ID
33413
Description
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma
Keywords
Versions (2)
- 11/7/18 11/7/18 -
- 12/7/18 12/7/18 -
Copyright Holder
GSK group of companies
Uploaded on
December 7, 2018
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837
Liver Biopsy Data
- StudyEvent: ODM
Description
Biopsy size
Alias
- UMLS CUI-1
- C1299482
- UMLS CUI-2
- C0193388
Description
Final diagnosis of biopsy
Alias
- UMLS CUI-1
- C0011900
- UMLS CUI-2
- C0193388
Description
Final diagnosis
Data type
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
Description
If ABNORMAL, check YES for all that apply
Data type
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
- UMLS CUI [1,3]
- C0205161
Description
Acute hepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0267797
Description
Chronic hepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0524910
Description
Cholestatic hepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0149904
Description
Drug-induced cholestasis
Data type
boolean
Alias
- UMLS CUI [1]
- C2062350
Description
Acute viral hepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0276622
Description
Chronic viral hepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0276623
Description
Drug-induced hepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C1262760
Description
Autoimmune hepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0241910
Description
Bridging necrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0333511
Description
Submassive hepatic necrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0151798
Description
Massive hepatic necrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0001364
Description
Steatosis - microvesicular
Data type
text
Alias
- UMLS CUI [1]
- C1850415
Description
Steatosis - macrovesicular
Data type
boolean
Alias
- UMLS CUI [1]
- C1837256
Description
Steatosis - mixed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2711227
- UMLS CUI [1,2]
- C0205430
Description
Non-alcoholic steatohepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C3241937
Description
Alcoholic hepatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0019187
Description
Hepatic granulomas
Data type
boolean
Alias
- UMLS CUI [1]
- C0745754
Description
Sarcoidosis
Data type
text
Alias
- UMLS CUI [1]
- C0036202
Description
Fibrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0016059
Description
Cirrhosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0023890
Description
Primary biliary cirrhosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0008312
Description
Primary sclerosing cholangitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0566602
Description
Autoimmune overlap syndrome
Data type
boolean
Alias
- UMLS CUI [1]
- C2702837
Description
Hemochromatosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0018995
Description
Alpha-1-antitrypsin deficiency
Data type
boolean
Alias
- UMLS CUI [1]
- C0221757
Description
Wilson's disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0019202
Description
Veno-occlusive disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0948441
Description
Budd-Chiari syndrome
Data type
boolean
Alias
- UMLS CUI [1]
- C0856761
Description
Neoplasia
Data type
boolean
Alias
- UMLS CUI [1]
- C1882062
Description
Other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Description
Liver architecture
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0935919
Description
check YES for all that apply
Data type
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Description
Normal
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
- UMLS CUI [1,3]
- C0205307
Description
Bridging fibrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0334160
Description
Diffuse fibrosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0016059
- UMLS CUI [1,2]
- C0205219
Description
Nodular regenerative hyperplasia
Data type
boolean
Alias
- UMLS CUI [1]
- C0020510
Description
Congenital hepatic fibrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0009714
Description
Cirrhosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0023890
Description
Centrilobular congestion
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0267821
- UMLS CUI [1,2]
- C0442080
Description
Endophlebitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0014234
Description
Veno-occlusive disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0948441
Description
Canalicular cholestasis
Data type
boolean
Alias
- UMLS CUI [1]
- C3150342
Description
Apoptosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0162638
Description
Focal (or spotty or mild) hepatocellular necrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0267800
Description
Interface hepatitis (periportal hepatitis or piecemeal necrosis)
Data type
boolean
Alias
- UMLS CUI [1]
- C0333515
Description
Ischaemic necrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C3887513
Description
Centroloular (Zone 3) necrosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027540
- UMLS CUI [1,2]
- C0205417
- UMLS CUI [1,3]
- C0305578
Description
Focal coagulative necrosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1522058
- UMLS CUI [1,2]
- C0205234
Description
Centrolobular (Zone 3) coagulative necrosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1522058
- UMLS CUI [1,2]
- C0205417
- UMLS CUI [1,3]
- C0305578
Description
Bridging hepatocellular necrosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1855038
- UMLS CUI [1,2]
- C0333511
Description
Massive or panlobular hepatocellular necrosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1855038
- UMLS CUI [1,2]
- C0442131
Description
Dysplasia
Data type
boolean
Alias
- UMLS CUI [1]
- C0334044
Description
Neoplasia
Data type
boolean
Alias
- UMLS CUI [1]
- C1882062
Description
Other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Description of Liver Cells or Hepatocytes
Alias
- UMLS CUI-1
- C0227525
- UMLS CUI-2
- C0678257
Description
Liver Cell or Hepatocyte Inclusions or Vacuoles
Alias
- UMLS CUI-1
- C0227525
- UMLS CUI-2
- C0042219
- UMLS CUI-3
- C1512693
Description
check YES for all that apply
Data type
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [1,3]
- C1512693
Description
No inclusions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1512693
Description
Macrovesicular steatosis
Data type
boolean
Alias
- UMLS CUI [1]
- C1837256
Description
Microvesicular steatosis
Data type
boolean
Alias
- UMLS CUI [1]
- C1850415
Description
Bile accumulation
Data type
boolean
Alias
- UMLS CUI [1]
- C3686784
Description
Diastase - resistant, PAS-positive cytoplasmic inclusions
