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ID
44895
Descrição
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
Palavras-chave
Versões (2)
- 24/04/2018 24/04/2018 - Halim Ugurlu
- 31/03/2022 31/03/2022 - Martin Dugas
Titular dos direitos
GSK
Transferido a
31 de março de 2022
DOI
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Licença
Creative Commons BY-NC 4.0
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GSK Study ID 104864-201-Laboratory (next Course)
Laboratory Tests
- StudyEvent: GSK Study ID 104864-201-Laboratory (next Course)
Similar models
Laboratory Tests
- StudyEvent: GSK Study ID 104864-201-Laboratory (next Course)
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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)
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)
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)
C0587081 (UMLS CUI-2)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
CL Item
Negative (0)
CL Item
Trace (1)
CL Item
Positive (2)
CL Item
Not Done (3)
CL Item
Negative (0)
CL Item
Trace (1)
CL Item
Positive (2)
CL Item
Not Done (3)
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])
CL Item
Negative (0)
CL Item
1-4 (Few) (1)
CL Item
>4(Many) (3)
CL Item
Negative (0)
CL Item
1-5 (Few) (1)
CL Item
>10 (Many) (3)
CL Item
6-10 (Moderate) (2)
CL Item
Negative (0)
CL Item
1-5 (Few) (1)
CL Item
>5(Many) (3)
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)
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])
C0005953 (UMLS CUI [1,2])
Basophilic Normoblasts (%)
Item
Basophilic Normoblasts (%)
text
C2238288 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
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])
C0005953 (UMLS CUI [1,2])
Promyelocytes (%)
Item
Promyelocytes (%)
text
C0033416 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Myelocytes (%)
Item
Myelocytes (%)
text
C0369715 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Metamyelocytes (%)
Item
Metamyelocytes (%)
text
C0229635 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Bands (%)
Item
Bands (%)
text
C1882076 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Basophils (%)
Item
Basophils (%)
text
C0549791 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Eosinophils (%)
Item
Eosinophils (%)
text
C1171399 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Neutrophils (%)
Item
Neutrophils (%)
text
C4028217 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Lymphocytes (%)
Item
Lymphocytes (%)
text
C0200635 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Plasma Cells (%)
Item
Plasma Cells (%)
text
C0032112 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Monocytes (%)
Item
Monocytes (%)
text
C0026473 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Reticulum Cells (%)
Item
Reticulum Cells (%)
text
C2238294 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Increased (2)
CL Item
Decreased (3)
CL Item
Normal (1)
CL Item
Increased (2)
CL Item
Decreased (3)
CL Item
Aplastic (1)
CL Item
Hypocellular (2)
CL Item
Normacellular (3)
CL Item
Hypercellular (4)
CL Item
Packed (5)
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])
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])
C0012634 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C1517060 (UMLS CUI [1,4])
C0225317 (UMLS CUI [2])
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])
C0150312 (UMLS CUI [1,2])
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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