Information:
Fel:
ID
30163
Beskrivning
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
Nyckelord
Versioner (2)
- 2018-05-16 2018-05-16 -
- 2018-05-16 2018-05-16 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
16 maj 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Oral GW786034 treatment for ovarian cancer NCT00281632
Post-Treatment Assessments
- StudyEvent: ODM
Similar models
Post-Treatment Assessments
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item Group
Electronically transferred laboratory data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Date of first CA-125 sample
Item
Date of first CA-125 sample
date
C0011008 (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)
physical examination findings
Item
Abnormal examination findings
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
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])
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])
PTT
Item
Activated Partial Thromboplastin Time (PTT)
float
C0030605 (UMLS CUI [1])
INR
Item
International Normalized Ratio
float
C0525032 (UMLS CUI [1])
Prothrombin time
Item
Prothrombin time
float
C0033707 (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])
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])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (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])
Lipase
Item
Serum lipase
float
C0373670 (UMLS CUI [1])
Amylase
Item
Serum Amylase
float
C0201883 (UMLS CUI [1])
T4
Item
T4 (only if TSH abnormal)
float
C0202231 (UMLS CUI [1])
TSH
Item
TSH
float
C0202230 (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])
Time
Item
Start time of ECG
time
C0040223 (UMLS CUI [1])
Date
Item
Start Date of ECG
date
C0011008 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)