ID

30140

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. 5/14/18 5/14/18 -
  2. 5/15/18 5/15/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 15, 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

Visit description: Treatment Period 2. Day 1

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
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
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]
Temperature
Description

Temperature

Data type

float

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

ECOG Performance Status

Alias
UMLS CUI-1
C1520224
ECOG
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

integer

Alias
UMLS CUI [1]
C1520224
Electronically transferred laboratory data - CA-125
Description

Electronically transferred laboratory data - CA-125

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C0201549
Date sample taken
Description

Date sample taken CA-125

Data type

date

Alias
UMLS CUI [1,1]
C1302413
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
If abnormal record below
Description

abnormal physical examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0459424
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
Laboratory name
Description

Laboratory name

Data type

text

Alias
UMLS CUI [1]
C1882331
Address
Description

Laboratory Address

Data type

text

Alias
UMLS CUI [1]
C3262820
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
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
Laboratory name
Description

Laboratory name

Data type

text

Alias
UMLS CUI [1]
C1882331
Address
Description

Laboratory Address

Data type

text

Alias
UMLS CUI [1]
C3262820
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
ALT (SGPT)
Description

ALT (SGPT)

Data type

float

Alias
UMLS CUI [1]
C0201836
AST (SGOT)
Description

AST (SGOT)

Data type

float

Alias
UMLS CUI [1]
C0201899
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
TSH
Description

TSH in serum

Data type

float

Alias
UMLS CUI [1]
C0202230
T4
Description

T4

Data type

float

Alias
UMLS CUI [1]
C0040165
Serum lipase
Description

Lipase

Data type

float

Alias
UMLS CUI [1]
C0373670
Serum Amylase
Description

Amylase

Data type

float

Alias
UMLS CUI [1]
C0201883
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
Pharmacokinetics - Blood
Description

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Planned Relative Time
Description

Planned Relative Time

Data type

text

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Description

Date Sample Taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample Identifier
Description

Sample Identifier

Data type

text

Alias
UMLS CUI [1]
C4071975
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned timepoint
Description

Planned timepoint

Data type

text

Alias
UMLS CUI [1]
C2348792
Investigational Product
Description

investigational product

Data type

text

Alias
UMLS CUI [1]
C0304229
Investigational Product Date of Dose
Description

Investigational Product Date of Dose

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Investigational Product Time of Dose
Description

Investigational Product Time of Dose

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Dose
Description

Dose

Data type

float

Measurement units
  • mg/Day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg/Day
Biomarker sample(s)
Description

Biomarker sample(s)

Alias
UMLS CUI-1
C0005516
Sample Type
Description

Biomarker Sample Type

Data type

text

Alias
UMLS CUI [1,1]
C2347029
UMLS CUI [1,2]
C0005516
Has sample been collected?
Description

Biomarker sample collected

Data type

boolean

Alias
UMLS CUI [1,1]
C0005516
UMLS CUI [1,2]
C0200345
If No, provide reason
Description

If no, reason

Data type

text

Alias
UMLS CUI [1]
C0681841
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Time sample taken
Description

Time sample taken

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
INVESTIGATIONAL PRODUCT
Description

INVESTIGATIONAL PRODUCT

Alias
UMLS CUI-1
C0304229
Investigational Product
Description

investigational product

Data type

text

Alias
UMLS CUI [1]
C0304229
Dose
Description

medication dosage

Data type

integer

Measurement units
  • mg/day
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0304229
mg/day
Start Date
Description

start date

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

stop date

Data type

date

Alias
UMLS CUI [1]
C0806020
Investigational product Container Number
Description

investigational product container number

Data type

integer

Alias
UMLS CUI [1,1]
C3898691
UMLS CUI [1,2]
C0449788
If there were any dosing deviations / changes, give reason
Description

reason for dosing deviations changes

Data type

text

Alias
UMLS CUI [1,1]
C1515926
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0392360
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned timepoint
Description

Planned timepoint

Data type

text

Alias
UMLS CUI [1]
C2348792
Investigational Product
Description

investigational product

Data type

text

Alias
UMLS CUI [1]
C0304229
Investigational Product Date of Dose
Description

Investigational Product Date of Dose

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Investigational Product Time of Dose
Description

Investigational Product Time of Dose

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Dose
Description

Dose

Data type

float

Measurement units
  • mg/Day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg/Day
Treatment Confirmation
Description

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If No, record reason(s)
Description

If No, record reason(s)

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0087111
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Similar models

Visit description: Treatment Period 2. Day 1

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])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
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])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item Group
ECOG Performance Status
C1520224 (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-2)
C0201549 (UMLS CUI-3)
Date sample taken CA-125
Item
Date sample taken
date
C1302413 (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)
abnormal physical examination
Item
If abnormal record below
text
C0031809 (UMLS CUI [1,1])
C0459424 (UMLS CUI [1,2])
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])
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])
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)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
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])
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])
TSH in serum
Item
TSH
float
C0202230 (UMLS CUI [1])
T4
Item
T4
float
C0040165 (UMLS CUI [1])
Lipase
Item
Serum lipase
float
C0373670 (UMLS CUI [1])
Amylase
Item
Serum Amylase
float
C0201883 (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
Pharmacokinetics - Blood
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose (1)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Identifier
text
C4071975 (UMLS CUI [1])
Sample Identifier
Code List
Sample Identifier
CL Item
101 (1)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Planned timepoint
text
C2348792 (UMLS CUI [1])
Planned timepoint
Code List
Planned timepoint
CL Item
Day 1 (1)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
investigational product
Code List
Investigational Product
CL Item
GW786034 (1)
Investigational Product Date of Dose
Item
Investigational Product Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigational Product Time of Dose
Item
Investigational Product Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Biomarker sample(s)
C0005516 (UMLS CUI-1)
Item
Sample Type
text
C2347029 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
Biomarker Sample Type
Code List
Sample Type
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])
Item
If No, provide reason
text
C0681841 (UMLS CUI [1])
If no, reason
Code List
If No, provide reason
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])
Item Group
INVESTIGATIONAL PRODUCT
C0304229 (UMLS CUI-1)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
investigational product
Code List
Investigational Product
CL Item
GW786034 (1)
(Comment:en)
medication dosage
Item
Dose
integer
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
start date
Item
Start Date
date
C0808070 (UMLS CUI [1])
stop date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
investigational product container number
Item
Investigational product Container Number
integer
C3898691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item
If there were any dosing deviations / changes, give reason
text
C1515926 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for dosing deviations changes
Code List
If there were any dosing deviations / changes, give reason
CL Item
Hypertension (17)
CL Item
Proteinuria (18)
CL Item
Fatigue (19)
CL Item
Diarrhea (20)
CL Item
Mucositis (21)
CL Item
Other Toxicity (22)
CL Item
Recovered from Toxicity (23)
CL Item
lntercurrent Illness (24)
CL Item
Subject Non-compliance (25)
CL Item
Investigator Error (26)
CL Item
Other, specify (CT)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Planned timepoint
text
C2348792 (UMLS CUI [1])
Planned timepoint
Code List
Planned timepoint
CL Item
Last dose prior to PK draw (1)
(Comment:en)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
investigational product
Code List
Investigational Product
CL Item
GW786034 (1)
Investigational Product Date of Dose
Item
Investigational Product Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigational Product Time of Dose
Item
Investigational Product Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If No, record reason(s)
Item
If No, record reason(s)
text
C0392360 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
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