ID

30163

Descripción

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

Palabras clave

Versiones (2)
  1. 16/5/18 16/5/18 -
  2. 16/5/18 16/5/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de mayo de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Oral GW786034 treatment for ovarian cancer NCT00281632

Inglés

Post-Treatment Assessments

1 formularios  
Header
Descripción

Header

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Vital signs
Descripción

Vital signs

Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure, systolic
Descripción

Blood pressure, systolic

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood pressure, diastolic
Descripción

Blood pressure, diastolic

Tipo de datos

integer

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

Body weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1]
C0039476
C
ECOG Performance Status Scale
Descripción

ECOG Performance Status Scale

Alias
UMLS CUI-1
C1520224
Electronically transferred laboratory data
Descripción

Electronically transferred laboratory data

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Date of first CA-125 sample
Descripción

Date of first CA-125 sample

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0201549
Physical examination
Descripción

Physical examination

Alias
UMLS CUI-1
C0031809
Has a physical examination been performed on the subject?
Descripción

physical examination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031809
Examination Status
Descripción

Examination Status

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0449438
Abnormal examination findings
Descripción

physical examination findings

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
If abnormal record below
Descripción

abnormal physical examination

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0459424
Pregnancy test
Descripción

Pregnancy test

Alias
UMLS CUI-1
C0430060
Concomitant Medications
Descripción

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Adverse Events
Descripción

Adverse Events

Alias
UMLS CUI-1
C0877248
Local Laboratory - Haematology
Descripción

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0022885
Lab ID
Descripción

Lab ID

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Date Sample taken Haematology
Descripción

Date Sample taken Haematology

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1302413
Haematocrit (HCT)
Descripción

Haematocrit (HCT)

Tipo de datos

float

Alias
UMLS CUI [1]
C0018935
Haemoglobin (Hb)
Descripción

Haemoglobin (Hb)

Tipo de datos

float

Alias
UMLS CUI [1]
C0518015
Platelet count (absolute)
Descripción

Platelet count (absolute)

Tipo de datos

float

Alias
UMLS CUI [1]
C0032181
White blood cell count (WBC) (Absolute)
Descripción

White blood cell count (WBC) (Absolute)

Tipo de datos

float

Alias
UMLS CUI [1]
C0023508
Neutrophil count (absolute)
Descripción

Neutrophil count (absolute)

Tipo de datos

float

Alias
UMLS CUI [1]
C0948762
Lymphocyte count (absolute)
Descripción

Lymphocyte count (absolute)

Tipo de datos

float

Alias
UMLS CUI [1]
C3544087
Activated Partial Thromboplastin Time (PTT)
Descripción

PTT

Tipo de datos

float

Unidades de medida
  • s
Alias
UMLS CUI [1]
C0030605
s
International Normalized Ratio
Descripción

International Normalized Ratio

Tipo de datos

float

Alias
UMLS CUI [1]
C0525032
Prothrombin time
Descripción

Prothrombin time

Tipo de datos

float

Alias
UMLS CUI [1]
C0033707
Local Laboratory - Clinical Chemistry
Descripción

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
Lab ID
Descripción

Lab ID

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Date sample taken clinical chemistry
Descripción

Date sample taken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1302413
Alkaline phosphatase
Descripción

Alkaline phosphatase

Tipo de datos

float

Alias
UMLS CUI [1]
C0201850
AST (SGOT)
Descripción

AST (SGOT)

Tipo de datos

float

Alias
UMLS CUI [1]
C0201899
ALT (SGPT)
Descripción

ALT (SGPT)

Tipo de datos

float

Alias
UMLS CUI [1]
C0201836
Albumin
Descripción

Albumin

Tipo de datos

float

Alias
UMLS CUI [1]
C0201838
Total bilirubin
Descripción

Total bilirubin

Tipo de datos

float

Alias
UMLS CUI [1]
C0201913
Blood Urea Nitrogen
Descripción

BUN

Tipo de datos

float

Alias
UMLS CUI [1]
C0005845
Calcium
Descripción

Calcium

Tipo de datos

float

Alias
UMLS CUI [1]
C0201925
Serum Creatinine
Descripción

Serum Creatinine

Tipo de datos

float

Alias
UMLS CUI [1]
C0201976
Glucose (fasting)
Descripción

Glucose (fasting)

Tipo de datos

float

Alias
UMLS CUI [1]
C0583513
LDH
Descripción

LDH

Tipo de datos

float

Alias
UMLS CUI [1]
C0202113
Potassium
Descripción

Potassium

Tipo de datos

float

Alias
UMLS CUI [1]
C0202194
Sodium
Descripción

Sodium

Tipo de datos

float

Alias
UMLS CUI [1]
C0337443
Serum lipase
Descripción

Lipase

Tipo de datos

float

Alias
UMLS CUI [1]
C0373670
Serum Amylase
Descripción

Amylase

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0201883
U/L
T4 (only if TSH abnormal)
Descripción

T4

Tipo de datos

float

Alias
UMLS CUI [1]
C0202231
TSH
Descripción

TSH

Tipo de datos

float

Unidades de medida
  • µU/ml
Alias
UMLS CUI [1]
C0202230
µU/ml
Urinalysis
Descripción

Urinalysis

Alias
UMLS CUI-1
C0042014
Date sample taken
Descripción

Date sample taken

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Laboratory name
Descripción

Laboratory name

Tipo de datos

text

Alias
UMLS CUI [1]
C3258037
Address
Descripción

Address

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
UPC ratio
Descripción

UPC ratio

Tipo de datos

float

Alias
UMLS CUI [1,1]
C1524119
UMLS CUI [1,2]
C0033684
UMLS CUI [1,3]
C1522609
Lab ID
Descripción

Lab ID

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
12 LEAD ECG MONITORING
Descripción

12 LEAD ECG MONITORING

Alias
UMLS CUI-1
C0430456
Start time of ECG
Descripción

Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Start Date of ECG
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Descripción

PR

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Descripción

QRS

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Descripción

QT

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Descripción

QTc

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Result of the ECG
Descripción

Result of the ECG

Tipo de datos

text

Alias
UMLS CUI [1]
C0438154
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Similar models

Post-Treatment Assessments

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital signs
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
ECOG Performance Status Scale
C1520224 (UMLS CUI-1)
Item Group
Electronically transferred laboratory data
C0200345 (UMLS CUI-1)
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])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
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])
Examination Status
Code List
Examination Status
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])
abnormal physical examination
Item
If abnormal record below
text
C0031809 (UMLS CUI [1,1])
C0459424 (UMLS CUI [1,2])
Item Group
Pregnancy test
C0430060 (UMLS CUI-1)
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Item Group
Local Laboratory - Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
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])
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)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
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])
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])
Item Group
Urinalysis
C0042014 (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])
UPC ratio
Item
UPC ratio
float
C1524119 (UMLS CUI [1,1])
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])
Item Group
12 LEAD ECG MONITORING
C0430456 (UMLS CUI-1)
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])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Volver a la parte superior de la página 

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