ID

13473

Beschreibung

Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel™) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

Stichworte

Versionen (5)
  1. 02.03.15 02.03.15 -
  2. 08.03.15 08.03.15 -
  3. 22.04.15 22.04.15 -
  4. 09.12.15 09.12.15 -
  5. 11.02.16 11.02.16 -
Hochgeladen am

11. Februar 2016

DOI

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Cycle AMLSG 21-13 DRKS00007189 NCT02013648 Akute myeloische Leukämie (AML)

Englisch

Cycle AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

1 Formulare  
At start of cycle
Beschreibung

At start of cycle

Point in time
Beschreibung

Point in time

Datentyp

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348792
Weight [kg]
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Beschreibung

Body surface area

Datentyp

integer

Maßeinheiten
  • squaremeter
Alias
UMLS CUI-1
C0005902
squaremeter
Temperature
Beschreibung

Temperature

Datentyp

integer

Maßeinheiten
  • Degree Celcius
Alias
UMLS CUI [1]
C0005903
Degree Celcius
Blood pressure
Beschreibung

Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI-1
C0005823
mmHg
Pulse
Beschreibung

Pulse

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
General Condition (WHO / ECOG)
Beschreibung

General Condition (WHO / ECOG)

Datentyp

integer

Alias
UMLS CUI-1
C1520224
For Induction I only
Beschreibung

For Induction I only

Administration of Hydroxyurea before start of Induction I?
Beschreibung

Administration of Hydroxyurea

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0806914
UMLS CUI [1,2]
C0020402
If yes, how many days before start of Induction I?
Beschreibung

How many days

Datentyp

integer

Alias
UMLS CUI [1]
C1948053
Date of last administration
Beschreibung

Date of last administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Cycle
Beschreibung

Cycle

Alias
UMLS CUI-1
C0087111
Start of Cycle
Beschreibung

Start of Cycle

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0087111
Cytarabine
Beschreibung

Cytarabine

Alias
UMLS CUI-1
C0010711
Total Dose[mg]
Beschreibung

Total Dose[mg]

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0010711
mg
Dose
Beschreibung

Dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C0178602
Reasons (if dose <1)
Beschreibung

Reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C0392360
Daunorubicin
Beschreibung

Daunorubicin

Alias
UMLS CUI-1
C0011015
Total Dose [mg]
Beschreibung

Total Dose [mg]

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI-1
C2986497
mg
Dose
Beschreibung

Dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C0178602
Reason
Beschreibung

Reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C0392360
Dasatinib
Beschreibung

Dasatinib

Alias
UMLS CUI-1
C1455147
Total Dose [mg]
Beschreibung

Total Dose [mg]

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI-1
C2986497
mg
Dose
Beschreibung

Dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C0178602
Reason
Beschreibung

Reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C0392360
Events
Beschreibung

Events

Alias
UMLS CUI-1
C0877248
Did any Adverse Events occur? If Yes, please document on CRF Adverse Event (7)
Beschreibung

Adverse Events

Datentyp

boolean

Alias
UMLS CUI-1
C0877248
Number of Days with Fever higher than 38.5°C
Beschreibung

Fever Days

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Number of Nights in Hospital (until discharge or start of next Cycle)
Beschreibung

Hospital nights

Datentyp

integer

Maßeinheiten
  • nights
Alias
UMLS CUI [1]
C0420496
nights
Inpatient Hospitalisation during Cycle
Beschreibung

Inpatient Hospitalisation during Cycle

Alias
UMLS CUI-1
C0420496
UMLS CUI-2
C1276413
Was the Patient hospitalised again after discharge in this Cycle?
Beschreibung

Hospitalisation after Discharge

Datentyp

boolean

Alias
UMLS CUI-1
C0019993
Number of Hospitalisations
Beschreibung

Number of Hospitalisations

Datentyp

integer

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0750480
Date of first Hospitalisation
Beschreibung

Date of first Hospitalisation

Datentyp

date

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0011008
Duration of all Hospitalsations in this Cycle
Beschreibung

Duration of all Hospitalsations in this Cycle

Datentyp

integer

Maßeinheiten
  • Nights
Alias
UMLS CUI-1
C0019993
UMLS CUI-2
C1515051
Nights
Reason(s) for Hospitalisation(s)
Beschreibung

Reason(s) for Hospitalisation(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0392360
MUGA/Echo Scan
Beschreibung

MUGA/Echo Scan

Echocardiography
Beschreibung

Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0013516
Echocardiography date
Beschreibung

Echocardiography date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0011008
Ejection fraction
Beschreibung

