ID

37721

Beschreibung

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

Stichworte

Versionen (1)
  1. 20.08.19 20.08.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. August 2019

DOI

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Lizenz

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

Englisch

Study Conclusion

1 Formulare  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Center number
Beschreibung

Study Coordinating Center, Identification number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2825181 (Study Coordinating Center)
UMLS CUI [1,2]
C1300638 (Identification number)
SNOMED
396278008
Patient Number
Beschreibung

Patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427 (undefined)
Patient Initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440 (Person Initials)
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C0008976 (Clinical Trials)
SNOMED
110465008
LOINC
LP231796-6
UMLS CUI-2
C1707478 (Conclusion)
Did the patient complete the study as planned?
Beschreibung

Clinical Trials, Complete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976 (Clinical Trials)
SNOMED
110465008
LOINC
LP231796-6
UMLS CUI [1,2]
C0205197 (Complete)
SNOMED
255594003
LOINC
LA13937-0
If 'No', mark the Primary cause of withdrawal.
Beschreibung

Clinical Trials, Withdraw, Reason and justification

Datentyp

text

Alias
UMLS CUI [1,1]
C0008976 (Clinical Trials)
SNOMED
110465008
LOINC
LP231796-6
UMLS CUI [1,2]
C2349954 (Withdraw (activity))
UMLS CUI [1,3]
C0566251 (Reason and justification)
SNOMED
288830005
Other - specify
Beschreibung

Clinical Trials, Withdraw, Reason and justification

Datentyp

text

Alias
UMLS CUI [1,1]
C0008976 (Clinical Trials)
SNOMED
110465008
LOINC
LP231796-6
UMLS CUI [1,2]
C2349954 (Withdraw (activity))
UMLS CUI [1,3]
C0566251 (Reason and justification)
SNOMED
288830005
Comment on the reason for withdrawal
Beschreibung

Clinical Trials, Withdraw, Reason and justification, Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0008976 (Clinical Trials)
SNOMED
110465008
LOINC
LP231796-6
UMLS CUI [1,2]
C2349954 (Withdraw (activity))
UMLS CUI [1,3]
C0566251 (Reason and justification)
SNOMED
288830005
UMLS CUI [1,4]
C0947611 (Comment)
LOINC
LP72293-1
Date of Final Study Evaluation
Beschreibung

Clinical Trials, Evaluation, Final, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0008976 (Clinical Trials)
SNOMED
110465008
LOINC
LP231796-6
UMLS CUI [1,2]
C0220825 (Evaluation)
LOINC
LP36377-7
UMLS CUI [1,3]
C3853528 (Final)
LOINC
LA16388-3
UMLS CUI [1,4]
C0011008 (Date in time)
SNOMED
410671006
Investigator's Signature
Beschreibung

Investigator's Signature

Alias
UMLS CUI-1
C2346576 (Investigator Signature)
Investigator's Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576 (Investigator Signature)
Date
Beschreibung

Investigator Signature, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576 (Investigator Signature)
UMLS CUI [1,2]
C0011008 (Date in time)
SNOMED
410671006
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Ähnliche Modelle

Study Conclusion

1 Formulare
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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