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

Lien

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

Mots-clés

Versions (1)
  1. 03/04/2017 03/04/2017 -
Téléchargé le

3 avril 2017

DOI

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Licence

Creative Commons BY 4.0
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Prodast Dabigatran NCT02507856 Serious Adverse Events

Allemand ( localization.languageCode.DE )

Prodast Dabigatran NCT02507856 Serious Adverse Events

1 Formulaires  
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Datum des Studieneinschlusses
Description

inclusion_date

Type de données

date

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

Patient Characteristics

Alias
UMLS CUI-1
C0815172
Patient No.
Description

Patient No.

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Sex
Description

tblAE.SEX

Type de données

integer

Alias
UMLS CUI [1]
C0079399
Year of birth
Description

tblAE.BRTHYR

Type de données

integer

Alias
UMLS CUI [1]
C2826771
Height
Description

tblAE.HEIGHT

Type de données

text

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

tblAE.WEIGHT

Type de données

integer

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Site address
Description

Site address

Alias
UMLS CUI-1
C0421449
Site
Description

tblAE.location

Type de données

text

Alias
UMLS CUI [1]
C0450429
Street
Description

tblAE.Site_Street

Type de données

text

Alias
UMLS CUI [1]
C1301826
City
Description

tblAE.city

Type de données

text

Alias
UMLS CUI [1]
C0008848
Phone
Description

tblAE.phone

Type de données

text

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

tblAE.fax

Type de données

text

Alias
UMLS CUI [1]
C1549619
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Event Number
Description

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

Type de données

integer

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

tblAE.AGE

Type de données

integer

Unités de mesure
  • years
Alias
UMLS CUI [1,1]
C0150907
UMLS CUI [1,2]
C0877248
years
Type of reportable event
Description

tblAE.reporttype

Type de données

integer

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

Type de données

text

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

tblAE.AESTDAT

Type de données

date

Alias
UMLS CUI [1]
C2697889
Start Time
Description

tblAE.AESTTIM

Type de données

time

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

undefined item

Type de données

integer

Alias
UMLS CUI [1]
C2826663
End Date
Description

tblAE.AEENDAT

Type de données

date

Alias
UMLS CUI [1]
C2697886
End Time
Description

tblAE.AEENTIM

Type de données

time

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

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

Type de données

text

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

tblAE.AEOUT

Type de données

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").
Description

tblAE.aedescr

Type de données

text

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

Type de données

integer

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

Type de données

integer

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

tblAE.AEREL

Type de données

integer

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

tblAE.AEACN2

Type de données

integer

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

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

Type de données

integer

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

tblAE.AESER

Type de données

integer

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

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

Type de données

integer

Alias
UMLS CUI [1]
C1519255
Associated AEs
Description

tblAE.assocAE

Type de données

text

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

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

Type de données

integer

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

Pregnancy

Alias
UMLS CUI-1
C0032961
Is patient pregnant?
Description

tblAE.pregnant

Type de données

integer

Alias
UMLS CUI [1]
C0032961
Week
Description

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

Type de données

integer

Alias
UMLS CUI [1]
C1135241
Details Antithrombotic Product
Description

Details Antithrombotic Product

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

tblAE.drugterm

Type de données

text

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

tblAE.drugform

Type de données

integer

Alias
UMLS CUI [1]
C1705957
Please specify
Description

tblAE.drugformoth

Type de données

text

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

tblAE.drugdose

Type de données

text

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

tblAE.drugdose

Type de données

integer

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

tblAE.drugunitoth

Type de données

text

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

tblAE.drugroute

Type de données

integer

Alias
UMLS CUI [1]
C0013153
Please specify
Description

tblAE.drugrouteoth

Type de données

text

Alias
UMLS CUI [1]
C0013153
Start date
Description

tblAE.drugstda

Type de données

date

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

tblAE.drugongo

Type de données

integer

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

tblAE.drugendat

Type de données

date

Alias
UMLS CUI [1]
C1531784
Indication for use
Description

tblAE.drugind

Type de données

text

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

Details Further Antithrombotic Product

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

tblAE.drugterm2

Type de données

text

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

tblAE.drugform2

Type de données

integer

Alias
UMLS CUI [1]
C1705957
Please specify
Description

tblAE.drugformoth2

Type de données

text

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

tblAE.drugdose2

Type de données

text

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

tblAE.drugunitoth2

Type de données

integer

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

tblAE.drugdose2

Type de données

text

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

tblAE.drugroute2

Type de données

integer

Alias
UMLS CUI [1]
C0013153
Please specify
Description

tblAE.drugrouteoth2

Type de données

text

Alias
UMLS CUI [1]
C0013153
Start date
Description

tblAE.drugstda2

Type de données

date

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

tblAE.drugongo2

Type de données

integer

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

tblAE.drugendat2

Type de données

date

Alias
UMLS CUI [1]
C1531784
Indication for use
Description

tblAE.drugind2

Type de données

text

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

Concomitant Therapies

Alias
UMLS CUI-1
C1707479
Concomitant diagnoses
Description

Concomitant diagnoses

Alias
UMLS CUI-1
C0243086
ID
Description

tblSAE_CDiag.cdiagid

Type de données

integer

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

tblSAE_CDiag.concdiag

Type de données

integer

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

tblSAE_CDiag.cdiagid

Type de données

integer

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

tblSAE_CDiag.concdiag

Type de données

integer

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

tblSAE_CDiag.cdiagid

Type de données

integer

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

tblSAE_CDiag.concdiag

Type de données

integer

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

tblSAE_CDiag.cdiagid

Type de données

integer

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

tblSAE_CDiag.concdiag

Type de données

integer

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

tblSAE_CDiag.cdiagid

Type de données

integer

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

tblSAE_CDiag.concdiag

Type de données

integer

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

tblSAE_CDiag.cdiagid

Type de données

integer

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

tblSAE_CDiag.concdiag

Type de données

integer

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

tblSAE_CDiag.cdiagid

Type de données

integer

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

ttblSAE_CDiag.concdiag

Type de données

integer

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

tblSAE_CDiag.cdiagid

Type de données

integer

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

tblSAE_CDiag.concdiag

Type de données

integer

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

tblSAE_CDiag.cdiagid

Type de données

integer

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

tblSAE_CDiag.concdiag

Type de données

integer

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

tblSAE_CDiag.cdiagid

Type de données

integer

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

tblSAE_CDiag.concdiag

Type de données

integer

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

Comments

Alias
UMLS CUI-1
C0947611
Comments
Description

tblAE.saecomm

Type de données

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Prodast Dabigatran NCT02507856 Serious Adverse Events

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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