Ejection fraction

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI-1
C0232174
%
Abnormalities
Beschreibung

Abnormalities

Datentyp

text

Alias
UMLS CUI-1
C1704258
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Intake of Medication? (If Yes, specify on CRF "Concomitant Medication"
Beschreibung

Intake of Medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2826668
Buccal Swab (For Induction I only)
Beschreibung

Buccal Swab (For Induction I only)

Buccal Swab
Beschreibung

Buccal Swab

Datentyp

boolean

Alias
UMLS CUI [1]
C0581714
Date of Buccal Swab
Beschreibung

Date of Buccal Swab

Datentyp

date

Alias
UMLS CUI [1,1]
C0581714
UMLS CUI [1,2]
C0011008
Pregnancy test (female Patients of child-bearing age only)
Beschreibung

Pregnancy test (female Patients of child-bearing age only)

Alias
UMLS CUI-1
C0032976
Pregnancy test date
Beschreibung

Pregnancy test date

Datentyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy test result
Beschreibung

Pregnancy test result

Datentyp

integer

Alias
UMLS CUI [1]
C0032961
Supportive Care (Period: Start Cycle – Start next Cycle / End of Study)
Beschreibung

Supportive Care (Period: Start Cycle – Start next Cycle / End of Study)

Alias
UMLS CUI-1
C0344211
Number of platelet concentrates Single Donor (HLA-ident)
Beschreibung

Number of platelet concentrates Single Donor (HLA-ident)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C2362067
Number of platelet concentrates Random / Pool
Beschreibung

Number of platelet concentrates Random / Pool

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C2713244
Date of first Transfusion platelet concentrates
Beschreibung

Date of first Transfusion platelet concentrates

Datentyp

date

Alias
UMLS CUI [1,1]
C2362067
UMLS CUI [1,2]
C0808070
Date of last Transfusion Platelet concentrate
Beschreibung

Date of last Transfusion Platelet concentrate

Datentyp

date

Alias
UMLS CUI [1,1]
C2362067
UMLS CUI [1,2]
C0806020
Number of Erythrocyte concentrates/Packed red blood cells
Beschreibung

Number of Erythrocyte concentrates/Packed red blood cells

Datentyp

integer

Alias
UMLS CUI [1,1]
C2316467
UMLS CUI [1,2]
C0014792
UMLS CUI [1,3]
C0750480
Date of first Transfusion Erythrocyte concentrate
Beschreibung

Date of first Transfusion Erythrocyte concentrate

Datentyp

date

Alias
UMLS CUI [1,1]
C2316467
UMLS CUI [1,2]
C0808070
Date of last Transfusion Erythrocyte concentrate
Beschreibung

Date of last Transfusion Erythrocyte concentrate

Datentyp

date

Alias
UMLS CUI [1,1]
C2316467
UMLS CUI [1,2]
C0806020
Hematological Regeneration
Beschreibung

Hematological Regeneration

Neutrophiles > 0.5 Giga/l
Beschreibung

Neutrophiles > 0.5 Giga/l

Datentyp

integer

Alias
UMLS CUI [1,1]
C1882078
UMLS CUI [1,2]
C0200633
Neutrophiles > 0.5 Giga/l Date
Beschreibung

Neutrophiles > 0.5 Giga/l Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1882078
UMLS CUI [1,2]
C0200633
UMLS CUI [1,3]
C0011008
Neutrophiles > 1.5 Giga/l
Beschreibung

Neutrophiles > 1.5 Giga/l

Datentyp

integer

Alias
UMLS CUI [1,1]
C1882078
UMLS CUI [1,2]
C0200633
Neutrophiles > 1.5 Giga/l Date
Beschreibung

Neutrophiles > 1.5 Giga/l Date

Datentyp

date

Alias
UMLS CUI-1
C0200633
Leukocytes > 1.0 Giga/l
Beschreibung

Leukocytes > 1.0 Giga/l

Datentyp

text

Alias
UMLS CUI [1,1]
C0301944
UMLS CUI [1,2]
C0023508
Leukocytes > 1.0 Giga/l Date
Beschreibung

Leukocytes > 1.0 Giga/l Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0301944
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C0011008
Platelets > 20 Giga/l
Beschreibung

Platelets > 20 Giga/l

Datentyp

integer

Alias
UMLS CUI [1,1]
C1882407
UMLS CUI [1,2]
C0005821
Platelets > 20 Giga/l Date
Beschreibung

Platelets > 20 Giga/l Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1882407
UMLS CUI [1,2]
C0005821
UMLS CUI [1,3]
C0011008
Platelets > 50 Giga/l
Beschreibung

