ID

32912

Description

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Keywords

Versions (1)
  1. 11/20/18 11/20/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 20, 2018

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Creative Commons BY-NC 3.0
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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

English

Liver Biopsy Diagnosis and Liver Architecture

1 forms  
Administrative data
Description

Administrative data

Study Name
Description

Study Name

Data type

text

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

DCI Name/Shortname
Description

DCI Name/Shortname

Data type

text

Status
Description

Status

Data type

text

Doc#
Description

Doc#

Data type

integer

Visit #
Description

Visit #

Data type

float

Liver Biopsy
Description

Liver Biopsy

Date of liver biopsy
Description

Complete a separate form for each liver biopsy performed.

Data type

date

Approximate size of liver biopsy
Description

Approximate size of liver biopsy

Data type

integer

Measurement units
  • mm
mm
A. Final Diagnosis
Description

A. Final Diagnosis

Normal
Description

check all that apply

Data type

boolean

Acute hepatitis
Description

Acute hepatitis

Data type

boolean

Chronic hepatitis
Description

Chronic hepatitis

Data type

boolean

Cholestatic hepatitis
Description

Cholestatic hepatitis

Data type

boolean

Drug-induced cholestasis
Description

Drug-induced cholestasis

Data type

boolean

Acute viral hepatitis
Description

Acute viral hepatitis

Data type

boolean

Chronic viral hepatitis
Description

Chronic viral hepatitis

Data type

boolean

Drug-induced hepatitis
Description

Drug-induced hepatitis

Data type

boolean

Autoimmune hepatitis
Description

Autoimmune hepatitis

Data type

boolean

Bridging necrosis
Description

Bridging necrosis

Data type

boolean

Submassive hepatic necrosis
Description

Submassive hepatic necrosis

Data type

boolean

Massive hepatic necrosis
Description

Massive hepatic necrosis

Data type

boolean

Steatosis - Microvesicular
Description

Steatosis - Microvesicular

Data type

boolean

Steatosis - Macrovesicular
Description

Steatosis - Macrovesicular

Data type

boolean

Steatosis - Mixed
Description

Steatosis - Mixed

Data type

boolean

Non-Alcoholic Steatohepatitis
Description

Non-Alcoholic Steatohepatitis

Data type

boolean

Alcoholic hepatitis
Description

Alcoholic hepatitis

Data type

boolean

Hepatic granulomas
Description

Hepatic granulomas

Data type

boolean

Sarcoidosis
Description

Sarcoidosis

Data type

boolean

Fibrosis
Description

Fibrosis

Data type

boolean

Cirrhosis
Description

Cirrhosis

Data type

boolean

Primary biliary cirrhosis
Description

Primary biliary cirrhosis

Data type

boolean

Primary sclerosing cholangitis
Description

Primary sclerosing cholangitis

Data type

boolean

Autoimmune overlap syndrome
Description

Autoimmune overlap syndrome

Data type

boolean

Hemochromatosis
Description

Hemochromatosis

Data type

boolean

Alpha -1 - Antitrypsin deficiency
Description

Alpha -1 - Antitrypsin deficiency

Data type

boolean

Wilson's disease
Description

Wilson's disease

Data type

boolean

Veno-occlusive disease
Description

Veno-occlusive disease

Data type

boolean

Budd-Chiari syndrome
Description

Budd-Chiari syndrome

Data type

boolean

Neoplasia
Description

Neoplasia

Data type

boolean

Other, specify
Description

Other, specify

Data type

text

B. Liver Architecture
Description

B. Liver Architecture

Normal
Description

Normal

Data type

boolean

Bridging fibrosis
Description

Bridging fibrosis

Data type

boolean

Diffuse fibrosis
Description

Diffuse fibrosis

Data type

boolean

Nodular regenerative hyperplasia
Description

Nodular regenerative hyperplasia

Data type

boolean

Congenital hepatic fibrosis
Description

Congenital hepatic fibrosis

Data type

boolean

Cirrhosis
Description

Cirrhosis

Data type

boolean

Centrilobular congestion
Description

Centrilobular congestion

Data type

boolean

Endophlebitis
Description

Endophlebitis

Data type

boolean

Veno-occlusive disease
Description

Veno-occlusive disease

Data type

boolean

Canalicular cholestasis
Description

Canalicular cholestasis

Data type

boolean

Apoptosis
Description

Apoptosis

Data type

boolean

Focal (or spotty or mild) hepatocellular necrosis
Description

Focal (or spotty or mild) hepatocellular necrosis

Data type

boolean

Interface hepatitis (periportal hepatitis or piecemeal necrosis)
Description

Interface hepatitis (periportal hepatitis or piecemeal necrosis)

