quality management

  1. StudyEvent: quality management
    1. quality management
Patient data
Description

Patient data

patient number
Description

Patientenidentifikationsnummer

Data type

string

Alias
Code-1
Patients
UMLS CUI-1
C0030705
SNOMED CT-1
116154003
Code-2
Identification number
UMLS CUI-2
C1300638
SNOMED CT-2
396278008
Health Insurance
Description

Krankenkasse

Data type

string

Alias
UMLS CUI-1
C0021682
Patient telephone number
Description

Telefon

Data type

string

Alias
UMLS CUI-1
C0421455
SNOMED CT-1
184103008
Patient surname
Description

Name

Data type

string

Alias
UMLS CUI-1
C0421448
SNOMED CT-1
184096005
Maiden Name
Description

Geburtsname

Data type

string

Alias
UMLS CUI-1
C0806887
SNOMED CT-1
423203003
LOINC-1
MTHU010481
Code-2
Patients
UMLS CUI-2
C0030705
SNOMED CT-2
116154003
Patient forename
Description

Vorname

Data type

string

Alias
UMLS CUI-1
C0421447
SNOMED CT-1
184095009
Patient sex
Description

Geschlecht

Data type

integer

Alias
UMLS CUI-1
C0150831
SNOMED CT-1
184100006
Patient date of birth
Description

Geburtsdatum

Data type

date

Alias
UMLS CUI-1
C0421451
SNOMED CT-1
184099003
Ethnicity / related nationality data
Description

Staatsangehörigkeit

Data type

string

Alias
UMLS CUI-1
C0438960
SNOMED CT-1
186034007
Code-2
Patients
UMLS CUI-2
C0030705
SNOMED CT-2
116154003
Patient address
Description

Patient address

Street Address
Description

Straße

Data type

string

Alias
UMLS CUI-1
C1301826
SNOMED CT-1
398099009
Code-2
Patient address
UMLS CUI-2
C0421449
SNOMED CT-2
184097001
Patient postal code
Description

PLZ

Data type

integer

Alias
UMLS CUI-1
C0421454
SNOMED CT-1
184102003
City of residence
Description

Ort

Data type

string

Alias
UMLS CUI-1
C2316883
SNOMED CT-1
433178008
Code-2
Patient address
UMLS CUI-2
C0421449
SNOMED CT-2
184097001
Therapeutic radiology procedure
Description

Therapeutic radiology procedure

Organ target(s)
Description

Zielgebiet

Data type

string

Alias
UMLS CUI-1
C0807185
Radiotherapy Technique
Description

Applikationsart

Data type

integer

Alias
Code-1
Technique
UMLS CUI-1
C0449851
SNOMED CT-1
246501002
Code-2
Therapeutic radiology procedure
UMLS CUI-2
C1522449
SNOMED CT-2
108290001
MedDRA-2
10037770
Start Radiotherapy
Description

Beginn

Data type

date

Alias
Code-1
Radiotherapy started (situation)
UMLS CUI-1
C0436382
SNOMED CT-1
168531007
End Radiotherapy
Description

Ende

Data type

date

Alias
Code-1
Radiotherapy completed (situation)
UMLS CUI-1
C0436385
SNOMED CT-1
168534004
total amount of radiation
Description

Gesamtdosis (Gy/Gbq)

Data type

integer

Alias
Code-1
Total radiation dose delivered (observable entity)
UMLS CUI-1
C2919490
SNOMED CT-1
445461008
Intent
Description

Intention

Data type

integer

Alias
UMLS CUI-1
C1283828
SNOMED CT-1
367565008
Code-2
Therapeutic radiology procedure
UMLS CUI-2
C1522449
SNOMED CT-2
108290001
MedDRA-2
10037770
Termination of Radiotherapy
Description

Beendigung der Strahlentherapie

Data type

integer

Alias
Code-1
Radiotherapy stopped (situation)
UMLS CUI-1
C0436384
SNOMED CT-1
168533005
Common Terminology Criteria for Adverse Events
Description

