ID

4604

Beschreibung

NCT01657604

Stichworte

Versionen (3)
  1. 07.01.14 07.01.14 -
  2. 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
  3. 20.09.21 20.09.21 -
Hochgeladen am

7. Januar 2014

DOI

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Bogen 2 Verlaufsbogen Seite 1 von 2 TIGER Studie Version 23052012 Condition DRKS00005243

Deutsch Englisch

Bogen 2 Verlaufsbogen Seite 1 von 2

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Administrative Items
Beschreibung

Administrative Items

Hospital Identifier
Beschreibung

Klinik-Nr.

Datentyp

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
Beschreibung

Patienten-Nr.

Datentyp

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
Beschreibung

Date of birth

Month of birth
Beschreibung

Geburtsmonat

Datentyp

integer

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

Geburtstag

Datentyp

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
Beschreibung

Administrative Items

Date of Evaluation
Beschreibung

Beurteilungsdatum

Datentyp

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
Number Follow-Up Report
Beschreibung

Nummer des Verlaufsbogen

Datentyp

integer

Alias
Code-1
Follow-Up Report
UMLS CUI 2011AB
C1704685
Code-2
Numbers
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
410680006
LOINC Version 232
MTHU024869
Sex
Beschreibung

Geschlecht

Datentyp

integer

Alias
Code-1
Patient sex
UMLS CUI 2011AB
C0150831
SNOMEDCT_2012_01_31
184100006
Therapy Phase
Beschreibung

Therapy Phase

Achievement goal of therapy of induction phase (after min. 2 years treatment) - date
Beschreibung

Erreichen des Therapiezieles der Induktionsphase (nach mindestens 24 Monaten Behandlung und 2-facher MMR) am:

Datentyp

date

Alias
Code-1
Achievement
UMLS CUI 2011AB
C0001072
Code-2
treatment goals
UMLS CUI 2011AB
C0679840
Code-3
Induction
UMLS CUI 2011AB
C0857127
MedDRA 14.1
10021721
Code-4
Phase
UMLS CUI 2011AB
C0205390
SNOMEDCT_2012_01_31
21191007
Code-5
Post
UMLS CUI 2011AB
C0231290
SNOMEDCT_2012_01_31
255234002
Code-6
Minimum
UMLS CUI 2011AB
C1524031
Date Nilotinib treatment stopped in combination treatment arm
Beschreibung

Absetzdatum von Nilotinib im Kombinationsarm am:

Datentyp

date

Alias
Code-1
Date treatment stopped (observable entity)
UMLS CUI 2011AB
C1531784
SNOMEDCT_2012_01_31
413947000
Code-2
Nilotinib
UMLS CUI 2011AB
C1721377
SNOMEDCT_2012_01_31
428468009
Code-3
Combination
UMLS CUI 2011AB
C1947911
Code-4
Protocol Treatment Arm
UMLS CUI 2011AB
C1522541
Achievement main phase (after min. 1 year treatment) - date
Beschreibung

Erreichen der Hauptphase (nach mindestens 12 Monaten Behandlung und mindestens 12 Monaten kontinuierlicher MR4) am:

Datentyp

date

Alias
Code-1
Achievement
UMLS CUI 2011AB
C0001072
Code-2
Main
UMLS CUI 2011AB
C1542147
Code-3
Phase
UMLS CUI 2011AB
C0205390
SNOMEDCT_2012_01_31
21191007
Code-4
Post
UMLS CUI 2011AB
C0231290
SNOMEDCT_2012_01_31
255234002
Code-5
Minimum
UMLS CUI 2011AB
C1524031
Code-6
One
UMLS CUI 2011AB
C0205447
SNOMEDCT_2012_01_31
421379005
Date main phase treatment stopped
Beschreibung

Absetzdatum der Hauptphasentherapie am:

Datentyp

date

Alias
Code-1
Date treatment stopped (observable entity)
UMLS CUI 2011AB
C1531784
SNOMEDCT_2012_01_31
413947000
Code-2
Main
UMLS CUI 2011AB
C1542147
Code-3
Phase
UMLS CUI 2011AB
C0205390
SNOMEDCT_2012_01_31
21191007
Code-4
Therapeutic procedure
UMLS CUI 2011AB
C0087111
SNOMEDCT_2012_01_31
277132007
MedDRA 14.1
10053757
LOINC Version 232
MTHU021209
Previous therapy within the interval
Beschreibung

Previous therapy within the interval

Nilotinib 2*300mg
Beschreibung

Nilotinib 2*300mg

other dosage (mg)
Beschreibung

andere Dosis (mg)

