ID
21020
Description
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
Keywords
Versions (1)
- 4/3/17 4/3/17 -
Uploaded on
April 3, 2017
DOI
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License
Creative Commons BY 4.0
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Prodast Dabigatran NCT02507856 Serious Adverse Events
Prodast Dabigatran NCT02507856 Serious Adverse Events
- StudyEvent: ODM
Description
Patient Characteristics
Alias
- UMLS CUI-1
- C0815172
Description
Patient No.
Data type
integer
Alias
- UMLS CUI [1]
- C2348585
Description
tblAE.SEX
Data type
integer
Alias
- UMLS CUI [1]
- C0079399
Description
tblAE.BRTHYR
Data type
integer
Alias
- UMLS CUI [1]
- C2826771
Description
tblAE.HEIGHT
Data type
text
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
tblAE.WEIGHT
Data type
integer
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Site address
Alias
- UMLS CUI-1
- C0421449
Description
tblAE.location
Data type
text
Alias
- UMLS CUI [1]
- C0450429
Description
tblAE.Site_Street
Data type
text
Alias
- UMLS CUI [1]
- C1301826
Description
tblAE.city
Data type
text
Alias
- UMLS CUI [1]
- C0008848
Description
tblAE.phone
Data type
text
Alias
- UMLS CUI [1,1]
- C1550483
- UMLS CUI [1,2]
- C1515258
Description
tblAE.fax
Data type
text
Alias
- UMLS CUI [1]
- C1549619
Description
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Description
If not yet done, remember to document patient characteristics: Weight and Height. Sex and Year of Birth.
Data type
integer
Alias
- UMLS CUI [1]
- C2826275
Description
tblAE.AGE
Data type
integer
Measurement units
- years
Alias
- UMLS CUI [1,1]
- C0150907
- UMLS CUI [1,2]
- C0877248
Description
tblAE.reporttype
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3641180
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3641180
Description
tblAE.AESTDAT
Data type
date
Alias
- UMLS CUI [1]
- C2697889
Description
tblAE.AESTTIM
Data type
time
Alias
- UMLS CUI [1]
- C1301880
Description
undefined item
Data type
integer
Alias
- UMLS CUI [1]
- C2826663
Description
tblAE.AEENDAT
Data type
date
Alias
- UMLS CUI [1]
- C2697886
Description
tblAE.AEENTIM
Data type
time
Alias
- UMLS CUI [1]
- C2826658
Description
If the answer is "yes", specify in the description below.
Data type
text
Alias
- UMLS CUI [1]
- C2981656
Description
tblAE.AEOUT
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
tblAE.aedescr
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2699044
Description
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
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
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“.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0003281
Description
tblAE.AEREL
Data type
integer
Alias
- UMLS CUI [1]
- C0003281
Description
tblAE.AEACN2
Data type
integer
Alias
- UMLS CUI [1]
- C0003281
Description
Study Outcomes are: - Stroke or TIA - Systemic embolism - Pulmonary (lung) embolism - Myocardial infarction - Major/Life threatening bleeding/gastrointestinal bleeding
Data type
integer
Alias
- UMLS CUI [1]
- C1624730
Description
tblAE.AESER
Data type
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
Include any further non-serious events that are associated with this serious event (occurence at the same time) and check for completeness
Data type
integer
Alias
- UMLS CUI [1]
- C1519255
Description
tblAE.assocAE
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Link this AE in the corresponding SAE report and report the SAE within 24 h the event was detected!
