ID

33413

Beschrijving

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

Trefwoorden

07-11-18 07-11-18 -
07-12-18 07-12-18 -

Houder van rechten

GSK group of companies

Geüploaded op

7 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

model
Details

Liver Biopsy Data

1 Formulieren

StudyEvent: ODM
1. Liver Biopsy Data

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Date of liver biopsy

Item Group

Date of liver biopsy

C0193388 (UMLS CUI-1)
C0011008 (UMLS CUI-2)

Date

Item

Date ofvliver biopsy

date

C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Biopsy size

Item Group

Biopsy size

C1299482 (UMLS CUI-1)
C0193388 (UMLS CUI-2)

Approximate size of liver biopsy

Item

Approximate size of liver biopsy

integer

C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0332232 (UMLS CUI [1,3])

Final diagnosis of biopsy

Item Group

Final diagnosis of biopsy

C0011900 (UMLS CUI-1)
C0193388 (UMLS CUI-2)

Final diagnosis

Item

Final diagnosis

text

C0011900 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])

Final diagnosis

Code List

Final diagnosis

CL Item

Normal (1)

CL Item

Abnormal (2)

If ABNORMAL, check YES for all that apply

Item

If ABNORMAL, check YES for all that apply

text

C0011900 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])

Acute hepatitis

Item

Acute hepatitis

boolean

C0267797 (UMLS CUI [1])

Chronic hepatitis

Item

Chronic hepatitis

boolean

C0524910 (UMLS CUI [1])

Cholestatic hepatitis

Item

Cholestatic hepatitis

boolean

C0149904 (UMLS CUI [1])

Drug-induced cholestasis

Item

Drug-induced cholestasis

boolean

C2062350 (UMLS CUI [1])

Acute viral hepatitis

Item

Acute viral hepatitis

boolean

C0276622 (UMLS CUI [1])

Chronic viral hepatitis

Item

Chronic viral hepatitis

boolean

C0276623 (UMLS CUI [1])

Drug-induced hepatitis

Item

Drug-induced hepatitis

boolean

C1262760 (UMLS CUI [1])

Autoimmune hepatitis

Item

Autoimmune hepatitis

boolean

C0241910 (UMLS CUI [1])

Bridging necrosis

Item

Bridging necrosis

boolean

C0333511 (UMLS CUI [1])

Submassive hepatic necrosis

Item

Submassive hepatic necrosis

boolean

C0151798 (UMLS CUI [1])

Massive hepatic necrosis

Item

Massive hepatic necrosis

boolean

C0001364 (UMLS CUI [1])

Steatosis - microvesicular

Item

Steatosis - microvesicular

text

C1850415 (UMLS CUI [1])

Steatosis - macrovesicular

Item

Steatosis - macrovesicular

boolean

C1837256 (UMLS CUI [1])

Steatosis - mixed

Item

Steatosis - mixed

boolean

C2711227 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])

Non-alcoholic steatohepatitis

Item

Non-alcoholic steatohepatitis

boolean

C3241937 (UMLS CUI [1])

Alcoholic hepatitis

Item

Alcoholic hepatitis

boolean

C0019187 (UMLS CUI [1])

Hepatic granulomas

Item

Hepatic granulomas

boolean

C0745754 (UMLS CUI [1])

Sarcoidosis

Item

Sarcoidosis

text

C0036202 (UMLS CUI [1])

Fibrosis

Item

Fibrosis

boolean

C0016059 (UMLS CUI [1])

Cirrhosis

Item

Cirrhosis

boolean

C0023890 (UMLS CUI [1])

Primary biliary cirrhosis

Item

Primary biliary cirrhosis

boolean

C0008312 (UMLS CUI [1])

Primary sclerosing cholangitis

Item

Primary sclerosing cholangitis

boolean

C0566602 (UMLS CUI [1])

Autoimmune overlap syndrome

Item

Autoimmune overlap syndrome

boolean

C2702837 (UMLS CUI [1])

Hemochromatosis

Item

Hemochromatosis

boolean

C0018995 (UMLS CUI [1])

Alpha-1-antitrypsin deficiency

Item

Alpha-1-antitrypsin deficiency

boolean

C0221757 (UMLS CUI [1])

Wilson's disease

Item

Wilson's disease

boolean

C0019202 (UMLS CUI [1])

Veno-occlusive disease

Item

Veno-occlusive disease

boolean

C0948441 (UMLS CUI [1])

