ID

42922

Descrição

http://clinicaltrials.gov/ct2/show/NCT01657604

Link

http://clinicaltrials.gov/ct2/show/NCT01657604

Palavras-chave

Versões (2)
  1. 25/01/2014 25/01/2014 -
  2. 17/09/2021 17/09/2021 -
Transferido a

17 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Ausschlusskriterien DRKS00005243 NCT01657604 Chronic Myeloid Leukemia

Alemão Inglês

Ausschlusskriterien

1 Formulários  
  1. StudyEvent: Chronic Myeloid Leukemia
    1. Ausschlusskriterien
Administrative Items
Descrição

Administrative Items

Alias
Code-1
Administrative Items
UMLS CUI 2011AB
C2598108
LOINC Version 232
MTHU029788
Hospital Identifier
Descrição

Klinik-Nr.

Tipo de dados

integer

Alias
Code-1
Identifier
UMLS CUI 2011AB
C0600091
SNOMEDCT_2012_01_31
118522005
Code-2
Hospitals
UMLS CUI 2011AB
C0019994
LOINC Version 232
MTHU002722
Patient identifier
Descrição

Patienten-Nr.

Tipo de dados

integer

Alias
Code-1
Identifier
UMLS CUI 2011AB
C0600091
SNOMEDCT_2012_01_31
118522005
Code-2
Patients
UMLS CUI 2011AB
C0030705
SNOMEDCT_2012_01_31
116154003
Date of birth
Descrição

Date of birth

Alias
Code-1
Patient date of birth
UMLS CUI 2011AB
C0421451
SNOMEDCT_2012_01_31
184099003
LOINC Version 232
MTHU009540
Month of birth
Descrição

Geburtsmonat

Tipo de dados

integer

Alias
Code-1
month
UMLS CUI 2011AB
C0439231
SNOMEDCT_2012_01_31
258706009
HL7 V3 2006_05
MO
Day of birth
Descrição

Geburtstag

Tipo de dados

integer

Alias
Code-1
day
UMLS CUI 2011AB
C0439228
SNOMEDCT_2012_01_31
258703001
LOINC Version 232
MTHU039849
HL7 V3 2006_05
D
Administrative Items
Descrição

Administrative Items

Alias
Code-1
Administrative Items
UMLS CUI 2011AB
C2598108
LOINC Version 232
MTHU029788
Date of Evaluation
Descrição

Beurteilungsdatum

Tipo de dados

date

Alias
Code-1
Evaluation
UMLS CUI 2011AB
C0220825
Code-2
Date in time
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Date of diagnosis
Descrição

Diagnosedatum

Tipo de dados

date

Alias
Code-1
Date of diagnosis
UMLS CUI 2011AB
C2316983
SNOMEDCT_2012_01_31
432213005
LOINC Version 232
MTHU038128
Sex
Descrição

Geschlecht

Tipo de dados

integer

Alias
Code-1
Patient sex
UMLS CUI 2011AB
C0150831
SNOMEDCT_2012_01_31
184100006
Exclusion Criterion
Descrição

Exclusion Criterion

Pre-existing impaired cardiac funktion: LVEF less than 45%, congenital Long-QT-Syndrome, anciently oder curreent existing clinically relevant ventricular or atrial tachyarrhythmia
Descrição

Vorbestehende beeinträchtige kardiale Funktion: LVEF kleiner als 45%, kongenitales Long-QT-Syndrom, vormals oder aktuell bestehende klinische relevante ventrikuläre oder atriale Tachyarrhythmien

Tipo de dados

boolean

Alias
Code-1
Left Ventricular Ejection Fraction
UMLS CUI 2011AB
CL433348
Code-2
Less Than
UMLS CUI 2011AB
C0439092
SNOMEDCT_2012_01_31
276139006
HL7 V3 2006_05
LT
Code-3
Forty
UMLS CUI 2011AB
CL447290
Code-4
Five
UMLS CUI 2011AB
C0205451
SNOMEDCT_2012_01_31
421820001
Code-5
Congenital long QT syndrome
UMLS CUI 2011AB
C1141890
SNOMEDCT_2012_01_31
442917000
MedDRA 14.1
10057926
Code-6
Previous
UMLS CUI 2011AB
C0205156
SNOMEDCT_2012_01_31
9130008
Clinically relevant Rest-Bradycardia (less than 50 bpm)
Descrição

Klinisch relevatne Ruhe-Bradykardie (weniger als 50 bpm)

Tipo de dados

boolean

Alias
Code-1
Clinical
UMLS CUI 2011AB
C0205210
SNOMEDCT_2012_01_31
58147004
Code-2
Relevance
UMLS CUI 2011AB
C2347946
Code-3
Bradycardia
UMLS CUI 2011AB
C0428977
SNOMEDCT_2012_01_31
48867003
MedDRA 14.1
10006093
ICD-10-CM Version 2010
R00.1
Code-4
Less Than
UMLS CUI 2011AB
C0439092
SNOMEDCT_2012_01_31
276139006
HL7 V3 2006_05
LT
Code-5
Fifty
UMLS CUI 2011AB
CL447144
Code-6
Beats per Minute
UMLS CUI 2011AB
C0439385
SNOMEDCT_2012_01_31
258983007
QTc greater than 450ms within screening-ecg
Descrição

QTc größer als 450ms auf Screening-EKG (Falss QTc größer als 450ms und Elektrolyte nicht im Normbereich vor Nilotinibgabe, so sollten Elektrolyte eingestellt werden und danach erneut das QTc-Kriterium getestet werden)

