ID

32902

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

Versies (1)
  1. 19-11-18 19-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

19 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

Engels

Injection Site Reaction

1 Formulieren  
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

Injection Site Reaction
Beschrijving

Injection Site Reaction

AE/SAE Number
Beschrijving

AE/SAE Number

Datatype

integer

Date of Injection
Beschrijving

Date of Injection

Datatype

date

Date of Reaction
Beschrijving

Date of Reaction

Datatype

date

Size of Skin Reaction
Beschrijving

record maximal size

Datatype

text

Maateenheden
  • mm
mm
Location of Injection
Beschrijving

Location of Injection

Datatype

text

If Other, specify
Beschrijving

If Other, specify

Datatype

text

Was the local reaction within 24 hours of dose?
Beschrijving

Was the local reaction within 24 hours of dose?

Datatype

boolean

Local reaction symptoms
Beschrijving

Local reaction symptoms

check all that apply
Beschrijving

check all that apply

Datatype

text

Redness/Erythema
Beschrijving

Redness/Erythema

Datatype

text

Itching/Pruritis
Beschrijving

Itching/Pruritis

Datatype

text

Raised
Beschrijving

Raised

Datatype

text

Warmth
Beschrijving

Warmth

Datatype

text

Other symptoms
Beschrijving

Other symptoms

Datatype

text

If Other symptoms, specify
Beschrijving

If Other symptoms, specify

Datatype

text

Was treatment given for this local reaction?
Beschrijving

Was treatment given for this local reaction?

Datatype

text

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

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?
Beschrijving

Serum sample obtained?

Datatype

boolean

If YES, please provide Date
Beschrijving

If YES, please provide Date

Datatype

date

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Similar models

Injection Site Reaction

1 Formulieren
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
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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