ID
29868
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 (1)
- 4/24/18 4/24/18 - Halim Ugurlu
Copyright Holder
GSK
Uploaded on
April 24, 2018
DOI
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License
Creative Commons BY-NC 3.0
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GSK Study ID 104864-201 Serious Adverse Experience
Serious Adverse Experience (SAE)
- StudyEvent: ODM
Description
Serious Adverse Experience (SAE)
Alias
- UMLS CUI-1
- C1519255
Description
Person Reporting SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0335038
- UMLS CUI [1,2]
- C1519255
Description
Serious Adverse Experience
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Reason(s) for considering this a serious AE
Data type
text
Alias
- UMLS CUI [1]
- C3828190
Description
Onset Data and Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Description
End Date and Time (if ongoing please leave blank)
Data type
datetime
Alias
- UMLS CUI [1]
- C2981425
Description
Outcome
Data type
text
Alias
- UMLS CUI [1]
- C1705586
Description
Experience Course
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
Common Toxicity Grade
Data type
text
Alias
- UMLS CUI [1]
- C2826262
Description
Action Taken with Respect to Investigational Drug
Data type
text
Alias
- UMLS CUI [1]
- C2826626
Description
SAE Abate
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Description
Study medication reintroduced
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0580673
Description
If Yes to study medication reintroduced (or dose increased)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
Description
Relationship to Investigational Drug
Data type
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C3854006
Description
Assessment of SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1710056
Description
Corrective Therapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
Withdrawn due to this specific SAE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Description
Relevant Laboratory Data - Please provide relevant abnormal laboratory data below
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0027365
Description
Relevant Laboratory Data-Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Description
Relevant Laboratory Data-Value
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0587081
Description
Relevant Laboratory Data-Units
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1519795
Description
Relevant Laboratory Data-Normal Range
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0086715
Description
Remarks (Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)
Data type
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0947611
Description
Additional Informations
Alias
- UMLS CUI-1
- C1546922
Description
Randomisation code broken at investigational site
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C1272691
- UMLS CUI [1,3]
- C2825164
Description
Randomisation/Study Medication Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
Investigators Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigators Signature Date
Data type
date
Alias
- UMLS CUI [1]
- C0807937
Description
Please PRINT name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Serious Adverse Experience (SAE)
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C3853704 (UMLS CUI [1,2])
C0580673 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C1272691 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])