Tipo de dados

boolean

Alias
Code-1
Corrected Prolonged QT Interval
UMLS CUI 2011AB
C0855333
SNOMEDCT_2012_01_31
10014383
Code-2
Greater Than
UMLS CUI 2011AB
C0439093
SNOMEDCT_2012_01_31
276140008
HL7 V3 2006_05
GT
Code-3
One Hundred
UMLS CUI 2011AB
CL447292
Code-4
Fifty
UMLS CUI 2011AB
CL447144
Code-5
Millisecond
UMLS CUI 2011AB
C0439223
SNOMEDCT_2012_01_31
258697002
Code-6
Electrocardiography
UMLS CUI 2011AB
C1623258
SNOMEDCT_2012_01_31
29303009
MedDRA 14.1
10014362
Myocardial infarct within the last 12 Month before the beginning of treatment
Descrição

Myokardinfarkt innerhalb der letzten 12 Monate vor Therapiebeginn

Tipo de dados

boolean

Alias
Code-1
H/O: Myocardial infarction in last year
UMLS CUI 2011AB
C0585891
SNOMEDCT_2012_01_31
308065005
Code-2
Prior
UMLS CUI 2011AB
C0332152
SNOMEDCT_2012_01_31
288556008
Code-3
Beginning
UMLS CUI 2011AB
C0439659
SNOMEDCT_2012_01_31
255395001
LOINC Version 232
MTHU026300
Code-4
Therapeutic procedure
UMLS CUI 2011AB
C0087111
SNOMEDCT_2012_01_31
277132007
MedDRA 14.1
10053757
LOINC Version 232
MTHU021209
Other clinically relevant heart diseases (e.g. unstable angina pectoris, severe cardiac insufficiency, uncontrolled hypertension)
Descrição

Andere klinisch relevante Herzerkrankungen (z.Bsp. Instabile Angina pectoris, schwere Herinsuffzienz, nicht kontrollierter Bluthochdruck)

Tipo de dados

boolean

Alias
Code-1
Heart Diseases
UMLS CUI 2011AB
C0018799
SNOMEDCT_2012_01_31
56265001
MedDRA 14.1
10061024
ICD-10-CM Version 2010
I51.9
ICD-9-CM Version 2011
429.9
Code-2
Clinical
UMLS CUI 2011AB
C0205210
SNOMEDCT_2012_01_31
58147004
Code-3
Relevance
UMLS CUI 2011AB
C2347946
Code-4
Angina, Unstable
UMLS CUI 2011AB
C0002965
SNOMEDCT_2012_01_31
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
Code-5
Congestive heart failure
UMLS CUI 2011AB
C0018802
SNOMEDCT_2012_01_31
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428
Code-6
Severe
UMLS CUI 2011AB
C0205082
SNOMEDCT_2012_01_31
24484000
Within the last year before beginning of treatment existing acute or chronic pancreatits
Descrição

Innerhalb des letzten Jahres vor Therapiebeginn bestehende akute oder chronische Pankreatitis

Tipo de dados

boolean

Alias
Code-1
Pancreatitis, Chronic
UMLS CUI 2011AB
C0149521
SNOMEDCT_2012_01_31
235494005
MedDRA 14.1
10033649
ICD-10-CM Version 2010
K86.1
ICD-9-CM Version 2011
577.1
Code-2
Or
UMLS CUI 2011AB
C1706533
SNOMEDCT_2012_01_31
420561004
Code-3
Acute Pancreatitis
UMLS CUI 2011AB
C0001339
SNOMEDCT_2012_01_31
197456007
MedDRA 14.1
10033647
ICD-10-CM Version 2010
K85.9
ICD-9-CM Version 2011
577
Code-4
During
UMLS CUI 2011AB
C0347984
SNOMEDCT_2012_01_31
371881003
Code-5
year
UMLS CUI 2011AB
C0439234
SNOMEDCT_2012_01_31
258707000
HL7 V3 2006_05
Y
Code-6
Last
UMLS CUI 2011AB
C1517741
Acute or chronic viurs hepatitis with moderate or severe liver dysfunction (Child-Pugh Score greater than 6), even if under control
Descrição

Akute oder chronische Virus-Hepatitis mit moderater oder schwerwiegender Leberfunktionsstörung (Child-Pugh Score größer als 6), auch falls unter Kontrolle

Tipo de dados

boolean

Alias
Code-1
acute
UMLS CUI 2011AB
C0205178
SNOMEDCT_2012_01_31
272118002
Code-2
Or
UMLS CUI 2011AB
C1706533
SNOMEDCT_2012_01_31
420561004
Code-3
chronic
UMLS CUI 2011AB
C0205191
SNOMEDCT_2012_01_31
90734009
Code-4
Viral hepatitis
UMLS CUI 2011AB
C0042721
SNOMEDCT_2012_01_31
3738000
MedDRA 14.1
10019799
LOINC Version 232
MTHU020837
ICD-10-CM Version 2010
B19.9
ICD-9-CM Version 2011
70
Code-5
Child-Pugh Classification
UMLS CUI 2011AB
C4050412
Code-6
Greater Than
UMLS CUI 2011AB
C0439093
SNOMEDCT_2012_01_31
276140008
Further exsiting uncontrolled Diseases (e.g. uncontrolled diabetes mellitus, presend or uncontrolled Infection, acute or chronic Liver or Kidney-Disease), with not acceptable security risk or that influence protocol compliance
Descrição

Weitere vorliegende unkontrollierte Erkrankung (z.Bsp. Unkontrollierter Diabetes mellitus, bestehende oder nicht kontrollierte Infektionen, akute oder chronische Leber- oder Nierenerkrankungen), die nicht akzeptable Sicherheitsrisiken darstellen oder die Protokoll-Compliance beeinträchtigen könnten