Data type

boolean

Ischaemic Necrosis
Description

Ischaemic Necrosis

Data type

boolean

Centrolobular (Zone 3) necrosis
Description

Centrolobular (Zone 3) necrosis

Data type

boolean

Focal coagulative necrosis
Description

Focal coagulative necrosis

Data type

boolean

Centrolobular (Zone 3) coagulative necrosis
Description

Centrolobular (Zone 3) coagulative necrosis

Data type

boolean

Bridging hepatocellular necrosis
Description

Bridging hepatocellular necrosis

Data type

boolean

Massive or panlobular hepatocellular necrosis
Description

Massive or panlobular hepatocellular necrosis

Data type

boolean

Dysplasia
Description

Dysplasia

Data type

boolean

Neoplasia
Description

Neoplasia

Data type

boolean

Other, specify
Description

Other, specify

Data type

boolean

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Similar models

Liver Biopsy Diagnosis and Liver Architecture

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Study Name
Item
Study Name
text
Site
Item
Site
text
Subject
Item
Subject
text
Visit Name
Item
Visit Name
text
DCI Name/Shortname
Item
DCI Name/Shortname
text
Status
Item
Status
text
Doc#
Item
Doc#
integer
Visit #
Item
Visit #
float
Item Group
Liver Biopsy
Date of liver biopsy
Item
Date of liver biopsy
date
Approximate size of liver biopsy
Item
Approximate size of liver biopsy
integer
Item Group
A. Final Diagnosis
Normal
Item
Normal
boolean
Acute hepatitis
Item
Acute hepatitis
boolean
Chronic hepatitis
Item
Chronic hepatitis
boolean
Cholestatic hepatitis
Item
Cholestatic hepatitis
boolean
Drug-induced cholestasis
Item
Drug-induced cholestasis
boolean
Acute viral hepatitis
Item
Acute viral hepatitis
boolean
Chronic viral hepatitis
Item
Chronic viral hepatitis
boolean
Drug-induced hepatitis
Item
Drug-induced hepatitis
boolean
Autoimmune hepatitis
Item
Autoimmune hepatitis
boolean
Bridging necrosis
Item
Bridging necrosis
boolean
Submassive hepatic necrosis
Item
Submassive hepatic necrosis
boolean
Massive hepatic necrosis
Item
Massive hepatic necrosis
boolean
Steatosis - Microvesicular
Item
Steatosis - Microvesicular
boolean
Steatosis - Macrovesicular
Item
Steatosis - Macrovesicular
boolean
Steatosis - Mixed
Item
Steatosis - Mixed
boolean
Non-Alcoholic Steatohepatitis
Item
Non-Alcoholic Steatohepatitis
boolean
Alcoholic hepatitis
Item
Alcoholic hepatitis
boolean
Hepatic granulomas
Item
Hepatic granulomas
boolean
Sarcoidosis
Item
Sarcoidosis
boolean
Fibrosis
Item
Fibrosis
boolean
Cirrhosis
Item
Cirrhosis
boolean
Primary biliary cirrhosis
Item
Primary biliary cirrhosis
boolean
Primary sclerosing cholangitis
Item
Primary sclerosing cholangitis
boolean
Autoimmune overlap syndrome
Item
Autoimmune overlap syndrome
boolean
Hemochromatosis
Item
Hemochromatosis
boolean
Alpha -1 - Antitrypsin deficiency
Item
Alpha -1 - Antitrypsin deficiency
boolean
Wilson's disease
Item
Wilson's disease
boolean
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
Budd-Chiari syndrome
Item
Budd-Chiari syndrome
boolean
Neoplasia
Item
Neoplasia
boolean
Other, specify
Item
Other, specify
text
Item Group
B. Liver Architecture
Normal
Item
Normal
boolean
Bridging fibrosis
Item
Bridging fibrosis
boolean
Diffuse fibrosis
Item
Diffuse fibrosis
boolean
Nodular regenerative hyperplasia
Item
Nodular regenerative hyperplasia
boolean
Congenital hepatic fibrosis
Item
Congenital hepatic fibrosis
boolean
Cirrhosis
Item
Cirrhosis
boolean
Centrilobular congestion
Item
Centrilobular congestion
boolean
Endophlebitis
Item
Endophlebitis
boolean
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
Canalicular cholestasis
Item
Canalicular cholestasis
boolean
Apoptosis
Item
Apoptosis
boolean
Focal (or spotty or mild) hepatocellular necrosis
Item
Focal (or spotty or mild) hepatocellular necrosis
boolean
Interface hepatitis (periportal hepatitis or piecemeal necrosis)
Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis)
boolean
Ischaemic Necrosis
Item
Ischaemic Necrosis
boolean
Centrolobular (Zone 3) necrosis
Item
Centrolobular (Zone 3) necrosis
boolean
Focal coagulative necrosis
Item
Focal coagulative necrosis
boolean
Centrolobular (Zone 3) coagulative necrosis
Item
Centrolobular (Zone 3) coagulative necrosis
boolean
Bridging hepatocellular necrosis
Item
Bridging hepatocellular necrosis
boolean
Massive or panlobular hepatocellular necrosis
Item
Massive or panlobular hepatocellular necrosis
boolean
Dysplasia
Item
Dysplasia
boolean
Neoplasia
Item
Neoplasia
boolean
Other, specify
Item
Other, specify
boolean
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