ID
44898
Description
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
Keywords
Versions (2)
- 4/24/18 4/24/18 - Halim Ugurlu
- 4/1/22 4/1/22 - Martin Dugas
Copyright Holder
GSK
Uploaded on
April 1, 2022
DOI
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License
Creative Commons BY-NC 4.0
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GSK Study ID 104864-201 Laboratory Tests
Laboratory Tests
- StudyEvent: GSK Study ID 104864-201 Laboratory Tests
Description
Laboratory Tests-Hematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Description
Screening, Day 1, Day 2.... If the laboratory changes during the study, a new set of reference ranges must be completed.
Data type
text
Alias
- UMLS CUI [1]
- C0545082
Description
Sample Date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Sample Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0040223
Description
Hemoglobin
Data type
float
Alias
- UMLS CUI [1]
- C0019046
Description
Hematocrit
Data type
float
Alias
- UMLS CUI [1]
- C0518014
Description
RBC
Data type
float
Alias
- UMLS CUI [1]
- C0014772
Description
WBC
Data type
text
Alias
- UMLS CUI [1]
- C0023508
Description
Neutrophils - segmented
Data type
float
Alias
- UMLS CUI [1]
- C0229640
Description
Bands
Data type
float
Alias
- UMLS CUI [1]
- C1882076
Description
Lymphocytes
Data type
float
Alias
- UMLS CUI [1]
- C0200635
Description
Monocytes
Data type
float
Alias
- UMLS CUI [1]
- C0026473
Description
Eosinophils
Data type
float
Alias
- UMLS CUI [1]
- C0857996
Description
Basophils
Data type
float
Alias
- UMLS CUI [1]
- C0200641
Description
Platelets
Data type
float
Alias
- UMLS CUI [1]
- C0005821
Description
Blast Cells
Data type
float
Alias
- UMLS CUI [1]
- C0368761
Description
Prothrombin Time (PT)
Data type
float
Alias
- UMLS CUI [1]
- C0033707
Description
Partial Thromboplastin Time
Data type
float
Alias
- UMLS CUI [1]
- C3525810
Description
Fibrinogen
Data type
float
Alias
- UMLS CUI [1]
- C0016006
Description
Laboratory Tests-Blood Chemistry
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0005774
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C0545082
Description
Sample Date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Sample Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0040223
Description
Sodium
Data type
float
Alias
- UMLS CUI [1]
- C0337443
Description
Potassium
Data type
float
Alias
- UMLS CUI [1]
- C0202194
Description
Chloride
Data type
float
Alias
- UMLS CUI [1]
- C0201952
Description
Bicarbonate
Data type
float
Alias
- UMLS CUI [1]
- C0202059
Description
Calcium
Data type
float
Alias
- UMLS CUI [1]
- C0201925
Description
Phosphorus
Data type
float
Alias
- UMLS CUI [1]
- C0031705
Description
Magnesium
Data type
float
Alias
- UMLS CUI [1]
- C0373675
Description
BUN
Data type
float
Alias
- UMLS CUI [1]
- C0005845
Description
Urea
Data type
float
Alias
- UMLS CUI [1]
- C0523961
Description
Uric Asid
Data type
float
Alias
- UMLS CUI [1]
- C0202239
Description
Creatinine
Data type
float
Alias
- UMLS CUI [1]
- C0201976
Description
Alkaline Phosphatase
Data type
float
Alias
- UMLS CUI [1]
- C0201850
Description
LDH
Data type
float
Alias
- UMLS CUI [1]
- C0202113
Description
SGOT/AST
Data type
float
Alias
- UMLS CUI [1]
- C0201899
Description
SGPT/ALT
Data type
float
Alias
- UMLS CUI [1]
- C0201836
Description
Total Bilirubin
Data type
float
Alias
- UMLS CUI [1]
- C0201913
Description
Direct Bilirubin
Data type
float
Alias
- UMLS CUI [1]
- C0201916
Description
Total Protein
Data type
float
Alias
- UMLS CUI [1]
- C0555903
Description
Albumin
Data type
float
Alias
- UMLS CUI [1]
- C0201838
Description
Creatinine Clearance
Data type
float
Alias
- UMLS CUI [1]
- C0373595
Description
Serum Beta HCG
Data type
float
Alias
- UMLS CUI [1]
- C2348195
Description
Are there clinically significant abnormal laboratory values?
