ID

44915

Beschrijving

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 1, Pre-Dose.

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Trefwoorden

Versies (2)
  1. 10-04-18 10-04-18 - Sarah Riepenhausen
  2. 13-04-22 13-04-22 - Martin Dugas
Houder van rechten

GlaxoSmithKline

Geüploaded op

13 april 2022

DOI

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Licentie

Creative Commons BY-NC 4.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

Duits Engels

Laboratory Examination - Treatment Period 2, Day 1, Pre-dose

1 Formulieren  
  1. StudyEvent: GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630
    1. Laboratory Examination - Treatment Period 2, Day 1, Pre-dose
Pregnancy Test
Beschrijving

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Pregnancy test Date
Beschrijving

Pregnancy test Date

Datatype

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy Test Results
Beschrijving

Pregnancy Test Results

Datatype

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Drug Screen
Beschrijving

Drug Screen

Alias
UMLS CUI-1
C0373483
Drug Screen Date and Time
Beschrijving

Drug Screen Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0373483
Results of Cocaine Testing
Beschrijving

Results of Cocaine Testing

Datatype

text

Alias
UMLS CUI [1,1]
C0009170
UMLS CUI [1,2]
C1254595
Results of Benzodiazepines Testing
Beschrijving

Results of Benzodiazepines Testing

Datatype

text

Alias
UMLS CUI [1,1]
C0005064
UMLS CUI [1,2]
C2826772
Results of Cannabis metabolites Testing
Beschrijving

Results of Cannabis metabolites Testing

Datatype

text

Alias
UMLS CUI [1,1]
C0936079
UMLS CUI [1,2]
C0870883
UMLS CUI [1,3]
C2826772
Results of Opiates Testing
Beschrijving

Results of Opiates Testing

Datatype

text

Alias
UMLS CUI [1,1]
C0376196
UMLS CUI [1,2]
C2826772
Results of Amphetamine Testing
Beschrijving

Results of Amphetamine Testing

Datatype

text

Alias
UMLS CUI [1,1]
C0002667
UMLS CUI [1,2]
C2826772
Results of Barbiturates Testing
Beschrijving

Results of Barbiturates Testing

Datatype

text

Alias
UMLS CUI [1,1]
C0004745
UMLS CUI [1,2]
C2826772
Results of Methadone Testing
Beschrijving

Results of Methadone Testing

Datatype

text

Alias
UMLS CUI [1,1]
C0025605
UMLS CUI [1,2]
C2826772
Alcohol breath test
Beschrijving

Alcohol breath test

Alias
UMLS CUI-1
C0202306
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0202306
Results of Alcohol test
Beschrijving

Results of Alcohol test

Datatype

float

Maateenheden
  • ‰
Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
‰
Carbon Monoxide test
Beschrijving

Carbon Monoxide test

Alias
UMLS CUI-1
C0007018
Carbon monoxide test date
Beschrijving

Carbon monoxide test date

Datatype

date

Alias
UMLS CUI [1,1]
C0007018
UMLS CUI [1,2]
C1302413
Carbon monoxide results
Beschrijving

Carbon monoxide results

Datatype

float

Alias
UMLS CUI [1,1]
C0007018
UMLS CUI [1,2]
C1254595
Haematology
Beschrijving

Haematology

Alias
UMLS CUI-1
C0018941
Haematology sampling date and time
Beschrijving

Haematology sampling date and time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Fasting
Beschrijving