Datentyp

integer

Alias
Code-1
Other
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Code-2
Dosage
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Code-3
Milligram
UMLS CUI 2011AB
C0439210
SNOMEDCT_2012_01_31
258684004
Start
Beschreibung

Beginn

Datentyp

date

Alias
Code-1
Date treatment started (observable entity)
UMLS CUI 2011AB
C1531783
SNOMEDCT_2012_01_31
413946009
Code-2
Nilotinib
UMLS CUI 2011AB
C1721377
SNOMEDCT_2012_01_31
427941004
Code-3
Twice
UMLS CUI 2011AB
C1948050
Code-4
Three
UMLS CUI 2011AB
C0205449
SNOMEDCT_2012_01_31
421291004
Code-5
One Hundred
UMLS CUI 2011AB
CL447292
Code-6
Milligram
UMLS CUI 2011AB
C0439210
SNOMEDCT_2012_01_31
258684004
End
Beschreibung

Ende

Datentyp

date

Alias
Code-1
Date treatment stopped (observable entity)
UMLS CUI 2011AB
C1531784
SNOMEDCT_2012_01_31
413947000
Code-2
Nilotinib
UMLS CUI 2011AB
C1721377
SNOMEDCT_2012_01_31
427941004
Code-3
Twice
UMLS CUI 2011AB
C1948050
Code-4
Three
UMLS CUI 2011AB
C0205449
SNOMEDCT_2012_01_31
421291004
Code-5
One Hundred
UMLS CUI 2011AB
CL447292
Code-6
Milligram
UMLS CUI 2011AB
C0439210
SNOMEDCT_2012_01_31
258684004
Days of treatment
Beschreibung

Therapietage

Datentyp

integer

Alias
Code-1
Number
UMLS CUI 2011AB
C0449788
SNOMEDCT_2012_01_31
410681005
Code-2
Therapeutic procedure
UMLS CUI 2011AB
C0087111
SNOMEDCT_2012_01_31
277132007
MedDRA 14.1
10053757
LOINC Version 232
MTHU021209
Code-3
day
UMLS CUI 2011AB
C0439228
SNOMEDCT_2012_01_31
258703001
LOINC Version 232
MTHU039849
HL7 V3 2006_05
D
Code-4
Nilotinib
UMLS CUI 2011AB
C1721377
SNOMEDCT_2012_01_31
427941004
Code-5
Twice
UMLS CUI 2011AB
C1948050
Code-6
Three
UMLS CUI 2011AB
C0205449
SNOMEDCT_2012_01_31
421291004
Cumulative Dose (mg)
Beschreibung

Gesamtdosis (mg)

Datentyp

integer

Alias
Code-1
Cumulative Dose
UMLS CUI 2011AB
C2986497
Code-2
Milligram
UMLS CUI 2011AB
C0439210
SNOMEDCT_2012_01_31
258684004
Code-3
Nilotinib
UMLS CUI 2011AB
C1721377
SNOMEDCT_2012_01_31
427941004
Code-4
Twice
UMLS CUI 2011AB
C1948050
Code-5
Three
UMLS CUI 2011AB
C0205449
SNOMEDCT_2012_01_31
421291004
Code-6
One Hundred
UMLS CUI 2011AB
CL447292
Treatment stop
Beschreibung

Absetzen

Datentyp

integer

Alias
Code-1
Stop
UMLS CUI 2011AB
C1947925
Code-2
Nilotinib
UMLS CUI 2011AB
C1721377
SNOMEDCT_2012_01_31
427941004
Code-3
Twice
UMLS CUI 2011AB
C1948050
Code-4
Three
UMLS CUI 2011AB
C0205449
SNOMEDCT_2012_01_31
421291004
Code-5
One Hundred
UMLS CUI 2011AB
CL447292
Code-6
Milligram
UMLS CUI 2011AB
C0439210
SNOMEDCT_2012_01_31
258684004
Reason for treatment stop
Beschreibung

Grund für Absetzen

Datentyp

string

Alias
Code-1
Indication of (contextual qualifier)
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008319
Code-2
Stop
UMLS CUI 2011AB
C1947925
Code-3
Nilotinib
UMLS CUI 2011AB
C1721377
SNOMEDCT_2012_01_31
427941004
Code-4
Twice
UMLS CUI 2011AB
C1948050
Code-5
Three
UMLS CUI 2011AB
C0205449
SNOMEDCT_2012_01_31
421291004
Code-6
One Hundred
UMLS CUI 2011AB
CL447292
Nilotinib - Rest
Beschreibung

