ID

37163

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. 7/5/19 7/5/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 5, 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

Study Medication 5 Days On, 2 Days Off for 3 Weeks Regimen

1 forms  
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
Weight
Description

Weight

Alias
UMLS CUI-1
C0005910
Body Weight - Unit
Description

Body Weight, Unit of measure

Data type

text

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1519795
Body Weight
Description

Body Weight

Data type

float

Alias
UMLS CUI [1]
C0005910
Oral Topotecan Study Medication Record - Daily X5 Days Regime - Days 1-5
Description

Oral Topotecan Study Medication Record - Daily X5 Days Regime - Days 1-5

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C0392920
Start Date
Description

Topotecan, Chemotherapy Regimen, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0808070
End Date
Description

Topotecan, Chemotherapy Regimen, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0806020
Scheduled Daily Dose for this Course
Description

Topotecan, Chemotherapy Regimen, Daily Dose, Scheduled

Data type

float

Measurement units
  • mg/m2
Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0205539
mg/m2
Actual Daily Dose for this Course
Description

Topotecan, Chemotherapy Regimen, Daily Dose, Actual

Data type

float

Measurement units
  • mg/m2
Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0237400
mg/m2
Oral Topotecan Study Medication Record - Daily X5 Days Regime - Days 8-12
Description

Oral Topotecan Study Medication Record - Daily X5 Days Regime - Days 8-12

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C0392920
Start Date
Description

Topotecan, Chemotherapy Regimen, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0808070
End Date
Description

Topotecan, Chemotherapy Regimen, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0806020
Scheduled Daily Dose for this Course
Description

Topotecan, Chemotherapy Regimen, Daily Dose, Scheduled

Data type

float

Measurement units
  • mg/m2
Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0205539
mg/m2
Actual Daily Dose for this Course
Description

Topotecan, Chemotherapy Regimen, Daily Dose, Actual

Data type

float

Measurement units
  • mg/m2
Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0237400
mg/m2
Oral Topotecan Study Medication Record - Daily X5 Days Regime - Days 15-19
Description

Oral Topotecan Study Medication Record - Daily X5 Days Regime - Days 15-19

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C0392920
Start Date
Description

Topotecan, Chemotherapy Regimen, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0808070
End Date
Description

Topotecan, Chemotherapy Regimen, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0806020
Scheduled Daily Dose for this Course
Description

Topotecan, Chemotherapy Regimen, Daily Dose, Scheduled

Data type

float

Measurement units
  • mg/m2
Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0205539
mg/m2
Actual Daily Dose for this Course
Description

Topotecan, Chemotherapy Regimen, Daily Dose, Actual

Data type

float

Measurement units
  • mg/m2
Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0237400
mg/m2
Dose Modification
Description

Dose Modification

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C0392920
UMLS CUI-3
C1707814
Was the topotecan dose reduced compared to the previous course?
Description

Topotecan, Chemotherapy Regimen, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1707814
Reason: (if applicable, mark more than one box below)
Description

Topotecan, Chemotherapy Regimen, Dose Reduced, Indication of

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0392360
Specify
Description

Topotecan, Chemotherapy Regimen, Dose Reduced, Indication of

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0392360
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Similar models

Study Medication 5 Days On, 2 Days Off for 3 Weeks Regimen

1 forms
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
Weight
C0005910 (UMLS CUI-1)
Item
Body Weight - Unit
text
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body Weight, Unit of measure
Code List
Body Weight - Unit
CL Item
kg (1)
CL Item
lbs (2)
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Item Group
Oral Topotecan Study Medication Record - Daily X5 Days Regime - Days 1-5
C0146224 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
Topotecan, Chemotherapy Regimen, Start Date
Item
Start Date
date
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, End Date
Item
End Date
date
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Daily Dose, Scheduled
Item
Scheduled Daily Dose for this Course
float
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0205539 (UMLS CUI [1,4])
Topotecan, Chemotherapy Regimen, Daily Dose, Actual
Item
Actual Daily Dose for this Course
float
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0237400 (UMLS CUI [1,4])
Item Group
Oral Topotecan Study Medication Record - Daily X5 Days Regime - Days 8-12
C0146224 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
Topotecan, Chemotherapy Regimen, Start Date
Item
Start Date
date
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, End Date
Item
End Date
date
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Daily Dose, Scheduled
Item
Scheduled Daily Dose for this Course
float
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0205539 (UMLS CUI [1,4])
Topotecan, Chemotherapy Regimen, Daily Dose, Actual
Item
Actual Daily Dose for this Course
float
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0237400 (UMLS CUI [1,4])
Item Group
Oral Topotecan Study Medication Record - Daily X5 Days Regime - Days 15-19
C0146224 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
Topotecan, Chemotherapy Regimen, Start Date
Item
Start Date
date
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, End Date
Item
End Date
date
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Daily Dose, Scheduled
Item
Scheduled Daily Dose for this Course
float
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0205539 (UMLS CUI [1,4])
Topotecan, Chemotherapy Regimen, Daily Dose, Actual
Item
Actual Daily Dose for this Course
float
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0237400 (UMLS CUI [1,4])
Item Group
Dose Modification
C0146224 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
C1707814 (UMLS CUI-3)
Topotecan, Chemotherapy Regimen, Dose Reduced
Item
Was the topotecan dose reduced compared to the previous course?
boolean
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
Item
Reason: (if applicable, mark more than one box below)
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Topotecan, Chemotherapy Regimen, Dose Reduced, Indication of
Code List
Reason: (if applicable, mark more than one box below)
CL Item
Hematology (1)
CL Item
Non-Hematology AE (2)
CL Item
Other, specify (3)
Topotecan, Chemotherapy Regimen, Dose Reduced, Indication of
Item
Specify
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
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