Fasting

Datatype

text

Alias
UMLS CUI [1]
C0015663
White blood cell count
Beschrijving

White blood cell count

Datatype

float

Alias
UMLS CUI [1]
C0023508
Red blood cell count
Beschrijving

Red blood cell count

Datatype

float

Alias
UMLS CUI [1]
C0014772
Haemoglobin
Beschrijving

Haemoglobin

Datatype

float

Maateenheden
  • g/dl
Alias
UMLS CUI [1]
C0518015
g/dl
Haematocrit
Beschrijving

Haematocrit

Datatype

float

Maateenheden
  • %
Alias
UMLS CUI [1]
C0018935
%
Mean cell volume
Beschrijving

Mean cell volume

Datatype

float

Alias
UMLS CUI [1]
C1948043
Mean cell haemoglobin
Beschrijving

Mean cell haemoglobin

Datatype

float

Alias
UMLS CUI [1]
C0369183
Mean cell haemoglobin concentration
Beschrijving

Mean cell haemoglobin concentration

Datatype

float

Alias
UMLS CUI [1]
C0474535
Platelet count
Beschrijving

Platelet count

Datatype

float

Alias
UMLS CUI [1]
C0005821
Reticulocytes
Beschrijving

Reticulocytes

Datatype

float

Alias
UMLS CUI [1]
C0206161
Neutrophil count
Beschrijving

Neutrophil count

Datatype

float

Alias
UMLS CUI [1]
C0948762
Lymphocyte count
Beschrijving

Lymphocyte count

Datatype

float

Alias
UMLS CUI [1]
C0200635
Monocyte count
Beschrijving

Monocyte count

Datatype

float

Alias
UMLS CUI [1]
C0750880
Eosinophil count
Beschrijving

Eosinophil count

Datatype

float

Alias
UMLS CUI [1]
C0200638
Basophil count
Beschrijving

Basophil count

Datatype

float

Alias
UMLS CUI [1]
C1883362
Clinical Chemistry
Beschrijving

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Date and time sample taken
Beschrijving

Date and time sample taken

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Fasting
Beschrijving

Fasting

Datatype

text

Alias
UMLS CUI [1]
C0015663
Alkaline phosphatase
Beschrijving

Alkaline phosphatase

Datatype

float

Alias
UMLS CUI [1]
C0201850
Alanine transaminase
Beschrijving

Alanine transaminase

Datatype

float

Alias
UMLS CUI [1]
C0201836
Aspartate transaminase
Beschrijving

Aspartate transaminase

Datatype

float

Alias
UMLS CUI [1]
C0004002
Gamma-glutamyl transpeptidase
Beschrijving

Gamma-glutamyl transpeptidase

Datatype

float

Alias
UMLS CUI [1]
C0202035
Lactate dehydrogenase
Beschrijving

Lactate dehydrogenase

Datatype

float

Alias
UMLS CUI [1]
C0202113
Urea
Beschrijving

Urea

Datatype

float

Alias
UMLS CUI [1]
C0523961
Sodium
Beschrijving

Sodium

Datatype

float

Maateenheden
  • mmol/l
Alias
UMLS CUI [1]
C0337443
mmol/l
Triglycerides
Beschrijving

Triglycerides

Datatype

float

Alias
UMLS CUI [1]
C0202236
Albumin
Beschrijving

Albumin

Datatype

float

Alias
UMLS CUI [1]
C0201838
Total protein
Beschrijving

Total protein

Datatype

float

Alias
UMLS CUI [1]
C0555903
Total Bilirubin
Beschrijving

Total Bilirubin

Datatype

float

Alias
UMLS CUI [1]
C0201913
Creatinine
Beschrijving

Creatinine

Datatype

float

Alias
UMLS CUI [1]
C0201975
Potassium
Beschrijving

Potassium

Datatype

float

Maateenheden
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Glucose
Beschrijving

Glucose

Datatype

float

Alias
UMLS CUI [1]
C0337438
Cholesterol
Beschrijving

Cholesterol

Datatype

float

Alias
UMLS CUI [1]
C0201950
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Similar models

