ID

44929

Beskrivning

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 28, Pre-dose.

Länk

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

Nyckelord

Versioner (2)
  1. 2018-04-10 2018-04-10 - Sarah Riepenhausen
  2. 2022-04-29 2022-04-29 - Martin Dugas
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

29 april 2022

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

Engelsk

Laboratory Examination - Treatment Period 2, Day 28, Pre-dose

1 Formulär  
  1. StudyEvent: GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630
    1. Laboratory Examination - Treatment Period 2, Day 28, Pre-dose
Pregnancy Test
Beskrivning

Pregnancy Test

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

Complete for Female Subjects Only.

Datatyp

date

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

Pregnancy Test Results

Datatyp

text

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

Drug Screen

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

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

Datatyp

datetime

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

If positive, exclude subject from the study.

Datatyp

text

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

If positive, exclude subject from the study.

Datatyp

text

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

If positive, exclude subject from the study.

Datatyp

text

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

If positive, exclude subject from the study.

Datatyp

text

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

If positive, exclude subject from the study.

Datatyp

text

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

If positive, exclude subject from the study.

Datatyp

text

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

If positive, exclude subject from the study.

Datatyp

text

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

Alcohol breath test

Alias
UMLS CUI-1
C0202306
Date sample taken
Beskrivning

Date sample taken

Datatyp

date

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

If positive, exclude subject from the study.

Datatyp

text

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

Carbon Monoxide test

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

Carbon monoxide test date

Datatyp

date

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

If positive, exclude subject from the study.

Datatyp

text

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

Haematology

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

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

Datatyp

datetime

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

Fasting

Datatyp

text

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

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

Datatyp

float

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

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

Datatyp

float

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

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

Datatyp

float

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

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

Datatyp

float

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

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

Datatyp

float

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

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

Datatyp

float

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

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

Datatyp

float

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

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

Datatyp

float

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

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

Datatyp

float

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

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

Datatyp

float

Alias
UMLS CUI [1]
C0948762
Lymphocyte count
Beskrivning

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

Datatyp

float

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

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

Datatyp

float

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

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

Datatyp

float

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

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

Datatyp

float

Alias
UMLS CUI [1]
C1883362
Clinical Chemistry
Beskrivning

Clinical Chemistry

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

Date and time sample taken

Datatyp

datetime

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

Fasting

Datatyp

text

Alias
UMLS CUI [1]
C0015663
Alkaline phasphatase
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0201850
Alanine transaminase
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0201836
Aspartate transaminase
Beskrivning

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

Datatyp

float

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

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

Datatyp

float

Alias
UMLS CUI [1]
C0202035
Lactate dehydrogenase
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0202113
Urea
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0523961
Sodium
Beskrivning

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

Datatyp

float

Måttenheter
  • mmol/l
Alias
UMLS CUI [1]
C0337443
mmol/l
Triglycerides
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0202236
Albumin
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0201838
Total protein
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0555903
Total Bilirubin
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0201913
Creatinine
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0201975
Potassium
Beskrivning

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

Datatyp

float

Måttenheter
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Glucose
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0337438
Cholesterol
Beskrivning

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

Datatyp

float

Alias
UMLS CUI [1]
C0201950
Tillbaka till toppen

Similar models

Laboratory Examination - Treatment Period 2, Day 28, Pre-dose

1 Formulär
  1. StudyEvent: GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630
    1. Laboratory Examination - Treatment Period 2, Day 28, Pre-dose
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
float
C0023508 (UMLS CUI [1])
Red blood cell count
Item
Red blood cell count (RBC) (absolute)
float
C0014772 (UMLS CUI [1])
Haemoglobin
Item
Haemoglobin (Hb)
float
C0518015 (UMLS CUI [1])
Haematocrit
Item
Haematocrit (HCT)
float
C0018935 (UMLS CUI [1])
Mean cell volume
Item
Mean cell volume (MCV)
float
C1948043 (UMLS CUI [1])
Mean cell haemoglobin
Item
Mean cell haemoglobin (MCH)
float
C0369183 (UMLS CUI [1])
Mean cell haemoglobin concentration
Item
Mean cell haemoglobin concentration (MCHC)
float
C0474535 (UMLS CUI [1])
Platelet count
Item
Platelet count (absolute)
float
C0005821 (UMLS CUI [1])
Reticulocytes
Item
Reticulocytes (absolute)
float
C0206161 (UMLS CUI [1])
Neutrophil count
Item
Neutrophil count (absolute)
float
C0948762 (UMLS CUI [1])
Lymphocyte count
Item
Lymphocyte count
float
C0200635 (UMLS CUI [1])
Monocyte count
Item
Monocyte count (absolute)
float
C0750880 (UMLS CUI [1])
Eosinophil count
Item
Eosinophil count (absolute)
float
C0200638 (UMLS CUI [1])
Basophil count
Item
Basophil count (absolute)
float
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
float
C0201850 (UMLS CUI [1])
Alanine transaminase
Item
Alanine transaminase
float
C0201836 (UMLS CUI [1])
Aspartate transaminase
Item
Aspartate transaminase
float
C0004002 (UMLS CUI [1])
Gamma-glutamyl transpeptidase
Item
Gamma-glutamyl transpeptidase
float
C0202035 (UMLS CUI [1])
Lactate dehydrogenase
Item
Lactate dehydrogenase
float
C0202113 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
float
C0202236 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total protein
Item
Total protein
float
C0555903 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201975 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0337438 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
float
C0201950 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial