ID
29862
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
Lien
https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Mots-clés
Versions (1)
- 24/04/2018 24/04/2018 - Halim Ugurlu
Détendeur de droits
GSK
Téléchargé le
24 avril 2018
DOI
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Licence
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
Description
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
Description
1- CR=Complete Response
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0205197
Description
Mark one of the following
Type de données
text
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0205197
Description
2- PR=Partial Response
Type de données
boolean
Alias
- UMLS CUI [1]
- C1521726
Description
15- HI=Hematologic Improvement
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0018943
- UMLS CUI [1,3]
- C1704632
- UMLS CUI [1,4]
- C2986411
Description
3- SD=Stable Disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C0677946
Description
4- PD=Progressive Disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C1335499
Description
Mark one of the following
Type de données
text
Alias
- UMLS CUI [1]
- C1335499
Description
8- ND= Complete Evaluation Not Done
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C1272696
Description
Response Assessment performed by
Type de données
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C0521982
Description
Study Status
Alias
- UMLS CUI-1
- C2348568
Description
Best Overall Response Assessment
Alias
- UMLS CUI-1
- C2986560
- UMLS CUI-2
- C1516048
Description
Complete this section only if the patient discontinues at Course 1. Mark the box if not required.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1514873
- UMLS CUI [1,2]
- C1518422
Description
Best Overall Response Assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986560
- UMLS CUI [1,2]
- C1516048
Description
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
Type de données
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
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
Complete the study
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348577
Description
If No to Complete the Study
Type de données
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Description
Date of Final Study Evaluation
Type de données
date
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C0011008
Description
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])