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Various Adverse Events: Hypoglycemia, Injection Site Reaction, Pancreatitis, Thyroid Nodes

1 forms  
Administrative data
Description

Administrative data

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

Status
Description

Status

Data type

text

Document Number
Description

Document Number

Data type

text

(Serious) Hypoglycaemic Events
Description

(Serious) Hypoglycaemic Events

Has the subject experiences any protocol defined hypoglycaemic events?
Description

any protocol defined hypoglycaemic events?

Data type

boolean

If Yes, please add Hypoglycaemic Event details on the following form.
Description

If Yes, please add Hypoglycaemic Event details on the following form.

Data type

text

Serious Adverse Events
Description

Serious Adverse Events

AE/SAE Reference Number
Description

AE/SAE Reference Number

Data type

integer

Start date of Event
Description

Start date of Event

Data type

date

Start Time of Event
Description

Start Time of Event

Data type

time

End date of Event
Description

End date of Event

Data type

date

End time of Event
Description

End time of Event

Data type

time

Blood Glucose Test Result at Time of Event
Description

Blood Glucose Test Result at Time of Event

Data type

text

Unit
Description

Unit

Data type

text

Frequency
Description

Frequency

Data type

text

Severity of hypoglycaemic event
Description

per ADA group guidelines

Data type

text

If Severe, check all that apply:
Description

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

Data type

text

Record the number of hospitalization days
Description

number of hospitalization days

Data type

integer

Enter the most severe intervention methods
Description

Intervention

Data type

text

Action Taken with Background or Anti-Hyperglycaemic Medications section
Description

if Yes, please update Anti-Hyperglycaemic Medications page

Data type

text

Injection Site Reaction
Description

Injection Site Reaction

AE/SAE Number
Description

AE/SAE Number

Data type

integer

Date of Injection
Description

Date of Injection

Data type

date

Date of Reaction
Description

Date of Reaction

Data type

date

Size of skin reaction - length
Description

maximum

Data type

integer

Measurement units
  • mm
mm
Size of skin reaction - width
Description

maximum

Data type

integer

Measurement units
  • mm
mm
Location of Injection
Description

Location of Injection

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Was the local reaction within 24 hrs of dose?
Description

timeframe of local reaction

Data type

boolean

Redness / Erythema
Description

Redness / Erythema

Data type

text

Itching / Pruritis
Description

Itching / Pruritis

Data type

text

Raised
Description

Raised

Data type

text

Warmth
Description

Warmth

Data type

text

Other symptoms
Description

Other symptoms

Data type

text

Specify Other symptoms
Description

Specify Other symptoms

Data type

text

Was treatment given for this local reaction?
Description

Was treatment given for this local reaction?

Data type

boolean

Was the serum sample obtained?
Description

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

Data type

boolean

If Yes, please provide date
Description

If Yes, please provide date

Data type

date

Pancreatitis
Description

Pancreatitis

AE/SAE Number
Description

AE/SAE Number

Data type

integer

Date of Onset
Description

Date of Onset

Data type

date

Was alcohol consumed on a regular basis?
Description

Alcohol

Data type

text

Average number of units consumed daily
Description

Average number of units consumed daily

Data type

integer

Is there a family history of Pancreatitis?
Description

Family History of Pancreatitis

Data type

boolean

Grandmother (maternal)
Description

Grandmother (maternal)

Data type

text

Grandfather (maternal)
Description

Grandfather (maternal)

Data type

text

Grandmother (paternal)
Description

Grandmother (paternal)

Data type

text

Grandfather (paternal)
Description

Grandfather (paternal)

