Informações:
Falhas:
ID
30039
Descrição
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853
Palavras-chave
Versões (2)
- 03/05/2018 03/05/2018 -
- 04/05/2018 04/05/2018 - Julian Varghese
Titular dos direitos
GlaxoSmithKline
Transferido a
4 de maio de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Oral GW786034 treatment for ovarian cancer NCT00281632
Visit description: Treatment Period 1. Day 1
- StudyEvent: ODM
Similar models
Visit description: Treatment Period 1. Day 1
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood pressure, systolic
Item
Blood pressure, systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure, diastolic
Item
Blood pressure, diastolic
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
ECOG
Item
ECOG
integer
C1520224 (UMLS CUI [1])
Item Group
Electronically transferred laboratory data - CA-125
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-3)
C0201549 (UMLS CUI-5)
C0022885 (UMLS CUI-3)
C0201549 (UMLS CUI-5)
Date sample taken CA-125
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0201549 (UMLS CUI [1,2])
C0201549 (UMLS CUI [1,2])
physical examination
Item
Has a physical examination been performed on the subject?
boolean
C0031809 (UMLS CUI [1])
Item
Examination Status
integer
C0031809 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
Normal (N)
(Comment:en)
CL Item
Abnormal (please specify) (A)
(Comment:en)
abnormal physical examination
Item
If abnormal record below
text
C0031809 (UMLS CUI [1,1])
C0459424 (UMLS CUI [1,2])
C0459424 (UMLS CUI [1,2])
Item Group
Local Laboratory - Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Laboratory Address
Item
Address
text
C3262820 (UMLS CUI [1])
Date Sample taken Haematology
Item
Date Sample taken Haematology
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Haematocrit (HCT)
Item
Haematocrit (HCT)
float
C0018935 (UMLS CUI [1])
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
float
C0518015 (UMLS CUI [1])
Platelet count (absolute)
Item
Platelet count (absolute)
float
C0032181 (UMLS CUI [1])
White blood cell count (WBC) (Absolute)
Item
White blood cell count (WBC) (Absolute)
float
C0023508 (UMLS CUI [1])
Neutrophil count (absolute)
Item
Neutrophil count (absolute)
float
C0948762 (UMLS CUI [1])
Lymphocyte count (absolute)
Item
Lymphocyte count (absolute)
float
C3544087 (UMLS CUI [1])
Item Group
Local Laboratory - Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Laboratory Address
Item
Address
text
C3262820 (UMLS CUI [1])
Date sample taken
Item
Date sample taken clinical chemistry
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
BUN
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
Glucose (fasting)
Item
Glucose (fasting)
float
C0583513 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
UPC ratio
Item
UPC ratio
float
C1524119 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
C0033684 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Item Group
Tumour Tissue Sample Collection
C0475358 (UMLS CUI-1)
C0005558 (UMLS CUI-2)
C0005558 (UMLS CUI-2)
tumor tissue collection
Item
Has a tissue sample been collected?
boolean
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,2])
Item
If No, tick appropriate reason
text
C0005558 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (OT)
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
CL Item
Derived During Study (1)
CL Item
Archieved (2)
Item
Preservation Method
text
C0475358 (UMLS CUI [1,1])
C1514402 (UMLS CUI [1,2])
C1514402 (UMLS CUI [1,2])
CL Item
FFPE (1)
CL Item
Fresh-frozen (2)
CL Item
Block (1)
CL Item
Slides (2)
Item
Type of Tissue Biopsy
text
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
CL Item
Core (1)
CL Item
Excisional (2)
CL Item
FNA (fine needle aspiration) (3)
CL Item
Punch (4)
CL Item
Other, specify (OT)
CL Item
Abdomen/abdominal wall (AB)
CL Item
Liver (LV)
CL Item
Lymph nodes (LN)
CL Item
Ovary (OV)
CL Item
Peritoneum (PM)
CL Item
Spleen (SP)
CL Item
Small intestine (SI)
CL Item
Other, specify (CT)
Item
Tissue Source
text
C0475358 (UMLS CUI [1,1])
C0449416 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0449416 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
CL Item
Primary (1)
CL Item
Metastasic (2)
CL Item
Unknown (U)
Date Biopsy Taken
Item
Date Biopsy Taken
date
C0005558 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
Time Biopsy Taken
Item
Time Biopsy Taken
partialDatetime
C0005558 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Consent for tumour genetic research
C0586888 (UMLS CUI-1)
C0243064 (UMLS CUI-2)
C0243064 (UMLS CUI-2)
consent for tumour genetic research
Item
Has consent been obtained for tumour genetic research?
boolean
C0021430 (UMLS CUI [1,1])
C0243064 (UMLS CUI [1,2])
C0243064 (UMLS CUI [1,2])
date of informed consent
Item
If yes, record date consent obtained
date
C2985782 (UMLS CUI [1])
Item
If no, tick one reason
text
C0566251 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
other reason
Item
if other, specify
text
C3840932 (UMLS CUI [1])
Withdrawal of consent
Item
Has subject withdrawn consent for tumour genetic research?
boolean
C1707492 (UMLS CUI [1,1])
C0243064 (UMLS CUI [1,2])
C0243064 (UMLS CUI [1,2])
Date of withdrawal of consent
Item
If Yes, record the date informed consent withdrawn for tumour genetic research
date
C0011008 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C0243064 (UMLS CUI [1,3])
C1707492 (UMLS CUI [1,2])
C0243064 (UMLS CUI [1,3])
Request made for destruction of tumour sample
Item
Has a request been made for tumour genetics tissue sample destruction?
boolean
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Item
If yes, tick one reason
text
C0392360 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0475358 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,2])
C0475358 (UMLS CUI [1,3])
CL Item
Subject withdrew consent for tumour genetic research (4)
CL Item
Other, specify (OT)
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
CL Item
Platelet poor plasma (1)
CL Item
Serum (2)
CL Item
Bone marrow aspirate (3)
CL Item
Whole blood (5)
CL Item
Urine (6)
CL Item
Mucus (7)
CL Item
Plasma (8)
CL Item
Saliva (9)
CL Item
Stool (10)
CL Item
Ascites (11)
CL Item
Cerebral spinal fluid (12)
CL Item
Pleural fluid (13)
CL Item
Buccal swab (15)
Biomarker sample collected
Item
Has sample been collected?
boolean
C0005516 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (OT)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Time sample taken
Item
Time sample taken
partialDatetime
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])