ID

32912

Beschrijving

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

Trefwoorden

  1. 20-11-18 20-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

20 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

Liver Biopsy Diagnosis and Liver Architecture

Administrative data
Beschrijving

Administrative data

Study Name
Beschrijving

Study Name

Datatype

text

Site
Beschrijving

Site

Datatype

text

Subject
Beschrijving

Subject

Datatype

text

Visit Name
Beschrijving

Visit Name

Datatype

text

DCI Name/Shortname
Beschrijving

DCI Name/Shortname

Datatype

text

Status
Beschrijving

Status

Datatype

text

Doc#
Beschrijving

Doc#

Datatype

integer

Visit #
Beschrijving

Visit #

Datatype

float

Liver Biopsy
Beschrijving

Liver Biopsy

Date of liver biopsy
Beschrijving

Complete a separate form for each liver biopsy performed.

Datatype

date

Approximate size of liver biopsy
Beschrijving

Approximate size of liver biopsy

Datatype

integer

Maateenheden
  • mm
mm
A. Final Diagnosis
Beschrijving

A. Final Diagnosis

Normal
Beschrijving

check all that apply

Datatype

boolean

Acute hepatitis
Beschrijving

Acute hepatitis

Datatype

boolean

Chronic hepatitis
Beschrijving

Chronic hepatitis

Datatype

boolean

Cholestatic hepatitis
Beschrijving

Cholestatic hepatitis

Datatype

boolean

Drug-induced cholestasis
Beschrijving

Drug-induced cholestasis

Datatype

boolean

Acute viral hepatitis
Beschrijving

Acute viral hepatitis

Datatype

boolean

Chronic viral hepatitis
Beschrijving

Chronic viral hepatitis

Datatype

boolean

Drug-induced hepatitis
Beschrijving

Drug-induced hepatitis

Datatype

boolean

Autoimmune hepatitis
Beschrijving

Autoimmune hepatitis

Datatype

boolean

Bridging necrosis
Beschrijving

Bridging necrosis

Datatype

boolean

Submassive hepatic necrosis
Beschrijving

Submassive hepatic necrosis

Datatype

boolean

Massive hepatic necrosis
Beschrijving

Massive hepatic necrosis

Datatype

boolean

Steatosis - Microvesicular
Beschrijving

Steatosis - Microvesicular

Datatype

boolean

Steatosis - Macrovesicular
Beschrijving

Steatosis - Macrovesicular

Datatype

boolean

Steatosis - Mixed
Beschrijving

Steatosis - Mixed

Datatype

boolean

Non-Alcoholic Steatohepatitis
Beschrijving

Non-Alcoholic Steatohepatitis

Datatype

boolean

Alcoholic hepatitis
Beschrijving

Alcoholic hepatitis

Datatype

boolean

Hepatic granulomas
Beschrijving

Hepatic granulomas

Datatype

boolean

Sarcoidosis
Beschrijving

Sarcoidosis

Datatype

boolean

Fibrosis
Beschrijving

Fibrosis

Datatype

boolean

Cirrhosis
Beschrijving

Cirrhosis

Datatype

boolean

Primary biliary cirrhosis
Beschrijving

Primary biliary cirrhosis

Datatype

boolean

Primary sclerosing cholangitis
Beschrijving

Primary sclerosing cholangitis

Datatype

boolean

Autoimmune overlap syndrome
Beschrijving

Autoimmune overlap syndrome

Datatype

boolean

Hemochromatosis
Beschrijving

Hemochromatosis

Datatype

boolean

Alpha -1 - Antitrypsin deficiency
Beschrijving

Alpha -1 - Antitrypsin deficiency

Datatype

boolean

Wilson's disease
Beschrijving

Wilson's disease

Datatype

boolean

Veno-occlusive disease
Beschrijving

Veno-occlusive disease

Datatype

boolean

Budd-Chiari syndrome
Beschrijving

Budd-Chiari syndrome

Datatype

boolean

Neoplasia
Beschrijving

Neoplasia

Datatype

boolean

Other, specify
Beschrijving

Other, specify

Datatype

text

B. Liver Architecture
Beschrijving

B. Liver Architecture

Normal
Beschrijving

Normal

Datatype

boolean

Bridging fibrosis
Beschrijving

Bridging fibrosis

Datatype

boolean

Diffuse fibrosis
Beschrijving

Diffuse fibrosis

Datatype

boolean

Nodular regenerative hyperplasia
Beschrijving

Nodular regenerative hyperplasia

Datatype

boolean

Congenital hepatic fibrosis
Beschrijving

Congenital hepatic fibrosis

Datatype

boolean

Cirrhosis
Beschrijving

Cirrhosis

Datatype

boolean

Centrilobular congestion
Beschrijving

Centrilobular congestion

Datatype

boolean

Endophlebitis
Beschrijving

Endophlebitis

Datatype

boolean

Veno-occlusive disease
Beschrijving

Veno-occlusive disease

Datatype

boolean

Canalicular cholestasis
Beschrijving

Canalicular cholestasis

Datatype

boolean

Apoptosis
Beschrijving

Apoptosis

Datatype

boolean

Focal (or spotty or mild) hepatocellular necrosis
Beschrijving

Focal (or spotty or mild) hepatocellular necrosis

Datatype

boolean

Interface hepatitis (periportal hepatitis or piecemeal necrosis)
Beschrijving

Interface hepatitis (periportal hepatitis or piecemeal necrosis)

Datatype

boolean

Ischaemic Necrosis
Beschrijving

Ischaemic Necrosis

Datatype

boolean

Centrolobular (Zone 3) necrosis
Beschrijving

Centrolobular (Zone 3) necrosis

Datatype

boolean

Focal coagulative necrosis
Beschrijving

Focal coagulative necrosis

Datatype

boolean

Centrolobular (Zone 3) coagulative necrosis
Beschrijving

Centrolobular (Zone 3) coagulative necrosis

Datatype

boolean

Bridging hepatocellular necrosis
Beschrijving

Bridging hepatocellular necrosis

Datatype

boolean

Massive or panlobular hepatocellular necrosis
Beschrijving

Massive or panlobular hepatocellular necrosis

Datatype

boolean

Dysplasia
Beschrijving

Dysplasia

Datatype

boolean

Neoplasia
Beschrijving

Neoplasia

Datatype

boolean

Other, specify
Beschrijving

Other, specify

Datatype

boolean

Similar models

Liver Biopsy Diagnosis and Liver Architecture

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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