Nilotinib - Rest

Start
Beschreibung

Beginn

Datentyp

date

Alias
Code-1
Start Date
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
End
Beschreibung

Ende

Datentyp

date

Alias
Code-1
End Date
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
PEG-IFN
Beschreibung

PEG-IFN

Start
Beschreibung

Beginn

Datentyp

date

Alias
Code-1
Date treatment started (observable entity)
UMLS CUI 2011AB
C1531783
SNOMEDCT_2012_01_31
413946009
Code-2
Pegylated Interferon Alfa
UMLS CUI 2011AB
C0907160
End
Beschreibung

Ende

Datentyp

date

Alias
Code-1
Date treatment stopped (observable entity)
UMLS CUI 2011AB
C1531784
SNOMEDCT_2012_01_31
413947000
Code-2
Pegylated Interferon Alfa
UMLS CUI 2011AB
C0907160
Single dose (μg)
Beschreibung

Einzeldosis (μg)

Datentyp

integer

Alias
Code-1
Single dose characteristic (observable entity)
UMLS CUI 2011AB
C1960417
SNOMEDCT_2012_01_31
426146003
Code-2
Microgram
UMLS CUI 2011AB
C0439211
SNOMEDCT_2012_01_31
258685003
Intervall (days)
Beschreibung

Intervall (Tage)

Datentyp

integer

Alias
Code-1
Interval
UMLS CUI 2011AB
C1272706
SNOMEDCT_2012_01_31
385673002
Number of Injections
Beschreibung

Anzahl Injektionen

Datentyp

integer

Alias
Code-1
Number
UMLS CUI 2011AB
C0449788
SNOMEDCT_2012_01_31
410681005
Code-2
Injection procedure
UMLS CUI 2011AB
C1533685
SNOMEDCT_2012_01_31
129326001
MedDRA 14.1
10052995
Treatment stop
Beschreibung

Absetzen

Datentyp

integer

Alias
Code-1
Stop
UMLS CUI 2011AB
C1947925
Code-2
Pegylated Interferon Alfa
UMLS CUI 2011AB
C0907160
Reason for treatment stop
Beschreibung

Grund für Absetzen

Datentyp

string

Alias
Code-1
Indication of (contextual qualifier)
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008319
Code-2
Stop
UMLS CUI 2011AB
C1947925
Code-3
Pegylated Interferon Alfa
UMLS CUI 2011AB
C0907160
PEG-IFN - Rest
Beschreibung

PEG-IFN - Rest

Start
Beschreibung

Beginn

Datentyp

date

Alias
Code-1
Start Date
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
Code-2
Pegylated Interferon Alfa
UMLS CUI 2011AB
C0907160
Code-3
Rest
UMLS CUI 2011AB
C0035253
SNOMEDCT_2012_01_31
258157001
End
Beschreibung

Ende

Datentyp

date

Alias
Code-1
End Date
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Code-2
Pegylated Interferon Alfa
UMLS CUI 2011AB
C0907160
Code-3
Rest
UMLS CUI 2011AB
C0035253
SNOMEDCT_2012_01_31
258157001
further drugs
Beschreibung

further drugs

Reason for further drug
Beschreibung

Grund

Datentyp

string

Alias
Code-1
Indication of (contextual qualifier)
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008319
Code-2
Further
UMLS CUI 2011AB
C1517331
Code-3
Pharmaceutical Preparations
UMLS CUI 2011AB
C0013227
SNOMEDCT_2012_01_31
410942007
Drug
Beschreibung

Medikament

Datentyp

string

Alias
Code-1
Pharmaceutical Preparations
UMLS CUI 2011AB
C0013227
SNOMEDCT_2012_01_31
410942007
Dosage
Beschreibung

Dosis

Datentyp

integer

Alias
Code-1
Dosage
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
277406006
Unit
Beschreibung

Einheit

Datentyp

string

Alias
Code-1
Dosage Form Unit
UMLS CUI 2011AB
C2348328
Start
Beschreibung

Beginn

Datentyp

date

Alias
Code-1
Date treatment started (observable entity)
UMLS CUI 2011AB
C1531783
SNOMEDCT_2012_01_31
413946009
Code-2
Further
UMLS CUI 2011AB
C1517331
Code-3
Pharmaceutical Preparations
UMLS CUI 2011AB
C0013227
SNOMEDCT_2012_01_31
410942007
End
Beschreibung

