ID
33413
Beskrivning
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
Nyckelord
Versioner (2)
- 2018-11-07 2018-11-07 -
- 2018-12-07 2018-12-07 -
Rättsinnehavare
GSK group of companies
Uppladdad den
7 december 2018
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
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.
A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837
Liver Biopsy Data
- StudyEvent: ODM
Beskrivning
Biopsy size
Alias
- UMLS CUI-1
- C1299482
- UMLS CUI-2
- C0193388
Beskrivning
Final diagnosis of biopsy
Alias
- UMLS CUI-1
- C0011900
- UMLS CUI-2
- C0193388
Beskrivning
Final diagnosis
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
Beskrivning
If ABNORMAL, check YES for all that apply
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
- UMLS CUI [1,3]
- C0205161
Beskrivning
Acute hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0267797
Beskrivning
Chronic hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0524910
Beskrivning
Cholestatic hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0149904
Beskrivning
Drug-induced cholestasis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2062350
Beskrivning
Acute viral hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0276622
Beskrivning
Chronic viral hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0276623
Beskrivning
Drug-induced hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1262760
Beskrivning
Autoimmune hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0241910
Beskrivning
Bridging necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0333511
Beskrivning
Submassive hepatic necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151798
Beskrivning
Massive hepatic necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001364
Beskrivning
Steatosis - microvesicular
Datatyp
text
Alias
- UMLS CUI [1]
- C1850415
Beskrivning
Steatosis - macrovesicular
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1837256
Beskrivning
Steatosis - mixed
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2711227
- UMLS CUI [1,2]
- C0205430
Beskrivning
Non-alcoholic steatohepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3241937
Beskrivning
Alcoholic hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019187
Beskrivning
Hepatic granulomas
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0745754
Beskrivning
Sarcoidosis
Datatyp
text
Alias
- UMLS CUI [1]
- C0036202
Beskrivning
Fibrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0016059
Beskrivning
Cirrhosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023890
Beskrivning
Primary biliary cirrhosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008312
Beskrivning
Primary sclerosing cholangitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0566602
Beskrivning
Autoimmune overlap syndrome
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2702837
Beskrivning
Hemochromatosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018995
Beskrivning
Alpha-1-antitrypsin deficiency
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0221757
Beskrivning
Wilson's disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019202
Beskrivning
Veno-occlusive disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0948441
Beskrivning
Budd-Chiari syndrome
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0856761
Beskrivning
Neoplasia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1882062
Beskrivning
Other, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beskrivning
Liver architecture
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0935919
Beskrivning
check YES for all that apply
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Beskrivning
Normal
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
- UMLS CUI [1,3]
- C0205307
Beskrivning
Bridging fibrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0334160
Beskrivning
Diffuse fibrosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0016059
- UMLS CUI [1,2]
- C0205219
Beskrivning
Nodular regenerative hyperplasia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0020510
Beskrivning
Congenital hepatic fibrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009714
Beskrivning
Cirrhosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023890
Beskrivning
Centrilobular congestion
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0267821
- UMLS CUI [1,2]
- C0442080
Beskrivning
Endophlebitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0014234
Beskrivning
Veno-occlusive disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0948441
Beskrivning
Canalicular cholestasis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3150342
Beskrivning
Apoptosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0162638
Beskrivning
Focal (or spotty or mild) hepatocellular necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0267800
Beskrivning
Interface hepatitis (periportal hepatitis or piecemeal necrosis)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0333515
Beskrivning
Ischaemic necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3887513
Beskrivning
Centroloular (Zone 3) necrosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0027540
- UMLS CUI [1,2]
- C0205417
- UMLS CUI [1,3]
- C0305578
Beskrivning
Focal coagulative necrosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1522058
- UMLS CUI [1,2]
- C0205234
Beskrivning
Centrolobular (Zone 3) coagulative necrosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1522058
- UMLS CUI [1,2]
- C0205417
- UMLS CUI [1,3]
- C0305578
Beskrivning
Bridging hepatocellular necrosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1855038
- UMLS CUI [1,2]
- C0333511
Beskrivning
Massive or panlobular hepatocellular necrosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1855038
- UMLS CUI [1,2]
- C0442131
Beskrivning
Dysplasia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0334044
Beskrivning
