ID

42258

Description

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

Keywords

Versions (1)
  1. 4/21/21 4/21/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 21, 2021

DOI

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License

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)

English

Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Patient Initials

Data type

text

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

Laboratory Tests - Haematology

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

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Day 1 not required
Description

Day 1 not required

Data type

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1514873
Sample Date
Description

Sample Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Sample Time
Description

Sample Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Laboratory Name
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C3258037
Haematology Test
Description

Haematology Test

Data type

integer

Alias
UMLS CUI [1]
C0018941
Haematology Value
Description

Haematology Value

Data type

text

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

Are there clinically significant abnormal laboratory values?

Data type

boolean

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

Laboratory Tests - Blood Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0005774
Visit
Description

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Day 1 not required
Description

Day 1 not required

Data type

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1514873
Sample Date
Description

Sample Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Sample Time
Description

Sample Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Laboratory Name
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C3258037
Blood Chemistry Test
Description

Blood Chemistry Test

Data type

integer

Alias
UMLS CUI [1]
C0525044
Blood Chemistry Value
Description

Blood Chemistry Value

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
Serum Beta HCG
Description

Serum Beta HCG

Data type

integer

Alias
UMLS CUI [1]
C2348195
Are there clinically significant abnormal laboratory values?
Description

Are there clinically significant abnormal laboratory values?

Data type

boolean

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

Laboratory Tests - Urinalysis

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

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Sample Date
Description

Sample Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Laboratory Name
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C3258037
Urinalysis Test
Description

Urinalysis Test

Data type

integer

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

Urinalysis Value

Data type

text

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

Was microscopy performed?

Data type

boolean

Alias
UMLS CUI [1]
C0430397
Microscopy
Description

Microscopy

Data type

text

Alias
UMLS CUI [1]
C0430397
Microscopy Result
Description

Microscopy Result

Data type

integer

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

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

Data type

boolean

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

Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Item
Visit
integer
C0545082 (UMLS CUI [1])
Visit
Code List
Visit
CL Item
Screening (1)
CL Item
Day 1 (2)
Item
Day 1 not required
integer
C0439228 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Day 1 not required
Code List
Day 1 not required
CL Item
Day 1 - Not required (1)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
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)
Item
Visit
integer
C0545082 (UMLS CUI [1])
Visit
Code List
Visit
CL Item
Screening (1)
CL Item
Day 1 (2)
Item
Day 1 not required
integer
C0439228 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Day 1 not required
Code List
Day 1 not required
CL Item
Day 1 - Not required (1)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
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)
Item
Serum Beta HCG
integer
C2348195 (UMLS CUI [1])
Serum Beta HCG
Code List
Serum Beta HCG
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not Done (3)
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)
Item
Visit
integer
C0545082 (UMLS CUI [1])
Visit
Code List
Visit
CL Item
Screening (1)
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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