Ende

Datentyp

date

Alias
Code-1
Date treatment stopped (observable entity)
UMLS CUI 2011AB
C1531784
SNOMEDCT_2012_01_31
413947000
Code-2
Further
UMLS CUI 2011AB
C1517331
Code-3
Pharmaceutical Preparations
UMLS CUI 2011AB
C0013227
SNOMEDCT_2012_01_31
410942007
Signature
Beschreibung

Signature

Comment
Beschreibung

Kommentar

Datentyp

string

Alias
Code-1
Comment
UMLS CUI 2011AB
C0947611
LOINC Version 232
MTHU013736
Hospital
Beschreibung

Klinik

Datentyp

string

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

Datum

Datentyp

date

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

Unterschrift

Datentyp

string

Alias
Code-1
Investigator Signature
UMLS CUI 2011AB
C2346576
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Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Items
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
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
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)
Nummer des Verlaufsbogen
Item
Number Follow-Up Report
integer
Follow-Up Report (Code-1)
C1704685 (UMLS CUI 2011AB)
Numbers (Code-2)
C0237753 (UMLS CUI 2011AB)
410680006 (SNOMEDCT_2012_01_31)
MTHU024869 (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)
C0024554 (UMLS CUI 2011AB)
10052007 (SNOMEDCT_2012_01_31)
CL Item
Female (weiblich)
C0015780 (UMLS CUI 2011AB)
1086007 (SNOMEDCT_2012_01_31)
Item Group
Therapy Phase
Erreichen des Therapiezieles der Induktionsphase (nach mindestens 24 Monaten Behandlung und 2-facher MMR) am:
Item
Achievement goal of therapy of induction phase (after min. 2 years treatment) - date
date
Achievement (Code-1)
C0001072 (UMLS CUI 2011AB)
treatment goals (Code-2)
C0679840 (UMLS CUI 2011AB)
Induction (Code-3)
C0857127 (UMLS CUI 2011AB)
10021721 (MedDRA 14.1)
Phase (Code-4)
C0205390 (UMLS CUI 2011AB)
21191007 (SNOMEDCT_2012_01_31)
Post (Code-5)
C0231290 (UMLS CUI 2011AB)
255234002 (SNOMEDCT_2012_01_31)
Minimum (Code-6)
C1524031 (UMLS CUI 2011AB)
Absetzdatum von Nilotinib im Kombinationsarm am:
Item
Date Nilotinib treatment stopped in combination treatment arm
date
Date treatment stopped (observable entity) (Code-1)
C1531784 (UMLS CUI 2011AB)
413947000 (SNOMEDCT_2012_01_31)
Nilotinib (Code-2)
C1721377 (UMLS CUI 2011AB)
428468009 (SNOMEDCT_2012_01_31)
Combination (Code-3)
C1947911 (UMLS CUI 2011AB)
Protocol Treatment Arm (Code-4)
C1522541 (UMLS CUI 2011AB)
Erreichen der Hauptphase (nach mindestens 12 Monaten Behandlung und mindestens 12 Monaten kontinuierlicher MR4) am:
Item
Achievement main phase (after min. 1 year treatment) - date
date
Achievement (Code-1)
C0001072 (UMLS CUI 2011AB)
Main (Code-2)
C1542147 (UMLS CUI 2011AB)
Phase (Code-3)
C0205390 (UMLS CUI 2011AB)
21191007 (SNOMEDCT_2012_01_31)
Post (Code-4)
C0231290 (UMLS CUI 2011AB)
255234002 (SNOMEDCT_2012_01_31)
Minimum (Code-5)
C1524031 (UMLS CUI 2011AB)
One (Code-6)
C0205447 (UMLS CUI 2011AB)
421379005 (SNOMEDCT_2012_01_31)
Absetzdatum der Hauptphasentherapie am:
Item
Date main phase treatment stopped
date
Date treatment stopped (observable entity) (Code-1)
C1531784 (UMLS CUI 2011AB)
413947000 (SNOMEDCT_2012_01_31)
Main (Code-2)
C1542147 (UMLS CUI 2011AB)
Phase (Code-3)
C0205390 (UMLS CUI 2011AB)
21191007 (SNOMEDCT_2012_01_31)
Therapeutic procedure (Code-4)
C0087111 (UMLS CUI 2011AB)
277132007 (SNOMEDCT_2012_01_31)
10053757 (MedDRA 14.1)
MTHU021209 (LOINC Version 232)
Item Group
Previous therapy within the interval
Item Group
Nilotinib 2*300mg
