ID

44916

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 Unscheduled Laboratory Results (Haematology, clinical chemistry, Urinalysis).

Link

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

Stichworte

Versionen (3)
  1. 06.04.18 06.04.18 - Sarah Riepenhausen
  2. 06.04.18 06.04.18 - Sarah Riepenhausen
  3. 13.04.22 13.04.22 - Martin Dugas
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

13. April 2022

DOI

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Lizenz

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

Deutsch Englisch

Unscheduled Laboratory Results

1 Formulare  
  1. StudyEvent: GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630
    1. Unscheduled Laboratory Results
Laboratory result data - Haematology
Beschreibung

Laboratory result data - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology - Date and Time sample Taken
Beschreibung

Haematology - Date and Time sample Taken

Datentyp

datetime

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

Fasting

Datentyp

text

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

White blood cell count (WBC) (Absolute)

Datentyp

float

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

red blood cell count (RBC) (absolute)

Datentyp

float

Alias
UMLS CUI [1]
C1287262
Haemoglobin (Hb)
Beschreibung

Haemoglobin (Hb)

Datentyp

float

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

Haematocrit (HCT)

Datentyp

float

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

Mean cell volume (MCV)

Datentyp

float

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

Mean cell haemoglobin (MCH)

Datentyp

float

Alias
UMLS CUI [1]
C1261502
Mean cell haemoglobin concentration (MCHC)
Beschreibung

Mean cell haemoglobin concentration (MCHC)

Datentyp

float

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

Platelet count (absolute)

Datentyp

float

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

Reticulocytes (absolute)

Datentyp

float

Alias
UMLS CUI [1]
C0035286
Neutrophil count (absolute)
Beschreibung

Neutrophil count (absolute)

Datentyp

float

Alias
UMLS CUI [1]
C0948762
Lymphocyte count (absolute)
Beschreibung

Lymphocyte count (absolute)

Datentyp

float

Alias
UMLS CUI [1]
C3544087
Monocyte count (absolute)
Beschreibung

Monocyte count (absolute)

Datentyp

float

Alias
UMLS CUI [1]
C0200637
Eosinophil count (absolute)
Beschreibung

Eosinophil count (absolute)

Datentyp

float

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

Basophil count (absolute)

Datentyp

float

Alias
UMLS CUI [1]
C0200641
Laboratory result data - Clinical chemistry
Beschreibung

Laboratory result data - Clinical chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0525044
Date and time of sampling
Beschreibung

Date and time of sampling

Datentyp

datetime

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

Fasting

Datentyp

text

Alias
UMLS CUI [1]
C0015663
Alkaline Phosphatase
Beschreibung

Alkaline Phosphatase

Datentyp

float

Alias
UMLS CUI [1]
C0201850
Alanine transaminase
Beschreibung

Alanine transaminase

Datentyp

float

Alias
UMLS CUI [1]
C0201836
Aspartate transaminase
Beschreibung

Aspartate transaminase

Datentyp

float

Alias
UMLS CUI [1]
C0201899
Gamma-glutamyl transpeptidase
Beschreibung

Gamma-glutamyl transpeptidase

Datentyp

float

Alias
UMLS CUI [1]
C0202035
Lactate dehydrogenase
Beschreibung

Lactate dehydrogenase

Datentyp

float

Alias
UMLS CUI [1]
C0202113
Urea
Beschreibung

Urea

Datentyp

float

Alias
UMLS CUI [1]
C0523961
Sodium
Beschreibung

Sodium

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0337443
mmol/l
Triglycerides
Beschreibung

Triglycerides

Datentyp

float

Alias
UMLS CUI [1]
C0202236
Albumin
Beschreibung

Albumin

Datentyp

float

Alias
UMLS CUI [1]
C0201838
Total protein
Beschreibung

Total protein

Datentyp

float

Alias
UMLS CUI [1]
C0555903
Total Bilirubin
Beschreibung

Total Bilirubin

Datentyp

float

Alias
UMLS CUI [1]
C0201913
Creatinine
Beschreibung

Creatinine

Datentyp

float

Alias
UMLS CUI [1]
C0201975
Potassium
Beschreibung

Potassium

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Glucose (fasting at screening assessment)
Beschreibung

Glucose (fasting at screening assessment)

Datentyp

float

Alias
UMLS CUI [1]
C0202045
Cholesterol
Beschreibung

Cholesterol

Datentyp

float

Alias
UMLS CUI [1]
C1445957
TSH
Beschreibung

TSH

Datentyp

float

Alias
UMLS CUI [1]
C0202230
Urinalysis
Beschreibung

Urinalysis

Alias
UMLS CUI-1
C0042014
Date and time sample taken
Beschreibung

Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Protein (Dipstick)
Beschreibung

