ID
29859
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
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Licentie
Creative Commons BY-NC 3.0
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GSK Study ID 104864-201 Adverse Experiences (non-serious)
Adverse Experiences (non-Serious)
- StudyEvent: ODM
Beschrijving
Adverse Experiences (non-Serious)
Alias
- UMLS CUI-1
- C1518404
Beschrijving
No Advers Experiences
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1298908
Beschrijving
If you consider this to be a serious adverse experience (SAE), please do not enter on this page but enter in the SAE section in the back of this binder (See tab for definitions of an SAE).
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Adverse Experiences (non-Serious)
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Record any adverse experiences (using standard medical terminology ) observed or elicited by the following direct question to patient: "Do you feel different in any way since starting the treatment or since the last visit ?" Provide the diagnosis not symptoms where possible. Enter one adverse experience per column
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
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
Relationship to Investigational Drug
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C3854006
Beschrijving
Corrective Therapy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
Withdrawn due to this specific AE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beschrijving
Investigators Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigators Signature Date
Datatype
date
Alias
- UMLS CUI [1]
- C0807937
Similar models
Adverse Experiences (non-Serious)
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])