ID

37907

Descripción

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

Palabras clave

Versiones (1)
  1. 29/8/19 29/8/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

29 de agosto de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Course 1 Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Center Number
Descripción

Center Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Descripción

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C1709561
Patient ID
Descripción

Patient ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Visit not done or Withdrawal from Study
Descripción

Visit not done or Withdrawal from Study

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1272696
UMLS CUI [2]
C0422727
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Descripción

Sitting (after 5 mins.)

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Descripción

Sitting after (5 mins.)

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Pulse
Descripción

Sitting (after 5 mins.)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature
Descripción

Temperature

Tipo de datos

float

Alias
UMLS CUI [1]
C0005903
Temperature Unit
Descripción

Temperature Unit

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Tumor Marker (CA-125)
Descripción

Tumor Marker (CA-125)

Alias
UMLS CUI-1
C0041365
UMLS CUI-2
C0201549
Tumor Marker Sample Date
Descripción

Tumor Marker Sample Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C0201549
UMLS CUI [1,3]
C1302413
Laboratory Name
Descripción

Laboratory Name

Tipo de datos

text

Alias
UMLS CUI [1]
C3258037
Tumor Marker Value
Descripción

Tumor Marker Value

Tipo de datos

integer

Unidades de medida
  • U/mL
Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C0201549
U/mL
Laboratory Tests - Haematology
Descripción

Laboratory Tests - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology - Sample Date
Descripción

Haematology - Sample Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0018941
Haematology - Laboratory Name
Descripción

Haematology - Laboratory Name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C0018941
Laboratory Tests - Haematology
Descripción

Laboratory Tests - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology Test
Descripción

Haematology Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018941
Haematology - No Result
Descripción

Haematology - No Result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
Haematology - Value
Descripción

Haematology - Value

Tipo de datos

text

Alias
UMLS CUI [1]
C0474523
Haematology - Value out of range and NOT clinically significant
Descripción

Haematology - Value out of range and NOT clinically significant

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0438215
UMLS CUI [1,3]
C2826293
Haematology - Value out of range and clinically significant
Descripción

Haematology - Value out of range and clinically significant

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0438215
UMLS CUI [1,3]
C2826293
Laboratory Tests - Chemistry
Descripción

Laboratory Tests - Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Chemistry - Sample Date
Descripción

Chemistry - Sample Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0008000
Chemistry - Laboratory Name
Descripción

Chemistry - Laboratory Name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C0008000
Laboratory Tests - Chemistry
Descripción

Laboratory Tests - Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Chemistry - Test
Descripción

Chemistry - Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0525044
Chemistry - No Result
Descripción

Chemistry - No Result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
Chemistry - Value
Descripción

Chemistry - Value

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
Chemistry - Value out of range and NOT clinically significant
Descripción

Chemistry - Value out of range and NOT clinically significant

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0438215
UMLS CUI [1,4]
C2826293
Chemistry - Value out of range and NOT clinically significant
Descripción

Chemistry - Value out of range and NOT clinically significant

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0438215
UMLS CUI [1,4]
C2826293
Lesion Assessment
Descripción

Lesion Assessment

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C1516048
Was Lesion Assessment done at this course?
Descripción

Was Lesion Assessment done at this course?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1516048
Lesion Assessment Record
Descripción

Lesion Assessment Record

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C1516048
Lesion No.
Descripción

Lesion No.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0221198
Lesion Site Code
Descripción

Lesion Site Code

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0449695
UMLS CUI [1,2]
C0805701
Lesion Site Description
Descripción

Lesion Site Description

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0449695
UMLS CUI [1,2]
C0678257
Lesion Measurement - Method Code
Descripción

Lesion Measurement - Method Code

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C2911685
UMLS CUI [1,4]
C0805701
Lesion Measurement - Date Performed
Descripción

Lesion Measurement - Date Performed

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0011008
Measurable/ Non measurable Lesion Code
Descripción

Measurable/ Non measurable Lesion Code

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1513040
UMLS CUI [2]
C1334988
Lesion Size - 1. Diameter (cm)
Descripción

