ID

44895

Beschreibung

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Link

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Stichworte

  1. 24.04.18 24.04.18 - Halim Ugurlu
  2. 31.03.22 31.03.22 - Martin Dugas
Rechteinhaber

GSK

Hochgeladen am

31. März 2022

DOI

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Lizenz

Creative Commons BY-NC 4.0

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GSK Study ID 104864-201-Laboratory (next Course)

Laboratory Tests

  1. StudyEvent: GSK Study ID 104864-201-Laboratory (next Course)
    1. Laboratory Tests
Identification Numbers
Beschreibung

Identification Numbers

Alias
UMLS CUI-1
C1300638
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Laboratory Tests-Hematology
Beschreibung

Laboratory Tests-Hematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Sample Date
Beschreibung

Sample Date

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Laboratory Name
Beschreibung

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Hemoglobin
Beschreibung

I.6

Datentyp

float

Maßeinheiten
  • g/dl
Alias
UMLS CUI [1]
C0019046
g/dl
Hematocrit
Beschreibung

I.7

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0518014
%
RBC
Beschreibung

I.8

Datentyp

float

Alias
UMLS CUI [1]
C0014772
WBC
Beschreibung

I.9

Datentyp

float

Alias
UMLS CUI [1]
C0023508
Neutrophils - segmented
Beschreibung

I.10

Datentyp

float

Alias
UMLS CUI [1]
C0229640
Bands
Beschreibung

Bands

Datentyp

text

Alias
UMLS CUI [1]
C1882076
Lymphocytes
Beschreibung

I.12

Datentyp

float

Alias
UMLS CUI [1]
C0200635
Monocytes
Beschreibung

I.13

Datentyp

float

Alias
UMLS CUI [1]
C0026473
Eosinophils
Beschreibung

I.14

Datentyp

float

Alias
UMLS CUI [1]
C0857996
Basophils
Beschreibung

I.15

Datentyp

float

Alias
UMLS CUI [1]
C0200641
Platelets
Beschreibung

I.16

Datentyp

float

Alias
UMLS CUI [1]
C0005821
Blast Cells
Beschreibung

I.17

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0368761
%
Prothrombin Time (PT)
Beschreibung

I.18

Datentyp

float

Alias
UMLS CUI [1]
C0033707
Partial Thromboplastin Time
Beschreibung

I.19

Datentyp

float

Alias
UMLS CUI [1]
C3525810
Fibrinogen
Beschreibung

I.20

Datentyp

float

Alias
UMLS CUI [1]
C0016006
Laboratory Tests-Blood Chemistry
Beschreibung

Laboratory Tests-Blood Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0005774
Visit
Beschreibung

Screening, Day 1, Day 2.... Day 1 tests are required only if not performed within the previous 7 days or if abnormal at the Screening visit. Do not fill day 1 if not required NOTE: If the laboratory changes during the study, a new set of reference ranges must be completed.

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Sample Date
Beschreibung

Sample Date

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Laboratory Name
Beschreibung

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Sodium
Beschreibung

I.24

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0337443
mmol/l
Potassium
Beschreibung

I.25

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Chloride
Beschreibung

I.26

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0201952
mmol/l
Bicarbonate
Beschreibung

