ID

38305

Description

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Keywords

Versions (2)
  1. 10/9/19 10/9/19 -
  2. 10/24/19 10/24/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 9, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

English

Common CRF: Liver Biopsy

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient name

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No
Description

Patients, Identification number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Liver Biopsy
Description

Liver Biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Description

Biopsy of liver, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0011008
Approximate size of liver biopsy
Description

Biopsy of liver, Specimen size

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1299482
mm
Biopsy size unit
Description

Biopsy of liver, Specimen size, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1299482
UMLS CUI [1,3]
C1519795
Final Diagnosis
Description

Biopsy of liver, Diagnosis Type - Final

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1546485
Other, specify
Description

Biopsy of liver, Diagnosis Type - Final

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1546485
Liver Architecture
Description

Biopsy of liver, Cellular structure aspects

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0935919
Other, specify
Description

Biopsy of liver, Cellular structure aspects

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0935919
Description of Liver Cells or Hepatocytes
Description

Biopsy of liver, Hepatocyte, Description

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C0678257
Other, specify
Description

Biopsy of liver, Hepatocyte, Description

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C0678257
Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

Biopsy of liver, Hepatocyte, Vacuole, Inclusion

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C0042219
UMLS CUI [1,4]
C1512693
Other, specify
Description

Biopsy of liver, Hepatocyte, Vacuole, Inclusion

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C0042219
UMLS CUI [1,4]
C1512693
Hepatocyte or Liver Cell Nuclear Abnormalities
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
Other, specify
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
Liver or Lobular Infiltrates
Description

Biopsy of liver, Infiltrate

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0205417
Other, specify
Description

Biopsy of liver, Infiltrate

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0205417
Portal Tract Inflammation
Description

Biopsy of liver, Portal Tract Inflammation

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C3854488
Other, specify
Description

Biopsy of liver, Portal Tract Inflammation

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C3854488
Bile Ducts
Description

Biopsy of liver, Bile duct structure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0005400
Other, specify
Description

Biopsy of liver, Bile duct structure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0005400
Portal Veins
Description

Biopsy of liver, Portal vein structure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0032718
Other, specify
Description

Biopsy of liver, Portal vein structure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0032718
Liver Infections
Description

Biopsy of liver, Hepatic infection

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1112211
Other, specify
Description

Biopsy of liver, Hepatic infection

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1112211
Parasites or Ova
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
Other, specify
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
Histologic Staining or Additional Studies Obtained
Description

Biopsy of liver, Staining method; Biopsy of liver, Study Subject Participation Status

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0487602
UMLS CUI [2,1]
C0193388
UMLS CUI [2,2]
C2348568
Other, specify
Description

Biopsy of liver, Staining method; Biopsy of liver, Study Subject Participation Status

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0487602
UMLS CUI [2,1]
C0193388
UMLS CUI [2,2]
C2348568
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Similar models

