ID
44895
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)
- 24.04.18 24.04.18 - Halim Ugurlu
- 31.03.22 31.03.22 - Martin Dugas
Rechteinhaber
GSK
Hochgeladen am
31. März 2022
DOI
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Lizenz
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)
Beschreibung
Laboratory Tests-Hematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschreibung
Sample Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Laboratory Name
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
I.6
Datentyp
float
Maßeinheiten
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Beschreibung
I.7
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0518014
Beschreibung
I.8
Datentyp
float
Alias
- UMLS CUI [1]
- C0014772
Beschreibung
I.9
Datentyp
float
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
I.10
Datentyp
float
Alias
- UMLS CUI [1]
- C0229640
Beschreibung
Bands
Datentyp
text
Alias
- UMLS CUI [1]
- C1882076
Beschreibung
I.12
Datentyp
float
Alias
- UMLS CUI [1]
- C0200635
Beschreibung
I.13
Datentyp
float
Alias
- UMLS CUI [1]
- C0026473
Beschreibung
I.14
Datentyp
float
Alias
- UMLS CUI [1]
- C0857996
Beschreibung
I.15
Datentyp
float
Alias
- UMLS CUI [1]
- C0200641
Beschreibung
I.16
Datentyp
float
Alias
- UMLS CUI [1]
- C0005821
Beschreibung
I.17
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0368761
Beschreibung
I.18
Datentyp
float
Alias
- UMLS CUI [1]
- C0033707
Beschreibung
I.19
Datentyp
float
Alias
- UMLS CUI [1]
- C3525810
Beschreibung
I.20
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
Laboratory Name
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
I.24
Datentyp
float
Maßeinheiten
- mmol/l
Alias
- UMLS CUI [1]
- C0337443
Beschreibung
I.25
Datentyp
float
Maßeinheiten
- mmol/l
Alias
- UMLS CUI [1]
- C0202194
Beschreibung
I.26
Datentyp
float
Maßeinheiten
- mmol/l
Alias
- UMLS CUI [1]
- C0201952
Beschreibung
I.27
Datentyp
float
Alias
- UMLS CUI [1]
- C0202059
Beschreibung
I.28
Datentyp
float
Alias
- UMLS CUI [1]
- C0201925
Beschreibung
I.29
Datentyp
float
Alias
- UMLS CUI [1]
- C0031705
Beschreibung
I.30
Datentyp
float
Alias
- UMLS CUI [1]
- C0373675
Beschreibung
I.31
Datentyp
float
Alias
- UMLS CUI [1]
- C0005845
Beschreibung
I.32
Datentyp
float
Alias
- UMLS CUI [1]
- C0523961
Beschreibung
I.33
Datentyp
float
Alias
- UMLS CUI [1]
- C0202239
Beschreibung
I.34
Datentyp
float
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
I.35
Datentyp
float
Alias
- UMLS CUI [1]
- C0201850
Beschreibung
I.36
Datentyp
float
Alias
- UMLS CUI [1]
- C0202113
Beschreibung
I.37
Datentyp
float
Alias
- UMLS CUI [1]
- C0201899
Beschreibung
I.38
Datentyp
float
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
I.39
Datentyp
float
Alias
- UMLS CUI [1]
- C0201913
Beschreibung
I.40
Datentyp
float
Alias
- UMLS CUI [1]
- C0201916
Beschreibung
I.41
Datentyp
float
Alias
- UMLS CUI [1]
- C0555903
Beschreibung
I.42
Datentyp
float
Alias
- UMLS CUI [1]
- C0201838
Beschreibung
I.43
Datentyp
float
Alias
- UMLS CUI [1]
- C0373595
Beschreibung
I.44
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
Sample Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Laboratory Name
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datentyp
text
Alias
- UMLS CUI [1]
- C0262923
Beschreibung
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datentyp
text
Alias
- UMLS CUI [1]
- C0004076
Beschreibung
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datentyp
text
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
text
Alias
- UMLS CUI [1]
- C4039763
Beschreibung
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datentyp
text
Alias
- UMLS CUI [1]
- C4039553
Beschreibung
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
Datentyp
text
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
Sample Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Laboratory Name
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Erythroid Series
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2350150
- UMLS CUI [1,2]
- C0005953
Beschreibung
Erythroid Series
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2238288
- UMLS CUI [1,2]
- C0005953
Beschreibung
Erythroid Series
Datentyp
text
Alias
- UMLS CUI [1]
- C2238289
Beschreibung
Erythroid Series
Datentyp
text
Alias
- UMLS CUI [1]
- C2238290
Beschreibung
Myeloblasts (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0229633
- UMLS CUI [1,2]
- C0005953
Beschreibung
Promyelocytes (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0033416
- UMLS CUI [1,2]
- C0005953
Beschreibung
Myelocytes (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0369715
- UMLS CUI [1,2]
- C0005953
Beschreibung
Metamyelocytes (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0229635
- UMLS CUI [1,2]
- C0005953
Beschreibung
Bands (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1882076
- UMLS CUI [1,2]
- C0005953
Beschreibung
Basophils (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0549791
- UMLS CUI [1,2]
- C0005953
Beschreibung
Eosinophils (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1171399
- UMLS CUI [1,2]
- C0005953
Beschreibung
Neutrophils (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C4028217
- UMLS CUI [1,2]
- C0005953
Beschreibung
Lymphocytes (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0200635
- UMLS CUI [1,2]
- C0005953
Beschreibung
Plasma Cells (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0032112
- UMLS CUI [1,2]
- C0005953
Beschreibung
Monocytes (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0026473
- UMLS CUI [1,2]
- C0005953
Beschreibung
Reticulum Cells (%)
Datentyp
text
Alias
- UMLS CUI [1]
- C2238294
Beschreibung
Megakaryocytes (%)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0025166
- UMLS CUI [1,2]
- C0005953
Beschreibung
Myeloid Erythroid Ratio
Datentyp
text
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
Sample Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Laboratory Name
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
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 (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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