ID

13473

Description

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)

Keywords

Versions (5)
  1. 3/2/15 3/2/15 -
  2. 3/8/15 3/8/15 -
  3. 4/22/15 4/22/15 -
  4. 12/9/15 12/9/15 -
  5. 2/11/16 2/11/16 -
Uploaded on

February 11, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Cycle AMLSG 21-13 DRKS00007189 NCT02013648 Akute myeloische Leukämie (AML)

English

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

1 forms  
At start of cycle
Description

At start of cycle

Point in time
Description

Point in time

Data type

integer

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

Weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Description

Body surface area

Data type

integer

Measurement units
  • squaremeter
Alias
UMLS CUI-1
C0005902
squaremeter
Temperature
Description

Temperature

Data type

integer

Measurement units
  • Degree Celcius
Alias
UMLS CUI [1]
C0005903
Degree Celcius
Blood pressure
Description

Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI-1
C0005823
mmHg
Pulse
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
General Condition (WHO / ECOG)
Description

General Condition (WHO / ECOG)

Data type

integer

Alias
UMLS CUI-1
C1520224
For Induction I only
Description

For Induction I only

Administration of Hydroxyurea before start of Induction I?
Description

Administration of Hydroxyurea

Data type

boolean

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

How many days

Data type

integer

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

Date of last administration

Data type

date

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

Cycle

Alias
UMLS CUI-1
C0087111
Start of Cycle
Description

Start of Cycle

Data type

date

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

Cytarabine

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

Total Dose[mg]

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0010711
mg
Dose
Description

Dose

Data type

integer

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

Reason

Data type

integer

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

Daunorubicin

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

Total Dose [mg]

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI-1
C2986497
mg
Dose
Description

Dose

Data type

integer

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

Reason

Data type

integer

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

Dasatinib

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

Total Dose [mg]

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI-1
C2986497
mg
Dose
Description

Dose

Data type

integer

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

Reason

Data type

integer

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

Events

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

Adverse Events

Data type

boolean

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

Fever Days

Data type

integer

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

Hospital nights

Data type

integer

Measurement units
  • nights
Alias
UMLS CUI [1]
C0420496
nights
Inpatient Hospitalisation during Cycle
Description

Inpatient Hospitalisation during Cycle

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

Hospitalisation after Discharge

Data type

boolean

Alias
UMLS CUI-1
C0019993
Number of Hospitalisations
Description

Number of Hospitalisations

Data type

integer

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

Date of first Hospitalisation

Data type

date

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

Duration of all Hospitalsations in this Cycle

Data type

integer

Measurement units
  • Nights
Alias
UMLS CUI-1
C0019993
UMLS CUI-2
C1515051
Nights
Reason(s) for Hospitalisation(s)
Description

Reason(s) for Hospitalisation(s)

Data type

text

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

MUGA/Echo Scan

Echocardiography
Description

Echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0013516
Echocardiography date
Description

Echocardiography date

Data type

date

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

Ejection fraction

Data type

integer

Measurement units
  • %
Alias
UMLS CUI-1
C0232174
%
Abnormalities
Description

Abnormalities

Data type

text

Alias
UMLS CUI-1
C1704258
Concomitant Medication
Description

Concomitant Medication

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

Intake of Medication

Data type

boolean

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

Buccal Swab (For Induction I only)

Buccal Swab
Description

Buccal Swab

Data type

boolean

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

Date of Buccal Swab

Data type

date

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

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

Alias
UMLS CUI-1
C0032976
Pregnancy test date
Description

Pregnancy test date

Data type

date

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

Pregnancy test result

Data type

integer

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

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

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

Number of platelet concentrates Single Donor (HLA-ident)

Data type

integer

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

Number of platelet concentrates Random / Pool

Data type

integer

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

Date of first Transfusion platelet concentrates

Data type

date

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

Date of last Transfusion Platelet concentrate

Data type

date

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

Number of Erythrocyte concentrates/Packed red blood cells

Data type

integer

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

Date of first Transfusion Erythrocyte concentrate

Data type

date

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

Date of last Transfusion Erythrocyte concentrate

Data type

date

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

Hematological Regeneration

Neutrophiles > 0.5 Giga/l
Description

Neutrophiles > 0.5 Giga/l

Data type

integer

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

Neutrophiles > 0.5 Giga/l Date

Data type

date

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

Neutrophiles > 1.5 Giga/l

Data type

integer

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

Neutrophiles > 1.5 Giga/l Date

Data type

date

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

Leukocytes > 1.0 Giga/l

Data type

text

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

Leukocytes > 1.0 Giga/l Date

Data type

date

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

Platelets > 20 Giga/l

Data type

integer

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

Platelets > 20 Giga/l Date

Data type

date

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

Platelets > 50 Giga/l

Data type

integer

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

Platelets > 50 Giga/l Date

Data type

date

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

Platelets > 100 Giga/l

Data type

integer

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

Platelets > 100 Giga/l Date

Data type

date

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

Further Therapy planned

Data type

boolean

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

Signature

Date
Description

Date

Data type

date

Alias
UMLS CUI-1
C0011008
Name of Investigator
Description

Name of Investigator

Data type

text

Alias
UMLS CUI-1
C0008961
Signature of investigator
Description

Signature of investigator

Data type

text

Alias
UMLS CUI-1
C2346576
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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