Data type

text

Mother
Description

Mother

Data type

text

Father
Description

Father

Data type

text

Sibling 1
Description

Sibling 1

Data type

text

specify
Description

specify

Data type

text

Sibling 2
Description

Sibling 2

Data type

text

specify
Description

specify

Data type

text

Other
Description

Other

Data type

text

specify
Description

specify

Data type

text

Recent Trauma / Vascular Invasive Procedures or Surgery
Description

Recent Trauma / Vascular Invasive Procedures or Surgery

Data type

text

Date of Procedure
Description

Date of Procedure

Data type

date

Recent Trauma / Vascular Invasive Procedures or Surgery
Description

Recent Trauma / Vascular Invasive Procedures or Surgery

Data type

text

Date of Procedure
Description

Date of Procedure

Data type

date

Recent Trauma / Vascular Invasive Procedures or Surgery
Description

Recent Trauma / Vascular Invasive Procedures or Surgery

Data type

text

Date of Procedure
Description

Date of Procedure

Data type

date

Symptoms of Gastrointestinal Illness Associated with Pancreatitis
Description

Symptoms of Gastrointestinal Illness Associated with Pancreatitis

Check below all that apply
Description

Check below all that apply

Data type

text

Pain in the Epigastrium
Description

Pain in the Epigastrium

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Pain in the Periumbical Region
Description

Pain in the Periumbical Region

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Pain in the Right Upper Quadrant
Description

Pain in the Right Upper Quadrant

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Pain in the Left Upper Quadrant
Description

Pain in the Left Upper Quadrant

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Pain in the Left Lower Quadrant
Description

Pain in the Left Lower Quadrant

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Pain in the Right Lower Quadrant
Description

Pain in the Right Lower Quadrant

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Pain in the Right Flank
Description

Pain in the Right Flank

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Pain in the Left Flank
Description

Pain in the Left Flank

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Pain in the Back
Description

Pain in the Back

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Other Symptoms
Description

Other Symptoms

Specify symptom
Description

Specify symptom

Data type

text

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Nausea
Description

Nausea

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Vomiting
Description

Vomiting

Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Fever
Description

Fever

Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
Date of Onset
Description

Date of Onset

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Biochemistry
Description

Biochemistry

Record lab results in corresponding categories below
Description

Record lab results in corresponding categories below

Data type

text

Alkaline phosphatase
Description

Alkaline phosphatase

Was lab test performed?
Description

Was lab test performed?

Data type

boolean

Lab Test Result
Description

Lab Test Result

Data type

text

Lab Unit
Description

Lab Unit

Data type

text

Other lab unit, specify
Description

Other lab unit, specify

Data type

text

Lab LLN
Description

Lab LLN

Data type

text

Lab ULN
Description

Lab ULN

Data type

text

Total bilirubin
Description

Total bilirubin

Was lab test performed?
Description

Was lab test performed?

Data type

boolean

Lab Test Result
Description

Lab Test Result

Data type

text

Lab Unit
Description

Lab Unit

Data type

text

Other lab unit, specify
Description

Other lab unit, specify

Data type

text

Lab LLN
Description

Lab LLN

Data type

text

Lab ULN
Description

Lab ULN

Data type

text

Direct bilirubin
Description

Direct bilirubin

Was lab test performed?
Description

Was lab test performed?

Data type

boolean

Lab Test Result
Description

Lab Test Result

Data type

text

Lab Unit
Description

Lab Unit

Data type

text

Other lab unit, specify
Description

Other lab unit, specify

Data type

text

Lab LLN
Description

Lab LLN

Data type

text

Lab ULN
Description

Lab ULN

Data type

text

Creatinine
Description

Creatinine

Was lab test performed?
Description

Was lab test performed?

Data type

boolean

Lab Test Result
Description

Lab Test Result

Data type

text

Lab Unit
Description

Lab Unit

Data type

text

Other lab unit, specify
Description

Other lab unit, specify

Data type

text

Lab LLN
Description

Lab LLN

Data type

text

Lab ULN
Description

Lab ULN

Data type

text

Other lab test
Description

Other lab test

Specify test
Description

Specify test

Data type

text

Lab Test Result
Description

Lab Test Result

Data type

text

Lab Unit
Description

Lab Unit

Data type

text

Other lab unit, specify
Description

Other lab unit, specify

Data type

text

Lab LLN
Description

Lab LLN

Data type

text

Lab ULN
Description

Lab ULN

Data type

text

Were additional Lab-Results Biochemistry evaluations performed?
Description

Were additional Lab-Results Biochemistry evaluations performed?

