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Erreur:
ID
37907
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
Mots-clés
Versions (1)
- 29/08/2019 29/08/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
29 août 2019
DOI
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Licence
Creative Commons BY-NC 3.0
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308
Course 1 Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record
Similar models
Course 1 Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Center Number
Item
Center Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
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])
C1272696 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2])
CL Item
Visit Not Done (1)
CL Item
Withdrawal from study (2)
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])
CL Item
°C (1)
CL Item
°F (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])
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])
C0201549 (UMLS CUI [1,2])
Item Group
Laboratory Tests - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
Haematology - Sample Date
Item
Haematology - Sample Date
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
Haematology - Laboratory Name
Item
Haematology - Laboratory Name
text
C3258037 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
Item Group
Laboratory Tests - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
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])
C1274040 (UMLS CUI [1,2])
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])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
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])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
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)
C0008000 (UMLS CUI-2)
Chemistry - Sample Date
Item
Chemistry - Sample Date
date
C1302413 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
Chemistry - Laboratory Name
Item
Chemistry - Laboratory Name
text
C3258037 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
Item Group
Laboratory Tests - Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI-2)
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])
C1274040 (UMLS CUI [1,2])
CL Item
No Result (1)
Chemistry - Value
Item
Chemistry - Value
text
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
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])
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
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])
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Code List
Chemistry - Value out of range and NOT clinically significant
CL Item
Value out of range and clinically significant (3)
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])
C1516048 (UMLS CUI [1,2])
Item Group
Lesion Assessment Record
C0221198 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
C1516048 (UMLS CUI-2)
Lesion No.
Item
Lesion No.
integer
C0237753 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
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])
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])
C0221198 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
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])
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])
C1513040 (UMLS CUI [1,2])
C1334988 (UMLS CUI [2])
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])
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])
C1301886 (UMLS CUI [1,2])
Item
Lesion Non-Evaluable
integer
C0221198 (UMLS CUI [1,1])
C1883425 (UMLS CUI [1,2])
C1883425 (UMLS CUI [1,2])
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])
C1883425 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
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])
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])
C1883425 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
CL Item
Not Done (1)
CL Item
Present (2)
CL Item
Absent (3)