Laboratory Examination - Treatment Period 2, Day 1, Pre-dose

1 Formulieren
  1. StudyEvent: GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630
    1. Laboratory Examination - Treatment Period 2, Day 1, Pre-dose
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C0032976 (UMLS CUI-1)
Pregnancy test Date
Item
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy Test Results
Code List
Pregnancy Test Results
CL Item
 (Positive)
CL Item
 (Negative)
Item Group
C0373483 (UMLS CUI-1)
Drug Screen Date and Time
Item
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0373483 (UMLS CUI [1,3])
Item
text
C0009170 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Results of Cocaine Testing
Code List
Results of Cocaine Testing
CL Item
 (positive)
CL Item
 (negative)
Item
text
C0005064 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
Results of Cocaine Testing
Code List
Results of Benzodiazepines Testing
CL Item
 (positive)
CL Item
 (negative)
Item
text
C0936079 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
C2826772 (UMLS CUI [1,3])
Results of Cocaine Testing
Code List
Results of Cannabis metabolites Testing
CL Item
 (positive)
CL Item
 (negative)
Item
text
C0376196 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
Results of Cocaine Testing
Code List
Results of Opiates Testing
CL Item
 (positive)
CL Item
 (negative)
Item
text
C0002667 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
Results of Amphetamine Testing
Code List
Results of Amphetamine Testing
CL Item
 (positive)
CL Item
 (negative)
Item
text
C0004745 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
Results of Amphetamine Testing
Code List
Results of Barbiturates Testing
CL Item
 (positive)
CL Item
 (negative)
Item
text
C0025605 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
Results of Amphetamine Testing
Code List
Results of Methadone Testing
CL Item
 (positive)
CL Item
 (negative)
Item Group
C0202306 (UMLS CUI-1)
Date sample taken
Item
date
C1302413 (UMLS CUI [1,1])
C0202306 (UMLS CUI [1,2])
Results of Alcohol test
Item
float
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
C0007018 (UMLS CUI-1)
Carbon monoxide test date
Item
date
C0007018 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Carbon monoxide results
Item
float
C0007018 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Item Group
C0018941 (UMLS CUI-1)
Haematology sampling date and time
Item
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
text
C0015663 (UMLS CUI [1])
Fasting
Code List
Fasting
CL Item
 (y)
CL Item
 (n)
White blood cell count
Item
float
C0023508 (UMLS CUI [1])
Red blood cell count
Item
float
C0014772 (UMLS CUI [1])
Haemoglobin
Item
float
C0518015 (UMLS CUI [1])
Haematocrit
Item
float
C0018935 (UMLS CUI [1])
Mean cell volume
Item
float
C1948043 (UMLS CUI [1])
Mean cell haemoglobin
Item
float
C0369183 (UMLS CUI [1])
Mean cell haemoglobin concentration
Item
float
C0474535 (UMLS CUI [1])
Platelet count
Item
float
C0005821 (UMLS CUI [1])
Reticulocytes
Item
float
C0206161 (UMLS CUI [1])
Neutrophil count
Item
float
C0948762 (UMLS CUI [1])
Lymphocyte count
Item
float
C0200635 (UMLS CUI [1])
Monocyte count
Item
float
C0750880 (UMLS CUI [1])
Eosinophil count
Item
float
C0200638 (UMLS CUI [1])
Basophil count
Item
float
C1883362 (UMLS CUI [1])
Item Group
C0008000 (UMLS CUI-1)
Date and time sample taken
Item
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Item
text
C0015663 (UMLS CUI [1])
Fasting
Code List
Fasting
CL Item
 (y)
CL Item
 (n)
Alkaline phosphatase
Item
float
C0201850 (UMLS CUI [1])
Alanine transaminase
Item
float
C0201836 (UMLS CUI [1])
Aspartate transaminase
Item
float
C0004002 (UMLS CUI [1])
Gamma-glutamyl transpeptidase
Item
float
C0202035 (UMLS CUI [1])
Lactate dehydrogenase
Item
float
C0202113 (UMLS CUI [1])
Urea
Item
float
C0523961 (UMLS CUI [1])
Sodium
Item
float
C0337443 (UMLS CUI [1])
Triglycerides
Item
float
C0202236 (UMLS CUI [1])
Albumin
Item
float
C0201838 (UMLS CUI [1])
Total protein
Item
float
C0555903 (UMLS CUI [1])
Total Bilirubin
Item
float
C0201913 (UMLS CUI [1])
Creatinine
Item
float
C0201975 (UMLS CUI [1])
Potassium
Item
float
C0202194 (UMLS CUI [1])
Glucose
Item
float
C0337438 (UMLS CUI [1])
Cholesterol
Item
float
C0201950 (UMLS CUI [1])
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