily dose at onset
    integer
    C0003280 (UMLS CUI [1,1])
    C0869039 (UMLS CUI [1,2])
    tblAE.drugdose
    Code List
    Total daily dose at onset
    CL Item
    g (1)
    CL Item
    mg (2)
    CL Item
    μg (3)
    CL Item
    ng (4)
    CL Item
    mL (5)
    CL Item
    L (6)
    CL Item
    IU (7)
    CL Item
    drops (8)
    CL Item
    - (10)
    CL Item
    Other (11)
    tblAE.drugunitoth
    Item
    Please specify unit
    text
    C0003280 (UMLS CUI [1,1])
    C0869039 (UMLS CUI [1,2])
    Item
    Route of administration
    integer
    C0013153 (UMLS CUI [1])
    tblAE.drugroute
    Code List
    Route of administration
    CL Item
    Intravenous (1)
    CL Item
    Oral (2)
    CL Item
    Topical (3)
    CL Item
    Subcutaneous (4)
    CL Item
    Transdermal (5)
    CL Item
    Sublingual (6)
    CL Item
    Intraocular (7)
    CL Item
    Intramuscular (8)
    CL Item
    Respiratory (Inhalation) (9)
    CL Item
    Intralesional (10)
    CL Item
    Intraperitoneal (11)
    CL Item
    Nasal (12)
    CL Item
    Vaginal (13)
    CL Item
    Rectal (14)
    CL Item
    Other (15)
    tblAE.drugrouteoth
    Item
    Please specify
    text
    C0013153 (UMLS CUI [1])
    tblAE.drugstda
    Item
    Start date
    date
    C0808070 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item
    Ongoing?
    integer
    C0549178 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    undefined item
    Code List
    Ongoing?
    CL Item
    Yes (1)
    tblAE.drugendat
    Item
    End date
    date
    C1531784 (UMLS CUI [1])
    tblAE.drugind
    Item
    Indication for use
    text
    C1283828 (UMLS CUI [1,1])
    C1707479 (UMLS CUI [1,2])
    C0003281 (UMLS CUI [1,3])
    Item Group
    Details Further Antithrombotic Product
    C0003281 (UMLS CUI-1)
    tblAE.drugterm2
    Item
    Medication (Handelsbezeichnung bevorzugt, sonst Inhaltsstoff)
    text
    C0003280 (UMLS CUI [1,1])
    C0919189 (UMLS CUI [1,2])
    Item
    Formulation
    integer
    C1705957 (UMLS CUI [1])
    tblAE.drugform2
    Code List
    Formulation
    CL Item
    Tablet  (1)
    CL Item
    Capsule  (2)
    CL Item
    Ointment [Salbe]  (3)
    CL Item
    Suppository [Zäpfchen]  (4)
    CL Item
    Aerosol  (5)
    CL Item
    Spray  (6)
    CL Item
    Solution  (7)
    CL Item
    Suspension  (8)
    CL Item
    Patch [Pflaster]  (9)
    CL Item
    Gas  (10)
    CL Item
    Gel  (11)
    CL Item
    Cream  (12)
    CL Item
    Powder  (13)
    CL Item
    Other (14)
    tblAE.drugformoth2
    Item
    Please specify
    text
    C1705957 (UMLS CUI [1])
    tblAE.drugdose2
    Item
    Total daily dose at onset
    text
    C0003280 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Item
    Please specify unit
    integer
    C0003280 (UMLS CUI [1,1])
    C0869039 (UMLS CUI [1,2])
    tblAE.drugunitoth2
    Code List
    Please specify unit
    CL Item
    g  (1)
    CL Item
    mg  (2)
    CL Item
    μg  (3)
    CL Item
    ng  (4)
    CL Item
    mL  (5)
    CL Item
    L  (6)
    CL Item
    IU  (7)
    CL Item
    drops  (8)
    CL Item
    -  (10)
    CL Item
    Other (11)
    tblAE.drugdose2
    Item
    Total daily dose at onset
    text
    C0003280 (UMLS CUI [1,1])
    C0869039 (UMLS CUI [1,2])
    Item
    Route of administration
    integer
    C0013153 (UMLS CUI [1])
    tblAE.drugroute2
    Code List
    Route of administration
    CL Item
    Intravenous (1)
    CL Item
    Oral (2)
    CL Item
    Topical (3)
    CL Item
    Subcutaneous (4)
    CL Item
    Transdermal (5)
    CL Item
    Sublingual (6)
    CL Item
    Intraocular (7)
    CL Item
    Intramuscular (8)
    CL Item
    Respiratory (Inhalation) (9)
    CL Item
    Intralesional (10)
    CL Item
    Intraperitoneal (11)
    CL Item
    Nasal (12)
    CL Item
    Vaginal (13)
    CL Item
    Rectal (14)
    CL Item
    Other (15)
    tblAE.drugrouteoth2
    Item
    Please specify
    text
    C0013153 (UMLS CUI [1])
    tblAE.drugstda2
    Item
    Start date
    date
    C0808070 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item
    Ongoing?
