ID
37211
Description
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
Keywords
Versions (1)
- 7/8/19 7/8/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
July 8, 2019
DOI
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License
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
Serious Adverse Experience (SAE)
- StudyEvent: ODM
Description
Serious Adverse Experience (SAE)
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event, Reporter
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0335038
Description
Serious Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event, Start Date, Start time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1301880
Description
Serious Adverse Event, End Date, End time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Description
Serious Adverse Event, Adverse Event Outcome
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Event, Course
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0750729
Description
Serious Adverse Event, Toxicity Grade
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826262
Description
Serious Adverse Event, Action Taken with Study Treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Description
Serious Adverse Event, Relationships, Experimental drug
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Description
Serious Adverse Event, Therapeutic procedure
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Description
Serious Adverse Event, Withdraw
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Description
Serious Adverse Event, Reason and Justification
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
Description
Serious Adverse Event, Abate
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Description
Serious Adverse Event, Experimental drug, Treatment Modification
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1299575
Description
Serious Adverse Event, Experimental drug, Treatment Modification, Recurrence
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1299575
- UMLS CUI [1,4]
- C0034897
Description
Serious Adverse Event, Causations
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Description
Serious Adverse Event, Causations
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Description
Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Description
Serious Adverse Event, Laboratory Procedures
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
Description
Serious Adverse Event, Laboratory Procedures, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C0011008
Description
Serious Adverse Event, Laboratory Procedures, Numerical Value
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C1522609
Description
Serious Adverse Event, Laboratory Procedures, Units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C1519795
Description
Serious Adverse Event, Laboratory Procedures, Normal Range
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C0086715
Description
Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Description
Randomization
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034656
Description
Serious Adverse Event, Randomization, Revealed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034656
- UMLS CUI [1,3]
- C0443289
Description
Serious Adverse Event, Randomization, Numbers
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034656
- UMLS CUI [1,3]
- C0237753
Description
Investigator's Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Description
Serious Adverse Event, Investigator Signature
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
Description
Serious Adverse Event, Investigator Signature, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
- UMLS CUI [1,3]
- C0011008
Description
Serious Adverse Event, Investigator Name
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826892
Similar models
Serious Adverse Experience (SAE)
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0335038 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C3853704 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1299575 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C1299575 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,2])
C0034656 (UMLS CUI-2)
C0034656 (UMLS CUI [1,2])
C0443289 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C2346576 (UMLS CUI-2)
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2826892 (UMLS CUI [1,2])