Platelets > 50 Giga/l

Datentyp

integer

Alias
UMLS CUI [1,1]
C1882407
UMLS CUI [1,2]
C0005821
Platelets > 50 Giga/l Date
Beschreibung

Platelets > 50 Giga/l Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1882407
UMLS CUI [1,2]
C0005821
UMLS CUI [1,3]
C0011008
Platelets > 100 Giga/l
Beschreibung

Platelets > 100 Giga/l

Datentyp

integer

Alias
UMLS CUI [1,1]
C1882407
UMLS CUI [1,2]
C0005821
Platelets > 100 Giga/l Date
Beschreibung

Platelets > 100 Giga/l Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1882407
UMLS CUI [1,2]
C0005821
UMLS CUI [1,3]
C0011008
Further Therapy planned
Beschreibung

Further Therapy planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C1553904
Signature
Beschreibung

Signature

Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI-1
C0011008
Name of Investigator
Beschreibung

Name of Investigator

Datentyp

text

Alias
UMLS CUI-1
C0008961
Signature of investigator
Beschreibung

Signature of investigator

Datentyp

text

Alias
UMLS CUI-1
C2346576
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Ähnliche Modelle

Cycle AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
At start of cycle
Item
Point in time
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Point in time
Code List
Point in time
CL Item
Induction I (1)
C3179010 (UMLS CUI-1)
CL Item
Induction II (optional) (2)
C3179010 (UMLS CUI-1)
CL Item
Consolid. I (3)
C3179017 (UMLS CUI-1)
CL Item
Consolid. II (4)
C3179017 (UMLS CUI-1)
CL Item
Consolid. III (5)
C3179017 (UMLS CUI-1)
CL Item
Consolid. IV (6)
C3179017 (UMLS CUI-1)
Weight
Item
Weight [kg]
integer
C0005910 (UMLS CUI [1])
Body surface area
Item
Body surface area
integer
C0005902 (UMLS CUI-1)
Temperature
Item
Temperature
integer
C0005903 (UMLS CUI [1])
Blood pressure
Item
Blood pressure
integer
C0005823 (UMLS CUI-1)
Pulse
Item
Pulse
integer
C0018810 (UMLS CUI [1])
General Condition (WHO / ECOG)
Item
General Condition (WHO / ECOG)
integer
C1520224 (UMLS CUI-1)
Item Group
For Induction I only
Administration of Hydroxyurea
Item
Administration of Hydroxyurea before start of Induction I?
boolean
C0806914 (UMLS CUI [1,1])
C0020402 (UMLS CUI [1,2])
How many days
Item
If yes, how many days before start of Induction I?
integer
C1948053 (UMLS CUI [1])
Date of last administration
Item
Date of last administration
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Cycle
C0087111 (UMLS CUI-1)
Start of Cycle
Item
Start of Cycle
date
C0808070 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item Group
Cytarabine
C0010711 (UMLS CUI-1)
Total Dose[mg]
Item
Total Dose[mg]
integer
C2986497 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
Item
Dose
integer
C1299575 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Dose
Code List
Dose
CL Item
complete scheduled Dose (1 )
C0178602 (UMLS CUI-1)
C0205307 (UMLS CUI-2)
CL Item
Withdrawal of consent (2 )
C0021430 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
CL Item
Dose reduced >10% (3 )
C0178602 (UMLS CUI-1)
C0392756 (UMLS CUI-2)
CL Item
Dose reduced and delayed (4 )
C0178602 (UMLS CUI-1)
C0392756 (UMLS CUI-2)
C0205421 (UMLS CUI-3)
CL Item
not administered (5 )
C0178602 (UMLS CUI-1)
C1548562 (UMLS CUI-2)
CL Item
discontinued and administered again (6 )
C0178602 (UMLS CUI-1)
C0443239 (UMLS CUI-2)
CL Item
completed prematurely (7 )
C0178602 (UMLS CUI-1)
C0205197 (UMLS CUI-2)
C1279919 (UMLS CUI-3)
CL Item
Other (please specify) (8 )
C1521902 (UMLS CUI-1)
Item
Reasons (if dose <1)
integer
C1299575 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason
Code List
Reasons (if dose <1)
CL Item
Toxicity (please specify) (1)
C0013221 (UMLS CUI-1)
CL Item
Withdrawal of consent (2)
C0021430 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
CL Item
Other (please specify) (3)
C1521902 (UMLS CUI-1)
Item Group
Daunorubicin
C0011015 (UMLS CUI-1)
Total Dose [mg]
Item
Total Dose [mg]
integer
C2986497 (UMLS CUI-1)
Item
Dose
integer
C1299575 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Dose
Code List
Dose
CL Item
complete scheduled Dose (1 )
C0178602 (UMLS CUI-1)
C0205307 (UMLS CUI-2)
CL Item
Withdrawal of consent (2 )
