ID
44895
Beskrivning
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
Länk
https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Nyckelord
Versioner (2)
- 2018-04-24 2018-04-24 - Halim Ugurlu
- 2022-03-31 2022-03-31 - Martin Dugas
Rättsinnehavare
GSK
Uppladdad den
31 mars 2022
DOI
För en begäran logga in.
Licens
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)
Beskrivning
Laboratory Tests-Hematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Laboratory Name
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
I.6
Datatyp
float
Måttenheter
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Beskrivning
I.7
Datatyp
float
Måttenheter
- %
Alias
- UMLS CUI [1]
- C0518014
Beskrivning
I.8
Datatyp
float
Alias
- UMLS CUI [1]
- C0014772
Beskrivning
I.9
Datatyp
float
Alias
- UMLS CUI [1]
- C0023508
Beskrivning
I.10
Datatyp
float
Alias
- UMLS CUI [1]
- C0229640
Beskrivning
Bands
Datatyp
text
Alias
- UMLS CUI [1]
- C1882076
Beskrivning
I.12
Datatyp
float
Alias
- UMLS CUI [1]
- C0200635
Beskrivning
I.13
Datatyp
float
Alias
- UMLS CUI [1]
- C0026473
Beskrivning
I.14
Datatyp
float
Alias
- UMLS CUI [1]
- C0857996
Beskrivning
I.15
Datatyp
float
Alias
- UMLS CUI [1]
- C0200641
Beskrivning
I.16
Datatyp
float
Alias
- UMLS CUI [1]
- C0005821
Beskrivning
I.17
Datatyp
float
Måttenheter
- %
Alias
- UMLS CUI [1]
- C0368761
Beskrivning
I.18
Datatyp
float
Alias
- UMLS CUI [1]
- C0033707
Beskrivning
I.19
Datatyp
float
Alias
- UMLS CUI [1]
- C3525810
Beskrivning
I.20
Datatyp
float
Alias
- UMLS CUI [1]
- C0016006
Beskrivning
Laboratory Tests-Blood Chemistry
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0005774
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C0545082
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Laboratory Name
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
I.24
Datatyp
float
Måttenheter
- mmol/l
Alias
- UMLS CUI [1]
- C0337443
Beskrivning
I.25
Datatyp
float
Måttenheter
- mmol/l
Alias
- UMLS CUI [1]
- C0202194
Beskrivning
I.26
Datatyp
float
Måttenheter
- mmol/l
Alias
- UMLS CUI [1]
- C0201952
Beskrivning
I.27
Datatyp
float
Alias
- UMLS CUI [1]
- C0202059
Beskrivning
I.28
Datatyp
float
Alias
- UMLS CUI [1]
- C0201925
Beskrivning
I.29
Datatyp
float
Alias
- UMLS CUI [1]
- C0031705
Beskrivning
I.30
Datatyp
float
Alias
- UMLS CUI [1]
- C0373675
Beskrivning
I.31
Datatyp
float
Alias
- UMLS CUI [1]
- C0005845
Beskrivning
I.32
Datatyp
float
Alias
- UMLS CUI [1]
- C0523961
Beskrivning
I.33
Datatyp
float
Alias
- UMLS CUI [1]
- C0202239
Beskrivning
I.34
Datatyp
float
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
I.35
Datatyp
float
Alias
- UMLS CUI [1]
- C0201850
Beskrivning
I.36
Datatyp
float
Alias
- UMLS CUI [1]
- C0202113
Beskrivning
I.37
Datatyp
float
Alias
- UMLS CUI [1]
- C0201899
Beskrivning
I.38
Datatyp
float
Alias
- UMLS CUI [1]
- C0201836
Beskrivning
I.39
Datatyp
float
Alias
- UMLS CUI [1]
- C0201913
Beskrivning
I.40
Datatyp
float
Alias
- UMLS CUI [1]
- C0201916
Beskrivning
I.41
Datatyp
float
Alias
- UMLS CUI [1]
- C0555903
Beskrivning
I.42
Datatyp
float
Alias
- UMLS CUI [1]
- C0201838
Beskrivning
I.43
Datatyp
float
Alias
- UMLS CUI [1]
- C0373595
Beskrivning
I.44
Datatyp
float
Alias
- UMLS CUI [1]
- C2348195
Beskrivning
Are there clinically significant abnormal laboratory values?
