ID

37130

Beschreibung

Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Stichworte

  1. 03.07.19 03.07.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

3. Juli 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0

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Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502

Study Conclusion

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

Administrative Data

Alias
UMLS CUI-1
C1320722
Center Number
Beschreibung

Institution name, Identifier

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Beschreibung

Patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the patient complete the study as planned?
Beschreibung

Clinical Research, Complete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0205197
If ’No’, mark the Primary cause of withdrawal
Beschreibung

Clinical Research, Withdraw, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C3146298
Specification / Comments on the reason for withdrawal
Beschreibung

Clinical Research, Withdraw, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C3146298
Date of Final Study Evaluation
Beschreibung

Clinical Research, Assessment Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C2985720

Ähnliche Modelle

Study Conclusion

  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Institution name, Identifier
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (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
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Clinical Research, Complete
Item
Did the patient complete the study as planned?
boolean
C0008972 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
If ’No’, mark the Primary cause of withdrawal
text
C0008972 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
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 Research, Withdraw, Indication
Item
Specification / Comments on the reason for withdrawal
text
C0008972 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Clinical Research, Assessment Date
Item
Date of Final Study Evaluation
date
C0008972 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])

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