ID

32913

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-11-20 2018-11-20 -
Rättsinnehavare

GSK group of companies

Uppladdad den

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

Engelsk

Liver Biopsy Data

1 Formulär  
  1. StudyEvent: ODM
    1. Liver Biopsy Data
Administrative data
Beskrivning

Administrative data

Study Name
Beskrivning

Study Name

Datatyp

text

Site
Beskrivning

Site

Datatyp

text

Subject
Beskrivning

Subject

Datatyp

text

Visit Name
Beskrivning

Visit Name

Datatyp

text

DCI Name/Shortname
Beskrivning

DCI Name/Shortname

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Doc#
Beskrivning

Doc#

Datatyp

integer

Visit #
Beskrivning

Visit #

Datatyp

float

Liver Biopsy
Beskrivning

Liver Biopsy

Date of liver biopsy
Beskrivning

Complete a separate form for each liver biopsy performed.

Datatyp

date

Approximate size of liver biopsy
Beskrivning

Approximate size of liver biopsy

Datatyp

integer

Måttenheter
  • mm
mm
C. Description of Liver Cells or Hepatocytes
Beskrivning

C. Description of Liver Cells or Hepatocytes

Normal
Beskrivning

Normal

Datatyp

boolean

Ballooning
Beskrivning

Ballooning

Datatyp

boolean

Acidophilic
Beskrivning

Acidophilic

Datatyp

boolean

Pseudoxanthomatous
Beskrivning

Pseudoxanthomatous

Datatyp

boolean

Multinucleated giant hepatocytes
Beskrivning

Multinucleated giant hepatocytes

Datatyp

boolean

Other, specify
Beskrivning

Other, specify

Datatyp

boolean

D. Liver Cells or Hepatocyte Inclusions or Vacuoles
Beskrivning

D. Liver Cells or Hepatocyte Inclusions or Vacuoles

No inclusions
Beskrivning

No inclusions

Datatyp

boolean

Macrovesicular Steatosis
Beskrivning

Macrovesicular Steatosis

Datatyp

boolean

Microvesicular Steatosis
Beskrivning

Microvesicular Steatosis

Datatyp

boolean

Bile accumulation
Beskrivning

Bile accumulation

Datatyp

boolean

Diastase-resistant, pas-positive cytoplasmic inclusions
Beskrivning

Diastase-resistant, pas-positive cytoplasmic inclusions

Datatyp

boolean

Alpha-1-Antitrypsin inclusions
Beskrivning

Alpha-1-Antitrypsin inclusions

Datatyp

boolean

Megamitochondria
Beskrivning

Megamitochondria

Datatyp

boolean

Mallory Bodies
Beskrivning

Mallory Bodies

Datatyp

boolean

"Ground Glass" inclusions
Beskrivning

"Ground Glass" inclusions

Datatyp

boolean

Lipofuscin pigment
Beskrivning

Lipofuscin pigment

Datatyp

boolean

Hemosiderin granules
Beskrivning

Hemosiderin granules

Datatyp

boolean

Orcein-positive cytoplasmin granules
Beskrivning

Orcein-positive cytoplasmin granules

Datatyp

boolean

Protoporphyrin crystals (birefringent under polarised light)
Beskrivning

Protoporphyrin crystals (birefringent under polarised light)

Datatyp

boolean

Uroporphyrin crystals (red fluorescence under ultraviolet light)
Beskrivning

Uroporphyrin crystals (red fluorescence under ultraviolet light)

Datatyp

boolean

Other, specify
Beskrivning

Other, specify

Datatyp

text

E. Hepatocyte or Liver Cell Nuclear Abnormalities
Beskrivning

E. Hepatocyte or Liver Cell Nuclear Abnormalities

None
Beskrivning

None

Datatyp

boolean

Hepatocellular mitoses
Beskrivning

Hepatocellular mitoses

Datatyp

boolean

Binucleated or multinucleated hepatocytes
Beskrivning

Binucleated or multinucleated hepatocytes

Datatyp

boolean

CMV Inclusion bodies
Beskrivning

CMV Inclusion bodies

Datatyp

boolean

HSV Inclusion
Beskrivning

HSV Inclusion

Datatyp

boolean

Varicella inclusions
Beskrivning

Varicella inclusions

Datatyp

boolean

Other, specify
Beskrivning

Other, specify

Datatyp

text

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Similar models

Liver Biopsy Data

1 Formulär
  1. StudyEvent: ODM
    1. Liver Biopsy Data
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Tillbaka till toppen 

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