Protein (Dipstick)

Datentyp

text

Alias
UMLS CUI [1,1]
C0033684
UMLS CUI [1,2]
C0430370
Protein, numeric
Beschreibung

Protein, numeric

Datentyp

float

Alias
UMLS CUI [1,1]
C0033684
UMLS CUI [1,2]
C0430370
Glucose (Dipstick)
Beschreibung

Glucose (Dipstick)

Datentyp

text

Alias
UMLS CUI [1,1]
C0017725
UMLS CUI [1,2]
C0430370
Glucose, numeric
Beschreibung

Glucose, numeric

Datentyp

float

Alias
UMLS CUI [1,1]
C0017725
UMLS CUI [1,2]
C0430370
Ketones (Dipstick)
Beschreibung

Ketones (Dipstick)

Datentyp

text

Alias
UMLS CUI [1,1]
C1991100
UMLS CUI [1,2]
C0430370
Ketones, numeric
Beschreibung

Ketones, numeric

Datentyp

float

Alias
UMLS CUI [1,1]
C1991100
UMLS CUI [1,2]
C0430370
Bilirubin (Dipstick)
Beschreibung

Bilirubin (Dipstick)

Datentyp

text

Alias
UMLS CUI [1,1]
C0430374
UMLS CUI [1,2]
C0430370
Bilirubin, numeric
Beschreibung

Bilirubin, numeric

Datentyp

float

Alias
UMLS CUI [1,1]
C0430374
UMLS CUI [1,2]
C0430370
Leucocytes (Dipstick)
Beschreibung

Leucocytes (Dipstick)

Datentyp

text

Alias
UMLS CUI [1,1]
C1256582
UMLS CUI [1,2]
C0430370
Leucocytes, numeric
Beschreibung

Leucocytes, numeric

Datentyp

float

Alias
UMLS CUI [1,1]
C1256582
UMLS CUI [1,2]
C0430370
Blood (Dipstick)
Beschreibung

Blood (Dipstick)

Datentyp

text

Alias
UMLS CUI [1]
C0430372
Blood, numeric
Beschreibung

Blood, numeric

Datentyp

float

Alias
UMLS CUI [1]
C0430372
Specific gravity (Dipstick)
Beschreibung

Specific gravity (Dipstick)

Datentyp

text

Alias
UMLS CUI [1,1]
C0202517
UMLS CUI [1,2]
C0430370
pH (Dipstick)
Beschreibung

pH (Dipstick)

Datentyp

text

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
White blood cells (microscopy)
Beschreibung

White blood cells (microscopy)

Datentyp

text

Alias
UMLS CUI [1,1]
C0919738
UMLS CUI [1,2]
C0026018
Red blood cells (microscopy)
Beschreibung

Red blood cells (microscopy)

Datentyp

text

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0026018
Hyaline casts (microscopy)
Beschreibung

Hyaline casts (microscopy)

Datentyp

text

Alias
UMLS CUI [1]
C0427894
Cellular casts (microscopy)
Beschreibung

Cellular casts (microscopy)

Datentyp

text

Alias
UMLS CUI [1]
C2699157
Bacteria (microscopy)
Beschreibung

Bacteria (microscopy)

Datentyp

text

Alias
UMLS CUI [1,1]
C1262012
UMLS CUI [1,2]
C0004618
UMLS CUI [1,3]
C0026018
Granular casts (microscopy)
Beschreibung

Granular casts (microscopy)

Datentyp

text

Alias
UMLS CUI [1,1]
C2697521
UMLS CUI [1,2]
C0026018
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Ähnliche Modelle