I.27

Datentyp

float

Alias
UMLS CUI [1]
C0202059
Calcium
Beschreibung

I.28

Datentyp

float

Alias
UMLS CUI [1]
C0201925
Phosphorus
Beschreibung

I.29

Datentyp

float

Alias
UMLS CUI [1]
C0031705
Magnesium
Beschreibung

I.30

Datentyp

float

Alias
UMLS CUI [1]
C0373675
BUN
Beschreibung

I.31

Datentyp

float

Alias
UMLS CUI [1]
C0005845
Urea
Beschreibung

I.32

Datentyp

float

Alias
UMLS CUI [1]
C0523961
Uric Acid
Beschreibung

I.33

Datentyp

float

Alias
UMLS CUI [1]
C0202239
Creatinine
Beschreibung

I.34

Datentyp

float

Alias
UMLS CUI [1]
C0201976
Alkaline Phosphatase
Beschreibung

I.35

Datentyp

float

Alias
UMLS CUI [1]
C0201850
LDH
Beschreibung

I.36

Datentyp

float

Alias
UMLS CUI [1]
C0202113
SGOT/AST
Beschreibung

I.37

Datentyp

float

Alias
UMLS CUI [1]
C0201899
SGPT/ALT
Beschreibung

I.38

Datentyp

float

Alias
UMLS CUI [1]
C0201836
Total Bilirubin
Beschreibung

I.39

Datentyp

float

Alias
UMLS CUI [1]
C0201913
Direct Bilirubin
Beschreibung

I.40

Datentyp

float

Alias
UMLS CUI [1]
C0201916
Total Protein
Beschreibung

I.41

Datentyp

float

Alias
UMLS CUI [1]
C0555903
Albumin
Beschreibung

I.42

Datentyp

float

Alias
UMLS CUI [1]
C0201838
Creatinine Clearance
Beschreibung

I.43

Datentyp

float

Alias
UMLS CUI [1]
C0373595
Serum Beta HCG
Beschreibung

I.44

Datentyp

float

Alias
UMLS CUI [1]
C2348195
Are there clinically significant abnormal laboratory values?
Beschreibung

Are there clinically significant abnormal laboratory values?

Datentyp

text

Alias
UMLS CUI [1]
C0438215
Laboratory Tests-Urinalysis
Beschreibung

Laboratory Tests-Urinalysis

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0587081
Sample Date
Beschreibung

Sample Date

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Laboratory Name
Beschreibung

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Protein
Beschreibung

Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

Datentyp

text

Alias
UMLS CUI [1]
C0262923
Glucose
Beschreibung

Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

Datentyp

text

Alias
UMLS CUI [1]
C0004076
Blood
Beschreibung

Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

Datentyp

text

Alias
UMLS CUI [1]
C0202514
Was microscopy performed?
Beschreibung

Complete microscopy if protein and/or blood results are positive Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

Datentyp

boolean

Alias
UMLS CUI [1]
C0430397
RBC/HPF
Beschreibung

Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

Datentyp

text

Alias
UMLS CUI [1]
C4039763
WBC/HPF
Beschreibung

Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

Datentyp

text

Alias
UMLS CUI [1]
C4039553
Casts/LPF
Beschreibung

Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

Datentyp

text

Alias
UMLS CUI [1]
C0439356
Crystals/LPF
Beschreibung

Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

Datentyp

text

Alias
UMLS CUI [1]
C1287304
Are there clinically significant abnormal laboratory values?
Beschreibung

If 'Yes', record the findings and/or diagnosis on page x for Screening, or in the Adverse Experience section

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
Laboratory Tests-Bone Marrow Examination
Beschreibung

Laboratory Tests-Bone Marrow Examination

Alias
UMLS CUI-1
C0005957
UMLS CUI-2
C0022885
Sample Date
Beschreibung

Sample Date

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Laboratory Name
Beschreibung

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Pronormoblasts (%)
Beschreibung

Erythroid Series

Datentyp

text

Alias
UMLS CUI [1,1]
C2350150
UMLS CUI [1,2]
C0005953
Basophilic Normoblasts (%)
Beschreibung

Erythroid Series

Datentyp

text

Alias
UMLS CUI [1,1]
C2238288
UMLS CUI [1,2]
C0005953
Polychromatophilic Normoblasts (%)
Beschreibung

Erythroid Series

Datentyp

text

Alias
UMLS CUI [1]
C2238289
Orthochromatic Normoblasts (%)
Beschreibung

Erythroid Series

Datentyp

text

Alias
UMLS CUI [1]
C2238290
Myeloblasts (%)
Beschreibung

Myeloblasts (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C0229633
UMLS CUI [1,2]
C0005953
Promyelocytes (%)
Beschreibung

