ID

32901

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

Hypoglycaemic Adverse Events

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

Hypoglycaemic AE/SAE
Descripción

Hypoglycaemic AE/SAE

Has the subject experienced any protocol defined hypoglycaemic events?
Descripción

Has the subject experienced any protocol defined hypoglycaemic events?

Tipo de datos

boolean

If YES, please record Hypoglycaemic Events details in the next section.
Descripción

If YES, please record Hypoglycaemic Events details in the next section.

Tipo de datos

text

Hypoglycaemic Events Data
Descripción

Hypoglycaemic Events Data

AE/SAE Reference Event Number
Descripción

AE/SAE Reference Event Number

Tipo de datos

integer

Start date of event
Descripción

Start date of event

Tipo de datos

date

Start time of Event
Descripción

Start time of Event

Tipo de datos

time

End date of Event
Descripción

End date of Event

Tipo de datos

date

End time of Event
Descripción

End time of Event

Tipo de datos

time

Blood Glucose Test Result at Time of Event
Descripción

Blood Glucose Test Result at Time of Event

Tipo de datos

integer

Unit
Descripción

Unit

Tipo de datos

text

Frequency
Descripción

Frequency

Tipo de datos

text

Severity of hypoglycaemic event
Descripción

(per ADA working group guidelines)

Tipo de datos

text

If Severe, check all that apply
Descripción

at least one criterion must be checked to fit the ADA criterion of severe

Tipo de datos

text

If Hospitalization was required, record the number of days
Descripción

If Hospitalization was required, record the number of days

Tipo de datos

integer

Intervention
Descripción

enter the most severe, record details on concomitant medication page if applicable

Tipo de datos

text

Action Taken with Background or Anti-hyperglycemic medication?
Descripción

Action Taken with Background or Anti-hyperglycemic medication?

Tipo de datos

text

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Similar models

Hypoglycaemic Adverse Events

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
Has the subject experienced any protocol defined hypoglycaemic events?
Item
Has the subject experienced any protocol defined hypoglycaemic events?
boolean
If YES, please record Hypoglycaemic Events details in the next section.
Item
If YES, please record Hypoglycaemic Events details in the next section.
text
Item Group
Hypoglycaemic Events Data
AE/SAE Reference Event Number
Item
AE/SAE Reference Event Number
integer
Start date of event
Item
Start date of event
date
Start time of Event
Item
Start time of Event
time
End date of Event
Item
End date of Event
date
End time of Event
Item
End time of Event
time
Blood Glucose Test Result at Time of Event
Item
Blood Glucose Test Result at Time of Event
integer
Item
Unit
text
Unit
Code List
Unit
CL Item
mg/dL (1)
CL Item
mmol/L (2)
Item
Frequency
text
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Severity of hypoglycaemic event
text
Severity of hypoglycaemic event
Code List
Severity of hypoglycaemic event
CL Item
Severe (1)
CL Item
Documented Symptomatic (2)
CL Item
Asymptomatic (3)
CL Item
Probable Symptomatic (4)
CL Item
Relative (5)
CL Item
Not Applicable (6)
Item
If Severe, check all that apply
text
If Severe, check all that apply
Code List
If Severe, check all that apply
CL Item
Assistance provided to the subject by a non-healthcare professional (e.g., relative or non-relative) at the location of the hypoglycemic event. (1)
CL Item
Assistance provided to the subject by a healthcare professional (i.e., a nurse, physician, or emergency medical service was contacted and responded) at the location of the hypoglycemic event. (2)
CL Item
Event required an unscheduled visit to the investigator (but did not require hospitalization). (3)
CL Item
Event required a visit to another healthcare professional (but did not require hospitalization). (4)
CL Item
The event required a visit to the emergency room. (5)
CL Item
The subject required hospitalization. Please follow serious adverse event instructions. (6)
If Hospitalization was required, record the number of days
Item
If Hospitalization was required, record the number of days
integer
Item
Intervention
text
Intervention
Code List
Intervention
CL Item
None (1)
CL Item
Minor; Administered sugary drinks or sweets (2)
CL Item
Immediate; glucose drinks or supplements (3)
CL Item
Extensive; glucose injection/infusion/glucagon (4)
Item
Action Taken with Background or Anti-hyperglycemic medication?
text
Action Taken with Background or Anti-hyperglycemic medication?
Code List
Action Taken with Background or Anti-hyperglycemic medication?
CL Item
Yes (If Yes, please update Anti-Hyperglycemic Medications Page ) (1)
CL Item
No (2)
CL Item
No Applicable (3)
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