    integer
    C0549178 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    undefined item
    Code List
    Ongoing?
    CL Item
    Yes (1)
    tblAE.drugendat2
    Item
    End date
    date
    C1531784 (UMLS CUI [1])
    tblAE.drugind2
    Item
    Indication for use
    text
    C1283828 (UMLS CUI [1,1])
    C1707479 (UMLS CUI [1,2])
    C0003281 (UMLS CUI [1,3])
    Item Group
    Concomitant Therapies
    C1707479 (UMLS CUI-1)
    Item Group
    Concomitant diagnoses
    C0243086 (UMLS CUI-1)
    tblSAE_CDiag.cdiagid
    Item
    ID
    integer
    C0243086 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    tblSAE_CDiag.concdiag
    Item
    Concomitant diagnose
    integer
    C0243086 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    tblSAE_CDiag.cdiagid
    Item
    ID
    integer
    C0243086 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    tblSAE_CDiag.concdiag
    Item
    Concomitant diagnose
    integer
    C0243086 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    tblSAE_CDiag.cdiagid
    Item
    ID
    integer
    C0243086 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    tblSAE_CDiag.concdiag
    Item
    Concomitant diagnose
    integer
    C0243086 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    tblSAE_CDiag.cdiagid
    Item
    ID
    integer
    C0243086 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    tblSAE_CDiag.concdiag
    Item
    Concomitant diagnose
    integer
    C0243086 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    tblSAE_CDiag.cdiagid
    Item
    ID
    integer
    C0243086 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    tblSAE_CDiag.concdiag
    Item
    Concomitant diagnose
    integer
    C0243086 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    tblSAE_CDiag.cdiagid
    Item
    ID
    integer
    C0243086 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    tblSAE_CDiag.concdiag
    Item
    Concomitant diagnose
    integer
    C0243086 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    tblSAE_CDiag.cdiagid
    Item
    ID
    integer
    C0243086 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    ttblSAE_CDiag.concdiag
    Item
    Concomitant diagnose
    integer
    C0243086 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    tblSAE_CDiag.cdiagid
    Item
    ID
    integer
    C0243086 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    tblSAE_CDiag.concdiag
    Item
    Concomitant diagnose
    integer
    C0243086 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    tblSAE_CDiag.cdiagid
    Item
    ID
    integer
    C0243086 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    tblSAE_CDiag.concdiag
    Item
    Concomitant diagnose
    integer
    C0243086 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    tblSAE_CDiag.cdiagid
    Item
    ID
    integer
    C0243086 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    tblSAE_CDiag.concdiag
    Item
    Concomitant diagnose
    integer
    C0243086 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Item Group
    Comments
    C0947611 (UMLS CUI-1)
    tblAE.saecomm
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
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