ID

15078

Description

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Laboratory documentation. Clinical Trial Number: NCT01117441.

Keywords

Versions (1)
  1. 5/15/16 5/15/16 -
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May 15, 2016

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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

English

Laboratory Parameters R-HR AIEOP-BFM ALL 2009 NCT01117441

1 forms  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Study ID
Description

Patient Study ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient Birth Date
Description

Patient Birth Date

Data type

date

Alias
UMLS CUI [1]
C0421451
Laboratory Parameters Study Section (of Randomisation group HR, Prot. IB-ASP+)
Description

Laboratory Parameters Study Section (of Randomisation group HR, Prot. IB-ASP+)

Alias
UMLS CUI-1
C0587081
UMLS CUI-2
C1515004
PEG-L-ASP: date of administration
Description

PEG-L-ASP: date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0071568
UMLS CUI [1,2]
C2584899
GOT measurement (degree of toxicity: Age norm (N))
Description

GOT measurement: toxicity grade

Data type

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C2826262
GOT measurement (degree of toxicity: Age norm (N))
Description

GPT measurement: toxicity grade

Data type

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C2826262
Bilirubin measurement (degree of toxicity: Age norm (N))
Description

Bilirubin measurement: toxicity grade

Data type

text

Alias
UMLS CUI [1,1]
C1278039
UMLS CUI [1,2]
C2826262
Amylases measurement (degree of toxicity: Age norm (N))
Description

Amylases measurement: toxicity grade

Data type

text

Alias
UMLS CUI [1,1]
C0201883
UMLS CUI [1,2]
C2826262
Lipase measurement (degree of toxicity: Age norm (N))
Description

Lipase measurement: toxicity grade

Data type

text

Alias
UMLS CUI [1,1]
C0373670
UMLS CUI [1,2]
C2826262
Laboratory Parameters Control Section (of Randomisation group HR, Prot. IB)
Description

Laboratory Parameters Control Section (of Randomisation group HR, Prot. IB)

Alias
UMLS CUI-1
C0587081
UMLS CUI-2
C0009932
Date in protocol (Day 38 + 52)
Description

Date in protocol

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2348563
GOT measurement (degree of toxicity: Age norm (N))
Description

GOT measurement: toxicity grade

Data type

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C2826262
GOT measurement (degree of toxicity: Age norm (N))
Description

GPT measurement: toxicity grade

Data type

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C2826262
Bilirubin measurement (degree of toxicity: Age norm (N))
Description

Bilirubin measurement: toxicity grade

Data type

text

Alias
UMLS CUI [1,1]
C1278039
UMLS CUI [1,2]
C2826262
Amylases measurement (degree of toxicity: Age norm (N))
Description

Amylases measurement: toxicity grade

Data type

text

Alias
UMLS CUI [1,1]
C0201883
UMLS CUI [1,2]
C2826262
Lipase measurement (degree of toxicity: Age norm (N))
Description

Lipase measurement: toxicity grade

Data type

text

Alias
UMLS CUI [1,1]
C0373670
UMLS CUI [1,2]
C2826262
Identification and Signature
Description

Identification and Signature

Alias
UMLS CUI-1
C0205396
UMLS CUI-3
C1519316
Investigator's name
Description

Investigator's name

Data type

text

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0027365
Date of report
Description

Date of report

Data type

date

Alias
UMLS CUI [1]
C1302584
Investigator's signature
Description

Investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Laboratory Parameters R-HR AIEOP-BFM ALL 2009 NCT01117441

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
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)
PEG-L-ASP: date of administration
Item
PEG-L-ASP: date of administration
date
C0071568 (UMLS CUI [1,1])
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])
GOT measurement
Code List
GOT measurement (degree of toxicity: Age norm (N))
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])
GPT measurement
Code List
GOT measurement (degree of toxicity: Age norm (N))
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])
Bilirubin measurement
Code List
Bilirubin measurement (degree of toxicity: Age norm (N))
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])
Amylases measurement
Code List
Amylases measurement (degree of toxicity: Age norm (N))
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])
Lipase measurement
Code List
Lipase measurement (degree of toxicity: Age norm (N))
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)
Date in protocol
Item
Date in protocol (Day 38 + 52)
date
C0011008 (UMLS CUI [1,1])
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])
GOT measurement
Code List
GOT measurement (degree of toxicity: Age norm (N))
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])
GPT measurement
Code List
GOT measurement (degree of toxicity: Age norm (N))
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])
Bilirubin measurement
Code List
Bilirubin measurement (degree of toxicity: Age norm (N))
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])
Amylases measurement
Code List
Amylases measurement (degree of toxicity: Age norm (N))
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])
Lipase measurement
Code List
Lipase measurement (degree of toxicity: Age norm (N))
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)
Investigator's name
Item
Investigator's name
text
C2346576 (UMLS CUI [1,1])
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])
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