ID

42279

Descripción

Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Palabras clave

Versiones (1)
  1. 28/4/21 28/4/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

28 de abril de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)

Inglés

Module 2 - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Descripción

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Laboratory Tests - Haematology
Descripción

Laboratory Tests - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Sample Date
Descripción

Sample Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Laboratory Name
Descripción

Laboratory Name

Tipo de datos

text

Alias
UMLS CUI [1]
C3258037
Haematology Test
Descripción

Haematology Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018941
Haematology Value
Descripción

Haematology Value

Tipo de datos

text

Alias
UMLS CUI [1]
C0474523
Are there clinically significant abnormal laboratory values?
Descripción

Are there clinically significant abnormal laboratory values?

Tipo de datos

boolean

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

Laboratory Tests - Blood Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0005774
Sample Date
Descripción

Sample Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Laboratory Name
Descripción

Laboratory Name

Tipo de datos

text

Alias
UMLS CUI [1]
C3258037
Blood Chemistry Test
Descripción

Blood Chemistry Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0525044
Blood Chemistry Value
Descripción

Blood Chemistry Value

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
Creatinine Clearance
Descripción

Creatinine Clearance

Tipo de datos

float

Alias
UMLS CUI [1]
C0373595
Are there clinically significant abnormal laboratory values?
Descripción

Are there clinically significant abnormal laboratory values?

Tipo de datos

boolean

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

Laboratory Tests - Urinalysis

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0042014
Sample Date
Descripción

Sample Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Laboratory Name
Descripción

Laboratory Name

Tipo de datos

text

Alias
UMLS CUI [1]
C3258037
Urinalysis Test
Descripción

Urinalysis Test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
Urinalysis Value
Descripción

Urinalysis Value

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1274040
Was microscopy performed?
Descripción

Was microscopy performed?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0430397
Microscopy
Descripción

Microscopy

Tipo de datos

text

Alias
UMLS CUI [1]
C0430397
Microscopy Result
Descripción

Microscopy Result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0587081
Are there clinically significant abnormal laboratory values?
Descripción

If "Yes" record the findings and/or diagnosis in the Adverse Experience section.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0438215
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Similar models

Module 2 - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Laboratory Tests - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Haematology Test
Code List
Haematology Test
CL Item
Haemoglobin (1)
CL Item
Haematocrit (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)
Item
Haematology Value
text
C0474523 (UMLS CUI [1])
Haematology Value
Code List
Haematology Value
CL Item
not done (ND)
CL Item
documented laboratory error (LE)
Are there clinically significant abnormal laboratory values?
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
C1254595 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Item
Blood Chemistry Test
integer
C0525044 (UMLS CUI [1])
Blood Chemistry Test
Code List
Blood Chemistry Test
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Calcium (5)
CL Item
Phosphorus (6)
CL Item
Magnesium (7)
CL Item
BUN (8)
CL Item
Urea (9)
CL Item
Uric Acid (10)
CL Item
Creatinine (11)
CL Item
Alkaline Phosphatase (12)
CL Item
LDH (13)
CL Item
SGOT/AST (14)
CL Item
SGPT/ALT (15)
CL Item
Total Bilirubin (16)
CL Item
Direct Bilirubin (17)
CL Item
Total Protein (18)
CL Item
Albumin (19)
CL Item
Creatinine (20)
CL Item
Clearance (21)
Item
Blood Chemistry Value
text
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Blood Chemistry Value
Code List
Blood Chemistry Value
CL Item
Not done (ND)
CL Item
documented laboratory error (LE)
Creatinine Clearance
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
Are there clinically significant abnormal laboratory values?
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)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Item
Urinalysis Test
integer
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis Test
Code List
Urinalysis Test
CL Item
Protein (1)
CL Item
Glucose (2)
CL Item
Blood (3)
Item
Urinalysis Value
text
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Urinalysis Value
Code List
Urinalysis Value
CL Item
not done (ND)
CL Item
documented laboratory error (LE)
CL Item
Negative (1)
CL Item
Trace (2)
CL Item
Positive (3)
CL Item
Not Done (4)
Was microscopy performed?
Item
Was microscopy performed?
boolean
C0430397 (UMLS CUI [1])
Item
Microscopy
text
C0430397 (UMLS CUI [1])
Microscopy
Code List
Microscopy
CL Item
RBC/HPF (RBC/HPF)
CL Item
WBC/HPF (WBC/HPF)
CL Item
Casts/LPF (Casts/LPF)
CL Item
Crystals/LPF (Crystals/LPF)
Item
Microscopy Result
integer
C0430397 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Microscopy Result
Code List
Microscopy Result
CL Item
Negative (1)
CL Item
Few (2)
CL Item
Moderate (3)
CL Item
Many (4)
Are there clinically significant abnormal laboratory values?
Item
Are there clinically significant abnormal laboratory values?
boolean
C0042014 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
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