Common CRF: Liver Biopsy

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Liver Biopsy
C0193388 (UMLS CUI-1)
Biopsy of liver, Date in time
Item
Date of liver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Biopsy of liver, Specimen size
Item
Approximate size of liver biopsy
integer
C0193388 (UMLS CUI [1,1])
C1299482 (UMLS CUI [1,2])
Item
Biopsy size unit
text
C0193388 (UMLS CUI [1,1])
C1299482 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Biopsy of liver, Specimen size, Unit of Measure
Code List
Biopsy size unit
CL Item
mm (1)
Item
Final Diagnosis
text
C0193388 (UMLS CUI [1,1])
C1546485 (UMLS CUI [1,2])
Biopsy of liver, Diagnosis Type - Final
Code List
Final Diagnosis
CL Item
Normal (1)
CL Item
Acute hepatitis (2)
CL Item
Chronic hepatitis (3)
CL Item
Cholestatic hepatitis  (4)
CL Item
Drug-induced cholestasis  (5)
CL Item
Acute viral hepatitis (6)
CL Item
Chronic viral hepatitis  (7)
CL Item
Drug-induced hepatitis  (8)
CL Item
Autoimmune hepatitis  (9)
CL Item
Bridging necrosis  (10)
CL Item
Submassive hepatic necrosis  (11)
CL Item
Massive hepatic necrosis  (12)
CL Item
Steatosis - microvesicular  (13)
CL Item
Steatosis - macrovesicular  (14)
CL Item
Steatosis - mixed  (15)
CL Item
Non-alcoholic steatohepatitis  (16)
CL Item
Alcoholic hepatitis (17)
CL Item
Hepatic granulomas  (18)
CL Item
Sarcoidosis Fibrosis (19)
CL Item
Cirrhosis (20)
CL Item
Primary biliary cirrhosis  (21)
CL Item
Primary sclerosing cholangitis  (22)
CL Item
Autoimmune overlap syndrome  (23)
CL Item
Hemochromatosis  (24)
CL Item
Alpha-1-antitrypsin deficiency  (25)
CL Item
Wilson's disease  (26)
CL Item
Veno-occlusive disease  (27)
CL Item
Budd-Chiari syndrome  (28)
CL Item
Neoplasia (29)
CL Item
Other, specify (30)
Biopsy of liver, Diagnosis Type - Final
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C1546485 (UMLS CUI [1,2])
Item
Liver Architecture
text
C0193388 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
Biopsy of liver, Cellular structure aspects
Code List
Liver Architecture
CL Item
Normal (1)
CL Item
Bridging fibrosis (2)
CL Item
Diffuse fibrosis (3)
CL Item
Nodular regenerative hyperplasia (4)
CL Item
Congenital hepatic fibrosis (5)
CL Item
Cirrhosis (6)
CL Item
Centrilobular congestion (7)
CL Item
Endophlebitis (8)
CL Item
Veno-occlusive disease (9)
CL Item
Canalicular cholestasis (10)
CL Item
Apoptosis (11)
CL Item
Focal (or spotty or mild) hepatocellular necrosis (12)
CL Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis)  (13)
CL Item
Ischaemic necrosis (14)
CL Item
Centrolobular (Zone 3) necrosis (15)
CL Item
Focal coagulative necrosis (16)
CL Item
Centrolobular (Zone 3) coagulative necrosis (17)
CL Item
Bridging hepatocellular necrosis (18)
CL Item
Massive or panlobular hepatocellular necrosis (19)
CL Item
Dysplasia (20)
CL Item
Neoplasia (21)
CL Item
Other, specify (22)
Biopsy of liver, Cellular structure aspects
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
Item
Description of Liver Cells or Hepatocytes
text
C0193388 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Biopsy of liver, Hepatocyte, Description
Code List
Description of Liver Cells or Hepatocytes
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, specify (6)
Biopsy of liver, Hepatocyte, Description
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles
text
C0193388 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,4])
Biopsy of liver, Hepatocyte, Vacuole, Inclusion
Code List
Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
No inclusions  (1)
CL Item
Macrovesicular steatosis (2)
CL Item
Microvesicular steatosis (3)
CL Item
Bile accumulation (4)
CL Item
Diastase-resistant, PAS-positive cytoplasmic inclusions  (5)
CL Item
Alpha-1-antitrypsin inclusions (6)
CL Item
Megamitochondria (7)
CL Item
Mallory bodies (8)
CL Item
"Ground Glass" inclusions (9)
CL Item
Lipofuscin pigment (10)
CL Item
Hemosiderin granules (11)
CL Item
Orcein-positive cytoplasmin granules (12)
CL Item
Protoporphyrin crystals (birefringent under polarised light)  (13)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (14)
CL Item
Other, specify (15)
Biopsy of liver, Hepatocyte, Vacuole, Inclusion
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,4])
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
text
C0193388 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
Biopsy of liver, Hepatocyte, Abnormal nuclear morphology
Code List
Hepatocyte or Liver Cell Nuclear Abnormalities
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, specify (7)
Biopsy of liver, Hepatocyte, Abnormal nuclear morphology
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
Item
Liver or Lobular Infiltrates
text
C0193388 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
Biopsy of liver, Infiltrate
Code List
Liver or Lobular Infiltrates
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphocytes (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, specify (8)
Biopsy of liver, Infiltrate
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
Item
Portal Tract Inflammation
text
C0193388 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
Biopsy of liver, Portal Tract Inflammation
Code List
Portal Tract Inflammation
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, specify (7)
Biopsy of liver, Portal Tract Inflammation
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
Item
Bile Ducts
text
C0193388 (UMLS CUI [1,1])
C0005400 (UMLS CUI [1,2])
Biopsy of liver, Bile duct structure
Code List
Bile Ducts
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, specify (6)
Biopsy of liver, Bile duct structure
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C0005400 (UMLS CUI [1,2])
Item
Portal Veins
text
C0193388 (UMLS CUI [1,1])
C0032718 (UMLS CUI [1,2])
Biopsy of liver, Portal vein structure
Code List
Portal Veins
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, specify (6)
Biopsy of liver, Portal vein structure
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C0032718 (UMLS CUI [1,2])
Item
Liver Infections
text
C0193388 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])
Biopsy of liver, Hepatic infection
Code List
Liver Infections
CL Item
Normal (1)
CL Item
Leishmaniasis donovani  (2)
CL Item
Plasmodium falciparum  (3)
CL Item
Toxoplasmosis  (4)
CL Item
Cryptococcus neoformans  (5)
CL Item
Histoplasma capsulatum  (6)
CL Item
Mycobacterium tuberculois  (7)
CL Item
Other mycobacterial species (8)
CL Item
Other, specify (9)
Biopsy of liver, Hepatic infection
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])
Item
Parasites or Ova
text
C0193388 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])
C1267673 (UMLS CUI [1,3])
Biopsy of liver, Parasite, Ovum of parasite
Code List
Parasites or Ova
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, specify (7)
Biopsy of liver, Parasite, Ovum of parasite
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])
C1267673 (UMLS CUI [1,3])
Item
Histologic Staining or Additional Studies Obtained
text
C0193388 (UMLS CUI [1,1])
C0487602 (UMLS CUI [1,2])
C0193388 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
Biopsy of liver, Staining method; Biopsy of liver, Study Subject Participation Status
Code List
Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and eosin (or H & E)  (1)
CL Item
Masson (2)
CL Item
Toluidine blue or Giemsa (3)
CL Item
Prussian blue (4)
CL Item
Periodic Acidic Schiff (PAS), with or without diastase  (5)
CL Item
Oil red O (6)
CL Item
Congo red (7)
CL Item
Hall's stain (8)
CL Item
Gridley's stain  (9)
CL Item
Rhodanine (copper) (10)
CL Item
Rubeanic acid (copper) (11)
CL Item
Orcein, aldehyde fuchsin or Victoria blue (12)
CL Item
Electron microscopy (13)
CL Item
Hepatitis A immunostains positive (14)
CL Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (15)
CL Item
Hepatitis D immunostains (16)
CL Item
Other immunostains (17)
CL Item
Other, specify (18)
Biopsy of liver, Staining method; Biopsy of liver, Study Subject Participation Status
Item
Other, specify
text
C0193388 (UMLS CUI [1,1])
C0487602 (UMLS CUI [1,2])
C0193388 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
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