ID
35253
Description
Study ID: 102970 Clinical Study ID: 102970 Study Title: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive
Keywords
Versions (1)
- 2/25/19 2/25/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 25, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970
LE Details
- StudyEvent: ODM
Description
Date of Visit/Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Description
Pharmacokinetics
Alias
- UMLS CUI-1
- C0031328
Description
Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005834
Description
Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Date in time, Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Description
Pharmacokinetic aspects, Experimental drug,Date last dose, Time last dose
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1762893
- UMLS CUI [1,4]
- C0946444
Description
Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Description
Liver, Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C1519255
Description
Liver, Adverse Event, Medical Monitor, Email, Last, Date in time, Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1708968
- UMLS CUI [1,4]
- C0013849
- UMLS CUI [1,5]
- C1517741
- UMLS CUI [1,6]
- C0011008
- UMLS CUI [1,7]
- C0040223
Description
Liver, Adverse Event, Medical Monitor, Email, First, Date in time, Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1708968
- UMLS CUI [1,4]
- C0013849
- UMLS CUI [1,5]
- C0205435
- UMLS CUI [1,6]
- C0011008
- UMLS CUI [1,7]
- C0040223
Description
Liver, Adverse Event, Clinical Trial Safety Documentation, Email, Last, Date in time, Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C3899555
- UMLS CUI [1,4]
- C0013849
- UMLS CUI [1,5]
- C1517741
- UMLS CUI [1,6]
- C0011008
- UMLS CUI [1,7]
- C0040223
Description
Liver, Adverse Event, Clinical Trial Safety Documentation, Email, First, Date in time, Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C3899555
- UMLS CUI [1,4]
- C0013849
- UMLS CUI [1,5]
- C0205435
- UMLS CUI [1,6]
- C0011008
- UMLS CUI [1,7]
- C0040223
Description
Liver, Adverse Event, Non-Serious Adverse Event, Date in time, Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1518404
- UMLS CUI [1,4]
- C0011008
- UMLS CUI [1,5]
- C0040223
Description
Liver, Adverse Event, Laboratory test finding, Abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C1704258
Description
Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Pregnancy
Data type
text
Alias
- UMLS CUI [1]
- C0032961
Description
Imaging of liver
Data type
boolean
Alias
- UMLS CUI [1]
- C2711860
Description
Imaging of liver, Normal
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0205307
Description
Biopsy of liver
Data type
boolean
Alias
- UMLS CUI [1]
- C0193388
Description
Herbal medicine (product); Complementary Medicine; Alternative Medicine; Dietary Supplements; Illicit medication use
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2240391
- UMLS CUI [1,2]
- C1148474
- UMLS CUI [1,3]
- C0002346
- UMLS CUI [1,4]
- C0242295
- UMLS CUI [1,5]
- C0281875
Description
Fasting, Change in diet
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0015663
- UMLS CUI [1,2]
- C3671772
Description
Liver, Adverse Event, Occurrence
Data type
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2745955
Description
Liver, Adverse Event, Experimental drug, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0808070
Description
Liver, Adverse Event, Experimental drug, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0806020
Description
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Description
Acute type A viral hepatitis
Data type
text
Alias
- UMLS CUI [1]
- C0276434
Description
Hepatitis B, Chronic
Data type
text
Alias
- UMLS CUI [1]
- C0524909
Description
Hepatitis C, Chronic
Data type
text
Alias
- UMLS CUI [1]
- C0524910
Description
Cytomegalovirus Hepatitis
Data type
text
Alias
- UMLS CUI [1]
- C0276252
Description
Infectious Mononucleosis; Epstein-Barr Virus
Data type
text
Alias
- UMLS CUI [1,1]
- C0021345
- UMLS CUI [1,2]
- C0014644
Description
Herpes Simplex Hepatitis
Data type
text
Alias
- UMLS CUI [1]
- C1963747
Description
Alcoholic Liver Diseases
Data type
text
Alias
- UMLS CUI [1]
- C0023896
Description
Nonalcoholic Steatohepatitis
Data type
text
Alias
- UMLS CUI [1]
- C3241937
Description
Fatty Liver
Data type
text
Alias
- UMLS CUI [1]
- C0015695
Description
Liver Cirrhosis
Data type
text
Alias
- UMLS CUI [1]
- C0023890
Description
Hemochromatosis
Data type
text
Alias
- UMLS CUI [1]
- C0018995
Description
Hepatitis, Autoimmune
Data type
text
Alias
- UMLS CUI [1]
- C0241910
Description
Gall Bladder Diseases
Data type
text
Alias
- UMLS CUI [1]
- C0016977
Description
Liver diseases; Drug-related disorder
Data type
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0277579
Description
Liver diseases; Other
Data type
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Description
Liver diseases; Other, Status
Data type
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Description
Pharmaceutical Preparations; Hypersensitivity
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0020517
Description
Rheumatoid Arthritis
Data type
text
Alias
- UMLS CUI [1]
- C0003873
Description
Psoriasis
Data type
text
Alias
- UMLS CUI [1]
- C0033860
Description
Thyroid Diseases
Data type
text
Alias
- UMLS CUI [1]
- C0040128
Description
Inflammatory Bowel Diseases
Data type
text
Alias
- UMLS CUI [1]
- C0021390
Description
