ID

32902

Descripción

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

Palabras clave

Versiones (1)
  1. 19/11/18 19/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

19 de noviembre de 2018

DOI

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Licencia

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

Inglés

Injection Site Reaction

1 formularios  
Administrative data
Descripción

Administrative data

Study Name
Descripción

Study Name

Tipo de datos

text

Site
Descripción

Site

Tipo de datos

text

Subject
Descripción

Subject

Tipo de datos

text

Visit Name
Descripción

Visit Name

Tipo de datos

text

DCI Name/Shortname
Descripción

DCI Name/Shortname

Tipo de datos

text

Status
Descripción

Status

Tipo de datos

text

Doc#
Descripción

Doc#

Tipo de datos

integer

Visit #
Descripción

Visit #

Tipo de datos

float

Injection Site Reaction
Descripción

Injection Site Reaction

AE/SAE Number
Descripción

AE/SAE Number

Tipo de datos

integer

Date of Injection
Descripción

Date of Injection

Tipo de datos

date

Date of Reaction
Descripción

Date of Reaction

Tipo de datos

date

Size of Skin Reaction
Descripción

record maximal size

Tipo de datos

text

Unidades de medida
  • mm
mm
Location of Injection
Descripción

Location of Injection

Tipo de datos

text

If Other, specify
Descripción

If Other, specify

Tipo de datos

text

Was the local reaction within 24 hours of dose?
Descripción

Was the local reaction within 24 hours of dose?

Tipo de datos

boolean

Local reaction symptoms
Descripción

Local reaction symptoms

check all that apply
Descripción

check all that apply

Tipo de datos

text

Redness/Erythema
Descripción

Redness/Erythema

Tipo de datos

text

Itching/Pruritis
Descripción

Itching/Pruritis

Tipo de datos

text

Raised
Descripción

Raised

Tipo de datos

text

Warmth
Descripción

Warmth

Tipo de datos

text

Other symptoms
Descripción

Other symptoms

Tipo de datos

text

If Other symptoms, specify
Descripción

If Other symptoms, specify

Tipo de datos

text

Was treatment given for this local reaction?
Descripción

Was treatment given for this local reaction?

Tipo de datos

text

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

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?
Descripción

Serum sample obtained?

Tipo de datos

boolean

If YES, please provide Date
Descripción

If YES, please provide Date

Tipo de datos

date

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Similar models

Injection Site Reaction

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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