C0021430 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
CL Item
Dose reduced >10% (3 )
C0178602 (UMLS CUI-1)
C0392756 (UMLS CUI-2)
CL Item
Dose reduced and delayed (4 )
C0178602 (UMLS CUI-1)
C0392756 (UMLS CUI-2)
C0205421 (UMLS CUI-3)
CL Item
not administered (5 )
C0178602 (UMLS CUI-1)
C1548562 (UMLS CUI-2)
CL Item
discontinued and administered again (6 )
C0178602 (UMLS CUI-1)
C0443239 (UMLS CUI-2)
CL Item
completed prematurely (7 )
C0178602 (UMLS CUI-1)
C0205197 (UMLS CUI-2)
C1279919 (UMLS CUI-3)
CL Item
Other (please specify) (8 )
C1521902 (UMLS CUI-1)
Item
Reason
integer
C1299575 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason
Code List
Reason
CL Item
Toxicity (please specify) (1)
C0013221 (UMLS CUI-1)
CL Item
Withdrawal of consent (2)
C0021430 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
CL Item
Other (please specify) (3)
C1521902 (UMLS CUI-1)
Item Group
Dasatinib
C1455147 (UMLS CUI-1)
Total Dose [mg]
Item
Total Dose [mg]
integer
C2986497 (UMLS CUI-1)
Item
Dose
integer
C1299575 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Dose
Code List
Dose
CL Item
complete scheduled Dose (1 )
C0178602 (UMLS CUI-1)
C0205307 (UMLS CUI-2)
CL Item
Withdrawal of consent (2 )
C0021430 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
CL Item
Dose reduced >10% (3 )
C0178602 (UMLS CUI-1)
C0392756 (UMLS CUI-2)
CL Item
Dose reduced and delayed (4 )
C0178602 (UMLS CUI-1)
C0392756 (UMLS CUI-2)
C0205421 (UMLS CUI-3)
CL Item
not administered (5 )
C0178602 (UMLS CUI-1)
C1548562 (UMLS CUI-2)
CL Item
discontinued and administered again (6 )
C0178602 (UMLS CUI-1)
C0443239 (UMLS CUI-2)
CL Item
completed prematurely (7 )
C0178602 (UMLS CUI-1)
C0205197 (UMLS CUI-2)
C1279919 (UMLS CUI-3)
CL Item
Other (please specify) (8 )
C1521902 (UMLS CUI-1)
Item
Reason
integer
C1299575 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason
Code List
Reason
CL Item
Toxicity (please specify) (1)
C0013221 (UMLS CUI-1)
CL Item
Withdrawal of consent (2)
C0021430 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
CL Item
Other (please specify) (3)
C1521902 (UMLS CUI-1)
Item Group
Events
C0877248 (UMLS CUI-1)
Adverse Events
Item
Did any Adverse Events occur? If Yes, please document on CRF Adverse Event (7)
boolean
C0877248 (UMLS CUI-1)
Fever Days
Item
Number of Days with Fever higher than 38.5°C
integer
C0015967 (UMLS CUI [1])
Hospital nights
Item
Number of Nights in Hospital (until discharge or start of next Cycle)
integer
C0420496 (UMLS CUI [1])
Item Group
Inpatient Hospitalisation during Cycle
C0420496 (UMLS CUI-1)
C1276413 (UMLS CUI-2)
Hospitalisation after Discharge
Item
Was the Patient hospitalised again after discharge in this Cycle?
boolean
C0019993 (UMLS CUI-1)
Number of Hospitalisations
Item
Number of Hospitalisations
integer
C0019993 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Date of first Hospitalisation
Item
Date of first Hospitalisation
date
C0019993 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Duration of all Hospitalsations in this Cycle
Item
Duration of all Hospitalsations in this Cycle
integer
C0019993 (UMLS CUI-1)
C1515051 (UMLS CUI-2)
Reason(s) for Hospitalisation(s)
Item
Reason(s) for Hospitalisation(s)
text
C0019993 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
MUGA/Echo Scan
Echocardiography
Item
Echocardiography
boolean
C0013516 (UMLS CUI [1])
Echocardiography date
Item
Echocardiography date
date
C0013516 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Ejection fraction
Item
Ejection fraction
integer
C0232174 (UMLS CUI-1)
Abnormalities
Item
Abnormalities
text
C1704258 (UMLS CUI-1)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Intake of Medication
Item
Intake of Medication? (If Yes, specify on CRF "Concomitant Medication"
boolean
C2826668 (UMLS CUI [1])
Item Group
Buccal Swab (For Induction I only)
Buccal Swab
Item
Buccal Swab
boolean
C0581714 (UMLS CUI [1])
Date of Buccal Swab
Item
Date of Buccal Swab
date
C0581714 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Pregnancy test (female Patients of child-bearing age only)
C0032976 (UMLS CUI-1)
Pregnancy test date
Item
