ID

32913

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

DOI

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License

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

English

Liver Biopsy Data

1 forms  
  1. StudyEvent: ODM
    1. Liver Biopsy Data
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
C. Description of Liver Cells or Hepatocytes
Description

C. Description of Liver Cells or Hepatocytes

Normal
Description

Normal

Data type

boolean

Ballooning
Description

Ballooning

Data type

boolean

Acidophilic
Description

Acidophilic

Data type

boolean

Pseudoxanthomatous
Description

Pseudoxanthomatous

Data type

boolean

Multinucleated giant hepatocytes
Description

Multinucleated giant hepatocytes

Data type

boolean

Other, specify
Description

Other, specify

Data type

boolean

D. Liver Cells or Hepatocyte Inclusions or Vacuoles
Description

D. Liver Cells or Hepatocyte Inclusions or Vacuoles

No inclusions
Description

No inclusions

Data type

boolean

Macrovesicular Steatosis
Description

Macrovesicular Steatosis

Data type

boolean

Microvesicular Steatosis
Description

Microvesicular Steatosis

Data type

boolean

Bile accumulation
Description

Bile accumulation

Data type

boolean

Diastase-resistant, pas-positive cytoplasmic inclusions
Description

Diastase-resistant, pas-positive cytoplasmic inclusions

Data type

boolean

Alpha-1-Antitrypsin inclusions
Description

Alpha-1-Antitrypsin inclusions

Data type

boolean

Megamitochondria
Description

Megamitochondria

Data type

boolean

Mallory Bodies
Description

Mallory Bodies

Data type

boolean

"Ground Glass" inclusions
Description

"Ground Glass" inclusions

Data type

boolean

Lipofuscin pigment
Description

Lipofuscin pigment

Data type

boolean

Hemosiderin granules
Description

Hemosiderin granules

Data type

boolean

Orcein-positive cytoplasmin granules
Description

Orcein-positive cytoplasmin granules

Data type

boolean

Protoporphyrin crystals (birefringent under polarised light)
Description

Protoporphyrin crystals (birefringent under polarised light)

Data type

boolean

Uroporphyrin crystals (red fluorescence under ultraviolet light)
Description

Uroporphyrin crystals (red fluorescence under ultraviolet light)

Data type

boolean

Other, specify
Description

Other, specify

Data type

text

E. Hepatocyte or Liver Cell Nuclear Abnormalities
Description

E. Hepatocyte or Liver Cell Nuclear Abnormalities

None
Description

None

Data type

boolean

Hepatocellular mitoses
Description

Hepatocellular mitoses

Data type

boolean

Binucleated or multinucleated hepatocytes
Description

Binucleated or multinucleated hepatocytes

Data type

boolean

CMV Inclusion bodies
Description

CMV Inclusion bodies

Data type

boolean

HSV Inclusion
Description

HSV Inclusion

Data type

boolean

Varicella inclusions
Description

Varicella inclusions

Data type

boolean

Other, specify
Description

Other, specify

Data type

text

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Similar models

Liver Biopsy Data

1 forms
  1. StudyEvent: ODM
    1. Liver Biopsy Data
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
C. Description of Liver Cells or Hepatocytes
Normal
Item
Normal
boolean
Ballooning
Item
Ballooning
boolean
Acidophilic
Item
Acidophilic
boolean
Pseudoxanthomatous
Item
Pseudoxanthomatous
boolean
Multinucleated giant hepatocytes
Item
Multinucleated giant hepatocytes
boolean
Other, specify
Item
Other, specify
boolean
Item Group
D. Liver Cells or Hepatocyte Inclusions or Vacuoles
No inclusions
Item
No inclusions
boolean
Macrovesicular Steatosis
Item
Macrovesicular Steatosis
boolean
Microvesicular Steatosis
Item
Microvesicular Steatosis
boolean
Bile accumulation
Item
Bile accumulation
boolean
Diastase-resistant, pas-positive cytoplasmic inclusions
Item
Diastase-resistant, pas-positive cytoplasmic inclusions
boolean
Alpha-1-Antitrypsin inclusions
Item
Alpha-1-Antitrypsin inclusions
boolean
Megamitochondria
Item
Megamitochondria
boolean
Mallory Bodies
Item
Mallory Bodies
boolean
"Ground Glass" inclusions
Item
"Ground Glass" inclusions
boolean
Lipofuscin pigment
Item
Lipofuscin pigment
boolean
Hemosiderin granules
Item
Hemosiderin granules
boolean
Orcein-positive cytoplasmin granules
Item
Orcein-positive cytoplasmin granules
boolean
Protoporphyrin crystals (birefringent under polarised light)
Item
Protoporphyrin crystals (birefringent under polarised light)
boolean
Uroporphyrin crystals (red fluorescence under ultraviolet light)
Item
Uroporphyrin crystals (red fluorescence under ultraviolet light)
boolean
Other, specify
Item
Other, specify
text
Item Group
E. Hepatocyte or Liver Cell Nuclear Abnormalities
None
Item
None
boolean
Hepatocellular mitoses
Item
Hepatocellular mitoses
boolean
Binucleated or multinucleated hepatocytes
Item
Binucleated or multinucleated hepatocytes
boolean
CMV Inclusion bodies
Item
CMV Inclusion bodies
boolean
HSV Inclusion
Item
HSV Inclusion
boolean
Varicella inclusions
Item
Varicella inclusions
boolean
Other, specify
Item
Other, specify
text
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