Item
Point in time
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
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)
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])
Start of Cycle
Item
Start of Cycle
date
C0808070 (UMLS CUI [1,1])
C0949634 (UMLS CUI [1,2])
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])
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])
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)
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])
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])
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)
Total Dose [mg]
Item
Total Dose [mg]
integer
C2986497 (UMLS CUI-1)
Item
Dose
integer
C1299575 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
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])
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)
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
C0420512 (UMLS CUI [1])
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])
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)
Intake of Medication
Item
Intake of Medication? (If Yes, specify on CRF "Concomitant Medication"
boolean
C2826668 (UMLS CUI [1])
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])
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])
Code List
Pregnancy test result
CL Item
negative (0)
C0205160 (UMLS CUI-1)
CL Item
positive (1)
C1446409 (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
Neutrophiles > 0.5 Giga/l
integer
C1882078 (UMLS CUI [1,1])
C0027950 (UMLS CUI [1,2])
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])
C0027950 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Neutrophiles > 1.5 Giga/l
integer
C1882078 (UMLS CUI [1,1])
C0027950 (UMLS CUI [1,2])
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
C0027950 (UMLS CUI-1)
Item
Leukocytes > 1.0 Giga/l
text
C0301944 (UMLS CUI [1,1])
C0023516 (UMLS CUI [1,2])
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])
C0023516 (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])
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])
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])
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])
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
C0807938 (UMLS CUI-1)