Tipo de dados

boolean

Alias
Code-1
Uncontrolled
UMLS CUI 2011AB
C0205318
SNOMEDCT_2012_01_31
19032002
Code-2
Disease
UMLS CUI 2011AB
C0012634
SNOMEDCT_2012_01_31
64572001
Code-3
Diabetes Mellitus
UMLS CUI 2011AB
C0011849
SNOMEDCT_2012_01_31
73211009
MedDRA 14.1
10012601
LOINC Version 232
MTHU020781
ICD-10-CM Version 2010
E08-E13
ICD-9-CM Version 2011
250
Code-4
Infection
UMLS CUI 2011AB
C0009450
SNOMEDCT_2012_01_31
40733004
MedDRA 14.1
10021789
LOINC Version 232
MTHU013250
Code-5
acute
UMLS CUI 2011AB
C0205178
SNOMEDCT_2012_01_31
272118002
Code-6
chronic
UMLS CUI 2011AB
C0205191
SNOMEDCT_2012_01_31
90734009
Affected gastrointestinal Function or Disease that can influence the absorption of trial medication (e.g. ulcera, uncontrolled nausea, vomitting or diarrhea, malabsorption-syndroms, small intestinal resection oder stomach bypass surgery)
Descrição

Beeinträchtigte gastrointestinale Funktionen oder Krankheiten, die die Absorption der Studienmedikamente beeinflussen könnten (z. Bsp. Ulcera, unkontrollierte Übelkeit, Erbrechen oder Diarrhoe, Malabsorptions-Syndrom, Dünndarmresektion oder Magen-Bypass Operation)

Tipo de dados

boolean

Alias
Code-1
Affected
UMLS CUI 2011AB
C0392760
SNOMEDCT_2012_01_31
247591002
Code-2
gastrointestinal function
UMLS CUI 2011AB
C0516983
Code-3
Or
UMLS CUI 2011AB
C1706533
SNOMEDCT_2012_01_31
420561004
Code-4
Gastrointestinal Diseases
UMLS CUI 2011AB
C0017178
SNOMEDCT_2012_01_31
119292006
MedDRA 14.1
10017944
Code-5
Disturbance
UMLS CUI 2011AB
C2699787
Code-6
drug absorption
UMLS CUI 2011AB
C0678745
Concomitting Medication with potentially QT Elongation
Descrição

Begleitmedikation mit potentieller QT – Verlängerung

Tipo de dados

boolean

Alias
Code-1
Concomitant Agent
UMLS CUI 2011AB
C2347852
Code-2
Potential
UMLS CUI 2011AB
C0237399
Code-3
Prolonged QT Interval
UMLS CUI 2011AB
C0151878
SNOMEDCT_2012_01_31
111975006
MedDRA 14.1
10037703
Concomitting Medication with proved induction- or inhibitationeffect on CYP450 Iso-Enzyme CYP3A4
Descrição

Begleitmedikation mit nachgewiesenem Induktions- oder Inhibitationseffekt auf das CYP450 iso-Enzym CYP3A4

Tipo de dados

boolean

Alias
Code-1
Concomitant Agent
UMLS CUI 2011AB
C2347852
Code-2
Cytochrome P450 3A4
UMLS CUI 2011AB
C1142644
SNOMEDCT_2012_01_31
422741004
Code-3
Enzyme Induction
UMLS CUI 2011AB
C0014431
Code-4
Or
UMLS CUI 2011AB
C1706533
SNOMEDCT_2012_01_31
420561004
Code-5
Enzyme Inhibition
UMLS CUI 2011AB
C1327624
Code-6
Proven
UMLS CUI 2011AB
C0456369
SNOMEDCT_2012_01_31
277025001
Severe surgery within the last two weeks before beginning of treatment, or in case of a surgery longer age, if the patient has not fully recovered
Descrição

Schwerwiegender chirurgischer Eingriff in den letzten beiden Wochen vor Therapiebeginn, oder bei länger zurückliegendem Eingriff, falls sich der Patient noch nicht vollständig von diesem erholt hat

Tipo de dados

boolean

Alias
Code-1
Severe
UMLS CUI 2011AB
C0205082
SNOMEDCT_2012_01_31
24484000
Code-2
Operative Surgical Procedure
UMLS CUI 2011AB
C0543467
SNOMEDCT_2012_01_31
387713003
MedDRA 14.1
10042609
LOINC Version 232
MTHU007597
Code-3
Last
UMLS CUI 2011AB
C1517741
Code-4
Two
UMLS CUI 2011AB
C0205448
SNOMEDCT_2012_01_31
420797005
Code-5
week
UMLS CUI 2011AB
C0439230
SNOMEDCT_2012_01_31
258705008
HL7 V3 2006_05
WK
Code-6
Prior
UMLS CUI 2011AB
C0332152
SNOMEDCT_2012_01_31
288556008
Gravidity, Lactation or women in childbearing years, without effective preventive measures. Postmenopausal is applied if last period is at least one year ago
Descrição

Schwangerschaft, Stillzeit oder Frauen im gebärfähigen Alter, die keine effektiven Verhütungsmaßnahmen vornehmen. Frauen im gebärfähigen Alter müssen innerhalb von zwei Wochen vor Therapiebeginn mit Nilotinib einen negativen Serum-Schwangerschaftstest vorliegen haben. Als post-menopausaler Lebensabschnitt gilt, wenn bei Frauen im fortgeschrittenen Lebensalter die letzte Regelblutung mindestens ein Jahr zurückliegt