Promyelocytes (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C0033416
UMLS CUI [1,2]
C0005953
Myelocytes (%)
Beschreibung

Myelocytes (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C0369715
UMLS CUI [1,2]
C0005953
Metamyelocytes (%)
Beschreibung

Metamyelocytes (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C0229635
UMLS CUI [1,2]
C0005953
Bands (%)
Beschreibung

Bands (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C1882076
UMLS CUI [1,2]
C0005953
Basophils (%)
Beschreibung

Basophils (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C0549791
UMLS CUI [1,2]
C0005953
Eosinophils (%)
Beschreibung

Eosinophils (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C1171399
UMLS CUI [1,2]
C0005953
Neutrophils (%)
Beschreibung

Neutrophils (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C4028217
UMLS CUI [1,2]
C0005953
Lymphocytes (%)
Beschreibung

Lymphocytes (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C0005953
Plasma Cells (%)
Beschreibung

Plasma Cells (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C0032112
UMLS CUI [1,2]
C0005953
Monocytes (%)
Beschreibung

Monocytes (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C0026473
UMLS CUI [1,2]
C0005953
Reticulum Cells (%)
Beschreibung

Reticulum Cells (%)

Datentyp

text

Alias
UMLS CUI [1]
C2238294
Megakaryocytes (%)
Beschreibung

Megakaryocytes (%)

Datentyp

text

Alias
UMLS CUI [1,1]
C0025166
UMLS CUI [1,2]
C0005953
Myeloid Erythroid Ratio
Beschreibung

Myeloid Erythroid Ratio

Datentyp

text

Alias
UMLS CUI [1]
C2238284
Cellularity of Specimen
Beschreibung

Cellularity of Specimen

Datentyp

text

Alias
UMLS CUI [1]
C1561532
Biopsy
Beschreibung

Biopsy

Datentyp

text

Alias
UMLS CUI [1]
C0005954
Does the patient have splenomegaly?
Beschreibung

Splenomegaly

Datentyp

boolean

Alias
UMLS CUI [1]
C0038002
Does the patient have extramedullary disease or soft tissue involvement?
Beschreibung

Extramedullary disease or soft tissue involvement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C1517060
UMLS CUI [2]
C0225317
If yes to Extramedullary disease or soft tissue involvement, please record the site(s)
Beschreibung

If yes to Extramedullary disease or soft tissue involvement

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C1517060
UMLS CUI [2]
C0225317
Cytogenetics
Beschreibung

Cytogenetics

Alias
UMLS CUI-1
C0010802
Sample Date
Beschreibung

Sample Date

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Laboratory Name
Beschreibung

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Chromosome Abnormalities Present
Beschreibung