Datatyp
text
Alias
- UMLS CUI [1]
- C0438215
Beskrivning
Laboratory Tests-Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0587081
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Laboratory Name
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatyp
text
Alias
- UMLS CUI [1]
- C0262923
Beskrivning
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatyp
text
Alias
- UMLS CUI [1]
- C0004076
Beskrivning
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatyp
text
Alias
- UMLS CUI [1]
- C0202514
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0430397
Beskrivning
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatyp
text
Alias
- UMLS CUI [1]
- C4039763
Beskrivning
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatyp
text
Alias
- UMLS CUI [1]
- C4039553
Beskrivning
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatyp
text
Alias
- UMLS CUI [1]
- C0439356
Beskrivning
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datatyp
text
Alias
- UMLS CUI [1]
- C1287304
Beskrivning
If 'Yes', record the findings and/or diagnosis on page x for Screening, or in the Adverse Experience section
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0438215
Beskrivning
Laboratory Tests-Bone Marrow Examination
Alias
- UMLS CUI-1
- C0005957
- UMLS CUI-2
- C0022885
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Laboratory Name
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
Erythroid Series
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2350150
- UMLS CUI [1,2]
- C0005953
Beskrivning
Erythroid Series
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2238288
- UMLS CUI [1,2]
- C0005953
Beskrivning
Erythroid Series
Datatyp
text
Alias
- UMLS CUI [1]
- C2238289
Beskrivning
Erythroid Series
Datatyp
text
Alias
- UMLS CUI [1]
- C2238290
Beskrivning
Myeloblasts (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0229633
- UMLS CUI [1,2]
- C0005953
Beskrivning
Promyelocytes (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0033416
- UMLS CUI [1,2]
- C0005953
Beskrivning
Myelocytes (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0369715
- UMLS CUI [1,2]
- C0005953
Beskrivning
Metamyelocytes (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0229635
- UMLS CUI [1,2]
- C0005953
Beskrivning
Bands (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1882076
- UMLS CUI [1,2]
- C0005953
Beskrivning
Basophils (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0549791
- UMLS CUI [1,2]
- C0005953
Beskrivning
Eosinophils (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1171399
- UMLS CUI [1,2]
- C0005953
Beskrivning
Neutrophils (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C4028217
- UMLS CUI [1,2]
- C0005953
Beskrivning
Lymphocytes (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0200635
- UMLS CUI [1,2]
- C0005953
Beskrivning
Plasma Cells (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032112
- UMLS CUI [1,2]
- C0005953
Beskrivning
Monocytes (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0026473
- UMLS CUI [1,2]
- C0005953
Beskrivning
Reticulum Cells (%)
Datatyp
text
Alias
- UMLS CUI [1]
- C2238294
Beskrivning
Megakaryocytes (%)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0025166
- UMLS CUI [1,2]
- C0005953
Beskrivning
Myeloid Erythroid Ratio
Datatyp
text
Alias
- UMLS CUI [1]
- C2238284
Beskrivning
Cellularity of Specimen
Datatyp
text
Alias
- UMLS CUI [1]
- C1561532
Beskrivning
Biopsy
Datatyp
text
Alias
- UMLS CUI [1]
- C0005954
Beskrivning
Splenomegaly
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038002
Beskrivning
Extramedullary disease or soft tissue involvement
Datatyp
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
Beskrivning
If yes to Extramedullary disease or soft tissue involvement
Datatyp
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
Beskrivning
Cytogenetics
Alias
- UMLS CUI-1
- C0010802
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Laboratory Name
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
Chromosome Abnormalities Present
Datatyp
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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