ID

37279

Descripción

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

Palabras clave

Versiones (1)
  1. 12/7/19 12/7/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de julio de 2019

DOI

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Licencia

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

Inglés

Study Conclusion

1 formularios  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Study Conclusion
Descripción

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Descripción

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

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C2349954
UMLS CUI [2,2]
C0011008
Was the subject withdrawn from the study?
Descripción

Withdraw

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2349954
If Yes, check the primary reason for withdrawal
Descripción

Withdraw, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0566251
Specify
Descripción

Withdraw, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0566251
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Similar models

Study Conclusion

1 formularios
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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