ID

37828

Description

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Keywords

Versions (2)
  1. 8/26/19 8/26/19 -
  2. 8/28/19 8/28/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 26, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

English

Course 1 (Day 1 ) - Vital Signs; Administration of Study Medications

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Center Number
Description

Center Number

Data type

text

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

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1709561
Patient ID
Description

Patient ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Day 1 Vital Signs
Description

Day 1 Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Sitting after 5 mins.

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Sitting after 5 mins.

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Pulse
Description

Sitting after 5 mins.

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature
Description

Temperature

Data type

float

Alias
UMLS CUI [1]
C0005903
Temperature Unit
Description

Temperature Unit

Data type

integer

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

Light clothes and shoes off. Round to the nearest kg or Ib.

Data type

integer

Alias
UMLS CUI [1]
C0005910
Wieght Unit
Description

Wieght Unit

Data type

integer

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

Body Surface Area

Data type

float

Measurement units
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Topotecan Administration
Description

Topotecan Administration

Alias
UMLS CUI-1
C3469597
UMLS CUI-2
C0146224
Total mg to be given (Topotecan)
Description

Total mg to be given (Topotecan)

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0439810
UMLS CUI [2]
C0146224
mg
Date Administered (Topotecan)
Description

Date Administered (Topotecan)

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C0146224
Start Time (Topotecan)
Description

Start Time (Topotecan)

Data type

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2]
C0146224
Stop Time (Topotecan)
Description

Stop Time (Topotecan)

Data type

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2]
C0146224
Was complete dose given? (Topotecan)
Description

Was complete dose given? (Topotecan)

Data type

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0146224
If complete dose Topotecan was not given, provide actual mg given:
Description

If complete dose Topotecan was not given, provide actual mg given:

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0146224
mg
Gemicitabine Administration
Description

Gemicitabine Administration

Alias
UMLS CUI-1
C3469597
Total mg to be given (Gemicitabine)
Description

Total mg to be given (Gemicitabine)

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0439810
mg
Date Administered (Gemicitabine)
Description

Date Administered (Gemicitabine)

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Start Time (Gemicitabine)
Description

Start Time (Gemicitabine)

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Time (Gemicitabine)
Description

Stop Time (Gemicitabine)

Data type

time

Alias
UMLS CUI [1]
C1522314
Was complete dose given? (Gemicitabine)
Description

Was complete dose given? (Gemicitabine)

Data type

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205197
If complete dose Gemcitabine was not given, provide actual mg given:
Description

If complete dose Gemcitabine was not given, provide actual mg given:

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205197
mg
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Similar models

Course 1 (Day 1 ) - Vital Signs; Administration of Study Medications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1709561 (UMLS CUI [1])
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item Group
Day 1 Vital Signs
C0518766 (UMLS CUI-1)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature Unit
integer
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Temperature Unit
Code List
Temperature Unit
CL Item
°C (1)
CL Item
°F (2)
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item
Wieght Unit
integer
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Wieght Unit
Code List
Wieght Unit
CL Item
kg (1)
CL Item
Ib (2)
Body Surface Area
Item
Body Surface Area
float
C0005902 (UMLS CUI [1])
Item Group
Topotecan Administration
C3469597 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
Total mg to be given (Topotecan)
Item
Total mg to be given (Topotecan)
float
C0178602 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Date Administered (Topotecan)
Item
Date Administered (Topotecan)
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Start Time (Topotecan)
Item
Start Time (Topotecan)
time
C1301880 (UMLS CUI [1])
C0146224 (UMLS CUI [2])
Stop Time (Topotecan)
Item
Stop Time (Topotecan)
time
C1522314 (UMLS CUI [1])
C0146224 (UMLS CUI [2])
Was complete dose given? (Topotecan)
Item
Was complete dose given? (Topotecan)
boolean
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
If complete dose Topotecan was not given, provide actual mg given:
Item
If complete dose Topotecan was not given, provide actual mg given:
float
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Item Group
Gemicitabine Administration
C3469597 (UMLS CUI-1)
Total mg to be given (Gemicitabine)
Item
Total mg to be given (Gemicitabine)
float
C0178602 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Date Administered (Gemicitabine)
Item
Date Administered (Gemicitabine)
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Start Time (Gemicitabine)
Item
Start Time (Gemicitabine)
time
C1301880 (UMLS CUI [1])
Stop Time (Gemicitabine)
Item
Stop Time (Gemicitabine)
time
C1522314 (UMLS CUI [1])
Was complete dose given? (Gemicitabine)
Item
Was complete dose given? (Gemicitabine)
boolean
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
If complete dose Gemcitabine was not given, provide actual mg given:
Item
If complete dose Gemcitabine was not given, provide actual mg given:
float
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
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