ID

37126

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)
  1. 7/3/19 7/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 3, 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

English

Course Delay

1 forms  
  1. StudyEvent: ODM
    1. Course Delay
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Center Number
Description

Institution name, Identifier

Data type

integer

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

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Course Delay
Description

Course Delay

Alias
UMLS CUI-1
C1299700
Was the course delayed?
Description

Course, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C1299700
Reason
Description

Course, Delay of drug therapy, Reason

Data type

text

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C1299700
UMLS CUI [1,3]
C0566251
Specify
Description

Course, Delay of drug therapy, Reason

Data type

text

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C1299700
UMLS CUI [1,3]
C0566251
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Similar models

Course Delay

1 forms
  1. StudyEvent: ODM
    1. Course Delay
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Course Delay
C1299700 (UMLS CUI-1)
Course, Delay of drug therapy
Item
Was the course delayed?
boolean
C0750729 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
Item
Reason
text
C0750729 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Course, Delay of drug therapy, Reason
Code List
Reason
CL Item
Hematology (1)
CL Item
Non-Hematology AE (2)
CL Item
Other, specify (3)
Course, Delay of drug therapy, Reason
Item
Specify
text
C0750729 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
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