ID

27863

Beschrijving

Study part: Adverse Events- Treatment. A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma. Provided by Prof. Dr. Ulrich Keilholz, Charité – University of medicine Berlin. EudraCT-Nummer: 2014-002439-32. NCT02936388.

Trefwoorden

  1. 03-12-17 03-12-17 -
Houder van rechten

Charité – University of medicine Berlin

Geüploaded op

3 december 2017

DOI

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Licentie

Creative Commons BY-NC 3.0

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Adverse Events- Treatment SirTac NCT02936388

Adverse Events- Treatment

AE - Behandlung
Beschrijving

AE - Behandlung

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0877248
Patienten-ID:
Beschrijving

Patienten-ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Random. Nr.:
Beschrijving

Random. Nr.

Datatype

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0034656
SIRT
Beschrijving

SIRT

Datatype

boolean

Alias
UMLS CUI [1]
C1831994
TACE
Beschrijving

TACE

Datatype

boolean

Alias
UMLS CUI [1]
C3539919
Datum der letzten Behandlung:
Beschrijving

date of therapy

Datatype

date

Alias
UMLS CUI [1]
C2584899
Zeit nach Behandlung:
Beschrijving

time post- therapy

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1882428
Akute Unverträglichkeitsreaktion / Allergische Reaktion (gegen Therapiebestandteile, applizierte Medikamente)
Beschrijving

Hypersensitivity study drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Katheterassoziierte Komplikationen (z.B. Hämatome, Gefäßverletzungen, Gefühlsstörungen oder Schmerzen an Einstichstelle, Blutungen)
Beschrijving

catheter complication Hematoma Pain

Datatype

boolean

Alias
UMLS CUI [1,1]
C1401416
UMLS CUI [1,2]
C0018944
UMLS CUI [1,3]
C0030193
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Rash (außer Unverträglichkeit / allergische Reaktion)
Beschrijving

Exanthema

Datatype

boolean

Alias
UMLS CUI [1]
C0015230
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Schmerzen (z.B. Oberbauch)
Beschrijving

Pain

Datatype

boolean

Alias
UMLS CUI [1]
C0030193
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Übelkeit
Beschrijving

Nausea

Datatype

boolean

Alias
UMLS CUI [1]
C0027497
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Erbrechen
Beschrijving

Vomiting

Datatype

boolean

Alias
UMLS CUI [1]
C0042963
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Schüttelfrost
Beschrijving

chills

Datatype

boolean

Alias
UMLS CUI [1]
C0085593
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Fieber
Beschrijving

Fever

Datatype

boolean

Alias
UMLS CUI [1]
C0015967
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Ulzerationen (im Magen-Darm-Trakt)
Beschrijving

ulcer

Datatype

boolean

Alias
UMLS CUI [1]
C0041582
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Blutungen (außer an Punktionsstelle)
Beschrijving

Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0019080
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Milzinfarkt
Beschrijving

splenic infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0037998
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Gastritis
Beschrijving

Gastritis

Datatype

boolean

Alias
UMLS CUI [1]
C0017152
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Pneumonitis
Beschrijving

Pneumonitis

Datatype

boolean

Alias
UMLS CUI [1]
C3714636
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Pankreatitis
Beschrijving

pancreatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0030305
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Cholezystitis
Beschrijving

Cholecystitis

Datatype

boolean

Alias
UMLS CUI [1]
C0008325
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Leberabszedierung
Beschrijving

liver abscess

Datatype

boolean

Alias
UMLS CUI [1]
C0023885
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Durchfall
Beschrijving

diarrhoea

Datatype

boolean

Alias
UMLS CUI [1]
C0011991
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Fatigue
Beschrijving

Fatigue

Datatype

boolean

Alias
UMLS CUI [1]
C0015672
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Thrombozytopenie
Beschrijving

Thrombocytopenia

Datatype

boolean

Alias
UMLS CUI [1]
C0040034
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Neutropenie
Beschrijving

Neutropenia

Datatype

boolean

Alias
UMLS CUI [1]
C0027947
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Anämie
Beschrijving

anemia

Datatype

boolean

Alias
UMLS CUI [1]
C0002871
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Leberversagen
Beschrijving