Tipo de dados

boolean

Alias
Code-1
Pregnancy
UMLS CUI 2011AB
C0032961
SNOMEDCT_2012_01_31
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Code-2
Breast Feeding
UMLS CUI 2011AB
C0006147
SNOMEDCT_2012_01_31
169741004
MedDRA 14.1
10006247
Code-3
Or
UMLS CUI 2011AB
C1706533
SNOMEDCT_2012_01_31
420561004
Code-4
Childbearing Potential
UMLS CUI 2011AB
CL447832
Code-5
Woman
UMLS CUI 2011AB
C0043210
SNOMEDCT_2012_01_31
224526002
Code-6
None
UMLS CUI 2011AB
C0549184
SNOMEDCT_2012_01_31
260413007
HIV positive
Descrição

HIV-Positivität, Test hierauf jedoch nicht obligatorisch

Tipo de dados

boolean

Alias
Code-1
HIV Seropositivity
UMLS CUI 2011AB
C0019699
SNOMEDCT_2012_01_31
165816005
MedDRA 14.1
10020180
Current autoimmune dieseases, including autoimmune hepatits
Descrição

Bestehende Autoimmunerkrankungen, inklusive Autoimmunhepatitis

Tipo de dados

boolean

Alias
Code-1
Current
UMLS CUI 2011AB
C0521116
SNOMEDCT_2012_01_31
15240007
Code-2
Autoimmune Disease
UMLS CUI 2011AB
C0004364
SNOMEDCT_2012_01_31
85828009
MedDRA 14.1
10061664
ICD-10-CM Version 2010
M30-M36
Code-3
Include
UMLS CUI 2011AB
C0332257
SNOMEDCT_2012_01_31
55919000
Code-4
Autoimmune Hepatitis
UMLS CUI 2011AB
C0241910
SNOMEDCT_2012_01_31
408335007
MedDRA 14.1
10003827
ICD-10-CM Version 2010
K75.4
ICD-9-CM Version 2011
571.42
Known severe hypersensitivity-reaction for PEG-Inferone alfa-2b or Interferone alfa-2b or their Excipients
Descrição

Bekannte schwerwiegende Hypersensitivität-Reaktionen auf Peginterferon alfa-2b oder Interferon alfa-2b oder dessen Arzneistoffträger

Tipo de dados

boolean

Alias
Code-1
Known
UMLS CUI 2011AB
C0205309
SNOMEDCT_2012_01_31
36692007
Code-2
Severe
UMLS CUI 2011AB
C0205082
SNOMEDCT_2012_01_31
24484000
Code-3
Allergic Reaction
UMLS CUI 2011AB
C1527304
SNOMEDCT_2012_01_31
421961002
MedDRA 14.1
10020756
ICD-10-CM Version 2010
T78.40
HL7 V3 2006_05
ALG
Code-4
peginterferon alfa-2a
UMLS CUI 2011AB
C0391001
SNOMEDCT_2012_01_31
421559001
Code-5
Interferon Alfa-2a
UMLS CUI 2011AB
C0021734
SNOMEDCT_2012_01_31
386914007
Code-6
Pharmaceutical Excipient
UMLS CUI 2011AB
C0015237
SNOMEDCT_2012_01_31
43747001
Known severe hypersensitivity-reaction for Nilotinib
Descrição

Bekannte schwerwiegende Hypersensitivität-Reaktionen auf Nilotinib

Tipo de dados

boolean

Alias
Code-1
Known
UMLS CUI 2011AB
C0205309
SNOMEDCT_2012_01_31
36692007
Code-2
Severe
UMLS CUI 2011AB
C0205082
SNOMEDCT_2012_01_31
24484000
Code-3
Allergic Reaction
UMLS CUI 2011AB
C1527304
SNOMEDCT_2012_01_31
421961002
MedDRA 14.1
10020756
ICD-10-CM Version 2010
T78.40
HL7 V3 2006_05
ALG
Code-4
Nilotinib
UMLS CUI 2011AB
C1721377
SNOMEDCT_2012_01_31
427941004
Patients with other primary malignant diesease, if they are current clinically relevant or require clinical intervention
Descrição

Patienten mit anderen primären malignen Erkrankungen, falls diese aktuell klinisch relevant sind oder klinischer Interventionen bedürfen

Tipo de dados

boolean

Alias
Code-1
Other
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Code-2
Primary Malignant Neoplasm
UMLS CUI 2011AB
C1306459
SNOMEDCT_2012_01_31
372087000
Code-3
If
UMLS CUI 2011AB
C0750557
Code-4
Current
UMLS CUI 2011AB
C0521116
SNOMEDCT_2012_01_31
15240007
Code-5
Clinical
UMLS CUI 2011AB
C0205210
SNOMEDCT_2012_01_31
58147004
Code-6
Relevance
UMLS CUI 2011AB
C2347946
Patient with missing willingness or without aibilty for protocol-compliance
Descrição

Patienten mit fehlender Bereitschaft oder fehlendem Vermögen zur Protokoll-Compliance

Tipo de dados

boolean

Alias
Code-1
Missing
UMLS CUI 2011AB
C1705492
Code-2
Attendance
UMLS CUI 2011AB
C2827364
Code-3
Or
UMLS CUI 2011AB
C1706533
SNOMEDCT_2012_01_31
420561004
Code-4
Ability
UMLS CUI 2011AB
C0085732
SNOMEDCT_2012_01_31
371150009
Code-5
For
UMLS CUI 2011AB
C0521125
SNOMEDCT_2012_01_31
86495002
Code-6
Compliance, Protocol
UMLS CUI 2011AB
C0525058
Signature
Descrição

Signature

Alias
Code-1
Signature
UMLS CUI 2011AB
C1519316
Hospital
Descrição

Klinik

Tipo de dados

string

Alias
Code-1
Hospitals
UMLS CUI 2011AB
C0019994
LOINC Version 232
MTHU002722
Date
Descrição