Chromosome Abnormalities Present

Datentyp

text

Alias
UMLS CUI [1,1]
C4015468
UMLS CUI [1,2]
C0150312

Ähnliche Modelle

Laboratory Tests

  1. StudyEvent: GSK Study ID 104864-201-Laboratory (next Course)
    1. Laboratory Tests
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Identification Numbers
C1300638 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Laboratory Tests-Hematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
I.6
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
I.7
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
I.8
Item
RBC
float
C0014772 (UMLS CUI [1])
I.9
Item
WBC
float
C0023508 (UMLS CUI [1])
I.10
Item
Neutrophils - segmented
float
C0229640 (UMLS CUI [1])
Bands
Item
Bands
text
C1882076 (UMLS CUI [1])
I.12
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
I.13
Item
Monocytes
float
C0026473 (UMLS CUI [1])
I.14
Item
Eosinophils
float
C0857996 (UMLS CUI [1])
I.15
Item
Basophils
float
C0200641 (UMLS CUI [1])
I.16
Item
Platelets
float
C0005821 (UMLS CUI [1])
I.17
Item
Blast Cells
float
C0368761 (UMLS CUI [1])
I.18
Item
Prothrombin Time (PT)
float
C0033707 (UMLS CUI [1])
I.19
Item
Partial Thromboplastin Time
float
C3525810 (UMLS CUI [1])
I.20
Item
Fibrinogen
float
C0016006 (UMLS CUI [1])
Item Group
Laboratory Tests-Blood Chemistry
C1254595 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
I.24
Item
Sodium
float
C0337443 (UMLS CUI [1])
I.25
Item
Potassium
float
C0202194 (UMLS CUI [1])
I.26
Item
Chloride
float
C0201952 (UMLS CUI [1])
I.27
Item
Bicarbonate
float
C0202059 (UMLS CUI [1])
I.28
Item
Calcium
float
C0201925 (UMLS CUI [1])
I.29
Item
Phosphorus
float
C0031705 (UMLS CUI [1])
I.30
Item
Magnesium
float
C0373675 (UMLS CUI [1])
I.31
Item
BUN
float
C0005845 (UMLS CUI [1])
I.32
Item
Urea
float
C0523961 (UMLS CUI [1])
I.33
Item
Uric Acid
float
C0202239 (UMLS CUI [1])
I.34
Item
Creatinine
float
C0201976 (UMLS CUI [1])
I.35
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
I.36
Item
LDH
float
C0202113 (UMLS CUI [1])
I.37
Item
SGOT/AST
float
C0201899 (UMLS CUI [1])
I.38
Item
SGPT/ALT
float
C0201836 (UMLS CUI [1])
I.39
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
I.40
Item
Direct Bilirubin
float
C0201916 (UMLS CUI [1])
I.41
Item
Total Protein
float
C0555903 (UMLS CUI [1])
I.42
Item
Albumin
float
C0201838 (UMLS CUI [1])
I.43
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
I.44
Item
Serum Beta HCG
float
C2348195 (UMLS CUI [1])
Item
Are there clinically significant abnormal laboratory values?
text
C0438215 (UMLS CUI [1])
Code List
Are there clinically significant abnormal laboratory values?
CL Item
No (1)
CL Item
Yes (If 'Yes', record findings and/or diagnosis on page for Screening or in the Adverse Experience section) (2)
Item Group
Laboratory Tests-Urinalysis
C0042014 (UMLS CUI-1)
C0587081 (UMLS CUI-2)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Item
Protein
text
C0262923 (UMLS CUI [1])
Code List
Protein
CL Item
Negative (0)
CL Item
Trace (1)
CL Item
Positive (2)
CL Item
Not Done (3)
Item
Glucose
text
C0004076 (UMLS CUI [1])
Code List
Glucose
CL Item
Negative  (0)
CL Item
Trace  (1)
CL Item
Positive  (2)
CL Item
Not Done (3)
Item
Blood
text
C0202514 (UMLS CUI [1])
Code List
Blood
CL Item
Negative  (0)
CL Item
Trace  (1)
CL Item
Positive  (2)
CL Item
Not Done (3)
Microscopy of Urin
Item
Was microscopy performed?
boolean
C0430397 (UMLS CUI [1])
Item
RBC/HPF
text
C4039763 (UMLS CUI [1])
Code List
RBC/HPF
CL Item
Negative (0)
CL Item
1-4 (Few) (1)
CL Item
>4(Many) (3)
Item
WBC/HPF
text
C4039553 (UMLS CUI [1])
Code List
WBC/HPF
CL Item
Negative  (0)
CL Item
1-5 (Few) (1)
CL Item
>10 (Many) (3)
CL Item
6-10 (Moderate) (2)
Item
Casts/LPF
text
C0439356 (UMLS CUI [1])
Code List
Casts/LPF
CL Item
Negative (0)
CL Item
1-5 (Few) (1)
CL Item
>5(Many) (3)
Item
Crystals/LPF
text
C1287304 (UMLS CUI [1])
Code List
Crystals/LPF
