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42258
Beschreibung
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
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- 21.04.21 21.04.21 -
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GlaxoSmithKline
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21. April 2021
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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)
Laboratory Tests - Haematology; Blood Chemistry; Urinalysis
- StudyEvent: ODM
Ähnliche Modelle
Laboratory Tests - Haematology; Blood Chemistry; Urinalysis
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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)
C0474523 (UMLS CUI-2)
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])
C1514873 (UMLS CUI [1,2])
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])
C0200345 (UMLS CUI [1,2])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
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)
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])
C0474523 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item Group
Laboratory Tests - Blood Chemistry
C1254595 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
C0005774 (UMLS CUI-2)
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])
C1514873 (UMLS CUI [1,2])
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])
C0200345 (UMLS CUI [1,2])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
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])
C1274040 (UMLS CUI [1,2])
CL Item
Not done (ND)
CL Item
documented laboratory error (LE)
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])
C0005774 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item Group
Laboratory Tests - Urinalysis
C0022885 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
C0042014 (UMLS CUI-2)
CL Item
Screening (1)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
CL Item
Protein (1)
CL Item
Glucose (2)
CL Item
Blood (3)
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])
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])
C0587081 (UMLS CUI [1,2])
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])
C0438215 (UMLS CUI [1,2])