Data type
boolean
Alias
- UMLS CUI [1]
- C0205708
Description
Alpha-1-antitrypsin inclusions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002191
- UMLS CUI [1,2]
- C1512693
- UMLS CUI [1,3]
- C0227525
Description
Megamitochondria
Data type
boolean
Alias
- UMLS CUI [1]
- C0544931
Description
Mallory bodies
Data type
boolean
Alias
- UMLS CUI [1]
- C0333744
Description
"Ground Glass" inclusions
Data type
boolean
Alias
- UMLS CUI [1]
- C0598786
Description
Lipofuscin pigment
Data type
boolean
Alias
- UMLS CUI [1]
- C0023789
Description
Hemosiderin granules
Data type
boolean
Alias
- UMLS CUI [1]
- C0019113
Description
Orcein - positive cytoplasmin granules
Data type
boolean
Alias
- UMLS CUI [1]
- C0069596
Description
Protoporphyrin crystals (birefringend under polarised light)
Data type
boolean
Alias
- UMLS CUI [1]
- C0033733
Description
Uroporchyrin crystals (red fluorescence under ultraviolet light)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042093
- UMLS CUI [1,2]
- C1378554
Description
Other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [1,3]
- C1512693
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C2348235
Description
Hepatocyte or Liver Cell Nuclear Abnormalities
Alias
- UMLS CUI-1
- C0227525
- UMLS CUI-2
- C1849376
Description
check all that apply
Data type
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Description
If OTHER, specify
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Liver or Lobular Infiltrates
Alias
- UMLS CUI-1
- C1400896
- UMLS CUI-2
- C0205417
Description
check all that apply
Data type
text
Alias
- UMLS CUI [1,1]
- C1400896
- UMLS CUI [1,2]
- C0205417
Description
If OTHER, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1400896
- UMLS CUI [1,2]
- C0205417
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Portal tract Inflamation
Alias
- UMLS CUI-1
- C3854488
Description
check all that apply
Data type
text
Alias
- UMLS CUI [1]
- C3854488
Description
If OTHER, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C3854488
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Bile ducts
Alias
- UMLS CUI-1
- C0005400
Description
Portal veins
Alias
- UMLS CUI-1
- C0032718
Description
Liver Infections
Alias
- UMLS CUI-1
- C1112211
Description
Check all that apply
Data type
text
Alias
- UMLS CUI [1]
- C1112211
Description
If OTHER, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1112211
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Parasites or Ova
Alias
- UMLS CUI-1
- C0030498
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0555117
Description
check all that apply
Data type
text
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0555117
Description
If OTHER, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0555117
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C2348235
Description
Histologic Staining or Additional Studies Obtained
Alias
- UMLS CUI-1
- C0487602
- UMLS CUI-2
- C0205462
- UMLS CUI-3
- C0023884
Description
Check YES for all that apply
Data type
text
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
Description
Haematoxylin and eosin (or H & E)
Data type
boolean
Alias
- UMLS CUI [1]
- C0523207
Description
Masson
Data type
boolean
Alias
- UMLS CUI [1]
- C1294297
Description
Toluidine blue or Giemsa
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0523203
- UMLS CUI [1,2]
- C0017542
Description
Prussian blue
Data type
boolean
Alias
- UMLS CUI [1]
- C0060234
Description
Periodic Acidic Schiff (PAS), with or without diastase
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0440048
- UMLS CUI [1,2]
- C0596624
- UMLS CUI [1,3]
- C0193388
Description
Oil red O
Data type
boolean
Alias
- UMLS CUI [1]
- C1294000
Description
Congo red
Data type
boolean
Alias
- UMLS CUI [1]
- C0009742
Description
Hall's stain
Data type
boolean
Alias
- UMLS CUI [1]
- C1720394
Description
Gridley's stain
Data type
boolean
Alias
- UMLS CUI [1]
- C1293978
Description
Rhodanine (copper)
Data type
boolean
Alias
- UMLS CUI [1]
- C0035486
Description
Rubeanic acid (copper)
Data type
boolean
Alias
- UMLS CUI [1]
- C0073680
Description
Orcein, aldehyde fuchsin or Victoria blue
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0491984
- UMLS CUI [1,2]
- C0078232
- UMLS CUI [1,3]
- C0069596
Description
Electron microscopy
Data type
boolean
Alias
- UMLS CUI [1]
- C0026019
Description
Hepatitis A immunostains positive
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0560226
- UMLS CUI [1,2]
- C3687908
Description
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201479
- UMLS CUI [1,2]
- C3687908
- UMLS CUI [1,3]
- C1446409
- UMLS CUI [2,1]
- C0201478
- UMLS CUI [2,2]
- C3687908
- UMLS CUI [2,3]
- C1446409
Description
Hepatitis D immunostains
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011226
- UMLS CUI [1,2]
- C3687908
Description
Other immunostains
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3687908
- UMLS CUI [1,2]
- C0205394
Description
Other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0205462
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Similar models
Liver Biopsy Data
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
C0332232 (UMLS CUI [1,3])
C0193388 (UMLS CUI-2)
C0193388 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0205430 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0205219 (UMLS CUI [1,2])
C0442080 (UMLS CUI [1,2])
C0205417 (UMLS CUI [1,2])
C0305578 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205417 (UMLS CUI [1,2])
C0305578 (UMLS CUI [1,3])
C0333511 (UMLS CUI [1,2])
C0442131 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0678257 (UMLS CUI-2)
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0042219 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])
C1378554 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C1849376 (UMLS CUI-2)
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0205417 (UMLS CUI-2)
C0205417 (UMLS CUI [1,2])
C0205417 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0023884 (UMLS CUI-2)
C0555117 (UMLS CUI-3)
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0205462 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0023884 (UMLS CUI [1,2])
C0017542 (UMLS CUI [1,2])
C0596624 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0078232 (UMLS CUI [1,2])
C0069596 (UMLS CUI [1,3])
C3687908 (UMLS CUI [1,2])
C3687908 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C0201478 (UMLS CUI [2,1])
C3687908 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
C3687908 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205462 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])