CL Item
Negative (0)
CL Item
1-2 (Few) (1)
CL Item
>2(Many) (3)
Are there clinically significant abnormal laboratory values?
Item
Are there clinically significant abnormal laboratory values?
boolean
C0438215 (UMLS CUI [1])
Item Group
Laboratory Tests-Bone Marrow Examination
C0005957 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Pronormoblasts (%)
Item
Pronormoblasts (%)
text
C2350150 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Basophilic Normoblasts (%)
Item
Basophilic Normoblasts (%)
text
C2238288 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Polychromatophilic Normoblasts (%)
Item
Polychromatophilic Normoblasts (%)
text
C2238289 (UMLS CUI [1])
Orthochromatic Normoblasts (%)
Item
Orthochromatic Normoblasts (%)
text
C2238290 (UMLS CUI [1])
Myeloblasts (%)
Item
Myeloblasts (%)
text
C0229633 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Promyelocytes (%)
Item
Promyelocytes (%)
text
C0033416 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Myelocytes (%)
Item
Myelocytes (%)
text
C0369715 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Metamyelocytes (%)
Item
Metamyelocytes (%)
text
C0229635 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Bands (%)
Item
Bands (%)
text
C1882076 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Basophils (%)
Item
Basophils (%)
text
C0549791 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Eosinophils (%)
Item
Eosinophils (%)
text
C1171399 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Neutrophils (%)
Item
Neutrophils (%)
text
C4028217 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Lymphocytes (%)
Item
Lymphocytes (%)
text
C0200635 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Plasma Cells (%)
Item
Plasma Cells (%)
text
C0032112 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Monocytes (%)
Item
Monocytes (%)
text
C0026473 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Reticulum Cells (%)
Item
Reticulum Cells (%)
text
C2238294 (UMLS CUI [1])
Item
Megakaryocytes (%)
text
C0025166 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Code List
Megakaryocytes (%)
CL Item
Normal (1)
CL Item
Increased (2)
CL Item
Decreased (3)
Item
Myeloid Erythroid Ratio
text
C2238284 (UMLS CUI [1])
Code List
Myeloid Erythroid Ratio
CL Item
Normal (1)
CL Item
Increased (2)
CL Item
Decreased (3)
Item
Cellularity of Specimen
text
C1561532 (UMLS CUI [1])
Code List
Cellularity of Specimen
CL Item
Aplastic (1)
CL Item
Hypocellular (2)
CL Item
Normacellular (3)
CL Item
Hypercellular (4)
CL Item
Packed (5)
Item
Biopsy
text
C0005954 (UMLS CUI [1])
Code List
Biopsy
CL Item
Normal (1)
CL Item
Presence of blast cell clusters (2)
CL Item
ALIP (3)
Splenomegaly
Item
Does the patient have splenomegaly?
boolean
C0038002 (UMLS CUI [1])
Extramedullary disease or soft tissue involvement
Item
Does the patient have extramedullary disease or soft tissue involvement?
boolean
C1515974 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C1517060 (UMLS CUI [1,4])
C0225317 (UMLS CUI [2])
If yes to Extramedullary disease or soft tissue involvement
Item
If yes to Extramedullary disease or soft tissue involvement, please record the site(s)
text
C1515974 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C1517060 (UMLS CUI [1,4])
C0225317 (UMLS CUI [2])
Item Group
Cytogenetics
C0010802 (UMLS CUI-1)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Item
Chromosome Abnormalities Present
text
C4015468 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Code List
Chromosome Abnormalities Present
CL Item
None (0)
CL Item
-5/del (5q) (1)
CL Item
-7/del (7q) (2)
CL Item
+8 (3)
CL Item
+9 del(9q) (4)
CL Item
-11q (5)
CL Item
-12p (6)
CL Item
del(13q) (7)
CL Item
-18 (8)
CL Item
+19 (9)
CL Item
+21 (10)
CL Item
3q21-26 (11)
CL Item
t(1;7) (12)
CL Item
Other, Specify.... (13)

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