andere Dosis (mg)
Item
other dosage (mg)
integer
Other (Code-1)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Dosage (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Milligram (Code-3)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
Beginn
Item
Start
date
Date treatment started (observable entity) (Code-1)
C1531783 (UMLS CUI 2011AB)
413946009 (SNOMEDCT_2012_01_31)
Nilotinib (Code-2)
C1721377 (UMLS CUI 2011AB)
427941004 (SNOMEDCT_2012_01_31)
Twice (Code-3)
C1948050 (UMLS CUI 2011AB)
Three (Code-4)
C0205449 (UMLS CUI 2011AB)
421291004 (SNOMEDCT_2012_01_31)
One Hundred (Code-5)
CL447292 (UMLS CUI 2011AB)
Milligram (Code-6)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
Ende
Item
End
date
Date treatment stopped (observable entity) (Code-1)
C1531784 (UMLS CUI 2011AB)
413947000 (SNOMEDCT_2012_01_31)
Nilotinib (Code-2)
C1721377 (UMLS CUI 2011AB)
427941004 (SNOMEDCT_2012_01_31)
Twice (Code-3)
C1948050 (UMLS CUI 2011AB)
Three (Code-4)
C0205449 (UMLS CUI 2011AB)
421291004 (SNOMEDCT_2012_01_31)
One Hundred (Code-5)
CL447292 (UMLS CUI 2011AB)
Milligram (Code-6)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
Therapietage
Item
Days of treatment
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Therapeutic procedure (Code-2)
C0087111 (UMLS CUI 2011AB)
277132007 (SNOMEDCT_2012_01_31)
10053757 (MedDRA 14.1)
MTHU021209 (LOINC Version 232)
day (Code-3)
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
MTHU039849 (LOINC Version 232)
D (HL7 V3 2006_05)
Nilotinib (Code-4)
C1721377 (UMLS CUI 2011AB)
427941004 (SNOMEDCT_2012_01_31)
Twice (Code-5)
C1948050 (UMLS CUI 2011AB)
Three (Code-6)
C0205449 (UMLS CUI 2011AB)
421291004 (SNOMEDCT_2012_01_31)
Gesamtdosis (mg)
Item
Cumulative Dose (mg)
integer
Cumulative Dose (Code-1)
C2986497 (UMLS CUI 2011AB)
Milligram (Code-2)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
Nilotinib (Code-3)
C1721377 (UMLS CUI 2011AB)
427941004 (SNOMEDCT_2012_01_31)
Twice (Code-4)
C1948050 (UMLS CUI 2011AB)
Three (Code-5)
C0205449 (UMLS CUI 2011AB)
421291004 (SNOMEDCT_2012_01_31)
One Hundred (Code-6)
CL447292 (UMLS CUI 2011AB)
Item
Treatment stop
integer
Stop (Code-1)
C1947925 (UMLS CUI 2011AB)
Nilotinib (Code-2)
C1721377 (UMLS CUI 2011AB)
427941004 (SNOMEDCT_2012_01_31)
Twice (Code-3)
C1948050 (UMLS CUI 2011AB)
Three (Code-4)
C0205449 (UMLS CUI 2011AB)
421291004 (SNOMEDCT_2012_01_31)
One Hundred (Code-5)
CL447292 (UMLS CUI 2011AB)
Milligram (Code-6)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
Absetzen
Code List
Treatment stop
CL Item
No (nein)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Yes (ja)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
G (G)
not_coded (Code-1)
CL Item
U (U)
not_coded (Code-1)
CL Item
A (A)
not_coded (Code-1)
CL Item
S (S)
not_coded (Code-1)
Grund für Absetzen
Item
Reason for treatment stop
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008319 (LOINC Version 232)
Stop (Code-2)
C1947925 (UMLS CUI 2011AB)
Nilotinib (Code-3)
C1721377 (UMLS CUI 2011AB)
427941004 (SNOMEDCT_2012_01_31)
Twice (Code-4)
C1948050 (UMLS CUI 2011AB)
Three (Code-5)
C0205449 (UMLS CUI 2011AB)
421291004 (SNOMEDCT_2012_01_31)
One Hundred (Code-6)
CL447292 (UMLS CUI 2011AB)
Item Group
Nilotinib - Rest
Beginn
Item
Start
date
Start Date (Code-1)
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Ende
Item
End
date
End Date (Code-1)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Item Group
PEG-IFN
Beginn
Item
