ID
29862
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 Response Assessment Study Conclusion
Response Assessment / Study Conclusion
- StudyEvent: ODM
Beschrijving
Response Assessment at the end of the Course
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0806020
- UMLS CUI-4
- C0750729
Beschrijving
1- CR=Complete Response
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0205197
Beschrijving
Mark one of the following
Datatype
text
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0205197
Beschrijving
2- PR=Partial Response
Datatype
boolean
Alias
- UMLS CUI [1]
- C1521726
Beschrijving
15- HI=Hematologic Improvement
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0018943
- UMLS CUI [1,3]
- C1704632
- UMLS CUI [1,4]
- C2986411
Beschrijving
3- SD=Stable Disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0677946
Beschrijving
4- PD=Progressive Disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C1335499
Beschrijving
Mark one of the following
Datatype
text
Alias
- UMLS CUI [1]
- C1335499
Beschrijving
8- ND= Complete Evaluation Not Done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C1272696
Beschrijving
Response Assessment performed by
Datatype
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C0521982
Beschrijving
Study Status
Alias
- UMLS CUI-1
- C2348568
Beschrijving
Best Overall Response Assessment
Alias
- UMLS CUI-1
- C2986560
- UMLS CUI-2
- C1516048
Beschrijving
Complete this section only if the patient discontinues at Course 1. Mark the box if not required.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1514873
- UMLS CUI [1,2]
- C1518422
Beschrijving
Best Overall Response Assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C2986560
- UMLS CUI [1,2]
- C1516048
Beschrijving
Please enter the date when blood counts return to normal or have stabilized following the last course of treatment. Patient will be considered to have finished treatment and will enter the Post Treatment Follow-up phase
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0005768
- UMLS CUI [1,4]
- C0079107
- UMLS CUI [1,5]
- C0005771
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschrijving
Complete the study
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348577
Beschrijving
If No to Complete the Study
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Beschrijving
Date of Final Study Evaluation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator`s Signature
Alias
- UMLS CUI-1
- C2346576
Similar models
Response Assessment / Study Conclusion
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C0806020 (UMLS CUI-3)
C0750729 (UMLS CUI-4)
C0205197 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C0018943 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C2986411 (UMLS CUI [1,4])
C1272696 (UMLS CUI [1,2])
C0521982 (UMLS CUI [1,2])
C1516048 (UMLS CUI-2)
C1518422 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,3])
C0079107 (UMLS CUI [1,4])
C0005771 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])