ID
29868
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 (1)
- 24-04-18 24-04-18 - Halim Ugurlu
Houder van rechten
GSK
Geüploaded op
24 april 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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GSK Study ID 104864-201 Serious Adverse Experience
Serious Adverse Experience (SAE)
- StudyEvent: ODM
Beschrijving
Serious Adverse Experience (SAE)
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Person Reporting SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0335038
- UMLS CUI [1,2]
- C1519255
Beschrijving
Serious Adverse Experience
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Reason(s) for considering this a serious AE
Datatype
text
Alias
- UMLS CUI [1]
- C3828190
Beschrijving
Onset Data and Time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Beschrijving
End Date and Time (if ongoing please leave blank)
Datatype
datetime
Alias
- UMLS CUI [1]
- C2981425
Beschrijving
Outcome
Datatype
text
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Experience Course
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
Common Toxicity Grade
Datatype
text
Alias
- UMLS CUI [1]
- C2826262
Beschrijving
Action Taken with Respect to Investigational Drug
Datatype
text
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
SAE Abate
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beschrijving
Study medication reintroduced
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0580673
Beschrijving
If Yes to study medication reintroduced (or dose increased)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
Beschrijving
Relationship to Investigational Drug
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C3854006
Beschrijving
Assessment of SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1710056
Beschrijving
Corrective Therapy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
Withdrawn due to this specific SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beschrijving
Relevant Laboratory Data - Please provide relevant abnormal laboratory data below
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0027365
Beschrijving
Relevant Laboratory Data-Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beschrijving
Relevant Laboratory Data-Value
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0587081
Beschrijving
Relevant Laboratory Data-Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1519795
Beschrijving
Relevant Laboratory Data-Normal Range
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0086715
Beschrijving
Remarks (Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0947611
Beschrijving
Additional Informations
Alias
- UMLS CUI-1
- C1546922
Beschrijving
Randomisation code broken at investigational site
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C1272691
- UMLS CUI [1,3]
- C2825164
Beschrijving
Randomisation/Study Medication Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschrijving
Investigators Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigators Signature Date
Datatype
date
Alias
- UMLS CUI [1]
- C0807937
Beschrijving
Please PRINT name
Datatype
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])