ID

37279

Descrição

Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Palavras-chave

Versões (1)
  1. 12.07.19 12.07.19 -
Titular dos direitos

GlaxoSmithKline

Transferido a

12. Juli 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173

Inglês

Study Conclusion

1 Formulários  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject Identifier
Descrição

Clinical Trial Subject Unique Identifier

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Study Conclusion
Descrição

Study Conclusion

Alias
UMLS CUI-1
C1707478 (Conclusion)
UMLS CUI-2
C0008972 (Clinical Research)
Date of subject completion or withdrawal
Descrição

Completion Status, Date in time; Withdraw, Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0805732 (Completion Status)
UMLS CUI [1,2]
C0011008 (Date in time)
SNOMED
410671006
UMLS CUI [2,1]
C2349954 (Withdraw (activity))
UMLS CUI [2,2]
C0011008 (Date in time)
SNOMED
410671006
Was the subject withdrawn from the study?
Descrição

Withdraw

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2349954 (Withdraw (activity))
If Yes, check the primary reason for withdrawal
Descrição

Withdraw, Reason and justification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2349954 (Withdraw (activity))
UMLS CUI [1,2]
C0566251 (Reason and justification)
SNOMED
288830005
Specify
Descrição

Withdraw, Reason and justification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2349954 (Withdraw (activity))
UMLS CUI [1,2]
C0566251 (Reason and justification)
SNOMED
288830005
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Similar models

Study Conclusion

1 Formulários
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Completion Status, Date in time; Withdraw, Date in time
Item
Date of subject completion or withdrawal
date
C0805732 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2349954 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Withdraw
Item
Was the subject withdrawn from the study?
boolean
C2349954 (UMLS CUI [1])
Item
If Yes, check the primary reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Withdraw, Reason and justification
Code List
If Yes, check the primary reason for withdrawal
CL Item
Adverse event  (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study  (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Disease progression (7)
CL Item
Other, specify (8)
Withdraw, Reason and justification
Item
Specify
text
C2349954 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
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