ID

32902

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

Versionen (1)
  1. 19.11.18 19.11.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

19. 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

Englisch

Injection Site Reaction

1 Formulare  
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

Injection Site Reaction
Beschreibung

Injection Site Reaction

AE/SAE Number
Beschreibung

AE/SAE Number

Datentyp

integer

Date of Injection
Beschreibung

Date of Injection

Datentyp

date

Date of Reaction
Beschreibung

Date of Reaction

Datentyp

date

Size of Skin Reaction
Beschreibung

record maximal size

Datentyp

text

Maßeinheiten
  • mm
mm
Location of Injection
Beschreibung

Location of Injection

Datentyp

text

If Other, specify
Beschreibung

If Other, specify

Datentyp

text

Was the local reaction within 24 hours of dose?
Beschreibung

Was the local reaction within 24 hours of dose?

Datentyp

boolean

Local reaction symptoms
Beschreibung

Local reaction symptoms

check all that apply
Beschreibung

check all that apply

Datentyp

text

Redness/Erythema
Beschreibung

Redness/Erythema

Datentyp

text

Itching/Pruritis
Beschreibung

Itching/Pruritis

Datentyp

text

Raised
Beschreibung

Raised

Datentyp

text

Warmth
Beschreibung

Warmth

Datentyp

text

Other symptoms
Beschreibung

Other symptoms

Datentyp

text

If Other symptoms, specify
Beschreibung

If Other symptoms, specify

Datentyp

text

Was treatment given for this local reaction?
Beschreibung

Was treatment given for this local reaction?

Datentyp

text

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

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?
Beschreibung

Serum sample obtained?

Datentyp

boolean

If YES, please provide Date
Beschreibung

If YES, please provide Date

Datentyp

date

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Ähnliche Modelle

Injection Site Reaction

1 Formulare
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
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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