ID

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. April 2017

DOI

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Lizenz

Creative Commons BY 4.0
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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
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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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