ID

37721

Description

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Keywords

Versions (1)
  1. 8/20/19 8/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 20, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

English

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Center number
Description

Study Coordinating Center, Identification number

Data type

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C1707478
Did the patient complete the study as planned?
Description

Clinical Trials, Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205197
If 'No', mark the Primary cause of withdrawal.
Description

Clinical Trials, Withdraw, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0566251
Other - specify
Description

Clinical Trials, Withdraw, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0566251
Comment on the reason for withdrawal
Description

Clinical Trials, Withdraw, Reason and justification, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0947611
Date of Final Study Evaluation
Description

Clinical Trials, Evaluation, Final, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C3853528
UMLS CUI [1,4]
C0011008
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Study Conclusion
C0008976 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Clinical Trials, Complete
Item
Did the patient complete the study as planned?
boolean
C0008976 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
If 'No', mark the Primary cause of withdrawal.
text
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Clinical Trials, Withdraw, Reason and justification
Code List
If 'No', mark the Primary cause of withdrawal.
CL Item
Adverse Experience (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other - specify (5)
Clinical Trials, Withdraw, Reason and justification
Item
Other - specify
text
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Clinical Trials, Withdraw, Reason and justification, Comment
Item
Comment on the reason for withdrawal
text
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Clinical Trials, Evaluation, Final, Date in time
Item
Date of Final Study Evaluation
date
C0008976 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C3853528 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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