ID
29868
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 (1)
- 2018-04-24 2018-04-24 - Halim Ugurlu
Rättsinnehavare
GSK
Uppladdad den
24 april 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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GSK Study ID 104864-201 Serious Adverse Experience
Serious Adverse Experience (SAE)
- StudyEvent: ODM
Beskrivning
Serious Adverse Experience (SAE)
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Person Reporting SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0335038
- UMLS CUI [1,2]
- C1519255
Beskrivning
Serious Adverse Experience
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Reason(s) for considering this a serious AE
Datatyp
text
Alias
- UMLS CUI [1]
- C3828190
Beskrivning
Onset Data and Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Beskrivning
End Date and Time (if ongoing please leave blank)
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2981425
Beskrivning
Outcome
Datatyp
text
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
Experience Course
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
Common Toxicity Grade
Datatyp
text
Alias
- UMLS CUI [1]
- C2826262
Beskrivning
Action Taken with Respect to Investigational Drug
Datatyp
text
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
SAE Abate
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beskrivning
Study medication reintroduced
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0580673
Beskrivning
If Yes to study medication reintroduced (or dose increased)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
Beskrivning
Relationship to Investigational Drug
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C3854006
Beskrivning
Assessment of SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1710056
Beskrivning
Corrective Therapy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
Withdrawn due to this specific SAE
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beskrivning
Relevant Laboratory Data - Please provide relevant abnormal laboratory data below
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0027365
Beskrivning
Relevant Laboratory Data-Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beskrivning
Relevant Laboratory Data-Value
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0587081
Beskrivning
Relevant Laboratory Data-Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1519795
Beskrivning
Relevant Laboratory Data-Normal Range
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0086715
Beskrivning
Remarks (Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0947611
Beskrivning
Additional Informations
Alias
- UMLS CUI-1
- C1546922
Beskrivning
Randomisation code broken at investigational site
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C1272691
- UMLS CUI [1,3]
- C2825164
Beskrivning
Randomisation/Study Medication Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
Investigators Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigators Signature Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0807937
Beskrivning
Please PRINT name
Datatyp
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])