ID

32913

Beschreibung

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

Stichworte

  1. 20.11.18 20.11.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

20. November 2018

DOI

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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

Liver Biopsy Data

  1. StudyEvent: ODM
    1. Liver Biopsy Data
Administrative data
Beschreibung

Administrative data

Study Name
Beschreibung

Study Name

Datentyp

text

Site
Beschreibung

Site

Datentyp

text

Subject
Beschreibung

Subject

Datentyp

text

Visit Name
Beschreibung

Visit Name

Datentyp

text

DCI Name/Shortname
Beschreibung

DCI Name/Shortname

Datentyp

text

Status
Beschreibung

Status

Datentyp

text

Doc#
Beschreibung

Doc#

Datentyp

integer

Visit #
Beschreibung

Visit #

Datentyp

float

Liver Biopsy
Beschreibung

Liver Biopsy

Date of liver biopsy
Beschreibung

Complete a separate form for each liver biopsy performed.

Datentyp

date

Approximate size of liver biopsy
Beschreibung

Approximate size of liver biopsy

Datentyp

integer

Maßeinheiten
  • mm
mm
C. Description of Liver Cells or Hepatocytes
Beschreibung

C. Description of Liver Cells or Hepatocytes

Normal
Beschreibung

Normal

Datentyp

boolean

Ballooning
Beschreibung

Ballooning

Datentyp

boolean

Acidophilic
Beschreibung

Acidophilic

Datentyp

boolean

Pseudoxanthomatous
Beschreibung

Pseudoxanthomatous

Datentyp

boolean

Multinucleated giant hepatocytes
Beschreibung

Multinucleated giant hepatocytes

Datentyp

boolean

Other, specify
Beschreibung

Other, specify

Datentyp

boolean

D. Liver Cells or Hepatocyte Inclusions or Vacuoles
Beschreibung

D. Liver Cells or Hepatocyte Inclusions or Vacuoles

No inclusions
Beschreibung

No inclusions

Datentyp

boolean

Macrovesicular Steatosis
Beschreibung

Macrovesicular Steatosis

Datentyp

boolean

Microvesicular Steatosis
Beschreibung

Microvesicular Steatosis

Datentyp

boolean

Bile accumulation
Beschreibung

Bile accumulation

Datentyp

boolean

Diastase-resistant, pas-positive cytoplasmic inclusions
Beschreibung

Diastase-resistant, pas-positive cytoplasmic inclusions

Datentyp

boolean

Alpha-1-Antitrypsin inclusions
Beschreibung

Alpha-1-Antitrypsin inclusions

Datentyp

boolean

Megamitochondria
Beschreibung

Megamitochondria

Datentyp

boolean

Mallory Bodies
Beschreibung

Mallory Bodies

Datentyp

boolean

"Ground Glass" inclusions
Beschreibung

"Ground Glass" inclusions

Datentyp

boolean

Lipofuscin pigment
Beschreibung

Lipofuscin pigment

Datentyp

boolean

Hemosiderin granules
Beschreibung

Hemosiderin granules

Datentyp

boolean

Orcein-positive cytoplasmin granules
Beschreibung

Orcein-positive cytoplasmin granules

Datentyp

boolean

Protoporphyrin crystals (birefringent under polarised light)
Beschreibung

Protoporphyrin crystals (birefringent under polarised light)

Datentyp

boolean

Uroporphyrin crystals (red fluorescence under ultraviolet light)
Beschreibung

Uroporphyrin crystals (red fluorescence under ultraviolet light)

Datentyp

boolean

Other, specify
Beschreibung

Other, specify

Datentyp

text

E. Hepatocyte or Liver Cell Nuclear Abnormalities
Beschreibung

E. Hepatocyte or Liver Cell Nuclear Abnormalities

None
Beschreibung

None

Datentyp

boolean

Hepatocellular mitoses
Beschreibung

Hepatocellular mitoses

Datentyp

boolean

Binucleated or multinucleated hepatocytes
Beschreibung

Binucleated or multinucleated hepatocytes

Datentyp

boolean

CMV Inclusion bodies
Beschreibung

CMV Inclusion bodies

Datentyp

boolean

HSV Inclusion
Beschreibung

HSV Inclusion

Datentyp

boolean

Varicella inclusions
Beschreibung

Varicella inclusions

Datentyp

boolean

Other, specify
Beschreibung

Other, specify

Datentyp

text

Ähnliche Modelle

Liver Biopsy Data

  1. StudyEvent: ODM
    1. Liver Biopsy Data
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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