Pregnancy test date
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test result
integer
C0032961 (UMLS CUI [1])
Pregnancy test result
Code List
Pregnancy test result
CL Item
negative (0)
C0205160 (UMLS CUI-1)
CL Item
positive (1)
C1446409 (UMLS CUI-1)
Item Group
Supportive Care (Period: Start Cycle – Start next Cycle / End of Study)
C0344211 (UMLS CUI-1)
Number of platelet concentrates Single Donor (HLA-ident)
Item
Number of platelet concentrates Single Donor (HLA-ident)
integer
C0005821 (UMLS CUI [1,1])
C2362067 (UMLS CUI [1,2])
Number of platelet concentrates Random / Pool
Item
Number of platelet concentrates Random / Pool
integer
C0005821 (UMLS CUI [1,1])
C2713244 (UMLS CUI [1,2])
Date of first Transfusion platelet concentrates
Item
Date of first Transfusion platelet concentrates
date
C2362067 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Date of last Transfusion Platelet concentrate
Item
Date of last Transfusion Platelet concentrate
date
C2362067 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Number of Erythrocyte concentrates/Packed red blood cells
Item
Number of Erythrocyte concentrates/Packed red blood cells
integer
C2316467 (UMLS CUI [1,1])
C0014792 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Date of first Transfusion Erythrocyte concentrate
Item
Date of first Transfusion Erythrocyte concentrate
date
C2316467 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Date of last Transfusion Erythrocyte concentrate
Item
Date of last Transfusion Erythrocyte concentrate
date
C2316467 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Hematological Regeneration
Item
Neutrophiles > 0.5 Giga/l
integer
C1882078 (UMLS CUI [1,1])
C0200633 (UMLS CUI [1,2])
Neutrophiles status
Code List
Neutrophiles > 0.5 Giga/l
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Neutrophiles > 0.5 Giga/l Date
Item
Neutrophiles > 0.5 Giga/l Date
date
C1882078 (UMLS CUI [1,1])
C0200633 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Neutrophiles > 1.5 Giga/l
integer
C1882078 (UMLS CUI [1,1])
C0200633 (UMLS CUI [1,2])
Neutrophiles > 1.5 Giga/l
Code List
Neutrophiles > 1.5 Giga/l
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Neutrophiles > 1.5 Giga/l Date
Item
Neutrophiles > 1.5 Giga/l Date
date
C0200633 (UMLS CUI-1)
Item
Leukocytes > 1.0 Giga/l
text
C0301944 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Leukocytes > 1.0 Giga/l
Code List
Leukocytes > 1.0 Giga/l
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Leukocytes > 1.0 Giga/l Date
Item
Leukocytes > 1.0 Giga/l Date
date
C0301944 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Platelets > 20 Giga/l
integer
C1882407 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
Platelets > 20 Giga/l
Code List
Platelets > 20 Giga/l
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Platelets > 20 Giga/l Date
Item
Platelets > 20 Giga/l Date
date
C1882407 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Platelets > 50 Giga/l
integer
C1882407 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
Platelets > 50 Giga/l Date
Code List
Platelets > 50 Giga/l
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Platelets > 50 Giga/l Date
Item
Platelets > 50 Giga/l Date
date
C1882407 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Platelets > 100 Giga/l
integer
C1882407 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
Platelets > 100 Giga/l
Code List
Platelets > 100 Giga/l
CL Item
never reduced (1)
CL Item
regenerated on this day (2)
CL Item
not yet regenerated (3)
CL Item
not regenerated until next Cycle (4)
CL Item
not regenerated until Death (5)
Platelets > 100 Giga/l Date
Item
Platelets > 100 Giga/l Date
date
C1882407 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Further Therapy planned
Item
Further Therapy planned
boolean
C1276413 (UMLS CUI [1,1])
C1553904 (UMLS CUI [1,2])
Item Group
Signature
Date
Item
Date
date
C0011008 (UMLS CUI-1)
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI-1)
Signature of investigator
Item
Signature of investigator
text
C2346576 (UMLS CUI-1)
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