ID

29642

Beschreibung

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 1, Day 1, Pre-dose.

Link

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

Stichworte

Versionen (1)
  1. 10.04.18 10.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. April 2018

DOI

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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

Englisch

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

1 Formulare  
Pregnancy Test
Beschreibung

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Pregnancy Test: Date sample taken
Beschreibung

Complete for Female Subjects Only.

Datentyp

date

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

Pregnancy Test Results

Datentyp

text

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

Drug Screen

Alias
UMLS CUI-1
C0373483
Date and Time of sample taken
Beschreibung

Day Month Year Hr:Min (00:00 - 23:59)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0373483
Cocaine: Mark the appropriate box
Beschreibung

If positive, exclude subject from the study.

Datentyp

text

Alias
UMLS CUI [1,1]
C0009170
UMLS CUI [1,2]
C1254595
Benzodiazepines: Mark the appropriate box
Beschreibung

If positive, exclude subject from the study.

Datentyp

text

Alias
UMLS CUI [1,1]
C0005064
UMLS CUI [1,2]
C2826772
Cannabis metabolites: Mark the appropriate box
Beschreibung

If positive, exclude subject from the study.

Datentyp

text

Alias
UMLS CUI [1,1]
C0936079
UMLS CUI [1,2]
C0870883
UMLS CUI [1,3]
C2826772
Opiates: Mark the appropriate box
Beschreibung

If positive, exclude subject from the study.

Datentyp

text

Alias
UMLS CUI [1,1]
C0376196
UMLS CUI [1,2]
C2826772
Amphetamine: Mark the appropriate box.
Beschreibung

If positive, exclude subject from the study.

Datentyp

text

Alias
UMLS CUI [1,1]
C0002667
UMLS CUI [1,2]
C2826772
Barbiturates: Mark the appropriate box.
Beschreibung

If positive, exclude subject from the study.

Datentyp

text

Alias
UMLS CUI [1,1]
C0004745
UMLS CUI [1,2]
C2826772
Methadone: Mark the appropriate box.
Beschreibung

If positive, exclude subject from the study.

Datentyp

text

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

Alcohol breath test

Alias
UMLS CUI-1
C0202306
Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0202306
Results of Alcohol test, Mark one:
Beschreibung

If positive, exclude subject from the study.

Datentyp

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
Carbon Monoxide test
Beschreibung

Carbon Monoxide test

Alias
UMLS CUI-1
C0007018
Carbon monoxide test, Date sample taken.
Beschreibung

Carbon monoxide test date

Datentyp

date

Alias
UMLS CUI [1,1]
C0007018
UMLS CUI [1,2]
C1302413
Carbon monoxide results: Mark one.
Beschreibung

If positive, exclude subject from the study.

Datentyp

text

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

Haematology

Alias
UMLS CUI-1
C0018941
Haematology: Date and time sample taken
Beschreibung

Day Month Year Hr : Min (00:00 - 23:59)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Has the subject fasted?
Beschreibung

Fasting

Datentyp

text

Alias
UMLS CUI [1]
C0015663
White blood cell count (WBC) (absolute)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0023508
Red blood cell count (RBC) (absolute)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0014772
Haemoglobin (Hb)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0518015
Haematocrit (HCT)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0018935
Mean cell volume (MCV)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C1948043
Mean cell haemoglobin (MCH)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0369183
Mean cell haemoglobin concentration (MCHC)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0474535
Platelet count (absolute)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0005821
Reticulocytes (absolute)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0206161
Neutrophil count (absolute)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0948762
Lymphocyte count
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0200635
Monocyte count (absolute)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0750880
Eosinophil count (absolute)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0200638
Basophil count (absolute)
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C1883362
Clinical Chemistry
Beschreibung

Clinical Chemistry

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

Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Has the subject fasted?
Beschreibung

Fasting

Datentyp

text

Alias
UMLS CUI [1]
C0015663
Alkaline phasphatase
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0201850
Alanine transaminase
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0201836
Aspartate transaminase
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

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

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0202035
Lactate dehydrogenase
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0202113
Urea
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0523961
Sodium
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0337443
Triglycerides
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0202236
Albumin
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0201838
Total protein
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0555903
Total Bilirubin
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0201913
Creatinine
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0201975
Potassium
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0202194
Glucose
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0337438
Cholesterol
Beschreibung