Budd-Chiari syndrome

Item

Budd-Chiari syndrome

boolean

C0856761 (UMLS CUI [1])

Neoplasia

Item

Neoplasia

boolean

C1882062 (UMLS CUI [1])

Other, specify

Item

Other, specify

text

C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Liver architecture

Item Group

Liver architecture

C0023884 (UMLS CUI-1)
C0935919 (UMLS CUI-2)

check YES for all that apply

Item

check YES for all that apply

text

C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])

Normal

Item

liver architecture Normal

boolean

C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])

Bridging fibrosis

Item

Bridging fibrosis

boolean

C0334160 (UMLS CUI [1])

Diffuse fibrosis

Item

Diffuse fibrosis

boolean

C0016059 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])

Nodular regenerative hyperplasia

Item

Nodular regenerative hyperplasia

boolean

C0020510 (UMLS CUI [1])

Congenital hepatic fibrosis

Item

Congenital hepatic fibrosis

boolean

C0009714 (UMLS CUI [1])

Cirrhosis

Item

Cirrhosis

boolean

C0023890 (UMLS CUI [1])

Centrilobular congestion

Item

Centrilobular congestion

boolean

C0267821 (UMLS CUI [1,1])
C0442080 (UMLS CUI [1,2])

Endophlebitis

Item

Endophlebitis

boolean

C0014234 (UMLS CUI [1])

Veno-occlusive disease

Item

Veno-occlusive disease

boolean

C0948441 (UMLS CUI [1])

Canalicular cholestasis

Item

Canalicular cholestasis

boolean

C3150342 (UMLS CUI [1])

Apoptosis

Item

Apoptosis

boolean

C0162638 (UMLS CUI [1])

Focal (or spotty or mild) hepatocellular necrosis

Item

Focal (or spotty or mild) hepatocellular necrosis

boolean

C0267800 (UMLS CUI [1])

Interface hepatitis (periportal hepatitis or piecemeal necrosis)

Item

Interface hepatitis (periportal hepatitis or piecemeal necrosis)

boolean

C0333515 (UMLS CUI [1])

Ischaemic necrosis

Item

Ischaemic necrosis

boolean

C3887513 (UMLS CUI [1])

Centroloular (Zone 3) necrosis

Item

Centrolobular (Zone 3) necrosis

boolean

C0027540 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0305578 (UMLS CUI [1,3])

Focal coagulative necrosis

Item

Focal coagulative necrosis

boolean

C1522058 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])

Centrolobular (Zone 3) coagulative necrosis

Item

Centrolobular (Zone 3) coagulative necrosis

boolean

C1522058 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0305578 (UMLS CUI [1,3])

Bridging hepatocellular necrosis

Item

Bridging hepatocellular necrosis

boolean

C1855038 (UMLS CUI [1,1])
C0333511 (UMLS CUI [1,2])

Massive or panlobular hepatocellular necrosis

Item

Massive or panlobular hepatocellular necrosis

boolean

C1855038 (UMLS CUI [1,1])
C0442131 (UMLS CUI [1,2])

Dysplasia

Item

Dysplasia

boolean

C0334044 (UMLS CUI [1])

Neoplasia

Item

Neoplasia

boolean

C1882062 (UMLS CUI [1])

Other, specify

Item

Other liver architecture, specify

text

C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Description of Liver Cells or Hepatocytes

Item Group

Description of Liver Cells or Hepatocytes

C0227525 (UMLS CUI-1)
C0678257 (UMLS CUI-2)

Check all that apply

Item

Check all that apply

text

C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])

Check all that apply

Code List

Check all that apply

CL Item

Normal (1)

CL Item

Ballooning (2)

CL Item

Acidophilic (3)

CL Item

Pseudoxanthomatous (4)

CL Item

Multinucleated giant hepatocytes (5)

CL Item

Other (6)

If OTHER, specify

Item

If OTHER, specify

text

C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])

Liver Cell or Hepatocyte Inclusions or Vacuoles

Item Group

Liver Cell or Hepatocyte Inclusions or Vacuoles

C0227525 (UMLS CUI-1)
C0042219 (UMLS CUI-2)
C1512693 (UMLS CUI-3)

check YES for all that apply

Item

check YES for all that apply

text

C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])

No inclusions

Item

No inclusions

boolean

C0227525 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])

Macrovesicular steatosis

Item

Macrovesicular steatosis

boolean

C1837256 (UMLS CUI [1])

Microvesicular steatosis

Item

Microvesicular steatosis

boolean

C1850415 (UMLS CUI [1])

Bile accumulation

Item

Bile accumulation

boolean

C3686784 (UMLS CUI [1])

Diastase - resistant, PAS-positive cytoplasmic inclusions

Item

Diastase - resistant, PAS-positive cytoplasmic inclusions

boolean

C0205708 (UMLS CUI [1])

Alpha-1-antitrypsin inclusions

Item

Alpha-1-antitrypsin inclusions

boolean

C0002191 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])

Megamitochondria

Item

Megamitochondria

boolean

C0544931 (UMLS CUI [1])

Mallory bodies

Item

Mallory bodies

boolean

C0333744 (UMLS CUI [1])

"Ground Glass" inclusions

Item

"Ground Glass" inclusions

boolean

C0598786 (UMLS CUI [1])

Lipofuscin pigment

Item

Lipofuscin pigment

boolean

C0023789 (UMLS CUI [1])

Hemosiderin granules

Item

Hemosiderin granules

boolean

C0019113 (UMLS CUI [1])

Orcein - positive cytoplasmin granules

Item

Orcein - positive cytoplasmin granules

boolean

C0069596 (UMLS CUI [1])

Protoporphyrin crystals (birefringend under polarised light)

Item

Protoporphyrin crystals (birefringend under polarised light)

boolean

C0033733 (UMLS CUI [1])

Uroporchyrin crystals (red fluorescence under ultraviolet light)

Item

Uroporchyrin crystals (red fluorescence under ultraviolet light)

boolean

C0042093 (UMLS CUI [1,1])
C1378554 (UMLS CUI [1,2])

Other, specify

Item

If Other Liver Cell or Hepatocyte Inclusions or Vacuoles, specify

text

C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])

Hepatocyte or Liver Cell Nuclear Abnormalities

Item Group

Hepatocyte or Liver Cell Nuclear Abnormalities

C0227525 (UMLS CUI-1)
C1849376 (UMLS CUI-2)

check all that apply

Item

check all that apply

text

C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])

check all that apply

Code List

check all that apply

CL Item

None (1)

CL Item

Hepatocellular mitosis (2)

CL Item

Binucleated or multinucleated hepatocytes (3)

CL Item

CMV inclusion bodies (4)

CL Item

HSV inclusions (5)

CL Item

Varicella inclusions (6)

CL Item

Other (7)

If OTHER, specify

Item

If OTHER, specify

boolean

C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Liver or Lobular Infiltrates

Item Group

Liver or Lobular Infiltrates

C1400896 (UMLS CUI-1)
C0205417 (UMLS CUI-2)

check all that apply

Item

check all that apply

text

C1400896 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])

check all that apply

Code List

check all that apply

CL Item

None (1)

CL Item

Eosinophils (2)

CL Item

Lymphosites (3)

CL Item

Plasma cells (4)

CL Item

Neutrophils (5)

CL Item

Macrophages and proliferating Kupffer cells (6)

CL Item

Granulomas (7)

CL Item

Other (8)

If OTHER, specify

Item

If OTHER, specify

text

C1400896 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Portal tract Inflamation

Item Group

Portal tract Inflamation

C3854488 (UMLS CUI-1)

check all that apply

Item

check all that apply

text

C3854488 (UMLS CUI [1])

check all that apply

Code List

check all that apply

CL Item

None (1)

CL Item

Eosinophils (2)

CL Item

Lymphoid aggregates and/or follicles (3)

CL Item

Plasma cells (4)

CL Item

Neutrophils (5)

CL Item

Histocytes and macrophages (6)

CL Item

Other (7)

If OTHER, specify

Item

If OTHER, specify

text

C3854488 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Bile ducts

Item Group

Bile ducts

C0005400 (UMLS CUI-1)

check all that apply

Item

check all that apply

text

C0005400 (UMLS CUI [1])

check all that apply

Code List

check all that apply

CL Item

Normal (1)

CL Item

Proliferation of bile ducts (bile ductular reaction) (2)

CL Item

Dilation, degeneration or disruption of portal bile ducts (3)

CL Item

Paucity of bile ducts (4)

CL Item

Periductal fibrosis (5)

CL Item

Other (6)

