ID

37213

Beschrijving

Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Trefwoorden

Versies (1)
  1. 08-07-19 08-07-19 -
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GlaxoSmithKline

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8 juli 2019

DOI

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Creative Commons BY-NC 3.0
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Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502

Engels

Laboratory Tests

1 Formulieren  
  1. StudyEvent: ODM
    1. Laboratory Tests
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Beschrijving

Patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschrijving

Person Initials

Datatype

text

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

Laboratory Tests - Hematology

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

Laboratory Procedures, Hematology finding, Visit

Datatype

text

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

Laboratory Procedures, Hematology finding, Specimen Collection Date

Datatype

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1302413
Sample Time
Beschrijving

Laboratory Procedures, Hematology finding, Sampling, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Laboratory Name
Beschrijving

Laboratory Procedures, Hematology finding, Performing Laboratory

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1882331
Test
Beschrijving

Laboratory Procedures, Hematology finding

Datatype

text

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

Laboratory Procedures, Hematology finding, Numerical Value

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1522609
Are there clinically significant abnormal laboratory values?
Beschrijving

Laboratory Procedures, Hematology finding, Abnormality

Datatype

boolean

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

Laboratory Tests - Blood Chemistry

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

Laboratory Procedures, Blood Chemical Analysis, Visit

Datatype

text

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

Laboratory Procedures, Blood Chemical Analysis, Specimen Collection Date

Datatype

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005774
UMLS CUI [1,3]
C1302413
Sample Time
Beschrijving

Laboratory Procedures, Blood Chemical Analysis, Sampling, Time

Datatype

time

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

Laboratory Procedures, Blood Chemical Analysis, Performing Laboratory

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005774
UMLS CUI [1,3]
C1882331
Test
Beschrijving

Laboratory Procedures, Blood Chemical Analysis

Datatype

text

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

Laboratory Procedures, Blood Chemical Analysis, Numerical Value

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005774
UMLS CUI [1,3]
C1522609
Are there clinically significant abnormal laboratory values?
Beschrijving

Laboratory Procedures, Blood Chemical Analysis, Abnormality

Datatype

boolean

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

Laboratory Tests - Urinalysis

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

Laboratory Procedures, Urinalysis, Visit

Datatype

text

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

Laboratory Procedures, Urinalysis, Specimen Collection Date

Datatype

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1302413
Laboratory Name
Beschrijving

Laboratory Procedures, Urinalysis, Performing Laboratory

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1882331
Test
Beschrijving

Laboratory Procedures, Urinalysis

Datatype

text

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

Laboratory Procedures, Urinalysis, Numerical Value

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1522609
Complete microscopy if protein and/or blood results are ’Positive’: Was microscopy performed?
Beschrijving

Laboratory Procedures, Urinalysis, Microscopic urinalysis

Datatype

boolean

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

Laboratory Procedures, Urinalysis, Microscopic urinalysis

Datatype

text

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

Laboratory Procedures, Urinalysis, Microscopic urinalysis, Numerical Value

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0430397
UMLS CUI [1,4]
C1522609
Are there clinically significant abnormal laboratory values?
Beschrijving

Laboratory Procedures, Urinalysis, Abnormality

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1704258
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Similar models

Laboratory Tests

1 Formulieren
  1. StudyEvent: ODM
    1. Laboratory Tests
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
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)
Laboratory Procedures, Hematology finding, Visit
Item
Visit
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Specimen Collection Date
Item
Sample Date
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
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
Item
Laboratory Name
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1882331 (UMLS CUI [1,3])
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding
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)
Laboratory Procedures, Hematology finding, Numerical Value
Item
Value
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Abnormality
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)
Laboratory Procedures, Blood Chemical Analysis, Visit
Item
Visit
text
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Laboratory Procedures, Blood Chemical Analysis, Specimen Collection Date
Item
Sample Date
date
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Laboratory Procedures, Blood Chemical Analysis, Sampling, 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
Item
Laboratory Name
text
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C1882331 (UMLS CUI [1,3])
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding
Code List
Test
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Calcium (5)
CL Item
BUN (6)
CL Item
Creatinine (7)
CL Item
Alkaline Phosphatase (8)
CL Item
SGOT/AST (9)
CL Item
SGPT/ALT (10)
CL Item
Total Bilirubin (11)
CL Item
Total Protein (12)
CL Item
Albumine (13)
CL Item
Creatinine Clearance (14)
CL Item
Serum Beta HCG (15)
Laboratory Procedures, Blood Chemical Analysis, Numerical Value
Item
Value
text
C0022885 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Laboratory Procedures, Blood Chemical Analysis, Abnormality
Item
Are there 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)
Laboratory Procedures, Urinalysis, Visit
Item
Visit
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Laboratory Procedures, Urinalysis, Specimen Collection Date
Item
Sample Date
date
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Laboratory Procedures, Urinalysis, Performing Laboratory
Item
Laboratory Name
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1882331 (UMLS CUI [1,3])
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding
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])
C1522609 (UMLS CUI [1,3])
Laboratory Procedures, Urinalysis, Numerical 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
Complete microscopy if protein and/or blood results are ’Positive’: Was microscopy performed?
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])
C1522609 (UMLS CUI [1,4])
Laboratory Procedures, Urinalysis, Microscopic urinalysis
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 clinically significant abnormal laboratory values?
boolean
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
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