Data type

boolean

Diagnostic Studies - Pancreatitis
Description

Diagnostic Studies - Pancreatitis

Was Abdominal Ultrasound performed?
Description

Was Abdominal Ultrasound performed?

Data type

boolean

Date of abdominal ultrasound
Description

Date of abdominal ultrasound

Data type

date

If Yes, record the result
Description

If Yes, record the result

Data type

text

Are there any evidence of cholelithiasis?
Description

Are there any evidence of cholelithiasis?

Data type

text

Was an additional Abdominal Ultrasound performed?
Description

Was an additional Abdominal Ultrasound performed?

Data type

boolean

Abdominal CT Scan
Description

Abdominal CT Scan

Was an abdominal CT Scan performed?
Description

Was an abdominal CT Scan performed?

Data type

boolean

If Yes, Date of Abdominal CT
Description

If Yes, Date of Abdominal CT

Data type

date

Record overall results
Description

Record overall results

Data type

text

If Abnormal, what are the diagnostic findings?
Description

If Abnormal, what are the diagnostic findings?

Data type

text

Specify other
Description

Specify other

Data type

text

Was an additional Abdominal CT Scan performed?
Description

Was an additional Abdominal CT Scan performed?

Data type

boolean

MRI
Description

MRI

Was MRI performed?
Description

Was MRI performed?

Data type

boolean

Date of MRI
Description

Date of MRI

Data type

date

Results of MRI
Description

Results of MRI

Data type

text

If Abnormal, what was the diagnostic finding?
Description

check all that apply

Data type

integer

Was additional MRI performed?
Description

Was additional MRI performed?

Data type

boolean

New Thyroid Nodules
Description

New Thyroid Nodules

Date of evaluation at which new nodule appeared
Description

Date of evaluation at which new nodule appeared

Data type

date

AE/SAE Reference Number
Description

AE/SAE Reference Number

Data type

integer

Type
Description

Type

Data type

text

Location
Description

Location

Data type

text

Bidimensional Measurement
Description

Bidimensional Measurement

length
Description

length

Data type

float

Measurement units
  • cm
cm
width
Description

width

Data type

float

Measurement units
  • cm
cm
Thyroid Nodules AE Details
Description

Thyroid Nodules AE Details

Was an action taken?
Description

Was an action taken?

Data type

boolean

If Yes, please check all that apply
Description

If Yes, please check all that apply

Data type

text

If Diagnostic Method was Fine Needle aspirate, please provide pathology results
Description

check only one

Data type

text

If Malignant, thyroid cancer, check all that apply
Description

If Malignant, thyroid cancer, check all that apply

Data type

text

Was an action taken due to fine needle aspirate pathology result?
Description

Was an action taken due to fine needle aspirate pathology result?

Data type

boolean

If Yes, please provide details:
Description

If Yes, please provide details:

Data type

text

Thyroid function tests
Description

Thyroid function tests

Record the details below
Description

Record the details below

Data type

boolean

Free T4
Description

Free T4

Result
Description

Result

Data type

text

Unit
Description

Unit

Data type

text

LLN
Description

LLN

Data type

text

ULN
Description

ULN

Data type

text

T4
Description

T4

Result
Description

Result

Data type

text

Unit
Description

Unit

Data type

text

LLN
Description

LLN

Data type

text

ULN
Description

ULN

Data type

text

TSH
Description

TSH

Result
Description

Result

Data type

text

Unit
Description

Unit

Data type

text

LLN
Description

LLN

Data type

text

ULN
Description

ULN

Data type

text

Free T3
Description

Free T3

Result
Description

Result

Data type

text

Unit
Description

Unit

Data type

text

LLN
Description

LLN

Data type

text

ULN
Description

ULN

Data type

text

T3 Uptake
Description

T3 Uptake

Result
Description

Result

Data type

text

Unit
Description

Unit

Data type

text

LLN
Description

LLN

Data type

text

ULN
Description

ULN

Data type

text

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Various Adverse Events: Hypoglycemia, Injection Site Reaction, Pancreatitis, Thyroid Nodes

