Informatie:
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ID
15442
Beschrijving
Study Description Stamm: International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation of therapy toxicity. Clinical Trial Number: NCT01117441.
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- 31-05-16 31-05-16 -
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31 mei 2016
DOI
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Creative Commons BY-NC-ND 3.0
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Documentation of therapy toxicity AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441
Documentation of therapy toxicity AIEOP-BFM ALL 2009 NCT01117441
- StudyEvent: ODM
Similar models
Documentation of therapy toxicity AIEOP-BFM ALL 2009 NCT01117441
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Patient Study ID
Item
Patient Study ID
text
C2348585 (UMLS CUI [1])
Patient Date of Birth
Item
Patient Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Randomization group 1: 2 vs 4 doses of Daunorubicin in Protc. IA
text
C2348563 (UMLS CUI [1])
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])
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])
C0175636 (UMLS CUI [1,2])
Item Group
Blood analysis (performed on day 22 of protocol IA/IA')
C0018941 (UMLS CUI-1)
Haemoglobin
Item
Haemoglobin
float
C0518015 (UMLS CUI [1])
White blood count
Item
White blood count
float
C0023508 (UMLS CUI [1])
Granulocyte measurement
Item
Granulocyte measurement
float
C0857490 (UMLS CUI [1])
Platelets measurement
Item
Platelets measurement
float
C0032181 (UMLS CUI [1])
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])
C2826262 (UMLS CUI [1,2])
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])
C2826262 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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))
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Identification and Signature
C0205396 (UMLS CUI-1)
C1519316 (UMLS CUI-2)
C1519316 (UMLS CUI-2)
Doctor's name
Item
Doctor's name
text
C0027365 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
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])