ID

37686

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. 8/16/19 8/16/19 -
  2. 8/16/19 8/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 16, 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

Screening - Demography; Vital Signs

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 [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Patient ID
Description

Patient ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Screening Visit
Description

Date of Screening Visit

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0220908
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Ethnic Origin
Description

Ethnic Origin

Data type

integer

Alias
UMLS CUI [1]
C0015031
If other ethnic origin, specify
Description

If other ethnic origin, specify

Data type

text

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

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

Diastolic Blood pressure

Data type

integer

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

Pulse

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
Height
Description

Height

Data type

integer

Alias
UMLS CUI [1]
C0005890
Height unit
Description

Height unit

Data type

integer

Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C1519795
Weight
Description

Weight

Data type

integer

Alias
UMLS CUI [1]
C0005910
Weigth unit
Description

Weigth unit

Data type

text

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1519795
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Similar models

Screening - Demography; Vital Signs

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
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Date of Screening Visit
Item
Date of Screening Visit
date
C1320303 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Ethnic Origin
integer
C0015031 (UMLS CUI [1])
Ethnic Origin
Code List
Ethnic Origin
CL Item
Caucasian (1)
CL Item
Black (2)
CL Item
Hispanic (3)
CL Item
Asian (4)
CL Item
Other - specify (5)
If other ethnic origin, specify
Item
If other ethnic origin, specify
text
C0015031 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
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)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Item
Height unit
integer
C0005890 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Height unit
Code List
Height unit
CL Item
cm (1)
CL Item
in. (2)
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item
Weigth unit
text
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Weigth unit
Code List
Weigth unit
CL Item
kg (1)
CL Item
Ib (2)
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