ID

32901

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 -
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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

Hypoglycaemic Adverse Events

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

Hypoglycaemic AE/SAE
Beschreibung

Hypoglycaemic AE/SAE

Has the subject experienced any protocol defined hypoglycaemic events?
Beschreibung

Has the subject experienced any protocol defined hypoglycaemic events?

Datentyp

boolean

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

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

Datentyp

text

Hypoglycaemic Events Data
Beschreibung

Hypoglycaemic Events Data

AE/SAE Reference Event Number
Beschreibung

AE/SAE Reference Event Number

Datentyp

integer

Start date of event
Beschreibung

Start date of event

Datentyp

date

Start time of Event
Beschreibung

Start time of Event

Datentyp

time

End date of Event
Beschreibung

End date of Event

Datentyp

date

End time of Event
Beschreibung

End time of Event

Datentyp

time

Blood Glucose Test Result at Time of Event
Beschreibung

Blood Glucose Test Result at Time of Event

Datentyp

integer

Unit
Beschreibung

Unit

Datentyp

text

Frequency
Beschreibung

Frequency

Datentyp

text

Severity of hypoglycaemic event
Beschreibung

(per ADA working group guidelines)

Datentyp

text

If Severe, check all that apply
Beschreibung

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

Datentyp

text

If Hospitalization was required, record the number of days
Beschreibung

If Hospitalization was required, record the number of days

Datentyp

integer

Intervention
Beschreibung

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

Datentyp

text

Action Taken with Background or Anti-hyperglycemic medication?
Beschreibung

Action Taken with Background or Anti-hyperglycemic medication?

Datentyp

text

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Ähnliche Modelle

Hypoglycaemic Adverse Events

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
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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