ID

37688

Beskrivning

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Nyckelord

Versioner (1)
  1. 2019-08-16 2019-08-16 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

16 augusti 2019

DOI

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Creative Commons BY-NC 3.0
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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

Engelsk

Laboratory Tests

1 Formulär  
  1. StudyEvent: ODM
    1. Laboratory Tests
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Center number
Beskrivning

Study Coordinating Center, Identification number

Datatyp

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beskrivning

Patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beskrivning

Person Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Laboratory Tests - Hematology
Beskrivning

Laboratory Tests - Hematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Visit
Beskrivning

Laboratory Procedures, Hematology finding, Visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0545082
Sample Date
Beskrivning

Laboratory Procedures, Hematology finding, Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Sample Time
Beskrivning

Laboratory Procedures, Hematology finding, Sampling, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Laboratory name
Beskrivning

Laboratory Procedures, Hematology finding, Performing laboratory name

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C3258037
Test
Beskrivning

Laboratory Procedures, Hematology finding

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
Value
Beskrivning

Laboratory Procedures, Hematology finding, Parameter value

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0549193
Are there clinically significant abnormal laboratory values?
Beskrivning

Laboratory Procedures, Hematology finding, Abnormaliity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1704258
Laboratory Tests - Blood Chemistry
Beskrivning

Laboratory Tests - Blood Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005774
Visit
Beskrivning

Laboratory Procedures, Blood Chemical Analysis, Visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005774
UMLS CUI [1,3]
C0545082
Sample Date
Beskrivning

Laboratory Procedures, Blood Chemical Analysis, Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005774
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Sample Time
Beskrivning

Laboratory Procedures, Blood Chemical Analysis, Sampling, Date in time

Datatyp

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005774
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Laboratory Name
Beskrivning

Laboratory Procedures, Blood Chemical Analysis, Performing laboratory name

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005774
UMLS CUI [1,3]
C3258037
Test
Beskrivning

Laboratory Procedures, Blood Chemical Analysis

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005774
Value
Beskrivning

Laboratory Procedures, Blood Chemical Analysis, Parameter value

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005774
UMLS CUI [1,3]
C0549193
Are there any clinically significant abnormal laboratory values?
Beskrivning

Laboratory Procedures, Blood Chemical Analysis, Abnormality

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005774
UMLS CUI [1,3]
C1704258
Laboratory Tests - Urinalysis
Beskrivning

Laboratory Tests - Urinalysis

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0042014
Visit
Beskrivning

Laboratory Procedures, Urinalysis, Visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0545082
Sample Date
Beskrivning

Laboratory Procedures, Urinalysis, Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Laboratory Name
Beskrivning

Laboratory Procedures, Urinalysis, Performing laboratory name

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C3258037
Test
Beskrivning

Laboratory Procedures, Urinalysis

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
Value
Beskrivning

Laboratory Procedures, Urinalysis, Parameter value

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0549193
Was microscopy performed? (Complete microscopy if protein and/or blood results are 'Positive'.)
Beskrivning

Laboratory Procedures, Urinalysis, Microscopic urinalysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0430397
Microscopy
Beskrivning

Laboratory Procedures, Urinalysis, Microscopic urinalysis

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0430397
Value
Beskrivning

Laboratory Procedures, Urinalysis, Microscopic urinalysis, Parameter value

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0430397
UMLS CUI [1,4]
C0549193
Are there any clinically significant abnormal laboratory values?
Beskrivning

Laboratory Procedures, Urinalysis, Abnormality

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1704258
Tissue Samples Obtained for Correlative Lab Studies
Beskrivning

Tissue Samples Obtained for Correlative Lab Studies

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1511524
UMLS CUI-3
C1292533
Visit
Beskrivning

Laboratory Procedures, Correlative Study, Tissue specimen, Visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1511524
UMLS CUI [1,3]
C1292533
UMLS CUI [1,4]
C0545082
Sample Date
Beskrivning

Laboratory Procedures, Correlative Study, Tissue specimen, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1511524
UMLS CUI [1,3]
C1292533
UMLS CUI [1,4]
C0011008
Test
Beskrivning

Laboratory Procedures, Correlative Study, Tissue specimen

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1511524
UMLS CUI [1,3]
C1292533
UMLS CUI [1,4]
C0011008
Normal Mucosa
Beskrivning

Laboratory Procedures, Correlative Study, Tissue specimen, Mucous Membrane, Normal

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1511524
UMLS CUI [1,3]
C1292533
UMLS CUI [1,4]
C0026724
UMLS CUI [1,5]
C0205307
Tumor
Beskrivning

Laboratory Procedures, Correlative Study, Tissue specimen, Malignant Neoplasms

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1511524
UMLS CUI [1,3]
C1292533
UMLS CUI [1,4]
C0006826
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Similar models