Start
date
Date treatment started (observable entity) (Code-1)
C1531783 (UMLS CUI 2011AB)
413946009 (SNOMEDCT_2012_01_31)
Pegylated Interferon Alfa (Code-2)
C0907160 (UMLS CUI 2011AB)
Ende
Item
End
date
Date treatment stopped (observable entity) (Code-1)
C1531784 (UMLS CUI 2011AB)
413947000 (SNOMEDCT_2012_01_31)
Pegylated Interferon Alfa (Code-2)
C0907160 (UMLS CUI 2011AB)
Einzeldosis (μg)
Item
Single dose (μg)
integer
Single dose characteristic (observable entity) (Code-1)
C1960417 (UMLS CUI 2011AB)
426146003 (SNOMEDCT_2012_01_31)
Microgram (Code-2)
C0439211 (UMLS CUI 2011AB)
258685003 (SNOMEDCT_2012_01_31)
Intervall (Tage)
Item
Intervall (days)
integer
Interval (Code-1)
C1272706 (UMLS CUI 2011AB)
385673002 (SNOMEDCT_2012_01_31)
Anzahl Injektionen
Item
Number of Injections
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Injection procedure (Code-2)
C1533685 (UMLS CUI 2011AB)
129326001 (SNOMEDCT_2012_01_31)
10052995 (MedDRA 14.1)
Item
Treatment stop
integer
Stop (Code-1)
C1947925 (UMLS CUI 2011AB)
Pegylated Interferon Alfa (Code-2)
C0907160 (UMLS CUI 2011AB)
Absetzen
Code List
Treatment stop
CL Item
No (nein)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Yes (ja)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
G (G)
not_coded (Code-1)
CL Item
U (U)
not_coded (Code-1)
CL Item
A (A)
not_coded (Code-1)
CL Item
S (S)
not_coded (Code-1)
Grund für Absetzen
Item
Reason for treatment stop
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008319 (LOINC Version 232)
Stop (Code-2)
C1947925 (UMLS CUI 2011AB)
Pegylated Interferon Alfa (Code-3)
C0907160 (UMLS CUI 2011AB)
Item Group
PEG-IFN - Rest
Beginn
Item
Start
date
Start Date (Code-1)
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Pegylated Interferon Alfa (Code-2)
C0907160 (UMLS CUI 2011AB)
Rest (Code-3)
C0035253 (UMLS CUI 2011AB)
258157001 (SNOMEDCT_2012_01_31)
Ende
Item
End
date
End Date (Code-1)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Pegylated Interferon Alfa (Code-2)
C0907160 (UMLS CUI 2011AB)
Rest (Code-3)
C0035253 (UMLS CUI 2011AB)
258157001 (SNOMEDCT_2012_01_31)
Item Group
further drugs
Grund
Item
Reason for further drug
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008319 (LOINC Version 232)
Further (Code-2)
C1517331 (UMLS CUI 2011AB)
Pharmaceutical Preparations (Code-3)
C0013227 (UMLS CUI 2011AB)
410942007 (SNOMEDCT_2012_01_31)
Medikament
Item
Drug
string
Pharmaceutical Preparations (Code-1)
C0013227 (UMLS CUI 2011AB)
410942007 (SNOMEDCT_2012_01_31)
Dosis
Item
Dosage
integer
Dosage (Code-1)
C0178602 (UMLS CUI 2011AB)
277406006 (SNOMEDCT_2012_01_31)
Einheit
Item
Unit
string
Dosage Form Unit (Code-1)
C2348328 (UMLS CUI 2011AB)
Beginn
Item
Start
date
Date treatment started (observable entity) (Code-1)
C1531783 (UMLS CUI 2011AB)
413946009 (SNOMEDCT_2012_01_31)
Further (Code-2)
C1517331 (UMLS CUI 2011AB)
Pharmaceutical Preparations (Code-3)
C0013227 (UMLS CUI 2011AB)
410942007 (SNOMEDCT_2012_01_31)
Ende
Item
End
date
Date treatment stopped (observable entity) (Code-1)
C1531784 (UMLS CUI 2011AB)
413947000 (SNOMEDCT_2012_01_31)
Further (Code-2)
C1517331 (UMLS CUI 2011AB)
Pharmaceutical Preparations (Code-3)
C0013227 (UMLS CUI 2011AB)
410942007 (SNOMEDCT_2012_01_31)
Item Group
Signature
Kommentar
Item
Comment
string
Comment (Code-1)
C0947611 (UMLS CUI 2011AB)
MTHU013736 (LOINC Version 232)
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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