ID
44895
Beschrijving
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
Trefwoorden
Versies (2)
- 4/24/18 4/24/18 - Halim Ugurlu
- 3/31/22 3/31/22 - Martin Dugas
Houder van rechten
GSK
Geüploaded op
March 31, 2022
DOI
Voor een aanvraag inloggen.
Licentie
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)
Beschrijving
Laboratory Tests-Hematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Laboratory Name
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
I.6
Datatype
float
Maateenheden
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Beschrijving
I.7
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0518014
Beschrijving
I.8
Datatype
float
Alias
- UMLS CUI [1]
- C0014772
Beschrijving
I.9
Datatype
float
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
I.10
Datatype
float
Alias
- UMLS CUI [1]
- C0229640
Beschrijving
Bands
Datatype
text
Alias
- UMLS CUI [1]
- C1882076
Beschrijving
I.12
Datatype
float
Alias
- UMLS CUI [1]
- C0200635
Beschrijving
I.13
Datatype
float
Alias
- UMLS CUI [1]
- C0026473
Beschrijving
I.14
Datatype
float
Alias
- UMLS CUI [1]
- C0857996
Beschrijving
I.15
Datatype
float
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
I.16
Datatype
float
Alias
- UMLS CUI [1]
- C0005821
Beschrijving
I.17
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0368761
Beschrijving
I.18
Datatype
float
Alias
- UMLS CUI [1]
- C0033707
Beschrijving
I.19
Datatype
float
Alias
- UMLS CUI [1]
- C3525810
Beschrijving
I.20
Datatype
float
Alias
- UMLS CUI [1]
- C0016006
Beschrijving
Laboratory Tests-Blood Chemistry
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0005774
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Laboratory Name
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
I.24
Datatype
float
Maateenheden
- mmol/l
Alias
- UMLS CUI [1]
- C0337443
Beschrijving
I.25
Datatype
float
Maateenheden
- mmol/l
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
I.26
Datatype
float
Maateenheden
- mmol/l
Alias
- UMLS CUI [1]
- C0201952
Beschrijving
I.27
Datatype
float
Alias
- UMLS CUI [1]
- C0202059
Beschrijving
I.28
Datatype
float
Alias
- UMLS CUI [1]
- C0201925
Beschrijving
I.29
Datatype
float
Alias
- UMLS CUI [1]
- C0031705
Beschrijving
I.30
Datatype
float
Alias
- UMLS CUI [1]
- C0373675
Beschrijving
I.31
Datatype
float
Alias
- UMLS CUI [1]
- C0005845
Beschrijving
I.32
Datatype
float
Alias
- UMLS CUI [1]
- C0523961
Beschrijving
I.33
Datatype
float
Alias
- UMLS CUI [1]
- C0202239
Beschrijving
I.34
Datatype
float
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
I.35
Datatype
float
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
I.36
Datatype
float
Alias
- UMLS CUI [1]
- C0202113
Beschrijving
I.37
Datatype
float
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
I.38
Datatype
float
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
I.39
Datatype
float
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
I.40
Datatype
float
Alias
- UMLS CUI [1]
- C0201916
Beschrijving
I.41
Datatype
float
Alias
- UMLS CUI [1]
- C0555903
Beschrijving
I.42
Datatype
float
Alias
- UMLS CUI [1]
- C0201838
Beschrijving
I.43
Datatype
float
Alias
- UMLS CUI [1]
- C0373595
Beschrijving
I.44
Datatype
float
Alias
- UMLS CUI [1]
- C2348195
Beschrijving
Are there clinically significant abnormal laboratory values?
Datatype
text
Alias
- UMLS CUI [1]
- C0438215
Beschrijving
Laboratory Tests-Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0587081
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Laboratory Name
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatype
text
Alias
- UMLS CUI [1]
- C0262923
Beschrijving
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatype
text
Alias
- UMLS CUI [1]
- C0004076
Beschrijving
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatype
text
Alias
- UMLS CUI [1]
- C0202514
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0430397
Beschrijving
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatype
text
Alias
- UMLS CUI [1]
- C4039763
Beschrijving
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatype
text
Alias
- UMLS CUI [1]
- C4039553
Beschrijving
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatype
text
Alias
- UMLS CUI [1]
- C0439356
Beschrijving
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatype
text
Alias
- UMLS CUI [1]
- C1287304
Beschrijving
If 'Yes', record the findings and/or diagnosis on page x for Screening, or in the Adverse Experience section
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438215
Beschrijving
Laboratory Tests-Bone Marrow Examination
Alias
- UMLS CUI-1
- C0005957
- UMLS CUI-2
- C0022885
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Laboratory Name
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Erythroid Series
Datatype
text
Alias
- UMLS CUI [1,1]
- C2350150
- UMLS CUI [1,2]
- C0005953
Beschrijving
Erythroid Series
Datatype
text
Alias
- UMLS CUI [1,1]
- C2238288
- UMLS CUI [1,2]
- C0005953
Beschrijving
Erythroid Series
Datatype
text
Alias
- UMLS CUI [1]
- C2238289
Beschrijving
Erythroid Series
Datatype
text
Alias
- UMLS CUI [1]
- C2238290
Beschrijving
Myeloblasts (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0229633
- UMLS CUI [1,2]
- C0005953
Beschrijving
Promyelocytes (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0033416
- UMLS CUI [1,2]
- C0005953
Beschrijving
Myelocytes (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0369715
- UMLS CUI [1,2]
- C0005953
Beschrijving
Metamyelocytes (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0229635
- UMLS CUI [1,2]
- C0005953
Beschrijving
Bands (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1882076
- UMLS CUI [1,2]
- C0005953
Beschrijving
Basophils (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0549791
- UMLS CUI [1,2]
- C0005953
Beschrijving
Eosinophils (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1171399
- UMLS CUI [1,2]
- C0005953
Beschrijving
Neutrophils (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C4028217
- UMLS CUI [1,2]
- C0005953
Beschrijving
Lymphocytes (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0200635
- UMLS CUI [1,2]
- C0005953
Beschrijving
Plasma Cells (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0032112
- UMLS CUI [1,2]
- C0005953
Beschrijving
Monocytes (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0026473
- UMLS CUI [1,2]
- C0005953
Beschrijving
Reticulum Cells (%)
Datatype
text
Alias
- UMLS CUI [1]
- C2238294
Beschrijving
Megakaryocytes (%)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0025166
- UMLS CUI [1,2]
- C0005953
Beschrijving
Myeloid Erythroid Ratio
Datatype
text
Alias
- UMLS CUI [1]
- C2238284
Beschrijving
Cellularity of Specimen
Datatype
text
Alias
- UMLS CUI [1]
- C1561532
Beschrijving
Biopsy
Datatype
text
Alias
- UMLS CUI [1]
- C0005954
Beschrijving
Splenomegaly
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038002
Beschrijving
Extramedullary disease or soft tissue involvement
Datatype
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
Beschrijving
If yes to Extramedullary disease or soft tissue involvement
Datatype
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
Beschrijving
Cytogenetics
Alias
- UMLS CUI-1
- C0010802
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Laboratory Name
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Chromosome Abnormalities Present
Datatype
text
Alias
- UMLS CUI [1,1]
- C4015468
- UMLS CUI [1,2]
- C0150312
Similar models
Laboratory Tests
- StudyEvent: GSK Study ID 104864-201-Laboratory (next Course)
C0474523 (UMLS CUI-2)
C0005774 (UMLS CUI-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])
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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