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Datentyp

text

Alias
UMLS CUI [1]
C0201950
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Pregnancy test Date
Item
Pregnancy Test: Date sample taken
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy Test Results
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy Test Results
Code List
Pregnancy Test Results
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Drug Screen
C0373483 (UMLS CUI-1)
Drug Screen Date and Time
Item
Date and Time of sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0373483 (UMLS CUI [1,3])
Item
Cocaine: Mark the appropriate box
text
C0009170 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Results of Cocaine Testing
Code List
Cocaine: Mark the appropriate box
CL Item
positive (positive)
CL Item
negative (negative)
Item
Benzodiazepines: Mark the appropriate box
text
C0005064 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
Results of Cocaine Testing
Code List
Benzodiazepines: Mark the appropriate box
CL Item
positive (positive)
CL Item
negative (negative)
Item
Cannabis metabolites: Mark the appropriate box
text
C0936079 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
C2826772 (UMLS CUI [1,3])
Results of Cocaine Testing
Code List
Cannabis metabolites: Mark the appropriate box
CL Item
positive (positive)
CL Item
negative (negative)
Item
Opiates: Mark the appropriate box
text
C0376196 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
Results of Cocaine Testing
Code List
Opiates: Mark the appropriate box
CL Item
positive (positive)
CL Item
negative (negative)
Item
Amphetamine: Mark the appropriate box.
text
C0002667 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
Results of Amphetamine Testing
Code List
Amphetamine: Mark the appropriate box.
CL Item
positive (positive)
CL Item
negative (negative)
Item
Barbiturates: Mark the appropriate box.
text
C0004745 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
Results of Amphetamine Testing
Code List
Barbiturates: Mark the appropriate box.
CL Item
positive (positive)
CL Item
negative (negative)
Item
Methadone: Mark the appropriate box.
text
C0025605 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
Results of Amphetamine Testing
Code List
Methadone: Mark the appropriate box.
CL Item
positive (positive)
CL Item
negative (negative)
Item Group
Alcohol breath test
C0202306 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0202306 (UMLS CUI [1,2])
Item
Results of Alcohol test, Mark one:
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Results of Alcohol test
Code List
Results of Alcohol test, Mark one:
CL Item
positive (positive)
CL Item
negative (negative)
Item Group
Carbon Monoxide test
C0007018 (UMLS CUI-1)
Carbon monoxide test date
Item
Carbon monoxide test, Date sample taken.
date
C0007018 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Carbon monoxide results: Mark one.
text
C0007018 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Carbon monoxide results
Code List
Carbon monoxide results: Mark one.
CL Item
positive (positive)
CL Item
negative (negative)
Item Group
Haematology
C0018941 (UMLS CUI-1)
Haematology sampling date and time
Item
Haematology: Date and time sample taken
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Has the subject fasted?
text
C0015663 (UMLS CUI [1])
Fasting
Code List
Has the subject fasted?
CL Item
yes (y)
CL Item
no (n)
White blood cell count
Item
White blood cell count (WBC) (absolute)
text
C0023508 (UMLS CUI [1])
Red blood cell count
Item
Red blood cell count (RBC) (absolute)
text
C0014772 (UMLS CUI [1])
Haemoglobin
Item
Haemoglobin (Hb)
text
C0518015 (UMLS CUI [1])
Haematocrit
Item
Haematocrit (HCT)
text
C0018935 (UMLS CUI [1])
Mean cell volume
Item
Mean cell volume (MCV)
text
C1948043 (UMLS CUI [1])
Mean cell haemoglobin
Item
Mean cell haemoglobin (MCH)
text
C0369183 (UMLS CUI [1])
Mean cell haemoglobin concentration
Item
Mean cell haemoglobin concentration (MCHC)
text
C0474535 (UMLS CUI [1])
Platelet count
Item
Platelet count (absolute)
text
C0005821 (UMLS CUI [1])
Reticulocytes
Item
Reticulocytes (absolute)
text
C0206161 (UMLS CUI [1])
Neutrophil count
Item
Neutrophil count (absolute)
text
C0948762 (UMLS CUI [1])
Lymphocyte count
Item
Lymphocyte count
text
C0200635 (UMLS CUI [1])
Monocyte count
Item
Monocyte count (absolute)
text
C0750880 (UMLS CUI [1])
Eosinophil count
Item
Eosinophil count (absolute)
text
C0200638 (UMLS CUI [1])
Basophil count
Item
Basophil count (absolute)
text
C1883362 (UMLS CUI [1])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Item
Has the subject fasted?
text
C0015663 (UMLS CUI [1])
Fasting
Code List
Has the subject fasted?
CL Item
yes (y)
CL Item
no (n)
Alkaline phosphatase
Item
Alkaline phasphatase
text
C0201850 (UMLS CUI [1])
Alanine transaminase
Item
Alanine transaminase
text
C0201836 (UMLS CUI [1])
Aspartate transaminase
Item
Aspartate transaminase
text
C0004002 (UMLS CUI [1])
Gamma-glutamyl transpeptidase
Item
Gamma-glutamyl transpeptidase
text
C0202035 (UMLS CUI [1])
Lactate dehydrogenase
Item
Lactate dehydrogenase
text
C0202113 (UMLS CUI [1])
Urea
Item
Urea
text
C0523961 (UMLS CUI [1])
Sodium
Item
Sodium
text
C0337443 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
text
C0202236 (UMLS CUI [1])
Albumin
Item
Albumin
text
C0201838 (UMLS CUI [1])
Total protein
Item
Total protein
text
C0555903 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1])
Creatinine
Item
Creatinine
text
C0201975 (UMLS CUI [1])
Potassium
Item
Potassium
text
C0202194 (UMLS CUI [1])
Glucose
Item
Glucose
text
C0337438 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
text
C0201950 (UMLS CUI [1])
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