Unscheduled Laboratory Results

1 Formulare
  1. StudyEvent: GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630
    1. Unscheduled Laboratory Results
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Haematology - 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])
No short-acting beta-agonist therapy for >= 8 hours
Code List
Fasting
CL Item
 (Y)
CL Item
 (N)
White blood cell count (WBC) (Absolute)
Item
float
C0023508 (UMLS CUI [1])
red blood cell count (RBC) (absolute)
Item
float
C1287262 (UMLS CUI [1])
Haemoglobin (Hb)
Item
float
C0518015 (UMLS CUI [1])
Haematocrit (HCT)
Item
float
C0018935 (UMLS CUI [1])
Mean cell volume (MCV)
Item
float
C1948043 (UMLS CUI [1])
Mean cell haemoglobin (MCH)
Item
float
C1261502 (UMLS CUI [1])
Mean cell haemoglobin concentration (MCHC)
Item
float
C0474535 (UMLS CUI [1])
Platelet count (absolute)
Item
float
C0005821 (UMLS CUI [1])
Reticulocytes (absolute)
Item
float
C0035286 (UMLS CUI [1])
Neutrophil count (absolute)
Item
float
C0948762 (UMLS CUI [1])
Lymphocyte count (absolute)
Item
float
C3544087 (UMLS CUI [1])
Monocyte count (absolute)
Item
float
C0200637 (UMLS CUI [1])
Eosinophil count (absolute)
Item
float
C0200638 (UMLS CUI [1])
Basophil count (absolute)
Item
float
C0200641 (UMLS CUI [1])
Item Group
C1254595 (UMLS CUI-1)
C0525044 (UMLS CUI-2)
Date and time of sampling
Item
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
text
C0015663 (UMLS CUI [1])
No short-acting beta-agonist therapy for >= 8 hours
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
C0201899 (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 (fasting at screening assessment)
Item
float
C0202045 (UMLS CUI [1])
Cholesterol
Item
float
C1445957 (UMLS CUI [1])
TSH
Item
float
C0202230 (UMLS CUI [1])
Item Group
C0042014 (UMLS CUI-1)
Date and time sample taken
Item
datetime
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
text
C0033684 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Protein
Code List
Protein (Dipstick)
CL Item
 (NR)
CL Item
 (NEG)
CL Item
 (TRA)
CL Item
 (1+)
CL Item
 (2+)
CL Item
 (3+)
CL Item
 (4+)
CL Item
 (5+)
Protein, numeric
Item
float
C0033684 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Item
text
C0017725 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Protein
Code List
Glucose (Dipstick)
CL Item
 (NR)
CL Item
 (NEG)
CL Item
 (TRA)
CL Item
 (1+)
CL Item
 (2+)
CL Item
 (3+)
CL Item
 (4+)
CL Item
 (5+)
Glucose, numeric
Item
float
C0017725 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Item
text
C1991100 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Protein
Code List
Ketones (Dipstick)
CL Item
 (NR)
CL Item
 (NEG)
CL Item
 (TRA)
CL Item
 (1+)
CL Item
 (2+)
CL Item
 (3+)
CL Item
 (4+)
CL Item
 (5+)
Ketones, numeric
Item
float
C1991100 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Item
text
C0430374 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Protein
Code List
Bilirubin (Dipstick)
CL Item
 (NR)
CL Item
 (NEG)
CL Item
 (TRA)
CL Item
 (1+)
CL Item
 (2+)
CL Item
 (3+)
CL Item
 (4+)
CL Item
 (5+)
Bilirubin, numeric
Item
float
C0430374 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Item
text
C1256582 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Protein
Code List
Leucocytes (Dipstick)
CL Item
 (NR)
CL Item
 (NEG)
CL Item
 (TRA)
CL Item
 (1+)
CL Item
 (2+)
CL Item
 (3+)
CL Item
 (4+)
CL Item
 (5+)
Leucocytes, numeric
Item
float
C1256582 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Item
text
C0430372 (UMLS CUI [1])
Protein
Code List
Blood (Dipstick)
CL Item
 (NR)
CL Item
 (NEG)
CL Item
 (TRA)
CL Item
 (1+)
CL Item
 (2+)
CL Item
 (3+)
CL Item
 (4+)
CL Item
 (5+)
Blood, numeric
Item
float
C0430372 (UMLS CUI [1])
Specific gravity (Dipstick)
Item
text
C0202517 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
pH (Dipstick)
Item
text
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
White blood cells (microscopy)
Item
text
C0919738 (UMLS CUI [1,1])
C0026018 (UMLS CUI [1,2])
Red blood cells (microscopy)
Item
text
C0014772 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0026018 (UMLS CUI [1,3])
Hyaline casts (microscopy)
Item
text
C0427894 (UMLS CUI [1])
Cellular casts (microscopy)
Item
text
C2699157 (UMLS CUI [1])
Bacteria (microscopy)
Item
text
C1262012 (UMLS CUI [1,1])
C0004618 (UMLS CUI [1,2])
C0026018 (UMLS CUI [1,3])
Granular casts (microscopy)
Item
text
C2697521 (UMLS CUI [1,1])
C0026018 (UMLS CUI [1,2])
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