Common Terminology Criteria for Adverse Events

Adverse event
Description

Nebenwirkungen

Data type

boolean

Alias
Code-Info
for_compare
UMLS CUI-1
C0877248
MedDRA-1
10060933
LOINC-1
MTHU014542
Laboratory Values
Description

Laborwerte

Data type

integer

Alias
Code-1
Other Metabolic and Laboratory Adverse Event
UMLS CUI-1
C1559945
CTCAE-1
MTHU117254
Genitourinary system
Description

Niere/Blase

Data type

integer

Alias
Code-1
Renal or Genitourinary Other Adverse Event
UMLS CUI-1
C1558061
CTCAE-1
MTHU117419
Skin
Description

Haut

Data type

integer

Alias
Code-1
Other Dermatology or Skin Adverse Event
UMLS CUI-1
C1559104
CTCAE-1
MTHU117246
Allergic Reaction
Description

Allergie

Data type

integer

Alias
Code-1
Adverse Event Associated with Allergy and Immunology
UMLS CUI-1
C1560126
CTCAE-1
MTHU112125
Gastrointestinal system
Description

Gastrointestinaltrakt

Data type

integer

Alias
Code-1
Adverse Event Associated with the Gastrointestinal System
UMLS CUI-1
C1559265
CTCAE-1
MTHU112146
Nervous system structure
Description

Nervensystem

Data type

integer

Alias
Code-1
Adverse Event Associated with the Nervous System
UMLS CUI-1
C1561270
CTCAE-1
MTHU112152
Fever
Description

Fieber

Data type

integer

Alias
Code-1
Fever Without Neutropenia Adverse Event
UMLS CUI-1
C1556366
CTCAE-1
MTHU116933
Infection
Description

Infektion

Data type

integer

Alias
Code-1
Adverse Event Associated with Infection
UMLS CUI-1
C1556682
CTCAE-1
MTHU112135
Systemic circulatory system
Description

Herz/Kreislauf

Data type

integer

Alias
Code-1
Adverse Event Associated with the Heart in General
UMLS CUI-1
C1556247
CTCAE-1
MTHU112147
Entire sensory organ
Description

Sinnesorgane

Data type

integer

Alias
Code-1
Adverse Event Associated with the Ear and Auditory System
UMLS CUI-1
C1560154
CTCAE-1
MTHU112144
General symptom
Description

Allgemeinsymptome

Data type

integer

Alias
Code-1
Adverse Event Associated with Constitutional Symptoms
UMLS CUI-1
C1556354
CTCAE-1
MTHU112129
Lung/Larynx
Description

Lunge/Kehlkopf

Data type

integer

Alias
Code-1
Adverse Event Associated with Pulmonary and Upper Respiratory Systems
UMLS CUI-1
C1557628
CTCAE-1
MTHU112139
Endocrine system
Description

Endokrines System

Data type

integer

Alias
Code-1
Adverse Event Associated with the Endocrine System
UMLS CUI-1
C1559198
CTCAE-1
MTHU112145
general appearance
Description

Allgemeinzustand

Data type

integer

Alias
Code-1
general appearance (physical finding)
UMLS CUI-1
C1148438
LOINC-1
MTHU015040
other adverse event
Description

Sonstige

Data type

integer

Alias
Code-1
Adverse event
UMLS CUI-1
C0877248
MedDRA-1
10060933
LOINC-1
MTHU014542
Code-2
Other
UMLS CUI-2
C0205395
SNOMED CT-2
74964008