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C1519255
Description
Pregnancy
Alias
- UMLS CUI-1
- C0032961
Description
Details Antithrombotic Product
Alias
- UMLS CUI-1
- C0003280
Description
tblAE.drugterm
Data type
text
Alias
- UMLS CUI [1,1]
- C0003280
- UMLS CUI [1,2]
- C0919189
Description
tblAE.drugform
Data type
integer
Alias
- UMLS CUI [1]
- C1705957
Description
tblAE.drugformoth
Data type
text
Alias
- UMLS CUI [1]
- C1705957
Description
tblAE.drugdose
Data type
text
Alias
- UMLS CUI [1,1]
- C0003280
- UMLS CUI [1,2]
- C0178602
Description
tblAE.drugdose
Data type
integer
Alias
- UMLS CUI [1,1]
- C0003280
- UMLS CUI [1,2]
- C0869039
Description
tblAE.drugunitoth
Data type
text
Alias
- UMLS CUI [1,1]
- C0003280
- UMLS CUI [1,2]
- C0869039
Description
tblAE.drugroute
Data type
integer
Alias
- UMLS CUI [1]
- C0013153
Description
tblAE.drugrouteoth
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
tblAE.drugstda
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Description
tblAE.drugongo
Data type
integer
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C0013216
Description
tblAE.drugendat
Data type
date
Alias
- UMLS CUI [1]
- C1531784
Description
tblAE.drugind
Data type
text
Alias
- UMLS CUI [1,1]
- C1283828
- UMLS CUI [1,2]
- C1707479
- UMLS CUI [1,3]
- C0003281
Description
Details Further Antithrombotic Product
Alias
- UMLS CUI-1
- C0003281
Description
tblAE.drugterm2
Data type
text
Alias
- UMLS CUI [1,1]
- C0003280
- UMLS CUI [1,2]
- C0919189
Description
tblAE.drugform2
Data type
integer
Alias
- UMLS CUI [1]
- C1705957
Description
tblAE.drugformoth2
Data type
text
Alias
- UMLS CUI [1]
- C1705957
Description
tblAE.drugdose2
Data type
text
Alias
- UMLS CUI [1,1]
- C0003280
- UMLS CUI [1,2]
- C0178602
Description
tblAE.drugunitoth2
Data type
integer
Alias
- UMLS CUI [1,1]
- C0003280
- UMLS CUI [1,2]
- C0869039
Description
tblAE.drugdose2
Data type
text
Alias
- UMLS CUI [1,1]
- C0003280
- UMLS CUI [1,2]
- C0869039
Description
tblAE.drugroute2
Data type
integer
Alias
- UMLS CUI [1]
- C0013153
Description
tblAE.drugrouteoth2
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
tblAE.drugstda2
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Description
tblAE.drugongo2
Data type
integer
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C0013216
Description
tblAE.drugendat2
Data type
date
Alias
- UMLS CUI [1]
- C1531784
Description
tblAE.drugind2
Data type
text
Alias
- UMLS CUI [1,1]
- C1283828
- UMLS CUI [1,2]
- C1707479
- UMLS CUI [1,3]
- C0003281
Description
Concomitant Therapies
Alias
- UMLS CUI-1
- C1707479
Description
Concomitant diagnoses
Alias
- UMLS CUI-1
- C0243086
Description
tblSAE_CDiag.cdiagid
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C1300638
Description
tblSAE_CDiag.concdiag
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C0011900
Description
tblSAE_CDiag.cdiagid
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C1300638
Description
tblSAE_CDiag.concdiag
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C0011900
Description
tblSAE_CDiag.cdiagid
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C1300638
Description
tblSAE_CDiag.concdiag
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C0011900
Description
tblSAE_CDiag.cdiagid
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C1300638
Description
tblSAE_CDiag.concdiag
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C0011900
Description
tblSAE_CDiag.cdiagid
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C1300638
Description
tblSAE_CDiag.concdiag
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C0011900
Description
tblSAE_CDiag.cdiagid
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C1300638
Description
tblSAE_CDiag.concdiag
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C0011900
Description
tblSAE_CDiag.cdiagid
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C1300638
Description
ttblSAE_CDiag.concdiag
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C0011900
Description
tblSAE_CDiag.cdiagid
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C1300638
Description
tblSAE_CDiag.concdiag
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C0011900
Description
tblSAE_CDiag.cdiagid
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C1300638
Description
tblSAE_CDiag.concdiag
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C0011900
Description
tblSAE_CDiag.cdiagid
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C1300638
Description
tblSAE_CDiag.concdiag
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243086
- UMLS CUI [1,2]
- C0011900
Description
Comments
Alias
- UMLS CUI-1
- C0947611
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