Datum

Tipo de dados

date

Alias
Code-1
Signature date
UMLS CUI 2011AB
C0807937
LOINC Version 232
MTHU008294
Signature
Descrição

Unterschrift

Tipo de dados

string

Alias
Code-1
Investigator Signature
UMLS CUI 2011AB
C2346576
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Ausschlusskriterien

1 Formulários
  1. StudyEvent: Chronic Myeloid Leukemia
    1. Ausschlusskriterien
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Items
Administrative Items (Code-1)
C2598108 (UMLS CUI 2011AB)
MTHU029788 (LOINC Version 232)
Klinik-Nr.
Item
Hospital Identifier
integer
Identifier (Code-1)
C0600091 (UMLS CUI 2011AB)
118522005 (SNOMEDCT_2012_01_31)
Hospitals (Code-2)
C0019994 (UMLS CUI 2011AB)
MTHU002722 (LOINC Version 232)
Patienten-Nr.
Item
Patient identifier
integer
Identifier (Code-1)
C0600091 (UMLS CUI 2011AB)
118522005 (SNOMEDCT_2012_01_31)
Patients (Code-2)
C0030705 (UMLS CUI 2011AB)
116154003 (SNOMEDCT_2012_01_31)
Item Group
Date of birth
Patient date of birth (Code-1)
C0421451 (UMLS CUI 2011AB)
184099003 (SNOMEDCT_2012_01_31)
MTHU009540 (LOINC Version 232)
Geburtsmonat
Item
Month of birth
integer
month (Code-1)
C0439231 (UMLS CUI 2011AB)
258706009 (SNOMEDCT_2012_01_31)
MO (HL7 V3 2006_05)
Geburtstag
Item
Day of birth
integer
day (Code-1)
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
MTHU039849 (LOINC Version 232)
D (HL7 V3 2006_05)
Item Group
Administrative Items
Administrative Items (Code-1)
C2598108 (UMLS CUI 2011AB)
MTHU029788 (LOINC Version 232)
Beurteilungsdatum
Item
Date of Evaluation
date
Evaluation (Code-1)
C0220825 (UMLS CUI 2011AB)
Date in time (Code-2)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Diagnosedatum
Item
Date of diagnosis
date
Date of diagnosis (Code-1)
C2316983 (UMLS CUI 2011AB)
432213005 (SNOMEDCT_2012_01_31)
MTHU038128 (LOINC Version 232)
Item
Sex
integer
Patient sex (Code-1)
C0150831 (UMLS CUI 2011AB)
184100006 (SNOMEDCT_2012_01_31)
Geschlecht
Code List
Sex
CL Item
Male (männlich)
Male gender (Code-1)
C0086582 (UMLS CUI 2011AB)
10052007 (SNOMEDCT_2012_01_31)
CL Item
Female (weiblich)
C0086287 (UMLS CUI 2011AB)
1086007 (SNOMEDCT_2012_01_31)
Item Group
Exclusion Criterion
Vorbestehende beeinträchtige kardiale Funktion: LVEF kleiner als 45%, kongenitales Long-QT-Syndrom, vormals oder aktuell bestehende klinische relevante ventrikuläre oder atriale Tachyarrhythmien
Item
Pre-existing impaired cardiac funktion: LVEF less than 45%, congenital Long-QT-Syndrome, anciently oder curreent existing clinically relevant ventricular or atrial tachyarrhythmia
boolean
Left Ventricular Ejection Fraction (Code-1)
CL433348 (UMLS CUI 2011AB)
Less Than (Code-2)
C0439092 (UMLS CUI 2011AB)
276139006 (SNOMEDCT_2012_01_31)
LT (HL7 V3 2006_05)
Forty (Code-3)
CL447290 (UMLS CUI 2011AB)
Five (Code-4)
C0205451 (UMLS CUI 2011AB)
421820001 (SNOMEDCT_2012_01_31)
Congenital long QT syndrome (Code-5)
C1141890 (UMLS CUI 2011AB)
442917000 (SNOMEDCT_2012_01_31)
10057926 (MedDRA 14.1)
Previous (Code-6)
C0205156 (UMLS CUI 2011AB)
9130008 (SNOMEDCT_2012_01_31)
Klinisch relevatne Ruhe-Bradykardie (weniger als 50 bpm)
Item
Clinically relevant Rest-Bradycardia (less than 50 bpm)
boolean
Clinical (Code-1)
C0205210 (UMLS CUI 2011AB)
58147004 (SNOMEDCT_2012_01_31)
Relevance (Code-2)
C2347946 (UMLS CUI 2011AB)
Bradycardia (Code-3)
C0428977 (UMLS CUI 2011AB)
48867003 (SNOMEDCT_2012_01_31)
10006093 (MedDRA 14.1)
R00.1 (ICD-10-CM Version 2010)
Less Than (Code-4)
C0439092 (UMLS CUI 2011AB)
276139006 (SNOMEDCT_2012_01_31)
LT (HL7 V3 2006_05)
Fifty (Code-5)
CL447144 (UMLS CUI 2011AB)
Beats per Minute (Code-6)
C0439385 (UMLS CUI 2011AB)
258983007 (SNOMEDCT_2012_01_31)
QTc größer als 450ms auf Screening-EKG (Falss QTc größer als 450ms und Elektrolyte nicht im Normbereich vor Nilotinibgabe, so sollten Elektrolyte eingestellt werden und danach erneut das QTc-Kriterium getestet werden)
Item
QTc greater than 450ms within screening-ecg
boolean
Corrected Prolonged QT Interval (Code-1)
C0855333 (UMLS CUI 2011AB)
10014383 (SNOMEDCT_2012_01_31)
Greater Than (Code-2)
C0439093 (UMLS CUI 2011AB)
276140008 (SNOMEDCT_2012_01_31)
GT (HL7 V3 2006_05)
