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ID
22291
Description
Study part: Exceptional laboratory assessments. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"
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Versions (1)
- 29/05/2017 29/05/2017 -
Détendeur de droits
Roche
Téléchargé le
29 mai 2017
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Creative Commons BY-NC 3.0
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EXCEPTIONAL LABORATORY ASSESSMENTS Roche H0650g Breast Cancer
EXCEPTIONAL LABORATORY ASSESSMENTS
- StudyEvent: ODM
Similar models
EXCEPTIONAL LABORATORY ASSESSMENTS
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
week
Item
WEEK
integer
C0439230 (UMLS CUI [1])
Laboratory name location
Item
NAME AND LOCATION OF LAB
text
C3258037 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
DATE SPECIMEN COLLECTED
Item
DATE SPECIMEN COLLECTED:
date
C0011008 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
Albumin
Item
1 ALBUMIN DONE?
boolean
C0201838 (UMLS CUI [1])
Laboratory test finding albumin
Item
1 ALBUMIN RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
C0201838 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
2 ALKALINE PHOSPHATASE DONE?
boolean
C0201850 (UMLS CUI [1])
Laboratory test finding Alkaline Phosphatase
Item
2 ALKALINE PHOSPHATASE RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0201850 (UMLS CUI [1,2])
C0201850 (UMLS CUI [1,2])
ALT/ SGPT
Item
3 ALT/ SGPT DONE?
boolean
C0580468 (UMLS CUI [1])
Laboratory test finding ALT/ SGPT
Item
3 ALT/ SGPT RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0580468 (UMLS CUI [1,2])
C0580468 (UMLS CUI [1,2])
AST / SGOT
Item
4 AST / SGOT DONE?
boolean
C0727806 (UMLS CUI [1])
Laboratory test finding AST / SGOT
Item
4 AST / SGOT RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0727806 (UMLS CUI [1,2])
C0727806 (UMLS CUI [1,2])
TOTAL BILIRUBIN
Item
5 TOTAL BILIRUBIN DONE?
boolean
C0201913 (UMLS CUI [1])
Laboratory test finding TOTAL BILIRUBIN
Item
5 TOTAL BILIRUBIN RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C0201913 (UMLS CUI [1,2])
BUN
Item
6 BUN DONE?
boolean
C0005845 (UMLS CUI [1])
Laboratory test finding BUN
Item
6 BUN RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0005845 (UMLS CUI [1,2])
C0005845 (UMLS CUI [1,2])
CALCIUM
Item
7 CALCIUM DONE?
boolean
C0201925 (UMLS CUI [1])
Laboratory test finding CALCIUM
Item
7 CALCIUM RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0201925 (UMLS CUI [1,2])
C0201925 (UMLS CUI [1,2])
CHOLESTEROL
Item
8 CHOLESTEROL DONE?
boolean
C1445957 (UMLS CUI [1])
Laboratory test finding CHOLESTEROL
Item
8 CHOLESTEROL RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C1445957 (UMLS CUI [1,2])
C1445957 (UMLS CUI [1,2])
CREATININE
Item
9 CREATININE DONE?
boolean
C0010294 (UMLS CUI [1])
Laboratory test finding CREATININE
Item
9 CREATININE RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0010294 (UMLS CUI [1,2])
C0010294 (UMLS CUI [1,2])
GLUCOSE
Item
10 GLUCOSE DONE?
boolean
C0202042 (UMLS CUI [1])
Laboratory test finding GLUCOSE
Item
10 GLUCOSE RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C0202042 (UMLS CUI [1,2])
TRIGLYCERIDES
Item
11 TRIGLYCERIDES DONE?
boolean
C0202236 (UMLS CUI [1])
Laboratory test finding TRIGLYCERIDES
Item
11 TRIGLYCERIDES RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0202236 (UMLS CUI [1,2])
C0202236 (UMLS CUI [1,2])
LDH
Item
12 LDH DONE?
boolean
C0202113 (UMLS CUI [1])
Laboratory test finding LDH
Item
12 LDH RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0202113 (UMLS CUI [1,2])
C0202113 (UMLS CUI [1,2])
PHOSPHORUS
Item
13 PHOSPHORUS DONE?
boolean
C0031705 (UMLS CUI [1])
Laboratory test finding PHOSPHORUS
Item
13 PHOSPHORUS RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0031705 (UMLS CUI [1,2])
C0031705 (UMLS CUI [1,2])
TOTAL PROTEIN
Item
14 TOTAL PROTEIN DONE?
boolean
C0555903 (UMLS CUI [1])
Laboratory test finding TOTAL PROTEIN
Item
14 TOTAL PROTEIN RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
C0555903 (UMLS CUI [1,2])
URIC ACID
Item
15 URIC ACID DONE?
boolean
C0041980 (UMLS CUI [1])
Laboratory test finding URIC ACID
Item
15 URIC ACID RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0041980 (UMLS CUI [1,2])
C0041980 (UMLS CUI [1,2])
CHLORIDE
Item
16 CHLORIDE DONE?
boolean
C0201952 (UMLS CUI [1])
Laboratory test finding CHLORIDE
Item
16 CHLORIDE RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0201952 (UMLS CUI [1,2])
C0201952 (UMLS CUI [1,2])
POTASSIUM
Item
17 POTASSIUM DONE?
boolean
C0202194 (UMLS CUI [1])
