ID
37211
Beschrijving
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
Trefwoorden
Versies (1)
- 08-07-19 08-07-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 juli 2019
DOI
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Licentie
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
Beschrijving
Serious Adverse Experience (SAE)
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event, Reporter
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0335038
Beschrijving
Serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Serious Adverse Event, Start Date, Start time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1301880
Beschrijving
Serious Adverse Event, End Date, End time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Beschrijving
Serious Adverse Event, Adverse Event Outcome
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
Serious Adverse Event, Course
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0750729
Beschrijving
Serious Adverse Event, Toxicity Grade
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826262
Beschrijving
Serious Adverse Event, Action Taken with Study Treatment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Beschrijving
Serious Adverse Event, Relationships, Experimental drug
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beschrijving
Serious Adverse Event, Therapeutic procedure
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Beschrijving
Serious Adverse Event, Withdraw
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Beschrijving
Serious Adverse Event, Reason and Justification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
Beschrijving
Serious Adverse Event, Abate
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beschrijving
Serious Adverse Event, Experimental drug, Treatment Modification
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1299575
Beschrijving
Serious Adverse Event, Experimental drug, Treatment Modification, Recurrence
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1299575
- UMLS CUI [1,4]
- C0034897
Beschrijving
Serious Adverse Event, Causations
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschrijving
Serious Adverse Event, Causations
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschrijving
Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Beschrijving
Serious Adverse Event, Laboratory Procedures
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
Beschrijving
Serious Adverse Event, Laboratory Procedures, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C0011008
Beschrijving
Serious Adverse Event, Laboratory Procedures, Numerical Value
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C1522609
Beschrijving
Serious Adverse Event, Laboratory Procedures, Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C1519795
Beschrijving
Serious Adverse Event, Laboratory Procedures, Normal Range
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C0086715
Beschrijving
Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschrijving
Randomization
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034656
Beschrijving
Serious Adverse Event, Randomization, Revealed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034656
- UMLS CUI [1,3]
- C0443289
Beschrijving
Serious Adverse Event, Randomization, Numbers
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034656
- UMLS CUI [1,3]
- C0237753
Beschrijving
Investigator's Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Beschrijving
Serious Adverse Event, Investigator Signature
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
Beschrijving
Serious Adverse Event, Investigator Signature, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
- UMLS CUI [1,3]
- C0011008
Beschrijving
Serious Adverse Event, Investigator Name
Datatype
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])