One Hundred (Code-3)
CL447292 (UMLS CUI 2011AB)
Fifty (Code-4)
CL447144 (UMLS CUI 2011AB)
Millisecond (Code-5)
C0439223 (UMLS CUI 2011AB)
258697002 (SNOMEDCT_2012_01_31)
Electrocardiography (Code-6)
C1623258 (UMLS CUI 2011AB)
29303009 (SNOMEDCT_2012_01_31)
10014362 (MedDRA 14.1)
Myokardinfarkt innerhalb der letzten 12 Monate vor Therapiebeginn
Item
Myocardial infarct within the last 12 Month before the beginning of treatment
boolean
H/O: Myocardial infarction in last year (Code-1)
C0585891 (UMLS CUI 2011AB)
308065005 (SNOMEDCT_2012_01_31)
Prior (Code-2)
C0332152 (UMLS CUI 2011AB)
288556008 (SNOMEDCT_2012_01_31)
Beginning (Code-3)
C0439659 (UMLS CUI 2011AB)
255395001 (SNOMEDCT_2012_01_31)
MTHU026300 (LOINC Version 232)
Therapeutic procedure (Code-4)
C0087111 (UMLS CUI 2011AB)
277132007 (SNOMEDCT_2012_01_31)
10053757 (MedDRA 14.1)
MTHU021209 (LOINC Version 232)
Andere klinisch relevante Herzerkrankungen (z.Bsp. Instabile Angina pectoris, schwere Herinsuffzienz, nicht kontrollierter Bluthochdruck)
Item
Other clinically relevant heart diseases (e.g. unstable angina pectoris, severe cardiac insufficiency, uncontrolled hypertension)
boolean
Heart Diseases (Code-1)
C0018799 (UMLS CUI 2011AB)
56265001 (SNOMEDCT_2012_01_31)
10061024 (MedDRA 14.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
Clinical (Code-2)
C0205210 (UMLS CUI 2011AB)
58147004 (SNOMEDCT_2012_01_31)
Relevance (Code-3)
C2347946 (UMLS CUI 2011AB)
Angina, Unstable (Code-4)
C0002965 (UMLS CUI 2011AB)
4557003 (SNOMEDCT_2012_01_31)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
Congestive heart failure (Code-5)
C0018802 (UMLS CUI 2011AB)
42343007 (SNOMEDCT_2012_01_31)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428 (ICD-9-CM Version 2011)
Severe (Code-6)
C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)
Innerhalb des letzten Jahres vor Therapiebeginn bestehende akute oder chronische Pankreatitis
Item
Within the last year before beginning of treatment existing acute or chronic pancreatits
boolean
Pancreatitis, Chronic (Code-1)
C0149521 (UMLS CUI 2011AB)
235494005 (SNOMEDCT_2012_01_31)
10033649 (MedDRA 14.1)
K86.1 (ICD-10-CM Version 2010)
577.1 (ICD-9-CM Version 2011)
Or (Code-2)
C1706533 (UMLS CUI 2011AB)
420561004 (SNOMEDCT_2012_01_31)
Acute Pancreatitis (Code-3)
C0001339 (UMLS CUI 2011AB)
197456007 (SNOMEDCT_2012_01_31)
10033647 (MedDRA 14.1)
K85.9 (ICD-10-CM Version 2010)
577 (ICD-9-CM Version 2011)
During (Code-4)
C0347984 (UMLS CUI 2011AB)
371881003 (SNOMEDCT_2012_01_31)
year (Code-5)
C0439234 (UMLS CUI 2011AB)
258707000 (SNOMEDCT_2012_01_31)
Y (HL7 V3 2006_05)
Last (Code-6)
C1517741 (UMLS CUI 2011AB)
Akute oder chronische Virus-Hepatitis mit moderater oder schwerwiegender Leberfunktionsstörung (Child-Pugh Score größer als 6), auch falls unter Kontrolle
Item
Acute or chronic viurs hepatitis with moderate or severe liver dysfunction (Child-Pugh Score greater than 6), even if under control
boolean
acute (Code-1)
C0205178 (UMLS CUI 2011AB)
272118002 (SNOMEDCT_2012_01_31)
Or (Code-2)
C1706533 (UMLS CUI 2011AB)
420561004 (SNOMEDCT_2012_01_31)
chronic (Code-3)
C0205191 (UMLS CUI 2011AB)
90734009 (SNOMEDCT_2012_01_31)
Viral hepatitis (Code-4)
C0042721 (UMLS CUI 2011AB)
3738000 (SNOMEDCT_2012_01_31)
10019799 (MedDRA 14.1)
MTHU020837 (LOINC Version 232)
B19.9 (ICD-10-CM Version 2010)
70 (ICD-9-CM Version 2011)
Child-Pugh Classification (Code-5)
C4050412 (UMLS CUI 2011AB)
Greater Than (Code-6)
C0439093 (UMLS CUI 2011AB)
276140008 (SNOMEDCT_2012_01_31)
Weitere vorliegende unkontrollierte Erkrankung (z.Bsp. Unkontrollierter Diabetes mellitus, bestehende oder nicht kontrollierte Infektionen, akute oder chronische Leber- oder Nierenerkrankungen), die nicht akzeptable Sicherheitsrisiken darstellen oder die Protokoll-Compliance beeinträchtigen könnten
Item
Further exsiting uncontrolled Diseases (e.g. uncontrolled diabetes mellitus, presend or uncontrolled Infection, acute or chronic Liver or Kidney-Disease), with not acceptable security risk or that influence protocol compliance
boolean
Uncontrolled (Code-1)
C0205318 (UMLS CUI 2011AB)
19032002 (SNOMEDCT_2012_01_31)