Similar models

quality management

  1. StudyEvent: quality management
    1. quality management
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient data
Patientenidentifikationsnummer
Item
patient number
string
Patients (Code-1)
C0030705 (UMLS CUI-1)
116154003 (SNOMED CT-1)
Identification number (Code-2)
C1300638 (UMLS CUI-2)
396278008 (SNOMED CT-2)
Krankenkasse
Item
Health Insurance
string
C0021682 (UMLS CUI-1)
Telefon
Item
Patient telephone number
string
C0421455 (UMLS CUI-1)
184103008 (SNOMED CT-1)
Name
Item
Patient surname
string
C0421448 (UMLS CUI-1)
184096005 (SNOMED CT-1)
Geburtsname
Item
Maiden Name
string
C0806887 (UMLS CUI-1)
423203003 (SNOMED CT-1)
MTHU010481 (LOINC-1)
Patients (Code-2)
C0030705 (UMLS CUI-2)
116154003 (SNOMED CT-2)
Vorname
Item
Patient forename
string
C0421447 (UMLS CUI-1)
184095009 (SNOMED CT-1)
Item
Patient sex
integer
C0150831 (UMLS CUI-1)
184100006 (SNOMED CT-1)
Code List
Patient sex
CL Item
Female (weiblich)
C0086287 (UMLS CUI-1)
1086007 (SNOMED CT-1)
CL Item
Male gender (männlich)
C0086582 (UMLS CUI-1)
10052007 (SNOMED CT-1)
Geburtsdatum
Item
Patient date of birth
date
C0421451 (UMLS CUI-1)
184099003 (SNOMED CT-1)
Staatsangehörigkeit
Item
Ethnicity / related nationality data
string
C0438960 (UMLS CUI-1)
186034007 (SNOMED CT-1)
Patients (Code-2)
C0030705 (UMLS CUI-2)
116154003 (SNOMED CT-2)
Item Group
Patient address
Straße
Item
Street Address
string
C1301826 (UMLS CUI-1)
398099009 (SNOMED CT-1)
Patient address (Code-2)
C0421449 (UMLS CUI-2)
184097001 (SNOMED CT-2)
PLZ
Item
Patient postal code
integer
C0421454 (UMLS CUI-1)
184102003 (SNOMED CT-1)
Ort
Item
City of residence
string
C2316883 (UMLS CUI-1)
433178008 (SNOMED CT-1)
Patient address (Code-2)
C0421449 (UMLS CUI-2)
184097001 (SNOMED CT-2)
Item Group
Therapeutic radiology procedure
Zielgebiet
Item
Organ target(s)
string
C0807185 (UMLS CUI-1)
Item
Radiotherapy Technique
integer
Technique (Code-1)
C0449851 (UMLS CUI-1)
246501002 (SNOMED CT-1)
Therapeutic radiology procedure (Code-2)
C1522449 (UMLS CUI-2)
108290001 (SNOMED CT-2)
10037770 (MedDRA-2)
Code List
Radiotherapy Technique
CL Item
Teleradiotherapy procedure (P = Percutan (Teletherapie))
Teleradiotherapy procedure (procedure) (Code-1)
C0419095 (UMLS CUI-1)
33195004 (SNOMED CT-1)
CL Item
Brachytherapy (P = Percutan (Brachytherapie))
extended_coding (Code-Info)
Brachytherapy (Code-1)
C0006098 (UMLS CUI-1)
399315003 (SNOMED CT-1)
10061018 (MedDRA-1)
CL Item
Intracavity Radiotherapy  (K = endokavitäare Kontakttherapie)
C0021864 (UMLS CUI-1)
384692006 (SNOMED CT-1)
CL Item
Internal radiotherapy - permanent seeds  (I = Interstitielle Kontakttherapie)
Internal radiotherapy - permanent seeds (procedure) (Code-1)
C0436265 (UMLS CUI-1)
169359004 (SNOMED CT-1)
CL Item
Internal metabolic radiotherapy (procedure) (M = Metabolische Therapie (radionuclide))
C0436254 (UMLS CUI-1)
169340001 (SNOMED CT-1)
CL Item
Afterloading cavity radiotherapy (procedure)  (A = afterloading)
C0436298 (UMLS CUI-1)
169387008 (SNOMED CT-1)
Beginn
Item
Start Radiotherapy
date
Radiotherapy started (situation) (Code-1)
C0436382 (UMLS CUI-1)
168531007 (SNOMED CT-1)
Ende
Item
End Radiotherapy
date
Radiotherapy completed (situation) (Code-1)
C0436385 (UMLS CUI-1)
168534004 (SNOMED CT-1)
Gesamtdosis (Gy/Gbq)
Item
total amount of radiation
integer
Total radiation dose delivered (observable entity) (Code-1)
C2919490 (UMLS CUI-1)
445461008 (SNOMED CT-1)
Item
Intent
integer
C1283828 (UMLS CUI-1)
367565008 (SNOMED CT-1)
Therapeutic radiology procedure (Code-2)