If OTHER, specify

Item

If OTHER, specify

boolean

C0005400 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Portal veins

Item Group

Portal veins

C0032718 (UMLS CUI-1)

check all that apply

Item

check all that apply

text

C0032718 (UMLS CUI [1])

check all that apply

Code List

check all that apply

CL Item

Normal (1)

CL Item

Pyelophlebitis (2)

CL Item

Thrombosis, sclerosis or occlusion of portal vein (3)

CL Item

Neoplastic invasion of portal vein (4)

CL Item

Granulomatous compression of portal vein (5)

CL Item

Other (6)

If OTHER, specify

Item

If OTHER, specify

text

C0032718 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Liver Infections

Item Group

Liver Infections

C1112211 (UMLS CUI-1)

Check all that apply

Item

Check all that apply

text

C1112211 (UMLS CUI [1])

Check all that apply

Code List

Check all that apply

CL Item

Normal (1)

CL Item

Leishmaniasis donovani (2)

CL Item

Plasmodium falciparum (3)

CL Item

Toxooplasmosis (4)

CL Item

Cryptococcus neoformans (5)

CL Item

Histoplasma capsulatum (6)

CL Item

Mycobacterium tuberculosis (7)

CL Item

Other mycrobacterial species (8)

CL Item

Other (9)

If OTHER, specify

Item

If OTHER, specify

text

C1112211 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Parasites or Ova

Item Group

Parasites or Ova

C0030498 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0555117 (UMLS CUI-3)

check all that apply

Item

check all that apply

text

C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])

check all that apply

Code List

check all that apply

CL Item

None (1)

CL Item

Schistosome and/or ova (2)

CL Item

Ascaris and/or ova (3)

CL Item

Toxocara and/or ova (4)

CL Item

Echinococcus cysts (5)

CL Item

Hepatic capillariasis worms and/or ova (6)

CL Item

Other (7)

If OTHER, specify

Item

If OTHER, specify

text

C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])

Histologic Staining or Additional Studies Obtained

Item Group

Histologic Staining or Additional Studies Obtained

C0487602 (UMLS CUI-1)
C0205462 (UMLS CUI-2)
C0023884 (UMLS CUI-3)

Check YES for all that apply

Item

Check YES for all that apply

text

C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Haematoxylin and eosin (or H & E)

Item

Haematoxylin and eosin (or H & E)

boolean

C0523207 (UMLS CUI [1])

Masson

Item

Masson

boolean

C1294297 (UMLS CUI [1])

Toluidine blue or Giemsa

Item

Toluidine blue or Giemsa

boolean

C0523203 (UMLS CUI [1,1])
C0017542 (UMLS CUI [1,2])

Prussian blue

Item

Prussian blue

boolean

C0060234 (UMLS CUI [1])

Periodic Acidic Schiff (PAS), with or without diastase

Item

Periodic Acidic Schiff (PAS), with or without diastase

boolean

C0440048 (UMLS CUI [1,1])
C0596624 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])

Oil red O

Item

Oil red O

boolean

C1294000 (UMLS CUI [1])

Congo red

Item

Congo red

boolean

C0009742 (UMLS CUI [1])

Hall's stain

Item

Hall's stain

boolean

C1720394 (UMLS CUI [1])

Gridley's stain

Item

Gridley's stain

boolean

C1293978 (UMLS CUI [1])

Rhodanine (copper)

Item

Rhodanine (copper)

boolean

C0035486 (UMLS CUI [1])

Rubeanic acid (copper)

Item

Rubeanic acid (copper)

boolean

C0073680 (UMLS CUI [1])

Orcein, aldehyde fuchsin or Victoria blue

Item

Orcein, aldehyde fuchsin or Victoria blue

boolean

C0491984 (UMLS CUI [1,1])
C0078232 (UMLS CUI [1,2])
C0069596 (UMLS CUI [1,3])

Electron microscopy

Item

Electron microscopy

boolean

C0026019 (UMLS CUI [1])

Hepatitis A immunostains positive

Item

Hepatitis A immunostains positive

boolean

C0560226 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])

Hepatitis B core antigen or hepatitis B surface antibody immunostains positive

Item

Hepatitis B core antigen or hepatitis B surface antibody immunostains positive

boolean

C0201479 (UMLS CUI [1,1])
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])

Hepatitis D immunostains

Item

Hepatitis D immunostains

boolean

C0011226 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])

Other immunostains

Item

Other immunostains

boolean

C3687908 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Other, specify

Item

Other histological staining, specify

text

C0487602 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

Liver Biopsy Data

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