Disease (Code-2)
C0012634 (UMLS CUI 2011AB)
64572001 (SNOMEDCT_2012_01_31)
Diabetes Mellitus (Code-3)
C0011849 (UMLS CUI 2011AB)
73211009 (SNOMEDCT_2012_01_31)
10012601 (MedDRA 14.1)
MTHU020781 (LOINC Version 232)
E08-E13 (ICD-10-CM Version 2010)
250 (ICD-9-CM Version 2011)
Infection (Code-4)
C0009450 (UMLS CUI 2011AB)
40733004 (SNOMEDCT_2012_01_31)
10021789 (MedDRA 14.1)
MTHU013250 (LOINC Version 232)
acute (Code-5)
C0205178 (UMLS CUI 2011AB)
272118002 (SNOMEDCT_2012_01_31)
chronic (Code-6)
C0205191 (UMLS CUI 2011AB)
90734009 (SNOMEDCT_2012_01_31)
Beeinträchtigte gastrointestinale Funktionen oder Krankheiten, die die Absorption der Studienmedikamente beeinflussen könnten (z. Bsp. Ulcera, unkontrollierte Übelkeit, Erbrechen oder Diarrhoe, Malabsorptions-Syndrom, Dünndarmresektion oder Magen-Bypass Operation)
Item
Affected gastrointestinal Function or Disease that can influence the absorption of trial medication (e.g. ulcera, uncontrolled nausea, vomitting or diarrhea, malabsorption-syndroms, small intestinal resection oder stomach bypass surgery)
boolean
Affected (Code-1)
C0392760 (UMLS CUI 2011AB)
247591002 (SNOMEDCT_2012_01_31)
gastrointestinal function (Code-2)
C0516983 (UMLS CUI 2011AB)
Or (Code-3)
C1706533 (UMLS CUI 2011AB)
420561004 (SNOMEDCT_2012_01_31)
Gastrointestinal Diseases (Code-4)
C0017178 (UMLS CUI 2011AB)
119292006 (SNOMEDCT_2012_01_31)
10017944 (MedDRA 14.1)
Disturbance (Code-5)
C2699787 (UMLS CUI 2011AB)
drug absorption (Code-6)
C0678745 (UMLS CUI 2011AB)
Begleitmedikation mit potentieller QT – Verlängerung
Item
Concomitting Medication with potentially QT Elongation
boolean
Concomitant Agent (Code-1)
C2347852 (UMLS CUI 2011AB)
Potential (Code-2)
C0237399 (UMLS CUI 2011AB)
Prolonged QT Interval (Code-3)
C0151878 (UMLS CUI 2011AB)
111975006 (SNOMEDCT_2012_01_31)
10037703 (MedDRA 14.1)
Begleitmedikation mit nachgewiesenem Induktions- oder Inhibitationseffekt auf das CYP450 iso-Enzym CYP3A4
Item
Concomitting Medication with proved induction- or inhibitationeffect on CYP450 Iso-Enzyme CYP3A4
boolean
Concomitant Agent (Code-1)
C2347852 (UMLS CUI 2011AB)
Cytochrome P450 3A4 (Code-2)
C1142644 (UMLS CUI 2011AB)
422741004 (SNOMEDCT_2012_01_31)
Enzyme Induction (Code-3)
C0014431 (UMLS CUI 2011AB)
Or (Code-4)
C1706533 (UMLS CUI 2011AB)
420561004 (SNOMEDCT_2012_01_31)
Enzyme Inhibition (Code-5)
C1327624 (UMLS CUI 2011AB)
Proven (Code-6)
C0456369 (UMLS CUI 2011AB)
277025001 (SNOMEDCT_2012_01_31)
Schwerwiegender chirurgischer Eingriff in den letzten beiden Wochen vor Therapiebeginn, oder bei länger zurückliegendem Eingriff, falls sich der Patient noch nicht vollständig von diesem erholt hat
Item
Severe surgery within the last two weeks before beginning of treatment, or in case of a surgery longer age, if the patient has not fully recovered
boolean
Severe (Code-1)
C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)
Operative Surgical Procedure (Code-2)
C0543467 (UMLS CUI 2011AB)
387713003 (SNOMEDCT_2012_01_31)
10042609 (MedDRA 14.1)
MTHU007597 (LOINC Version 232)
Last (Code-3)
C1517741 (UMLS CUI 2011AB)
Two (Code-4)
C0205448 (UMLS CUI 2011AB)
420797005 (SNOMEDCT_2012_01_31)
week (Code-5)
C0439230 (UMLS CUI 2011AB)
258705008 (SNOMEDCT_2012_01_31)
WK (HL7 V3 2006_05)
Prior (Code-6)
C0332152 (UMLS CUI 2011AB)
288556008 (SNOMEDCT_2012_01_31)
Schwangerschaft, Stillzeit oder Frauen im gebärfähigen Alter, die keine effektiven Verhütungsmaßnahmen vornehmen. Frauen im gebärfähigen Alter müssen innerhalb von zwei Wochen vor Therapiebeginn mit Nilotinib einen negativen Serum-Schwangerschaftstest vorliegen haben. Als post-menopausaler Lebensabschnitt gilt, wenn bei Frauen im fortgeschrittenen Lebensalter die letzte Regelblutung mindestens ein Jahr zurückliegt
Item
Gravidity, Lactation or women in childbearing years, without effective preventive measures. Postmenopausal is applied if last period is at least one year ago
boolean
Pregnancy (Code-1)
C0032961 (UMLS CUI 2011AB)
289908002 (SNOMEDCT_2012_01_31)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Breast Feeding (Code-2)
C0006147 (UMLS CUI 2011AB)
169741004 (SNOMEDCT_2012_01_31)