C1522449 (UMLS CUI-2)
108290001 (SNOMED CT-2)
10037770 (MedDRA-2)
Code List
Intent
CL Item
Curative - procedure intent  (kurativ)
Curative - procedure intent (qualifier value) (Code-1)
C1276305 (UMLS CUI-1)
373808002 (SNOMED CT-1)
CL Item
Palliative - procedure intent (palliativ)
Palliative - procedure intent (qualifier value) (Code-1)
C1285530 (UMLS CUI-1)
363676003 (SNOMED CT-1)
CL Item
Adjuvant - intent (adjuvant)
Adjuvant - intent (qualifier value) (Code-1)
C1298675 (UMLS CUI-1)
373846009 (SNOMED CT-1)
CL Item
Neo-adjuvant - intent  (neoadjuvant)
Neo-adjuvant - intent (qualifier value) (Code-1)
C1298676 (UMLS CUI-1)
373847000 (SNOMED CT-1)
Item
Termination of Radiotherapy
integer
Radiotherapy stopped (situation) (Code-1)
C0436384 (UMLS CUI-1)
168533005 (SNOMED CT-1)
Code List
Termination of Radiotherapy
CL Item
Discontinue because of adverse effects (Abbruch wegen Nebenwirkungen)
Adverse effects (Code-1)
C0879626 (UMLS CUI-1)
281647001 (SNOMED CT-1)
10067484 (MedDRA-1)
Discontinue (Code-2)
C1444662 (UMLS CUI-2)
410546004 (SNOMED CT-2)
Indication of (contextual qualifier) (Code-3)
C0392360 (UMLS CUI-3)
230165009 (SNOMED CT-3)
MTHU008319 (LOINC-3)
CL Item
regular End of Therapy (reguläres Ende)
Regular (Code-1)
C0449581 (UMLS CUI-1)
17854005 (SNOMED CT-1)
End (Code-2)
C1272693 (UMLS CUI-2)
385656004 (SNOMED CT-2)
CL Item
Refusal of Treatment (Pat. verw. Therapie)
C0040809 (UMLS CUI-1)
105480006 (SNOMED CT-1)
10056407 (MedDRA-1)
Item Group
Common Terminology Criteria for Adverse Events
Nebenwirkungen
Item
Adverse event
boolean
for_compare (Code-Info)
C0877248 (UMLS CUI-1)
10060933 (MedDRA-1)
MTHU014542 (LOINC-1)
Item
Laboratory Values
integer
Other Metabolic and Laboratory Adverse Event (Code-1)
C1559945 (UMLS CUI-1)
MTHU117254 (CTCAE-1)
Code List
Laboratory Values
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Other Metabolic and Laboratory Adverse Event (Code-2)
C1559945 (UMLS CUI-2)
MTHU117254 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Other Metabolic and Laboratory Adverse Event (Code-2)
C1559945 (UMLS CUI-2)
MTHU117254 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Other Metabolic and Laboratory Adverse Event (Code-2)
C1559945 (UMLS CUI-2)
MTHU117254 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Other Metabolic and Laboratory Adverse Event (Code-2)
C1559945 (UMLS CUI-2)
MTHU117254 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Other Metabolic and Laboratory Adverse Event (Code-2)
C1559945 (UMLS CUI-2)
MTHU117254 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Other Metabolic and Laboratory Adverse Event (Code-2)
C1559945 (UMLS CUI-2)
MTHU117254 (CTCAE-2)
Item
Genitourinary system
integer
Renal or Genitourinary Other Adverse Event (Code-1)
C1558061 (UMLS CUI-1)
MTHU117419 (CTCAE-1)
Code List
Genitourinary system
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Renal or Genitourinary Other Adverse Event (Code-2)
C1558061 (UMLS CUI-2)
MTHU117419 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Renal or Genitourinary Other Adverse Event (Code-2)
C1558061 (UMLS CUI-2)
MTHU117419 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Renal or Genitourinary Other Adverse Event (Code-2)
C1558061 (UMLS CUI-2)
MTHU117419 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Renal or Genitourinary Other Adverse Event (Code-2)
C1558061 (UMLS CUI-2)
MTHU117419 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Renal or Genitourinary Other Adverse Event (Code-2)
C1558061 (UMLS CUI-2)