Laboratory Tests

1 Formulär
  1. StudyEvent: ODM
    1. Laboratory Tests
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Laboratory Tests - Hematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Visit
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Visit
Code List
Visit
CL Item
Screening (1)
CL Item
Day 1 (2)
Laboratory Procedures, Hematology finding, Sampling, Date in time
Item
Sample Date
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Sampling, Time
Item
Sample Time
time
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Performing laboratory name
Item
Laboratory name
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C3258037 (UMLS CUI [1,3])
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding, Parameter
Code List
Test
CL Item
Hemoglobin (1)
CL Item
Hematocrit (2)
CL Item
RBC (3)
CL Item
WBC (4)
CL Item
Neutrophils - segmented (5)
CL Item
Bands (6)
CL Item
Lymphocytes (7)
CL Item
Monocytes (8)
CL Item
Eosinophils (9)
CL Item
Basophils (10)
CL Item
Platelets (11)
CL Item
PT (12)
CL Item
PTT (13)
Laboratory Procedures, Hematology finding, Parameter value
Item
Value
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Abnormaliity
Item
Are there clinically significant abnormal laboratory values?
boolean
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item Group
Laboratory Tests - Blood Chemistry
C0022885 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
Item
Visit
text
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Laboratory Procedures, Blood Chemical Analysis, Visit
Code List
Visit
CL Item
Screening (1)
CL Item
Day 1 (2)
Laboratory Procedures, Blood Chemical Analysis, Sampling, Date in time
Item
Sample Date
date
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Blood Chemical Analysis, Sampling, Date in time
Item
Sample Time
time
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Blood Chemical Analysis, Performing laboratory name
Item
Laboratory Name
text
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C3258037 (UMLS CUI [1,3])
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
Laboratory Procedures, Blood Chemical Analysis
Code List
Test
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
BUN (5)
CL Item
Creatinine (6)
CL Item
Alkaline Phosphatase (7)
CL Item
SGOT/AST (8)
CL Item
SGPT/ALT (9)
CL Item
Total Bilirubine (10)
CL Item
Total Protein (11)
CL Item
Albumin (12)
CL Item
Creatinine Clearance (13)
CL Item
CEA (14)
CL Item
Serum Beta HCG (15)
Laboratory Procedures, Blood Chemical Analysis, Parameter value
Item
Value
text
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
Laboratory Procedures, Blood Chemical Analysis, Abnormality
Item
Are there any clinically significant abnormal laboratory values?
boolean
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item Group
Laboratory Tests - Urinalysis
C0022885 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
Item
Visit
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Laboratory Procedures, Urinalysis, Visit
Code List
Visit
CL Item
Screening (1)
Laboratory Procedures, Urinalysis, Sampling, Date in time
Item
Sample Date
date
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Urinalysis, Performing laboratory name
Item
Laboratory Name
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C3258037 (UMLS CUI [1,3])
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Laboratory Procedures, Urinalysis
Code List
Test
CL Item
Protein (1)
CL Item
Glucose (2)
CL Item
Blood (3)
Item
Value
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
Laboratory Procedures, Urinalysis, Parameter value
Code List
Value
CL Item
Neg (1)
CL Item
Trace (2)
CL Item
Pos (3)
CL Item
Not Done (4)
Laboratory Procedures, Urinalysis, Microscopic urinalysis
Item
Was microscopy performed? (Complete microscopy if protein and/or blood results are 'Positive'.)
boolean
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0430397 (UMLS CUI [1,3])
Item
Microscopy
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0430397 (UMLS CUI [1,3])
Laboratory Procedures, Urinalysis, Microscopic urinalysis
Code List
Microscopy
CL Item
RBC/HPF (1)
CL Item
WBC/HPF (2)
CL Item
Casts/LPF (3)
CL Item
Crystals/LPF (4)
Item
Value
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0430397 (UMLS CUI [1,3])
C0549193 (UMLS CUI [1,4])
Laboratory Procedures, Urinalysis, Microscopic urinalysis, Parameter value
Code List
Value
CL Item
Neg (1)
CL Item
Few (2)
CL Item
Moderate (3)
CL Item
Many (4)
Laboratory Procedures, Urinalysis, Abnormality
Item
Are there any clinically significant abnormal laboratory values?
boolean
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item Group
Tissue Samples Obtained for Correlative Lab Studies
C0022885 (UMLS CUI-1)
C1511524 (UMLS CUI-2)
C1292533 (UMLS CUI-3)
Item
Visit
text
C0022885 (UMLS CUI [1,1])
C1511524 (UMLS CUI [1,2])
C1292533 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Laboratory Procedures, Correlative Study, Tissue specimen, Visit
Code List
Visit
CL Item
Screening (1)
CL Item
Days 10-14 (2)
Laboratory Procedures, Correlative Study, Tissue specimen, Date in time
Item
Sample Date
date
C0022885 (UMLS CUI [1,1])
C1511524 (UMLS CUI [1,2])
C1292533 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Correlative Study, Tissue specimen
Item
Test
text
C0022885 (UMLS CUI [1,1])
C1511524 (UMLS CUI [1,2])
C1292533 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Normal Mucosa
text
C0022885 (UMLS CUI [1,1])
C1511524 (UMLS CUI [1,2])
C1292533 (UMLS CUI [1,3])
C0026724 (UMLS CUI [1,4])
C0205307 (UMLS CUI [1,5])
Laboratory Procedures, Correlative Study, Tissue specimen, Mucous Membrane, Normal
Code List
Normal Mucosa
CL Item
MicroA/Prot (1)
CL Item
Topo (2)
Item
Tumor
text
C0022885 (UMLS CUI [1,1])
C1511524 (UMLS CUI [1,2])
C1292533 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
Laboratory Procedures, Correlative Study, Tissue specimen, Mucous Membrane, Normal
Code List
Tumor
CL Item
MicroA/Prot (1)
CL Item
Topo (2)
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