10006247 (MedDRA 14.1)
Or (Code-3)
C1706533 (UMLS CUI 2011AB)
420561004 (SNOMEDCT_2012_01_31)
Childbearing Potential (Code-4)
CL447832 (UMLS CUI 2011AB)
Woman (Code-5)
C0043210 (UMLS CUI 2011AB)
224526002 (SNOMEDCT_2012_01_31)
None (Code-6)
C0549184 (UMLS CUI 2011AB)
260413007 (SNOMEDCT_2012_01_31)
HIV-Positivität, Test hierauf jedoch nicht obligatorisch
Item
HIV positive
boolean
HIV Seropositivity (Code-1)
C0019699 (UMLS CUI 2011AB)
165816005 (SNOMEDCT_2012_01_31)
10020180 (MedDRA 14.1)
Bestehende Autoimmunerkrankungen, inklusive Autoimmunhepatitis
Item
Current autoimmune dieseases, including autoimmune hepatits
boolean
Current (Code-1)
C0521116 (UMLS CUI 2011AB)
15240007 (SNOMEDCT_2012_01_31)
Autoimmune Disease (Code-2)
C0004364 (UMLS CUI 2011AB)
85828009 (SNOMEDCT_2012_01_31)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
Include (Code-3)
C0332257 (UMLS CUI 2011AB)
55919000 (SNOMEDCT_2012_01_31)
Autoimmune Hepatitis (Code-4)
C0241910 (UMLS CUI 2011AB)
408335007 (SNOMEDCT_2012_01_31)
10003827 (MedDRA 14.1)
K75.4 (ICD-10-CM Version 2010)
571.42 (ICD-9-CM Version 2011)
Bekannte schwerwiegende Hypersensitivität-Reaktionen auf Peginterferon alfa-2b oder Interferon alfa-2b oder dessen Arzneistoffträger
Item
Known severe hypersensitivity-reaction for PEG-Inferone alfa-2b or Interferone alfa-2b or their Excipients
boolean
Known (Code-1)
C0205309 (UMLS CUI 2011AB)
36692007 (SNOMEDCT_2012_01_31)
Severe (Code-2)
C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)
Allergic Reaction (Code-3)
C1527304 (UMLS CUI 2011AB)
421961002 (SNOMEDCT_2012_01_31)
10020756 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)
ALG (HL7 V3 2006_05)
peginterferon alfa-2a (Code-4)
C0391001 (UMLS CUI 2011AB)
421559001 (SNOMEDCT_2012_01_31)
Interferon Alfa-2a (Code-5)
C0021734 (UMLS CUI 2011AB)
386914007 (SNOMEDCT_2012_01_31)
Pharmaceutical Excipient (Code-6)
C0015237 (UMLS CUI 2011AB)
43747001 (SNOMEDCT_2012_01_31)
Bekannte schwerwiegende Hypersensitivität-Reaktionen auf Nilotinib
Item
Known severe hypersensitivity-reaction for Nilotinib
boolean
Known (Code-1)
C0205309 (UMLS CUI 2011AB)
36692007 (SNOMEDCT_2012_01_31)
Severe (Code-2)
C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)
Allergic Reaction (Code-3)
C1527304 (UMLS CUI 2011AB)
421961002 (SNOMEDCT_2012_01_31)
10020756 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)
ALG (HL7 V3 2006_05)
Nilotinib (Code-4)
C1721377 (UMLS CUI 2011AB)
427941004 (SNOMEDCT_2012_01_31)
Patienten mit anderen primären malignen Erkrankungen, falls diese aktuell klinisch relevant sind oder klinischer Interventionen bedürfen
Item
Patients with other primary malignant diesease, if they are current clinically relevant or require clinical intervention
boolean
Other (Code-1)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Primary Malignant Neoplasm (Code-2)
C1306459 (UMLS CUI 2011AB)
372087000 (SNOMEDCT_2012_01_31)
If (Code-3)
C0750557 (UMLS CUI 2011AB)
Current (Code-4)
C0521116 (UMLS CUI 2011AB)
15240007 (SNOMEDCT_2012_01_31)
Clinical (Code-5)
C0205210 (UMLS CUI 2011AB)
58147004 (SNOMEDCT_2012_01_31)
Relevance (Code-6)
C2347946 (UMLS CUI 2011AB)
Patienten mit fehlender Bereitschaft oder fehlendem Vermögen zur Protokoll-Compliance
Item
Patient with missing willingness or without aibilty for protocol-compliance
boolean
Missing (Code-1)
C1705492 (UMLS CUI 2011AB)
Attendance (Code-2)
C2827364 (UMLS CUI 2011AB)
Or (Code-3)
C1706533 (UMLS CUI 2011AB)
420561004 (SNOMEDCT_2012_01_31)
Ability (Code-4)
C0085732 (UMLS CUI 2011AB)
371150009 (SNOMEDCT_2012_01_31)
For (Code-5)
C0521125 (UMLS CUI 2011AB)
86495002 (SNOMEDCT_2012_01_31)
Compliance, Protocol (Code-6)
C0525058 (UMLS CUI 2011AB)
Item Group
Signature
Signature (Code-1)
C1519316 (UMLS CUI 2011AB)
Klinik
Item
Hospital
string
Hospitals (Code-1)
C0019994 (UMLS CUI 2011AB)
MTHU002722 (LOINC Version 232)
Datum
Item
Date
date
Signature date (Code-1)
C0807937 (UMLS CUI 2011AB)
MTHU008294 (LOINC Version 232)
Unterschrift
Item
Signature
string
Investigator Signature (Code-1)
C2346576 (UMLS CUI 2011AB)
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