MTHU117419 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Renal or Genitourinary Other Adverse Event (Code-2)
C1558061 (UMLS CUI-2)
MTHU117419 (CTCAE-2)
Item
Skin
integer
Other Dermatology or Skin Adverse Event (Code-1)
C1559104 (UMLS CUI-1)
MTHU117246 (CTCAE-1)
Code List
Skin
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Other Dermatology or Skin Adverse Event (Code-2)
C1559104 (UMLS CUI-2)
MTHU117246 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Other Dermatology or Skin Adverse Event (Code-2)
C1559104 (UMLS CUI-2)
MTHU117246 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Other Dermatology or Skin Adverse Event (Code-2)
C1559104 (UMLS CUI-2)
MTHU117246 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Other Dermatology or Skin Adverse Event (Code-2)
C1559104 (UMLS CUI-2)
MTHU117246 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Other Dermatology or Skin Adverse Event (Code-2)
C1559104 (UMLS CUI-2)
MTHU117246 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Other Dermatology or Skin Adverse Event (Code-2)
C1559104 (UMLS CUI-2)
MTHU117246 (CTCAE-2)
CL Item
only in connection with Allergy (only in connection with Allergy)
Item
Allergic Reaction
integer
Adverse Event Associated with Allergy and Immunology (Code-1)
C1560126 (UMLS CUI-1)
MTHU112125 (CTCAE-1)
Code List
Allergic Reaction
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Adverse Event Associated with Allergy and Immunology (Code-2)
C1560126 (UMLS CUI-2)
MTHU112125 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Adverse Event Associated with Allergy and Immunology (Code-2)
C1560126 (UMLS CUI-2)
MTHU112125 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Adverse Event Associated with Allergy and Immunology (Code-2)
C1560126 (UMLS CUI-2)
MTHU112125 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Adverse Event Associated with Allergy and Immunology (Code-2)
C1560126 (UMLS CUI-2)
MTHU112125 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Adverse Event Associated with Allergy and Immunology (Code-2)
C1560126 (UMLS CUI-2)
MTHU112125 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Adverse Event Associated with Allergy and Immunology (Code-2)
C1560126 (UMLS CUI-2)
MTHU112125 (CTCAE-2)
CL Item
only in connection with Skin (only in connection with Skin)
Item
Gastrointestinal system
integer
Adverse Event Associated with the Gastrointestinal System (Code-1)
C1559265 (UMLS CUI-1)
MTHU112146 (CTCAE-1)
Code List
Gastrointestinal system
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Adverse Event Associated with the Gastrointestinal System (Code-2)
C1559265 (UMLS CUI-2)
MTHU112146 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Adverse Event Associated with the Gastrointestinal System (Code-2)
C1559265 (UMLS CUI-2)
MTHU112146 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Adverse Event Associated with the Gastrointestinal System (Code-2)
C1559265 (UMLS CUI-2)
MTHU112146 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Adverse Event Associated with the Gastrointestinal System (Code-2)
C1559265 (UMLS CUI-2)
MTHU112146 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Adverse Event Associated with the Gastrointestinal System (Code-2)
C1559265 (UMLS CUI-2)
MTHU112146 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Adverse Event Associated with the Gastrointestinal System (Code-2)
C1559265 (UMLS CUI-2)
MTHU112146 (CTCAE-2)
Item
Nervous system structure
integer
Adverse Event Associated with the Nervous System (Code-1)
C1561270 (UMLS CUI-1)
MTHU112152 (CTCAE-1)
Code List
Nervous system structure