Neoplasia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1882062
Beskrivning
Other, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Description of Liver Cells or Hepatocytes
Alias
- UMLS CUI-1
- C0227525
- UMLS CUI-2
- C0678257
Beskrivning
Liver Cell or Hepatocyte Inclusions or Vacuoles
Alias
- UMLS CUI-1
- C0227525
- UMLS CUI-2
- C0042219
- UMLS CUI-3
- C1512693
Beskrivning
check YES for all that apply
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [1,3]
- C1512693
Beskrivning
No inclusions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1512693
Beskrivning
Macrovesicular steatosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1837256
Beskrivning
Microvesicular steatosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1850415
Beskrivning
Bile accumulation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3686784
Beskrivning
Diastase - resistant, PAS-positive cytoplasmic inclusions
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205708
Beskrivning
Alpha-1-antitrypsin inclusions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0002191
- UMLS CUI [1,2]
- C1512693
- UMLS CUI [1,3]
- C0227525
Beskrivning
Megamitochondria
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0544931
Beskrivning
Mallory bodies
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0333744
Beskrivning
"Ground Glass" inclusions
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0598786
Beskrivning
Lipofuscin pigment
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023789
Beskrivning
Hemosiderin granules
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019113
Beskrivning
Orcein - positive cytoplasmin granules
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0069596
Beskrivning
Protoporphyrin crystals (birefringend under polarised light)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0033733
Beskrivning
Uroporchyrin crystals (red fluorescence under ultraviolet light)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0042093
- UMLS CUI [1,2]
- C1378554
Beskrivning
Other, specify
Datatyp
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
Beskrivning
Hepatocyte or Liver Cell Nuclear Abnormalities
Alias
- UMLS CUI-1
- C0227525
- UMLS CUI-2
- C1849376
Beskrivning
check all that apply
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Beskrivning
If OTHER, specify
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Liver or Lobular Infiltrates
Alias
- UMLS CUI-1
- C1400896
- UMLS CUI-2
- C0205417
Beskrivning
check all that apply
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1400896
- UMLS CUI [1,2]
- C0205417
Beskrivning
If OTHER, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1400896
- UMLS CUI [1,2]
- C0205417
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Portal tract Inflamation
Alias
- UMLS CUI-1
- C3854488
Beskrivning
check all that apply
Datatyp
text
Alias
- UMLS CUI [1]
- C3854488
Beskrivning
If OTHER, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3854488
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Bile ducts
Alias
- UMLS CUI-1
- C0005400
Beskrivning
Portal veins
Alias
- UMLS CUI-1
- C0032718
Beskrivning
Liver Infections
Alias
- UMLS CUI-1
- C1112211
Beskrivning
Check all that apply
Datatyp
text
Alias
- UMLS CUI [1]
- C1112211
Beskrivning
If OTHER, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1112211
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Parasites or Ova
Alias
- UMLS CUI-1
- C0030498
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0555117
Beskrivning
check all that apply
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0555117
Beskrivning
If OTHER, specify
Datatyp
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
Beskrivning
Histologic Staining or Additional Studies Obtained
Alias
- UMLS CUI-1
- C0487602
- UMLS CUI-2
- C0205462
- UMLS CUI-3
- C0023884
Beskrivning
Check YES for all that apply
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
Beskrivning
Haematoxylin and eosin (or H & E)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0523207
Beskrivning
Masson
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1294297
Beskrivning
Toluidine blue or Giemsa
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0523203
- UMLS CUI [1,2]
- C0017542
Beskrivning
Prussian blue
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0060234
Beskrivning
Periodic Acidic Schiff (PAS), with or without diastase
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0440048
- UMLS CUI [1,2]
- C0596624
- UMLS CUI [1,3]
- C0193388
Beskrivning
Oil red O
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1294000
Beskrivning
Congo red
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009742
Beskrivning
Hall's stain
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1720394
Beskrivning
Gridley's stain
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1293978
Beskrivning
Rhodanine (copper)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0035486
Beskrivning
Rubeanic acid (copper)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0073680
Beskrivning
Orcein, aldehyde fuchsin or Victoria blue
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0491984
- UMLS CUI [1,2]
- C0078232
- UMLS CUI [1,3]
- C0069596
Beskrivning
Electron microscopy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0026019
Beskrivning
Hepatitis A immunostains positive
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0560226
- UMLS CUI [1,2]
- C3687908
Beskrivning
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Datatyp
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
Beskrivning
Hepatitis D immunostains
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0011226
- UMLS CUI [1,2]
- C3687908
Beskrivning
Other immunostains
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3687908
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other, specify
Datatyp
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])