ID

37130

Beskrivning

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

Nyckelord

  1. 2019-07-03 2019-07-03 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 juli 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Center Number
Beskrivning

Institution name, Identifier

Datatyp

integer

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

Patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beskrivning

Person Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Study Conclusion
Beskrivning

Study Conclusion

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

Clinical Research, Complete

Datatyp

boolean

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

Clinical Research, Withdraw, Indication

Datatyp

text

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

Clinical Research, Withdraw, Indication

Datatyp

text

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

Clinical Research, Assessment Date

Datatyp

date

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

Similar models

Study Conclusion

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

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial