inclusion_date
Item
Datum des Studieneinschlusses
date
C1512693 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
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])
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])
Code List
Ongoing? Remember to document Follow-up report with the end date as soon as the event ended.
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])
Code List
Did the patient receive therapy/treatment due to the adverse event?
Item
Outcome of adverse event
integer
C1705586 (UMLS CUI [1])
Code List
Outcome of adverse event
CL Item
not yet recovered (2)
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])
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])
Code List
Was an antithrombotic medication taken within 7 days prior to the onset of the event?
Item
Causal relationship with the application of the antithrombotic product
integer
C0003281 (UMLS CUI [1])
Code List
Causal relationship with the application of the antithrombotic product
Item
Action taken with suspect antithrombotic drug due to event [please answer independently of causal relationship]
integer
C0003281 (UMLS CUI [1])
Code List
Action taken with suspect antithrombotic drug due to event [please answer independently of causal relationship]
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])
Code List
Was the event an study outcome event (Endpunktereignis)? Document and link outcome event and check for completeness
Item
Was the event serious?
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Was the event serious?
Item
SAE reason
integer
C1519255 (UMLS CUI [1])
CL Item
immediately life threatening (2)
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])
Code List
Is this non-serious event associated with a serious event (occurence at the same time)?
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])
CL Item
Ointment [Salbe] (3)
CL Item
Suppository [Zäpfchen] (4)
CL Item
Patch [Pflaster] (9)
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])
Code List
Total daily dose at onset
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])
Code List
Route of administration
CL Item
Intramuscular (8)
CL Item
Respiratory (Inhalation) (9)
CL Item
Intralesional (10)
CL Item
Intraperitoneal (11)
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])
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])
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])
CL Item
Ointment [Salbe] (3)
CL Item
Suppository [Zäpfchen] (4)
CL Item
Patch [Pflaster] (9)
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])
Code List
Please specify unit
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])
Code List
Route of administration
CL Item
Intramuscular (8)
CL Item
Respiratory (Inhalation) (9)
CL Item
Intralesional (10)
CL Item
Intraperitoneal (11)
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])
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])
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])