ID

37648

Description

Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian 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: HycamtinTM Study Indication: Ovarian Cancer

Keywords

Versions (1)
  1. 8/13/19 8/13/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 13, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612

English

Cycle 7

1 forms  
  1. StudyEvent: ODM
    1. Cycle 7
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Day 1-5
Description

Day 1-5

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0449438
Has the cycle been delayed?
Description

Clinical Trials, Delay of chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1299577
If Yes, please document the reason
Description

Clinical Trials, Delay of chemotherapy, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1299577
UMLS CUI [1,3]
C0566251
Please specify
Description

Clinical Trials, Delay of chemotherapy, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1299577
UMLS CUI [1,3]
C0566251
Administration of study medication topotecan (oral)
Description

Administration of study medication topotecan (oral)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0146224
UMLS CUI-3
C3469597
Day
Description

Experimental drug, Topotecan, Administration of medication, Day

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C0439228
Date
Description

Experimental drug, Topotecan, Administration of medication, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C0011008
Planned daily dose for this cycle
Description

Experimental drug, Topotecan, Daily Dose, Planned

Data type

text

Measurement units
  • mg/m2
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C1301732
Administered dose for this cycle
Description

Experimental drug, Topotecan, Dosage

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0178602
mg
Administration of study medication topotecan (oral)
Description

Administration of study medication topotecan (oral)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0146224
UMLS CUI-3
C3469597
Capsules dispensed on
Description

Experimental drug, Topotecan, Dispense, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C1880359
UMLS CUI [1,4]
C0011008
Number of 1 mg capsules
Description

Experimental drug, Topotecan, Capsule, Dispensed Amount

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C0805077
Number of 0,25 mg capsules
Description

Experimental drug, Topotecan, Capsule, Dispensed Amount

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C0805077
Capsules returned by the patient on
Description

Experimental drug, Topotecan, Returned, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0332156
UMLS CUI [1,4]
C0011008
Number of 1 mg capsules
Description

Experimental drug, Topotecan, Capsule, Returned Amount

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C2699071
Number of 0,25 mg capsules
Description

Experimental drug, Topotecan, Capsule, Returned Amount

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0006935
UMLS CUI [1,4]
C2699071
Has the dose been modified when compared to the previous cycle?
Description

Experimental drug, Topotecan, Medication dose changed

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C1608430
If "yes", please document the reason
Description

Experimental drug, Topotecan, Medication dose changed, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C1608430
UMLS CUI [1,4]
C0566251
Please specify
Description

Experimental drug, Topotecan, Medication dose changed, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C1608430
UMLS CUI [1,4]
C0566251
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Similar models

Cycle 7

1 forms
  1. StudyEvent: ODM
    1. Cycle 7
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Item Group
Day 1-5
C0008976 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Clinical Trials, Delay of chemotherapy
Item
Has the cycle been delayed?
boolean
C0008976 (UMLS CUI [1,1])
C1299577 (UMLS CUI [1,2])
Item
If Yes, please document the reason
text
C0008976 (UMLS CUI [1,1])
C1299577 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Clinical Trials, Delay of chemotherapy, Reason and justification
Code List
If Yes, please document the reason
CL Item
hematological AE (1)
CL Item
non-hematological AE (2)
CL Item
Other, please specify (3)
Item
Please specify
text
C0008976 (UMLS CUI [1,1])
C1299577 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Clinical Trials, Delay of chemotherapy, Reason and justification
Code List
Please specify
Item Group
Administration of study medication topotecan (oral)
C0304229 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
C3469597 (UMLS CUI-3)
Item
Day
text
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,4])
Experimental drug, Topotecan, Administration of medication, Day
Code List
Day
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Experimental drug, Topotecan, Administration of medication, Date in time
Item
Date
date
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Planned daily dose for this cycle
text
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Visit
Code List
Planned daily dose for this cycle
CL Item
Baseline (1)
CL Item
Day 1 (2)
CL Item
Day 8 (3)
CL Item
Day 15 (4)
Experimental drug, Topotecan, Dosage
Item
Administered dose for this cycle
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Item Group
Administration of study medication topotecan (oral)
C0304229 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
C3469597 (UMLS CUI-3)
Experimental drug, Topotecan, Dispense, Date in time
Item
Capsules dispensed on
date
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C1880359 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsule, Dispensed Amount
Item
Number of 1 mg capsules
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C0805077 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsule, Dispensed Amount
Item
Number of 0,25 mg capsules
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C0805077 (UMLS CUI [1,4])
Experimental drug, Topotecan, Returned, Date in time
Item
Capsules returned by the patient on
date
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsule, Returned Amount
Item
Number of 1 mg capsules
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C2699071 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsule, Returned Amount
Item
Number of 0,25 mg capsules
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C2699071 (UMLS CUI [1,4])
Experimental drug, Topotecan, Medication dose changed
Item
Has the dose been modified when compared to the previous cycle?
boolean
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C1608430 (UMLS CUI [1,3])
Item
If "yes", please document the reason
text
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C1608430 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Experimental drug, Topotecan, Medication dose changed, Reason and justification
Code List
If "yes", please document the reason
CL Item
hematological AE (1)
CL Item
non-hematological AE (2)
CL Item
Other, please specify (3)
Experimental drug, Topotecan, Medication dose changed, Reason and justification
Item
Please specify
text
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C1608430 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
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