ID

32902

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. 2018-11-19 2018-11-19 -
Rättsinnehavare

GSK group of companies

Uppladdad den

19 november 2018

DOI

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Licens

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

Engelsk

Injection Site Reaction

1 Formulär  
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

Injection Site Reaction
Beskrivning

Injection Site Reaction

AE/SAE Number
Beskrivning

AE/SAE Number

Datatyp

integer

Date of Injection
Beskrivning

Date of Injection

Datatyp

date

Date of Reaction
Beskrivning

Date of Reaction

Datatyp

date

Size of Skin Reaction
Beskrivning

record maximal size

Datatyp

text

Måttenheter
  • mm
mm
Location of Injection
Beskrivning

Location of Injection

Datatyp

text

If Other, specify
Beskrivning

If Other, specify

Datatyp

text

Was the local reaction within 24 hours of dose?
Beskrivning

Was the local reaction within 24 hours of dose?

Datatyp

boolean

Local reaction symptoms
Beskrivning

Local reaction symptoms

check all that apply
Beskrivning

check all that apply

Datatyp

text

Redness/Erythema
Beskrivning

Redness/Erythema

Datatyp

text

Itching/Pruritis
Beskrivning

Itching/Pruritis

Datatyp

text

Raised
Beskrivning

Raised

Datatyp

text

Warmth
Beskrivning

Warmth

Datatyp

text

Other symptoms
Beskrivning

Other symptoms

Datatyp

text

If Other symptoms, specify
Beskrivning

If Other symptoms, specify

Datatyp

text

Was treatment given for this local reaction?
Beskrivning

Was treatment given for this local reaction?

Datatyp

text

Subjects with a severe injection site reaction or a severe systemic allergic reaction must have three 1mL serum samples obtained for immunogenicity testing.
Beskrivning

Subjects with a severe injection site reaction or a severe systemic allergic reaction must have three 1mL serum samples obtained for immunogenicity testing.

Serum sample obtained?
Beskrivning

Serum sample obtained?

Datatyp

boolean

If YES, please provide Date
Beskrivning

If YES, please provide Date

Datatyp

date

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Similar models

Injection Site Reaction

1 Formulär
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
Injection Site Reaction
AE/SAE Number
Item
AE/SAE Number
integer
Date of Injection
Item
Date of Injection
date
Date of Reaction
Item
Date of Reaction
date
Size of Skin Reaction
Item
Size of Skin Reaction
text
Item
Location of Injection
text
Location of Injection
Code List
Location of Injection
CL Item
Left Abdomen (1)
CL Item
Right Abdomen (2)
CL Item
Other (3)
If Other, specify
Item
If Other, specify
text
Was the local reaction within 24 hours of dose?
Item
Was the local reaction within 24 hours of dose?
boolean
Item Group
Local reaction symptoms
check all that apply
Item
check all that apply
text
Item
Redness/Erythema
text
Redness/Erythema
Code List
Redness/Erythema
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Itching/Pruritis
text
Itching/Pruritis
Code List
Itching/Pruritis
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Raised
text
Raised
Code List
Raised
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Warmth
text
Warmth
Code List
Warmth
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Other symptoms
text
Other symptoms
Code List
Other symptoms
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
If Other symptoms, specify
Item
If Other symptoms, specify
text
Item
Was treatment given for this local reaction?
text
Was treatment given for this local reaction?
Code List
Was treatment given for this local reaction?
CL Item
No (1)
CL Item
Yes (If Yes, please record all treatments on the concomitant medications/Non-drug Therapies eCRF) (2)
Item Group
Subjects with a severe injection site reaction or a severe systemic allergic reaction must have three 1mL serum samples obtained for immunogenicity testing.
Serum sample obtained?
Item
Serum sample obtained?
boolean
If YES, please provide Date
Item
If YES, please provide Date
date
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