ID

30163

Description

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

Keywords

Versions (2)
  1. 5/16/18 5/16/18 -
  2. 5/16/18 5/16/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 16, 2018

DOI

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License

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

English

Post-Treatment Assessments

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Vital signs
Description

Vital signs

Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure, systolic
Description

Blood pressure, systolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood pressure, diastolic
Description

Blood pressure, diastolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperature
Description

Temperature

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0039476
C
ECOG Performance Status Scale
Description

ECOG Performance Status Scale

Alias
UMLS CUI-1
C1520224
Electronically transferred laboratory data
Description

Electronically transferred laboratory data

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

Date of first CA-125 sample

Data type

date

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

Physical examination

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

physical examination

Data type

boolean

Alias
UMLS CUI [1]
C0031809
Examination Status
Description

Examination Status

Data type

integer

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

physical examination findings

Data type

text

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

abnormal physical examination

Data type

text

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

Pregnancy test

Alias
UMLS CUI-1
C0430060
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Local Laboratory - Haematology
Description

Local Laboratory - Haematology

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

Lab ID

Data type

text

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

Date Sample taken Haematology

Data type

date

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

Haematocrit (HCT)

Data type

float

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

Haemoglobin (Hb)

Data type

float

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

Platelet count (absolute)

Data type

float

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

White blood cell count (WBC) (Absolute)

Data type

float

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

Neutrophil count (absolute)

Data type

float

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

Lymphocyte count (absolute)

Data type

float

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

PTT

Data type

float

Measurement units
  • s
Alias
UMLS CUI [1]
C0030605
s
International Normalized Ratio
Description

International Normalized Ratio

Data type

float

Alias
UMLS CUI [1]
C0525032
Prothrombin time
Description

Prothrombin time

Data type

float

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

Local Laboratory - Clinical Chemistry

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

Lab ID

Data type

integer

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

Date sample taken

Data type

date

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

Alkaline phosphatase

Data type

float

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

AST (SGOT)

Data type

float

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

ALT (SGPT)

Data type

float

Alias
UMLS CUI [1]
C0201836
Albumin
Description

Albumin

Data type

float

Alias
UMLS CUI [1]
C0201838
Total bilirubin
Description

Total bilirubin

Data type

float

Alias
UMLS CUI [1]
C0201913
Blood Urea Nitrogen
Description

BUN

Data type

float

Alias
UMLS CUI [1]
C0005845
Calcium
Description

Calcium

Data type

float

Alias
UMLS CUI [1]
C0201925
Serum Creatinine
Description

Serum Creatinine

Data type

float

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

Glucose (fasting)

Data type

float

Alias
UMLS CUI [1]
C0583513
LDH
Description

LDH

Data type

float

Alias
UMLS CUI [1]
C0202113
Potassium
Description

Potassium

Data type

float

Alias
UMLS CUI [1]
C0202194
Sodium
Description

Sodium

Data type

float

Alias
UMLS CUI [1]
C0337443
Serum lipase
Description

Lipase

Data type

float

Alias
UMLS CUI [1]
C0373670
Serum Amylase
Description

Amylase

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201883
U/L
T4 (only if TSH abnormal)
Description

T4

Data type

float

Alias
UMLS CUI [1]
C0202231
TSH
Description

TSH

Data type

float

Measurement units
  • µU/ml
Alias
UMLS CUI [1]
C0202230
µU/ml
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Laboratory name
Description

Laboratory name

Data type

text

Alias
UMLS CUI [1]
C3258037
Address
Description

Address

Data type

text

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

UPC ratio

Data type

float

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

Lab ID

Data type

text

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

12 LEAD ECG MONITORING

Alias
UMLS CUI-1
C0430456
Start time of ECG
Description

Time

Data type

time

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

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

PR

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Result of the ECG
Description

Result of the ECG

Data type

text

Alias
UMLS CUI [1]
C0438154
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Similar models

Post-Treatment Assessments

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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