Anglais

Hypoglycaemic Adverse Events

1 Formulaires  
Administrative data
Description

Administrative data

Study Name
Description

Study Name

Type de données

text

Site
Description

Site

Type de données

text

Subject
Description

Subject

Type de données

text

Visit Name
Description

Visit Name

Type de données

text

DCI Name/Shortname
Description

DCI Name/Shortname

Type de données

text

Status
Description

Status

Type de données

text

Doc#
Description

Doc#

Type de données

integer

Visit #
Description

Visit #

Type de données

float

Hypoglycaemic AE/SAE
Description

Hypoglycaemic AE/SAE

Has the subject experienced any protocol defined hypoglycaemic events?
Description

Has the subject experienced any protocol defined hypoglycaemic events?

Type de données

boolean

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

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

Type de données

text

Hypoglycaemic Events Data
Description

Hypoglycaemic Events Data

AE/SAE Reference Event Number
Description

AE/SAE Reference Event Number

Type de données

integer

Start date of event
Description

Start date of event

Type de données

date

Start time of Event
Description

Start time of Event

Type de données

time

End date of Event
Description

End date of Event

Type de données

date

End time of Event
Description

End time of Event

Type de données

time

Blood Glucose Test Result at Time of Event
Description

Blood Glucose Test Result at Time of Event

Type de données

integer

Unit
Description

Unit

Type de données

text

Frequency
Description

Frequency

Type de données

text

Severity of hypoglycaemic event
Description

(per ADA working group guidelines)

Type de données

text

If Severe, check all that apply
Description

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

Type de données

text

If Hospitalization was required, record the number of days
Description

If Hospitalization was required, record the number of days

Type de données

integer

Intervention
Description

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

Type de données

text

Action Taken with Background or Anti-hyperglycemic medication?
Description

Action Taken with Background or Anti-hyperglycemic medication?

Type de données

text

Retour au début de la page

Similar models

Hypoglycaemic Adverse Events

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
Retour au début de la page