Item
Randomization group 1: 2 vs 4 doses of Daunorubicin in Protc. IA
text
C2348563 (UMLS CUI [1])
Code List
Randomization group 1: 2 vs 4 doses of Daunorubicin in Protc. IA
CL Item
Prot. IA (Prot. IA)
CL Item
Prot. IA' (Prot. IA')
Start date of documentation
Item
Start date of documentation (day 22 in protocol IA/IA')
date
C0808070 (UMLS CUI [1,1])
C0175636 (UMLS CUI [1,2])
End date of documentation
Item
End date of documentation (day before start of protocol IB)
date
C0806020 (UMLS CUI [1,1])
C0175636 (UMLS CUI [1,2])
Haemoglobin
Item
Haemoglobin measurement performed?
boolean
C0518015 (UMLS CUI [1])
Item
If Haemoglobin measurement performed, specify toxicity grade:
text
C0518015 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Code List
If Haemoglobin measurement performed, specify toxicity grade:
CL Item
0-2 (≥ 8.0 g/dL) (0-2 (≥ 8.0 g/dL))
CL Item
3 (6.5 -< 8.0 g/dL) (3 (6.5 -< 8.0 g/dL))
CL Item
4 (< 6.5 g/dL) (4 (< 6.5 g/dL))
White blood count
Item
White blood count measurement performed?
boolean
C0023508 (UMLS CUI [1])
Item
If White blood count performed, specify toxicity grade:
text
C0023508 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Code List
If White blood count performed, specify toxicity grade:
CL Item
3 (1.0 -< 2.0 Gp/L) (3 (1.0 -< 2.0 Gp/L))
CL Item
4 (< 1.0 Gp/L) (4 (< 1.0 Gp/L))
CL Item
0-2 (≥ 2.0 Gp/L) (0-2 (≥ 2.0 Gp/L))
Granulocyte measurement
Item
Granulocyte measurement performed?
boolean
C0857490 (UMLS CUI [1])
Item
If Granulocyte measurement performed, specify toxicity grade:
text
C0857490 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Code List
If Granulocyte measurement performed, specify toxicity grade:
CL Item
3 (0.5 -< 1.0 Gp/L) (3 (0.5 -< 1.0 Gp/L))
CL Item
4 (< 0.5 Gp/L) (4 (< 0.5 Gp/L))
CL Item
0-2 (≥ 1.0 Gp/L) (0-2 (≥ 1.0 Gp/L))
Platelets measurement
Item
Platelets measurement performed?
boolean
C0032181 (UMLS CUI [1])
Item
If Platelets measurement performed, specify toxicity grade:
text
C0032181 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Code List
If Platelets measurement performed, specify toxicity grade:
CL Item
0-2 (≥ 50 Gp/L) (0-2 (≥ 50 Gp/L))
CL Item
3 (10 -< 50 Gp/L) (3 (10 -< 50 Gp/L))
CL Item
4 (< 10 Gp/L) (4 (< 10 Gp/L))
Duration of leukopenia
Item
Numbers of days in aplasia (leukopenia) during the period from day 22 in Prot. IA/IA' to start of Protocol IB) Leukozytes < 1000/μl
float
C0023530 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of agranulocytosis
Item
Numbers of days in aplasia (leukopenia) during the period from day 22 in Prot. IA/IA' to start of Protocol IB) Granulocytes < 500/μl
float
C0001824 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Stomatitis
Item
Examination for stomatits performed?
boolean
C0038362 (UMLS CUI [1])
Item
If examination for stomatitis performed, specify toxicity grade:
text
C0038362 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Code List
If examination for stomatitis performed, specify toxicity grade:
CL Item
0-2 (no painless/ painful ulcera, eating still possible) (0-2 (no painless/ painful ulcera, eating still possible))
CL Item
3 (painful ulcera, eating not possible) (3 (painful ulcera, eating not possible))
CL Item
4 (parenteral nutrition necessary due to stomatitis) (4 (parenteral nutrition necessary due to stomatitis))
Doctor's name
Item
Doctor's name
text
C0027365 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Doctor's signature
Item
Doctor's signature
text
C1519316 (UMLS CUI [1])