ID

30371

Beschrijving

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

Trefwoorden

  1. 30-05-18 30-05-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

30 mei 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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Oral GW786034 treatment for ovarian cancer NCT00281632

Unscheduled Visit

  1. StudyEvent: ODM
    1. Unscheduled Visit
Header
Beschrijving

Header

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Vital signs
Beschrijving

Vital signs

Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure, systolic
Beschrijving

Blood pressure, systolic

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood pressure, diastolic
Beschrijving

Blood pressure, diastolic

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Body weight
Beschrijving

Body weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • C
Alias
UMLS CUI [1]
C0039476
C
Electronically transferred laboratory data
Beschrijving

Electronically transferred laboratory data

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

Date of first CA-125 sample

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0201549
Local Laboratory - Haematology
Beschrijving

Local Laboratory - Haematology

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

Lab ID

Datatype

text

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

Date Sample taken Haematology

Datatype

date

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

Haematocrit (HCT)

Datatype

float

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

Haemoglobin (Hb)

Datatype

float

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

Platelet count (absolute)

Datatype

float

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

White blood cell count (WBC) (Absolute)

Datatype

float

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

Neutrophil count (absolute)

Datatype

float

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

Lymphocyte count (absolute)

Datatype

float

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

PTT

Datatype

float

Maateenheden
  • s
Alias
UMLS CUI [1]
C0030605
s
International Normalized Ratio
Beschrijving

International Normalized Ratio

Datatype

float

Alias
UMLS CUI [1]
C0525032
Prothrombin time
Beschrijving

Prothrombin time

Datatype

float

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

Local Laboratory - Clinical Chemistry

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

Lab ID

Datatype

integer

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

Date sample taken

Datatype

date

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

Alkaline phosphatase

Datatype

float

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

AST (SGOT)

Datatype

float

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

ALT (SGPT)

Datatype

float

Alias
UMLS CUI [1]
C0201836
Albumin
Beschrijving

Albumin

Datatype

float

Alias
UMLS CUI [1]
C0201838
Total bilirubin
Beschrijving

Total bilirubin

Datatype

float

Alias
UMLS CUI [1]
C0201913
Blood Urea Nitrogen
Beschrijving

BUN

Datatype

float

Alias
UMLS CUI [1]
C0005845
Calcium
Beschrijving

Calcium

Datatype

float

Alias
UMLS CUI [1]
C0201925
Serum Creatinine
Beschrijving

Serum Creatinine

Datatype

float

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

Glucose (fasting)

Datatype

float

Alias
UMLS CUI [1]
C0583513
LDH
Beschrijving

LDH

Datatype

float

Alias
UMLS CUI [1]
C0202113
Potassium
Beschrijving

Potassium

Datatype

float

Alias
UMLS CUI [1]
C0202194
Sodium
Beschrijving

Sodium

Datatype

float

Alias
UMLS CUI [1]
C0337443
Serum lipase
Beschrijving

Lipase

Datatype

float

Alias
UMLS CUI [1]
C0373670
Serum Amylase
Beschrijving

Amylase

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201883
U/L
T4 (only if TSH abnormal)
Beschrijving

T4

Datatype

float

Alias
UMLS CUI [1]
C0202231
TSH
Beschrijving

TSH

Datatype

float

Maateenheden
  • µU/ml
Alias
UMLS CUI [1]
C0202230
µU/ml
Urinalysis
Beschrijving

Urinalysis

Alias
UMLS CUI-1
C0042014
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Laboratory name
Beschrijving

Laboratory name

Datatype

text

Alias
UMLS CUI [1]
C3258037
Address
Beschrijving

Address

Datatype

text

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

UPC ratio

Datatype

float

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

Lab ID

Datatype

text

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

12 LEAD ECG MONITORING

Alias
UMLS CUI-1
C0430456
Start time of ECG
Beschrijving

Time

Datatype

time

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

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Beschrijving

PR

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Beschrijving

QRS

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Beschrijving

QT

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Beschrijving

QTc

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Result of the ECG
Beschrijving

Result of the ECG

Datatype

text

Alias
UMLS CUI [1]
C0438154

Similar models

Unscheduled Visit

  1. StudyEvent: ODM
    1. Unscheduled Visit
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
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
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])
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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