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ID
15078
Description
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Laboratory documentation. Clinical Trial Number: NCT01117441.
Mots-clés
Versions (1)
- 15/05/2016 15/05/2016 -
Téléchargé le
15 mai 2016
DOI
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Creative Commons BY-NC-ND 3.0
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Laboratory Parameters R-HR AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441
Laboratory Parameters R-HR AIEOP-BFM ALL 2009 NCT01117441
- StudyEvent: ODM
Similar models
Laboratory Parameters R-HR AIEOP-BFM ALL 2009 NCT01117441
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Patient Study ID
Item
Patient Study ID
text
C2348585 (UMLS CUI [1])
Patient Birth Date
Item
Patient Birth Date
date
C0421451 (UMLS CUI [1])
Item Group
Laboratory Parameters Study Section (of Randomisation group HR, Prot. IB-ASP+)
C0587081 (UMLS CUI-1)
C1515004 (UMLS CUI-2)
C1515004 (UMLS CUI-2)
PEG-L-ASP: date of administration
Item
PEG-L-ASP: date of administration
date
C0071568 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
C2584899 (UMLS CUI [1,2])
Item
GOT measurement (degree of toxicity: Age norm (N))
text
C0201899 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
CL Item
1 (>N - 2.5xN) (1 (>N - 2.5xN))
CL Item
2 (>2.5 - 5.0xN) (2 (>2.5 - 5.0xN))
CL Item
3 (>5.0 - 20.0xN) (3 (>5.0 - 20.0xN))
CL Item
4 (>20.0xN) (4 (>20.0xN))
CL Item
0 (N) (0 (N))
Item
GOT measurement (degree of toxicity: Age norm (N))
text
C0201836 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
CL Item
1 (>N - 2.5xN) (1 (>N - 2.5xN))
CL Item
2 (>2.5 - 5.0xN) (2 (>2.5 - 5.0xN))
CL Item
3 (>5.0 - 20.0xN) (3 (>5.0 - 20.0xN))
CL Item
4 (>20.0xN) (4 (>20.0xN))
CL Item
0 (N) (0 (N))
Item
Bilirubin measurement (degree of toxicity: Age norm (N))
text
C1278039 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
CL Item
0 (N) (0 (N))
CL Item
1 (>N - 1.5xN) (1 (>N - 1.5xN))
CL Item
2 (>1.5 - 3.0xN) (2 (>1.5 - 3.0xN))
CL Item
3 (>3.0 - 10.0xN) (3 (>3.0 - 10.0xN))
CL Item
4 (>10.0xN) (4 (>10.0xN))
Item
Amylases measurement (degree of toxicity: Age norm (N))
text
C0201883 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
CL Item
0 (N) (0 (N))
CL Item
1 (>N - 1.5xN) (1 (>N - 1.5xN))
CL Item
2 (>1.5 - 2.0xN) (2 (>1.5 - 2.0xN))
CL Item
3 (>2.0 - 5.0xN) (3 (>2.0 - 5.0xN))
CL Item
4 (>5.0xN) (4 (>5.0xN))
Item
Lipase measurement (degree of toxicity: Age norm (N))
text
C0373670 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
CL Item
0 (N) (0 (N))
CL Item
1 (>N - 1.5xN) (1 (>N - 1.5xN))
CL Item
2 (>1.5 - 2.0xN) (2 (>1.5 - 2.0xN))
CL Item
3 (>2.0 - 5.0xN) (3 (>2.0 - 5.0xN))
CL Item
4 (>5.0xN) (4 (>5.0xN))
Item Group
Laboratory Parameters Control Section (of Randomisation group HR, Prot. IB)
C0587081 (UMLS CUI-1)
C0009932 (UMLS CUI-2)
C0009932 (UMLS CUI-2)
Date in protocol
Item
Date in protocol (Day 38 + 52)
date
C0011008 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
Item
GOT measurement (degree of toxicity: Age norm (N))
text
C0201899 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
CL Item
1 (>N - 2.5xN) (1 (>N - 2.5xN))
CL Item
2 (>2.5 - 5.0xN) (2 (>2.5 - 5.0xN))
CL Item
3 (>5.0 - 20.0xN) (3 (>5.0 - 20.0xN))
CL Item
4 (>20.0xN) (4 (>20.0xN))
CL Item
0 (N) (0 (N))
Item
GOT measurement (degree of toxicity: Age norm (N))
text
C0201836 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
CL Item
1 (>N - 2.5xN) (1 (>N - 2.5xN))
CL Item
2 (>2.5 - 5.0xN) (2 (>2.5 - 5.0xN))
CL Item
3 (>5.0 - 20.0xN) (3 (>5.0 - 20.0xN))
CL Item
4 (>20.0xN) (4 (>20.0xN))
CL Item
0 (N) (0 (N))
Item
Bilirubin measurement (degree of toxicity: Age norm (N))
text
C1278039 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
CL Item
0 (N) (0 (N))
CL Item
1 (>N - 1.5xN) (1 (>N - 1.5xN))
CL Item
2 (>1.5 - 3.0xN) (2 (>1.5 - 3.0xN))
CL Item
3 (>3.0 - 10.0xN) (3 (>3.0 - 10.0xN))
CL Item
4 (>10.0xN) (4 (>10.0xN))
Item
Amylases measurement (degree of toxicity: Age norm (N))
text
C0201883 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
CL Item
0 (N) (0 (N))
CL Item
1 (>N - 1.5xN) (1 (>N - 1.5xN))
CL Item
2 (>1.5 - 2.0xN) (2 (>1.5 - 2.0xN))
CL Item
3 (>2.0 - 5.0xN) (3 (>2.0 - 5.0xN))
CL Item
4 (>5.0xN) (4 (>5.0xN))
Item
Lipase measurement (degree of toxicity: Age norm (N))
text
C0373670 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
CL Item
0 (N) (0 (N))
CL Item
1 (>N - 1.5xN) (1 (>N - 1.5xN))
CL Item
2 (>1.5 - 2.0xN) (2 (>1.5 - 2.0xN))
CL Item
3 (>2.0 - 5.0xN) (3 (>2.0 - 5.0xN))
CL Item
4 (>5.0xN) (4 (>5.0xN))
Item Group
Identification and Signature
C0205396 (UMLS CUI-1)
C1519316 (UMLS CUI-3)
C1519316 (UMLS CUI-3)
Investigator's name
Item
Investigator's name
text
C2346576 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,2])
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])