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Adverse Event Associated with the Nervous System (Code-2)
C1561270 (UMLS CUI-2)
MTHU112152 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Adverse Event Associated with the Nervous System (Code-2)
C1561270 (UMLS CUI-2)
MTHU112152 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Adverse Event Associated with the Nervous System (Code-2)
C1561270 (UMLS CUI-2)
MTHU112152 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Adverse Event Associated with the Nervous System (Code-2)
C1561270 (UMLS CUI-2)
MTHU112152 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Adverse Event Associated with the Nervous System (Code-2)
C1561270 (UMLS CUI-2)
MTHU112152 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Adverse Event Associated with the Nervous System (Code-2)
C1561270 (UMLS CUI-2)
MTHU112152 (CTCAE-2)
Item
Fever
integer
Fever Without Neutropenia Adverse Event (Code-1)
C1556366 (UMLS CUI-1)
MTHU116933 (CTCAE-1)
Code List
Fever
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Fever Without Neutropenia Adverse Event (Code-2)
C1556366 (UMLS CUI-2)
MTHU116933 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Fever Without Neutropenia Adverse Event (Code-2)
C1556366 (UMLS CUI-2)
MTHU116933 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Fever Without Neutropenia Adverse Event (Code-2)
C1556366 (UMLS CUI-2)
MTHU116933 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Fever Without Neutropenia Adverse Event (Code-2)
C1556366 (UMLS CUI-2)
MTHU116933 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Fever Without Neutropenia Adverse Event (Code-2)
C1556366 (UMLS CUI-2)
MTHU116933 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Fever Without Neutropenia Adverse Event (Code-2)
C1556366 (UMLS CUI-2)
MTHU116933 (CTCAE-2)
CL Item
only in connection with Infection (only in connection with Infection)
Item
Infection
integer
Adverse Event Associated with Infection (Code-1)
C1556682 (UMLS CUI-1)
MTHU112135 (CTCAE-1)
Code List
Infection
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Adverse Event Associated with Infection (Code-2)
C1556682 (UMLS CUI-2)
MTHU112135 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Adverse Event Associated with Infection (Code-2)
C1556682 (UMLS CUI-2)
MTHU112135 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Adverse Event Associated with Infection (Code-2)
C1556682 (UMLS CUI-2)
MTHU112135 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Adverse Event Associated with Infection (Code-2)
C1556682 (UMLS CUI-2)
MTHU112135 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Adverse Event Associated with Infection (Code-2)
C1556682 (UMLS CUI-2)
MTHU112135 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Adverse Event Associated with Infection (Code-2)
C1556682 (UMLS CUI-2)
MTHU112135 (CTCAE-2)
CL Item
only in connection with fever (only in connection with fever)
Item
Systemic circulatory system
integer
Adverse Event Associated with the Heart in General (Code-1)
C1556247 (UMLS CUI-1)
MTHU112147 (CTCAE-1)
Code List
Systemic circulatory system
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Adverse Event Associated with the Heart in General (Code-2)
C1556247 (UMLS CUI-2)
MTHU112147 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Adverse Event Associated with the Heart in General (Code-2)
C1556247 (UMLS CUI-2)
MTHU112147 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Adverse Event Associated with the Heart in General (Code-2)