Laboratory test finding POTASSIUM
Item
17 POTASSIUM RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C0202194 (UMLS CUI [1,2])
SODIUM
Item
18 SODIUM DONE?
boolean
C0337443 (UMLS CUI [1])
Laboratory test finding SODIUM
Item
18 SODIUM RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0337443 (UMLS CUI [1,2])
C0337443 (UMLS CUI [1,2])
BICARBONATE
Item
19 BICARBONATE DONE?
boolean
C0202059 (UMLS CUI [1])
Laboratory test finding BICARBONATE
Item
19 BICARBONATE RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0202059 (UMLS CUI [1,2])
C0202059 (UMLS CUI [1,2])
DATE SPECIMEN COLLECTED
Item
DATE SPECIMEN COLLECTED:
date
C0011008 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
WBC
Item
20 WBC DONE?
boolean
C0023508 (UMLS CUI [1])
Laboratory test finding WBC
Item
20 WBC RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C0023508 (UMLS CUI [1,2])
RBC
Item
21 RBC DONE?
boolean
C0014772 (UMLS CUI [1])
Laboratory test finding RBC
Item
21 RBC RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,2])
HEMOGLOBIN
Item
22 HEMOGLOBIN DONE?
boolean
C0019046 (UMLS CUI [1])
Laboratory test finding HEMOGLOBIN
Item
22 HEMOGLOBIN RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C0019046 (UMLS CUI [1,2])
HEMATOCRIT
Item
23 HEMATOCRIT DONE?
boolean
C0518014 (UMLS CUI [1])
Laboratory test finding HEMATOCRIT
Item
23 HEMATOCRIT RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
C0518014 (UMLS CUI [1,2])
SEGS
Item
24 SEGS DONE?
boolean
C0200633 (UMLS CUI [1])
Laboratory test finding SEGS
Item
24 SEGS RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0200633 (UMLS CUI [1,2])
C0200633 (UMLS CUI [1,2])
LYMPHOCYTES
Item
25 LYMPHOCYTES DONE?
boolean
C0024264 (UMLS CUI [1])
Laboratory test finding LYMPHOCYTES
Item
25 LYMPHOCYTES RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0024264 (UMLS CUI [1,2])
C0024264 (UMLS CUI [1,2])
EOSINOPHILS
Item
26 EOSINOPHILS DONE?
boolean
C0200638 (UMLS CUI [1])
Laboratory test finding EOSINOPHILS
Item
26 EOSINOPHILS RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
C0200638 (UMLS CUI [1,2])
BASOPHILS
Item
27 BASOPHILS DONE?
boolean
C0200641 (UMLS CUI [1])
Laboratory test finding BASOPHILS
Item
27 BASOPHILS RESULT (incl. units)
text
C0200641 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
MONOCYTES
Item
28 MONOCYTES DONE?
boolean
C0026473 (UMLS CUI [1])
Laboratory test finding MONOCYTES
Item
28 MONOCYTES RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0026473 (UMLS CUI [1,2])
C0026473 (UMLS CUI [1,2])
PLATELETS
Item
29 PLATELETS DONE?
boolean
C0005821 (UMLS CUI [1])
Laboratory test finding PLATELETS
Item
29 PLATELETS RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,2])
OTHER
Item
30 OTHER
text
C0205394 (UMLS CUI [1])
OTHER
Item
31 OTHER
text
C0205394 (UMLS CUI [1])
DATE SPECIMEN COLLECTED
Item
DATE SPECIMEN COLLECTED:
date
C0011008 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
PT
Item
32 PT DONE?
boolean
C0033707 (UMLS CUI [1])
Laboratory test finding PT
Item
32 PT RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0033707 (UMLS CUI [1,2])
C0033707 (UMLS CUI [1,2])
PTT
Item
33 PTT DONE?
boolean
C0030605 (UMLS CUI [1])
Laboratory test finding PTT
Item
33 PTT RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0030605 (UMLS CUI [1,2])
C0030605 (UMLS CUI [1,2])
DATE SPECIMEN COLLECTED
Item
DATE SPECIMEN COLLECTED:
date
C0011008 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
SPECIFIC GRAVITY
Item
34 SPECIFIC GRAVITY DONE?
boolean
C0042015 (UMLS CUI [1])
Laboratory test finding SPECIFIC GRAVITY
Item
34 SPECIFIC GRAVITY RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0042015 (UMLS CUI [1,2])
C0042015 (UMLS CUI [1,2])
pH
Item
35 pH DONE?
boolean
C0202165 (UMLS CUI [1])
Laboratory test finding pH
Item
35 pH RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0202165 (UMLS CUI [1,2])
C0202165 (UMLS CUI [1,2])
PROTEIN
Item
36 PROTEIN DONE?
boolean
C0262923 (UMLS CUI [1])
Laboratory test finding PROTEIN
Item
36 PROTEIN RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C0262923 (UMLS CUI [1,2])
GLUCOSE
Item
37 GLUCOSE DONE?
boolean
C0202042 (UMLS CUI [1])
Laboratory test finding GLUCOSE
Item
37 GLUCOSE RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C0202042 (UMLS CUI [1,2])
RBC
Item
38 RBC DONE?
boolean
C0014772 (UMLS CUI [1])
Laboratory test finding RBC
Item
38 RBC RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,2])
WBC
Item
39 WBC DONE?
boolean
C0023508 (UMLS CUI [1])
Laboratory test finding WBC
Item
39 WBC RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C0023508 (UMLS CUI [1,2])
CASTS
Item
40 CASTS DONE?
boolean
C0151990 (UMLS CUI [1])
Laboratory test finding CASTS
Item
40 CASTS RESULT (incl. units)
text
C0587081 (UMLS CUI [1,1])
C0151990 (UMLS CUI [1,2])
C0151990 (UMLS CUI [1,2])