Lesion Size - 1. Diameter (cm)

Tipo de datos

float

Unidades de medida
  • cm
Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C1301886
cm
Lesion Size - 2. Diameter (cm)
Descripción

Lesion Size - 2. Diameter (cm)

Tipo de datos

float

Unidades de medida
  • cm
Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C1301886
cm
Lesion Non-Evaluable
Descripción

Lesion Non-Evaluable

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1883425
Lesion Non-Evaluable - Lesion Measurement Method Code
Descripción

Lesion Non-Evaluable - Lesion Measurement Method Code

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1883425
UMLS CUI [1,3]
C1299991
UMLS CUI [1,4]
C0805701
Lesion Non-Evaluable - Date Performed
Descripción

Lesion Non-Evaluable - Date Performed

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1883425
UMLS CUI [1,3]
C0011008
Lesion Non-Evaluable Status
Descripción

Lesion Non-Evaluable Status

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1883425
UMLS CUI [1,3]
C0449438
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Similar models

Course 1 Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Center Number
Item
Center Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1709561 (UMLS CUI [1])
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit not done or Withdrawal from Study
text
C0545082 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2])
Visit not done or Withdrawal from Study
Code List
Visit not done or Withdrawal from Study
CL Item
Visit Not Done (1)
CL Item
Withdrawal from study (2)
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)
Item Group
Tumor Marker (CA-125)
C0041365 (UMLS CUI-1)
C0201549 (UMLS CUI-2)
Tumor Marker Sample Date
Item
Tumor Marker Sample Date
date
C0041365 (UMLS CUI [1,1])
C0201549 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Tumor Marker Value
Item
Tumor Marker Value
integer
C0041365 (UMLS CUI [1,1])
C0201549 (UMLS CUI [1,2])
Item Group
Laboratory Tests - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Haematology - Sample Date
Item
Haematology - Sample Date
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haematology - Laboratory Name
Item
Haematology - Laboratory Name
text
C3258037 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Item Group
Laboratory Tests - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Haematology Test
Code List
Haematology Test
CL Item
Hemoglobin  (1)
CL Item
Hematocrit  (2)
CL Item
RBC  (3)
CL Item
WBC  (4)
CL Item
Neutrophils  (5)
CL Item
Bands  (6)
CL Item
Lymphocytes  (7)
CL Item
Monocytes  (8)
CL Item
Eosinophils  (9)
CL Item
Basophils  (10)
CL Item
Platelets  (11)
CL Item
Granulocytes (12)
Item
Haematology - No Result
integer
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Haematology - No Result
Code List
Haematology - No Result
CL Item
No Result (1)
Haematology - Value
Item
Haematology - Value
text
C0474523 (UMLS CUI [1])
Item
Haematology - Value out of range and NOT clinically significant
integer
C0474523 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Haematology - Value out of range and NOT clinically significant
Code List
Haematology - Value out of range and NOT clinically significant
CL Item
Value out of range and NOT clinically significant (2)
Item
Haematology - Value out of range and clinically significant
integer
C0474523 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Haematology - Value out of range and clinically significant
Code List
Haematology - Value out of range and clinically significant
CL Item
Value out of range and clinically significant (3)
Item Group
Laboratory Tests - Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Chemistry - Sample Date
Item
Chemistry - Sample Date
date
C1302413 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Chemistry - Laboratory Name
Item
Chemistry - Laboratory Name
text
C3258037 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item Group
Laboratory Tests - Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Chemistry - Test
integer
C0525044 (UMLS CUI [1])
Chemistry - Test
Code List
Chemistry - Test
CL Item
Total Protein  (1)
CL Item
Albumin  (2)
CL Item
Total Bilirubin  (3)
CL Item
SGPT (ALT)  (4)
CL Item