C1556247 (UMLS CUI-2)
MTHU112147 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Adverse Event Associated with the Heart in General (Code-2)
C1556247 (UMLS CUI-2)
MTHU112147 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Adverse Event Associated with the Heart in General (Code-2)
C1556247 (UMLS CUI-2)
MTHU112147 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Adverse Event Associated with the Heart in General (Code-2)
C1556247 (UMLS CUI-2)
MTHU112147 (CTCAE-2)
Item
Entire sensory organ
integer
Adverse Event Associated with the Ear and Auditory System (Code-1)
C1560154 (UMLS CUI-1)
MTHU112144 (CTCAE-1)
Code List
Entire sensory organ
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Adverse Event Associated with the Ear and Auditory System (Code-2)
C1560154 (UMLS CUI-2)
MTHU112144 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Adverse Event Associated with the Ear and Auditory System (Code-2)
C1560154 (UMLS CUI-2)
MTHU112144 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Adverse Event Associated with the Ear and Auditory System (Code-2)
C1560154 (UMLS CUI-2)
MTHU112144 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Adverse Event Associated with the Ear and Auditory System (Code-2)
C1560154 (UMLS CUI-2)
MTHU112144 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Adverse Event Associated with the Ear and Auditory System (Code-2)
C1560154 (UMLS CUI-2)
MTHU112144 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Adverse Event Associated with the Ear and Auditory System (Code-2)
C1560154 (UMLS CUI-2)
MTHU112144 (CTCAE-2)
Item
General symptom
integer
Adverse Event Associated with Constitutional Symptoms (Code-1)
C1556354 (UMLS CUI-1)
MTHU112129 (CTCAE-1)
Code List
General symptom
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Adverse Event Associated with Constitutional Symptoms (Code-2)
C1556354 (UMLS CUI-2)
MTHU112129 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Adverse Event Associated with Constitutional Symptoms (Code-2)
C1556354 (UMLS CUI-2)
MTHU112129 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Adverse Event Associated with Constitutional Symptoms (Code-2)
C1556354 (UMLS CUI-2)
MTHU112129 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Adverse Event Associated with Constitutional Symptoms (Code-2)
C1556354 (UMLS CUI-2)
MTHU112129 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Adverse Event Associated with Constitutional Symptoms (Code-2)
C1556354 (UMLS CUI-2)
MTHU112129 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Adverse Event Associated with Constitutional Symptoms (Code-2)
C1556354 (UMLS CUI-2)
MTHU112129 (CTCAE-2)
Item
Lung/Larynx
integer
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-1)
C1557628 (UMLS CUI-1)
MTHU112139 (CTCAE-1)
Code List
Lung/Larynx
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-2)
C1557628 (UMLS CUI-2)
MTHU112139 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-2)
C1557628 (UMLS CUI-2)
MTHU112139 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-2)
C1557628 (UMLS CUI-2)
MTHU112139 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-2)
C1557628 (UMLS CUI-2)
MTHU112139 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-2)
C1557628 (UMLS CUI-2)
MTHU112139 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-2)
C1557628 (UMLS CUI-2)
MTHU112139 (CTCAE-2)
Item
Endocrine system
integer
Adverse Event Associated with the Endocrine System (Code-1)
C1559198 (UMLS CUI-1)
MTHU112145 (CTCAE-1)
Code List
Endocrine system
