ID

37209

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. 7/8/19 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

English

Prenext Course Visit

1 forms  
  1. StudyEvent: ODM
    1. Prenext Course Visit
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
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C0392920
UMLS CUI-3
C1519255
Has the patient had any serious adverse experiences during this course?
Description

Topotecan, Chemotherapy Regimen, Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1519255
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Temperature
Description

Body temperature measurement, Route

Data type

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Temperature
Description

Body Temperature, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Temperature
Description

Body Temperature

Data type

float

Alias
UMLS CUI [1]
C0005903
After 5 Minutes Sitting - Sitting Blood Pressure - Systolic
Description

Systolic Pressure, Sitting position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
After 5 Minutes Sitting - Sitting Blood Pressure - Diastolic
Description

Diastolic blood pressure, Sitting position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
After 5 Minutes Sitting - Pulse
Description

Heart rate while sitting

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2029904
bpm
12-Lead Electrocardiogram
Description

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Mark the box if not required
Description

12 lead ECG, Requirement

Data type

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1514873
Date Performed
Description

12 lead ECG, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Finding
Description

12 lead ECG, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Topotecan Study Medication Compliance - Daily X5 Days Regimen
Description

Topotecan Study Medication Compliance - Daily X5 Days Regimen

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C0392920
Number of Capsules Dispensed
Description

Topotecan, Chemotherapy Regimen, Dispensed Amount

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0805077
Number of Capsules Taken
Description

Topotecan, Chemotherapy Regimen, Capsule, Taken

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C1883727
Number of Capsules Returned
Description

Topotecan, Chemotherapy Regimen, Returned Amount

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2699071
Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 1-5
Description

Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 1-5

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C0392920
Number of Capsules Dispensed
Description

Topotecan, Chemotherapy Regimen, Dispensed Amount

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0805077
Number of Capsules Taken
Description

Topotecan, Chemotherapy Regimen, Capsule, Taken

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C1883727
Number of Capsules Returned
Description

Topotecan, Chemotherapy Regimen, Returned Amount

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2699071
Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 8-12
Description

Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 8-12

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C0392920
Number of Capsules Dispensed
Description

Topotecan, Chemotherapy Regimen, Dispensed Amount

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0805077
Number of Capsules Taken
Description

Topotecan, Chemotherapy Regimen, Capsule, Taken

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C1883727
Number of Capsules Returned
Description

Topotecan, Chemotherapy Regimen, Returned Amount

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2699071
Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 15-19
Description

Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 15-19

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C0392920
Number of Capsules Dispensed
Description

Topotecan, Chemotherapy Regimen, Dispensed Amount

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0805077
Number of Capsules Taken
Description

Topotecan, Chemotherapy Regimen, Capsule, Taken

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C1883727
Number of Capsules Returned
Description

Topotecan, Chemotherapy Regimen, Returned Amount

Data type

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2699071
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Similar models

Prenext Course Visit

1 forms
  1. StudyEvent: ODM
    1. Prenext Course Visit
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
Serious Adverse Event
C0146224 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Topotecan, Chemotherapy Regimen, Serious Adverse Event
Item
Has the patient had any serious adverse experiences during this course?
boolean
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Temperature
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Body temperature measurement, Route
Code List
Temperature
CL Item
Oral (1)
CL Item
Axillary  (2)
CL Item
Rectal  (3)
CL Item
Tympanic (4)
Item
Temperature
text
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body Temperature, Unit of Measure
Code List
Temperature
CL Item
°C (1)
CL Item
°F (2)
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Systolic Pressure, Sitting position
Item
After 5 Minutes Sitting - Sitting Blood Pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic blood pressure, Sitting position
Item
After 5 Minutes Sitting - Sitting Blood Pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Heart rate while sitting
Item
After 5 Minutes Sitting - Pulse
integer
C2029904 (UMLS CUI [1])
Item Group
12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
12 lead ECG, Requirement
Item
Mark the box if not required
boolean
C0430456 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
12 lead ECG, Date in time
Item
Date Performed
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Finding
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Finding
CL Item
No significant worsening since screening. (1)
CL Item
Worsening since screening (2)
Item Group
Topotecan Study Medication Compliance - Daily X5 Days Regimen
C0146224 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
Item
Number of Capsules Dispensed
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0805077 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Dispensed
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item
Number of Capsules Taken
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Taken
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item
Number of Capsules Returned
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2699071 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Returned
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item Group
Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 1-5
C0146224 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
Item
Number of Capsules Dispensed
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0805077 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Dispensed
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item
Number of Capsules Taken
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Taken
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item
Number of Capsules Returned
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2699071 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Returned
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item Group
Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 8-12
C0146224 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
Item
Number of Capsules Dispensed
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0805077 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Dispensed
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item
Number of Capsules Taken
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Taken
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item
Number of Capsules Returned
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2699071 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Returned
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item Group
Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 15-19
C0146224 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
Item
Number of Capsules Dispensed
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0805077 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Dispensed
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item
Number of Capsules Taken
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Taken
CL Item
1.0mg (1)
CL Item
0.25mg (2)
Item
Number of Capsules Returned
text
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2699071 (UMLS CUI [1,3])
Topotecan, Chemotherapy Regimen, Dispensed Amount
Code List
Number of Capsules Returned
CL Item
1.0mg (1)
CL Item
0.25mg (2)
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