SGOT (AST)  (5)
CL Item
Alkaline Phosphatase  (6)
CL Item
Glucose  (7)
CL Item
LDH  (8)
CL Item
BUN  (9)
CL Item
Serum Creatinine  (10)
CL Item
Uric Acid  (11)
CL Item
Calcium  (12)
CL Item
Phosphorus  (13)
CL Item
Sodium  (14)
CL Item
Potassium  (15)
CL Item
Chloride  (16)
CL Item
Bicarbonate (17)
Item
Chemistry - No Result
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Chemistry - No Result
Code List
Chemistry - No Result
CL Item
No Result (1)
Chemistry - Value
Item
Chemistry - Value
text
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Chemistry - Value out of range and NOT clinically significant
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Chemistry - Value out of range and NOT clinically significant
Code List
Chemistry - Value out of range and NOT clinically significant
CL Item
Value out of range and NOT clinically significant (2)
Item
Chemistry - Value out of range and NOT clinically significant
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Chemistry - Value out of range and NOT clinically significant
Code List
Chemistry - Value out of range and NOT clinically significant
CL Item
Value out of range and clinically significant (3)
Item Group
Lesion Assessment
C0221198 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Was Lesion Assessment done at this course?
Item
Was Lesion Assessment done at this course?
boolean
C0221198 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Item Group
Lesion Assessment Record
C0221198 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Lesion No.
Item
Lesion No.
integer
C0237753 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
Lesion Site Code
integer
C0449695 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Lesion Site Code
Code List
Lesion Site Code
CL Item
Abdominal/Pelvic  (01)
CL Item
Hepatic  (02)
CL Item
Pulmonary  (03)
CL Item
Lymph Node  (04)
CL Item
Chest Wall  (05)
CL Item
Other (99)
Lesion Site Description
Item
Lesion Site Description
text
C0449695 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Lesion Measurement - Method Code
integer
C1299991 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Method Code
Code List
Lesion Measurement - Method Code
CL Item
Physical Measurement  (01)
CL Item
CT scan  (02)
CL Item
MRI scan  (03)
CL Item
Radiography  (04)
CL Item
Chest X-Ray  (05)
CL Item
Radionuclide scan  (06)
CL Item
Other (99)
Lesion Measurement - Date Performed
Item
Lesion Measurement - Date Performed
date
C1299991 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Measurable/ Non measurable Lesion Code
integer
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1334988 (UMLS CUI [2])
Measurable/ Non measurable Lesion Code
Code List
Measurable/ Non measurable Lesion Code
CL Item
Measurable (1)
CL Item
Non-measurable (2)
Lesion Size - 1. Diameter (cm)
Item
Lesion Size - 1. Diameter (cm)
float
C0449453 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Lesion Size - 2. Diameter (cm)
Item
Lesion Size - 2. Diameter (cm)
float
C0449453 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Item
Lesion Non-Evaluable
integer
C0221198 (UMLS CUI [1,1])
C1883425 (UMLS CUI [1,2])
Lesion Non-Evaluable
Code List
Lesion Non-Evaluable
CL Item
Ascites (1)
CL Item
Bone Metastases (2)
CL Item
Pleural Effusion (3)
Item
Lesion Non-Evaluable - Lesion Measurement Method Code
integer
C0221198 (UMLS CUI [1,1])
C1883425 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Lesion Non-Evaluable - Lesion Measurement Method Code
Code List
Lesion Non-Evaluable - Lesion Measurement Method Code
CL Item
Physical Measurement  (01)
CL Item
CT scan  (02)
CL Item
MRI scan (03)
CL Item
Radiography (04)
CL Item
Chest X-Ray  (05)
CL Item
Radionuclide scan  (06)
CL Item
Other (99)
Lesion Non-Evaluable - Date Performed
Item
Lesion Non-Evaluable - Date Performed
date
C0221198 (UMLS CUI [1,1])
C1883425 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Lesion Non-Evaluable Status
integer
C0221198 (UMLS CUI [1,1])
C1883425 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Lesion Non-Evaluable Status
Code List
Lesion Non-Evaluable Status
CL Item
Not Done (1)
CL Item
Present (2)
CL Item
Absent (3)
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