ID

32901

Descrizione

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

Keywords

versioni (1)
  1. 19/11/18 19/11/18 -
Titolare del copyright

GSK group of companies

Caricato su

19 novembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Hypoglycaemic Adverse Events

1 moduli  
Administrative data
Descrizione

Administrative data

Study Name
Descrizione

Study Name

Tipo di dati

text

Site
Descrizione

Site

Tipo di dati

text

Subject
Descrizione

Subject

Tipo di dati

text

Visit Name
Descrizione

Visit Name

Tipo di dati

text

DCI Name/Shortname
Descrizione

DCI Name/Shortname

Tipo di dati

text

Status
Descrizione

Status

Tipo di dati

text

Doc#
Descrizione

Doc#

Tipo di dati

integer

Visit #
Descrizione

Visit #

Tipo di dati

float

Hypoglycaemic AE/SAE
Descrizione

Hypoglycaemic AE/SAE

Has the subject experienced any protocol defined hypoglycaemic events?
Descrizione

Has the subject experienced any protocol defined hypoglycaemic events?

Tipo di dati

boolean

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

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

Tipo di dati

text

Hypoglycaemic Events Data
Descrizione

Hypoglycaemic Events Data

AE/SAE Reference Event Number
Descrizione

AE/SAE Reference Event Number

Tipo di dati

integer

Start date of event
Descrizione

Start date of event

Tipo di dati

date

Start time of Event
Descrizione

Start time of Event

Tipo di dati

time

End date of Event
Descrizione

End date of Event

Tipo di dati

date

End time of Event
Descrizione

End time of Event

Tipo di dati

time

Blood Glucose Test Result at Time of Event
Descrizione

Blood Glucose Test Result at Time of Event

Tipo di dati

integer

Unit
Descrizione

Unit

Tipo di dati

text

Frequency
Descrizione

Frequency

Tipo di dati

text

Severity of hypoglycaemic event
Descrizione

(per ADA working group guidelines)

Tipo di dati

text

If Severe, check all that apply
Descrizione

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

Tipo di dati

text

If Hospitalization was required, record the number of days
Descrizione

If Hospitalization was required, record the number of days

Tipo di dati

integer

Intervention
Descrizione

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

Tipo di dati

text

Action Taken with Background or Anti-hyperglycemic medication?
Descrizione

Action Taken with Background or Anti-hyperglycemic medication?

Tipo di dati

text

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Similar models

Hypoglycaemic Adverse Events

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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