Hepatic Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1306571
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Akutes Nierenversagen
Beschrijving

Renal Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Chronisches Nierenversagen
Beschrijving

Chronic kidney insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C0403447
Schweregrad
Beschrijving

intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Dauer
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Lokalisation / Kommentare / Beschreibung
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
SAE?
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Ausgefüllt/bestätigt am:
Beschrijving

date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Name Prüfarzt
Beschrijving

investigator name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Unterschrift Prüfarzt
Beschrijving

investigator signature

Datatype

text

Alias
UMLS CUI [1]
C2346576

Similar models

Adverse Events- Treatment

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
AE - Behandlung
C0087111 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Patienten-ID
Item
Patienten-ID:
text
C2348585 (UMLS CUI [1])
Random. Nr.
Item
Random. Nr.:
text
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
SIRT
Item
SIRT
boolean
C1831994 (UMLS CUI [1])
TACE
Item
TACE
boolean
C3539919 (UMLS CUI [1])
date of therapy
Item
Datum der letzten Behandlung:
date
C2584899 (UMLS CUI [1])
time post- therapy
Item
Zeit nach Behandlung:
time
C0040223 (UMLS CUI [1,1])
C1882428 (UMLS CUI [1,2])
Hypersensitivity study drug
Item
Akute Unverträglichkeitsreaktion / Allergische Reaktion (gegen Therapiebestandteile, applizierte Medikamente)
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
catheter complication Hematoma Pain
Item
Katheterassoziierte Komplikationen (z.B. Hämatome, Gefäßverletzungen, Gefühlsstörungen oder Schmerzen an Einstichstelle, Blutungen)
boolean
C1401416 (UMLS CUI [1,1])
C0018944 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Exanthema
Item
Rash (außer Unverträglichkeit / allergische Reaktion)
boolean
C0015230 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Pain
Item
Schmerzen (z.B. Oberbauch)
boolean
C0030193 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Nausea
Item
Übelkeit
boolean
C0027497 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Vomiting
Item
Erbrechen
boolean
C0042963 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
chills
Item
Schüttelfrost
boolean
C0085593 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Fever
Item
Fieber
boolean
C0015967 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
ulcer
Item
Ulzerationen (im Magen-Darm-Trakt)
boolean
C0041582 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Hemorrhage
Item
Blutungen (außer an Punktionsstelle)
boolean
C0019080 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
splenic infarction
Item
Milzinfarkt
boolean
C0037998 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Gastritis
Item
Gastritis
boolean
C0017152 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Pneumonitis
Item
Pneumonitis
boolean
C3714636 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
pancreatitis
Item
Pankreatitis
boolean
C0030305 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Cholecystitis
Item
Cholezystitis
boolean
C0008325 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
liver abscess
Item
Leberabszedierung
boolean
C0023885 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
diarrhoea
Item
Durchfall
boolean
C0011991 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Thrombocytopenia
Item
Thrombozytopenie
boolean
C0040034 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Neutropenia
Item
Neutropenie
boolean
C0027947 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
anemia
Item
Anämie
boolean
C0002871 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Hepatic Insufficiency
Item
Leberversagen
boolean
C1306571 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Renal Insufficiency
Item
Akutes Nierenversagen
boolean
C1565489 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Chronic kidney insufficiency
Item
Chronisches Nierenversagen
boolean
C0403447 (UMLS CUI [1])
intensity
Item
Schweregrad
text
C1710066 (UMLS CUI [1])
duration
Item
Dauer
text
C0449238 (UMLS CUI [1])
comment
Item
Lokalisation / Kommentare / Beschreibung
text
C0947611 (UMLS CUI [1])
SAE
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
date
Item
Ausgefüllt/bestätigt am:
date
C0011008 (UMLS CUI [1])
investigator name
Item
Name Prüfarzt
text
C2826892 (UMLS CUI [1])
investigator signature
Item
Unterschrift Prüfarzt
text
C2346576 (UMLS CUI [1])

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