Data type
text
Alias
- UMLS CUI [1]
- C0438215
Description
Laboratory Tests-Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0587081
Description
Screening, Day 1, Day 2....
Data type
text
Alias
- UMLS CUI [1]
- C0545082
Description
Sample Date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Data type
float
Alias
- UMLS CUI [1]
- C0262923
Description
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Data type
float
Alias
- UMLS CUI [1]
- C0004076
Description
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Data type
float
Alias
- UMLS CUI [1]
- C0202514
Description
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.
Data type
boolean
Alias
- UMLS CUI [1]
- C0430397
Description
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Data type
float
Alias
- UMLS CUI [1]
- C4039763
Description
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Data type
float
Alias
- UMLS CUI [1]
- C4039553
Description
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Data type
float
Alias
- UMLS CUI [1]
- C0439356
Description
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Data type
text
Alias
- UMLS CUI [1]
- C1287304
Description
If 'Yes', record the findings and/or diagnosis on page x for Screening, or in the Adverse Experience section
Data type
boolean
Alias
- UMLS CUI [1]
- C0438215
Description
Laboratory Tests-Bone Marrow Examination
Alias
- UMLS CUI-1
- C0005957
- UMLS CUI-2
- C0022885
Description
Screening, visit 1...
Data type
text
Alias
- UMLS CUI [1]
- C0545082
Description
Sample Date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Erythroid Series
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C2350150
- UMLS CUI [1,2]
- C0005953
Description
Erythroid Series
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C2238288
- UMLS CUI [1,2]
- C0005953
Description
Erythroid Series
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C2238289
Description
Erythroid Series
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C2238290
Description
Neutrophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C4028217
- UMLS CUI [1,2]
- C0005953
Description
Eosinophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C1171399
- UMLS CUI [1,2]
- C0005953
Description
Basophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0549791
- UMLS CUI [1,2]
- C0005953
Description
Bands
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C1882076
- UMLS CUI [1,2]
- C0005953
Description
Metamyelocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0229635
- UMLS CUI [1,2]
- C0005953
Description
Myelocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0369715
- UMLS CUI [1,2]
- C0005953
Description
Promyelocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0033416
- UMLS CUI [1,2]
- C0005953
Description
Myeloblasts
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0229633
- UMLS CUI [1,2]
- C0005953
Description
Lymphocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0200635
- UMLS CUI [1,2]
- C0005953
Description
Plasma Cells
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0032112
- UMLS CUI [1,2]
- C0005953
Description
Monocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0026473
- UMLS CUI [1,2]
- C0005953
Description
Reticulum Cells
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C2238294
Description
Megakaryocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0025166
- UMLS CUI [1,2]
- C0005953
Description
Myeloid Erythroid Ratio
Data type
float
Alias
- UMLS CUI [1]
- C2238284
Description
Cellularity of Specimen
Data type
text
Alias
- UMLS CUI [1]
- C1561532
Description
Biopsy
Data type
text
Alias
- UMLS CUI [1]
- C0005954
Description
Splenomegaly
Data type
boolean
Alias
- UMLS CUI [1]
- C0038002
Description
Extramedullary disease or soft tissue involvement
Data type
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
Description
If yes to Extramedullary disease or soft tissue involvement
Data type
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
Description
Cytogenetics
Alias
- UMLS CUI-1
- C0010802
Description
Screening, Visit-1 ...
Data type
text
Alias
- UMLS CUI [1]
- C0545082
Description
Sample Date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Chromosome Abnormalities Present
Data type
text
Alias
- UMLS CUI [1,1]
- C4015468
- UMLS CUI [1,2]
- C0150312
Similar models
Laboratory Tests
- StudyEvent: GSK Study ID 104864-201 Laboratory Tests
C0474523 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0005774 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0587081 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
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])
C0150312 (UMLS CUI [1,2])
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