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