Lupus Erythematosus
Data type
text
Alias
- UMLS CUI [1]
- C0409974
Description
Sjogren's Syndrome
Data type
text
Alias
- UMLS CUI [1]
- C1527336
Description
Vitiligo
Data type
text
Alias
- UMLS CUI [1]
- C0042900
Description
Alcohol Intake at Start of Liver Event
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C0332162
Description
Alcohol consumption
Data type
boolean
Alias
- UMLS CUI [1]
- C0001948
Description
Alcohol consumption; alcohol units/week
Data type
integer
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Description
Liver Imaging
Alias
- UMLS CUI-1
- C2711860
Description
Imaging of liver, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0011008
Description
Imaging of liver, Imaging modality
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
Description
Imaging of liver, Adequate
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0332306
Description
Imaging of liver, Liver size
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0426688
Description
Imaging of liver, Texture Perceiption
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0679033
Description
Imaging of liver, Fatty Liver
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0015695
Description
Imaging of liver, Ascites
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0003962
Description
Imaging of liver, Lesion of liver, Focal
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0577053
- UMLS CUI [1,3]
- C0205234
Description
Imaging of liver, Gallstones/Gallbladder problems, Lesions
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C3842395
- UMLS CUI [1,3]
- C0221198
Description
Imaging of liver, Biliary duct structure, lesions
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0005423
- UMLS CUI [1,3]
- C0221198
Description
Imaging of liver, Portal vein structure, Structure of hepatic vein, Abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0032718
- UMLS CUI [1,3]
- C0019155
- UMLS CUI [1,4]
- C1704258
Description
Liver Biopsy
Alias
- UMLS CUI-1
- C0193388
Description
Biopsy of liver, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0011008
Description
Biopsy of liver, Specimen size
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1299482
Description
Biopsy of liver, Diagnosis
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0011900
Description
Biopsy of liver, Cellular structure aspects
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0935919
Description
Biopsy of liver, Hepatocyte
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0227525
Description
Biopsy of liver, Hepatocyte, Inclusion, Vacuoles
Data type
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [1,3]
- C1512693
Description
Biopsy of Liver, Hepatocyte, Abnormal nuclear morphology
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0227525
- UMLS CUI [1,3]
- C1849376
Description
Biopsy of liver, Infiltrates
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1400896
Description
Biopsy of liver, Portal Tract Inflammation
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C3854488
Description
Biopsy of liver, Bile Duct structure
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0005400
Description
Biopsy of liver, Portal Vein structure
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0032718
Description
Biopsy of liver, Hepatic Infection
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1112211
Description
Biopsy of liver, Parasite, Ovum of parasite
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0030498
- UMLS CUI [1,3]
- C1267673
Description
Biopsy of liver, Staining method
Data type
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0487602
Similar models
LE Details
- StudyEvent: ODM
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
C0946444 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
C0040223 (UMLS CUI [1,7])
C0877248 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
C0040223 (UMLS CUI [1,7])
C0877248 (UMLS CUI [1,2])
C3899555 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
C0040223 (UMLS CUI [1,7])
C0877248 (UMLS CUI [1,2])
C3899555 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
C0040223 (UMLS CUI [1,7])
C0877248 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
C0877248 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
C0205307 (UMLS CUI [1,2])
C1148474 (UMLS CUI [1,2])
C0002346 (UMLS CUI [1,3])
C0242295 (UMLS CUI [1,4])
C0281875 (UMLS CUI [1,5])
C3671772 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C0014644 (UMLS CUI [1,2])
C0277579 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0020517 (UMLS CUI [1,2])
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0332162 (UMLS CUI-4)
C0560579 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1275506 (UMLS CUI [1,2])
C0332306 (UMLS CUI [1,2])
C0426688 (UMLS CUI [1,2])
C0679033 (UMLS CUI [1,2])
C0015695 (UMLS CUI [1,2])
C0003962 (UMLS CUI [1,2])
C0577053 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,3])
C3842395 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C0005423 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C0032718 (UMLS CUI [1,2])
C0019155 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1299482 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
C1400896 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
C0005400 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,2])
C1112211 (UMLS CUI [1,2])
C0030498 (UMLS CUI [1,2])
C1267673 (UMLS CUI [1,3])
C0487602 (UMLS CUI [1,2])