ID

30137

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. 14/5/18 14/5/18 -
  2. 15/5/18 15/5/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

14 de mayo de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Visit description: Treatment Period 2. Day 1

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
Centre Number
Descripción

Centre Number

Tipo de datos

integer

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

Temperature

Tipo de datos

float

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

ECOG Performance Status

Alias
UMLS CUI-1
C1520224
ECOG
Descripción

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

Tipo de datos

integer

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

Electronically transferred laboratory data - CA-125

Alias
UMLS CUI-1
C0200345
UMLS CUI-3
C0022885
UMLS CUI-5
C0201549
Date sample taken
Descripción

Date sample taken CA-125

Tipo de datos

date

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

abnormal physical examination

Tipo de datos

text

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

Laboratory name

Tipo de datos

text

Alias
UMLS CUI [1]
C1882331
Address
Descripción

Laboratory Address

Tipo de datos

text

Alias
UMLS CUI [1]
C3262820
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
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
Laboratory name
Descripción

Laboratory name

Tipo de datos

text

Alias
UMLS CUI [1]
C1882331
Address
Descripción

Laboratory Address

Tipo de datos

text

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

ALT (SGPT)

Tipo de datos

float

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

AST (SGOT)

Tipo de datos

float

Alias
UMLS CUI [1]
C0201899
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
TSH
Descripción

TSH in serum

Tipo de datos

float

Alias
UMLS CUI [1]
C0202230
T4
Descripción

T4

Tipo de datos

float

Alias
UMLS CUI [1]
C0040165
Serum lipase
Descripción

Lipase

Tipo de datos

float

Alias
UMLS CUI [1]
C0373670
Serum Amylase
Descripción

Amylase

Tipo de datos

float

Alias
UMLS CUI [1]
C0201883
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
Tumour Tissue Sample Collection
Descripción

Tumour Tissue Sample Collection

Alias
UMLS CUI-1
C0475358
UMLS CUI-2
C0005558
Has a tissue sample been collected?
Descripción

tumor tissue collection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
If No, tick appropriate reason
Descripción

no biopsy reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0392360
If other, please specify
Descripción

Other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
Sample Collection
Descripción

Sample Collection

Tipo de datos

text

Alias
UMLS CUI [1]
C1547864
Preservation Method
Descripción

Biopsy sample preservation method

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1514402
Form Type
Descripción

tissue sample form type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0332479
Type of Tissue Biopsy
Descripción

Type of Tissue Biopsy

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0332307
Organ Code
Descripción

Organ code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0805701
Tissue Source
Descripción

Tissue Source

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0449416
UMLS CUI [1,3]
C0678257
Date Biopsy Taken
Descripción

Date Biopsy Taken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1302413
Time Biopsy Taken
Descripción

Time Biopsy Taken

Tipo de datos

partialDatetime

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0040223
Consent for tumour genetic research
Descripción

Consent for tumour genetic research

Alias
UMLS CUI-1
C0586888
UMLS CUI-2
C0243064
Has consent been obtained for tumour genetic research?
Descripción

consent for tumour genetic research

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0243064
If yes, record date consent obtained
Descripción

date of informed consent

Tipo de datos

date

Alias
UMLS CUI [1]
C2985782
If no, tick one reason
Descripción

reason no consent given

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1705492
if other, specify
Descripción

other reason

Tipo de datos

text

Alias
UMLS CUI [1]
C3840932
Withdrawal of consent
Descripción

Withdrawal of consent

Has subject withdrawn consent for tumour genetic research?
Descripción

Withdrawal of consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0243064
If Yes, record the date informed consent withdrawn for tumour genetic research
Descripción

Date of withdrawal of consent

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1707492
UMLS CUI [1,3]
C0243064
Sample Destruction
Descripción

Sample Destruction

Alias
UMLS CUI-1
C1948029
UMLS CUI-2
C0475358
Has a request been made for tumour genetics tissue sample destruction?
Descripción

Request made for destruction of tumour sample

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
If yes, tick one reason
Descripción

Reason for tumour sample destruction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0475358
If other, please specify
Descripción

Other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
Biomarker sample(s)
Descripción

Biomarker sample(s)

Alias
UMLS CUI-1
C0005516
Sample Type
Descripción

Biomarker Sample Type

Tipo de datos

text

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

Biomarker sample collected

Tipo de datos

boolean

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

If no, reason

Tipo de datos

text

Alias
UMLS CUI [1]
C0681841
Date sample taken
Descripción

Date sample taken

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Time sample taken
Descripción

Time sample taken

Tipo de datos

partialDatetime

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
PHARMACOKINETICS - BLOOD
Descripción