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Adverse Event Associated with the Endocrine System (Code-2)
C1559198 (UMLS CUI-2)
MTHU112145 (CTCAE-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Adverse Event Associated with the Endocrine System (Code-2)
C1559198 (UMLS CUI-2)
MTHU112145 (CTCAE-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Adverse Event Associated with the Endocrine System (Code-2)
C1559198 (UMLS CUI-2)
MTHU112145 (CTCAE-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Adverse Event Associated with the Endocrine System (Code-2)
C1559198 (UMLS CUI-2)
MTHU112145 (CTCAE-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Adverse Event Associated with the Endocrine System (Code-2)
C1559198 (UMLS CUI-2)
MTHU112145 (CTCAE-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Adverse Event Associated with the Endocrine System (Code-2)
C1559198 (UMLS CUI-2)
MTHU112145 (CTCAE-2)
Item
general appearance
integer
general appearance (physical finding) (Code-1)
C1148438 (UMLS CUI-1)
MTHU015040 (LOINC-1)
Code List
general appearance
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
general appearance (physical finding) (Code-2)
C1148438 (UMLS CUI-2)
MTHU015040 (LOINC-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
general appearance (physical finding) (Code-2)
C1148438 (UMLS CUI-2)
MTHU015040 (LOINC-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
general appearance (physical finding) (Code-2)
C1148438 (UMLS CUI-2)
MTHU015040 (LOINC-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
general appearance (physical finding) (Code-2)
C1148438 (UMLS CUI-2)
MTHU015040 (LOINC-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
general appearance (physical finding) (Code-2)
C1148438 (UMLS CUI-2)
MTHU015040 (LOINC-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Common Terminology Criteria for Adverse Events (Code-1)
C1516728 (UMLS CUI-1)
Unknown (Code-2)
C0439673 (UMLS CUI-2)
261665006 (SNOMED CT-2)
general appearance (physical finding) (Code-3)
C1148438 (UMLS CUI-3)
MTHU015040 (LOINC-3)
Item
other adverse event
integer
Adverse event (Code-1)
C0877248 (UMLS CUI-1)
10060933 (MedDRA-1)
MTHU014542 (LOINC-1)
Other (Code-2)
C0205395 (UMLS CUI-2)
74964008 (SNOMED CT-2)
Code List
other adverse event
CL Item
no adverse event (0 = keine)
Absent Adverse Event (Code-1)
C2699517 (UMLS CUI-1)
Other (Code-2)
C0205395 (UMLS CUI-2)
74964008 (SNOMED CT-2)
10060933 (MedDRA-2)
MTHU014542 (LOINC-2)
CL Item
mild adverse event (1 = gering/leicht)
Mild Adverse Event (Code-1)
C1513302 (UMLS CUI-1)
Other (Code-2)
C0205395 (UMLS CUI-2)
74964008 (SNOMED CT-2)
10060933 (MedDRA-2)
MTHU014542 (LOINC-2)
CL Item
moderate adverse event (2 = mäßig/deutlich)
Moderate Adverse Event (Code-1)
C1513374 (UMLS CUI-1)
Other (Code-2)
C0205395 (UMLS CUI-2)
74964008 (SNOMED CT-2)
10060933 (MedDRA-2)
MTHU014542 (LOINC-2)
CL Item
strong adverse event (3 = stark/ausgeprägt)
Severe Adverse Event (Code-1)
C1519275 (UMLS CUI-1)
Other (Code-2)
C0205395 (UMLS CUI-2)
74964008 (SNOMED CT-2)
10060933 (MedDRA-2)
MTHU014542 (LOINC-2)
CL Item
Life Threatening adverse event (4 = lebensbedrohlich)
Life Threatening Adverse Event (Code-1)
C1517874 (UMLS CUI-1)
Other (Code-2)
C0205395 (UMLS CUI-2)
74964008 (SNOMED CT-2)
10060933 (MedDRA-2)
MTHU014542 (LOINC-2)
CL Item
unknown adverse event (X = Nebenwirkungen unbekannt)
Adverse event (Code-1)
C0877248 (UMLS CUI-1)
10060933 (MedDRA-1)
MTHU014542 (LOINC-1)
Unknown (Code-2)
C0439673 (UMLS CUI-2)
261665006 (SNOMED CT-2)
Other (Code-3)
C0205395 (UMLS CUI-3)
74964008 (SNOMED CT-3)