PHARMACOKINETICS - BLOOD

Alias
UMLS CUI-1
C0031327
UMLS CUI-3
C0005767
PHARMACOKINETICS - BLOOD
Descripción

PHARMACOKINETICS - BLOOD

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

Planned Relative Time

Tipo de datos

text

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Descripción

Date Sample Taken

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Sample Identifier
Descripción

Sample Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C4071975
Investigational Product
Descripción

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned timepoint
Descripción

Planned timepoint

Tipo de datos

text

Alias
UMLS CUI [1]
C2348792
Investigational Product Date of Dose
Descripción

Investigational Product Date of Dose

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Investigational Product
Descripción

investigational product

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
Investigational Product Time of Dose
Descripción

Investigational Product Time of Dose

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
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Similar models

Visit description: Treatment Period 2. Day 1

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])
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-3)
C0201549 (UMLS CUI-5)
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
Tumour Tissue Sample Collection
C0475358 (UMLS CUI-1)
C0005558 (UMLS CUI-2)
tumor tissue collection
Item
Has a tissue sample been collected?
boolean
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Item
If No, tick appropriate reason
text
C0005558 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
no biopsy reason
Code List
If No, tick appropriate reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (OT)
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
Item
Sample Collection
text
C1547864 (UMLS CUI [1])
Sample Collection
Code List
Sample Collection
CL Item
Derived During Study (1)
CL Item
Archieved (2)
Item
Preservation Method
text
C0475358 (UMLS CUI [1,1])
C1514402 (UMLS CUI [1,2])
Biopsy sample preservation method
Code List
Preservation Method
CL Item
FFPE (1)
CL Item
Fresh-frozen (2)
Item
Form Type
text
C0475358 (UMLS CUI [1,1])
C0332479 (UMLS CUI [1,2])
tissue sample form type
Code List
Form Type
CL Item
Block (1)
CL Item
Slides (2)
Item
Type of Tissue Biopsy
text
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of Tissue Biopsy
Code List
Type of Tissue Biopsy
CL Item
Core (1)
CL Item
Excisional (2)
CL Item
FNA (fine needle aspiration) (3)
CL Item
Punch (4)
CL Item
Other, specify (OT)
Item
Organ Code
text
C0678852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Organ code
Code List
Organ Code
CL Item
Abdomen/abdominal wall  (AB)
CL Item
Liver  (LV)
CL Item
Lymph nodes  (LN)
CL Item
Ovary  (OV)
CL Item
Peritoneum (PM)
CL Item
Spleen (SP)
CL Item
Small intestine (SI)
CL Item
Other, specify (CT)
Item
Tissue Source
text
C0475358 (UMLS CUI [1,1])
C0449416 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Tissue Source
Code List
Tissue Source
CL Item
Primary (1)
CL Item
Metastasic (2)
CL Item
Unknown (U)
Date Biopsy Taken
Item
Date Biopsy Taken
date
C0005558 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time Biopsy Taken
Item
Time Biopsy Taken
partialDatetime
C0005558 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Consent for tumour genetic research
C0586888 (UMLS CUI-1)
C0243064 (UMLS CUI-2)
consent for tumour genetic research
Item
Has consent been obtained for tumour genetic research?
boolean
C0021430 (UMLS CUI [1,1])
C0243064 (UMLS CUI [1,2])
date of informed consent
Item
If yes, record date consent obtained
date
C2985782 (UMLS CUI [1])
Item
If no, tick one reason
text
C0566251 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
reason no consent given
Code List
If no, tick one reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
other reason
Item
if other, specify
text
C3840932 (UMLS CUI [1])
Item Group
Withdrawal of consent
Withdrawal of consent
Item
Has subject withdrawn consent for tumour genetic research?
boolean
C1707492 (UMLS CUI [1,1])
C0243064 (UMLS CUI [1,2])
Date of withdrawal of consent
Item
If Yes, record the date informed consent withdrawn for tumour genetic research
date
C0011008 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C0243064 (UMLS CUI [1,3])
Item Group
Sample Destruction
C1948029 (UMLS CUI-1)
C0475358 (UMLS CUI-2)
Request made for destruction of tumour sample
Item
Has a request been made for tumour genetics tissue sample destruction?
boolean
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Item
If yes, tick one reason
text
C0392360 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0475358 (UMLS CUI [1,3])
Reason for tumour sample destruction
Code List
If yes, tick one reason
CL Item
Subject withdrew consent for tumour genetic research (4)
CL Item
Other, specify (OT)
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
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
PHARMACOKINETICS - BLOOD
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-3)
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)
Investigational Product Date of Dose
Item
Investigational Product Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
investigational product
Code List
Investigational Product
CL Item
GW786034 (1)
Investigational Product Time of Dose
Item
Investigational Product Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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