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Item
Visit Name
text
Visit Name
Code List
Visit Name
CL Item
Hypoglycemia (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Item Group
(Serious) Hypoglycaemic Events
any protocol defined hypoglycaemic events?
Item
Has the subject experiences any protocol defined hypoglycaemic events?
boolean
If Yes, please add Hypoglycaemic Event details on the following form.
Item
If Yes, please add Hypoglycaemic Event details on the following form.
text
Item Group
Serious Adverse Events
AE/SAE Reference Number
Item
AE/SAE Reference 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
text
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 professionals (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.re., 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 (record the number of hospitalization days further) (6)
number of hospitalization days
Item
Record the number of hospitalization days
integer
Item
Enter the most severe intervention methods
text
Intervention
Code List
Enter the most severe intervention methods
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-Hyperglycaemic Medications section
text
anti-hyperglycemic medication?
Code List
Action Taken with Background or Anti-Hyperglycaemic Medications section
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
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 - length
Item
Size of skin reaction - length
integer
Size of skin reaction - width
Item
Size of skin reaction - width
integer
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
timeframe of local reaction
Item
Was the local reaction within 24 hrs of dose?
boolean
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)
Specify Other symptoms
Item
Specify Other symptoms
text
Was treatment given for this local reaction?
Item
Was treatment given for this local reaction?
boolean
serum sample obtained?
Item
Was the serum sample obtained?
boolean
If Yes, please provide date
Item
If Yes, please provide date
date
Item Group
Pancreatitis
AE/SAE Number
Item
AE/SAE Number
integer
Date of Onset
Item
Date of Onset
date
Item
Was alcohol consumed on a regular basis?
text
Alcohol
Code List
Was alcohol consumed on a regular basis?
CL Item
Unknown (1)
CL Item
Yes (record the average number of units) (2)
CL Item
No (3)
Average number of units consumed daily
Item
Average number of units consumed daily
integer
Family History of Pancreatitis
Item
Is there a family history of Pancreatitis?
boolean
Item
Grandmother (maternal)
text
Grandmother (maternal)
Code List
Grandmother (maternal)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
Grandfather (maternal)
text
Grandfather (maternal)
Code List
Grandfather (maternal)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
Grandmother (paternal)
text
Grandmother (paternal)
Code List
Grandmother (paternal)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
Grandfather (paternal)
text
Grandfather (paternal)
Code List
Grandfather (paternal)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
Mother
text
Mother
Code List
Mother
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
Father
text
Father
Code List
Father
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
Sibling 1
text
Sibling
Code List
Sibling 1
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
specify
Item
specify
text
Item
Sibling 2
text
Sibling 2
Code List
Sibling 2
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
specify
Item
specify
text
Item
Other
text
Other
Code List
Other
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
specify
Item
specify
text
Recent Trauma / Vascular Invasive Procedures or Surgery
Item
Recent Trauma / Vascular Invasive Procedures or Surgery
text
Date of Procedure
Item
Date of Procedure
date
Recent Trauma / Vascular Invasive Procedures or Surgery
Item
Recent Trauma / Vascular Invasive Procedures or Surgery
text
Date of Procedure
Item
Date of Procedure
date
Recent Trauma / Vascular Invasive Procedures or Surgery
Item
Recent Trauma / Vascular Invasive Procedures or Surgery
text
Date of Procedure
Item
Date of Procedure
date
Item Group
Symptoms of Gastrointestinal Illness Associated with Pancreatitis
Check below all that apply
Item
text
Item Group
Pain in the Epigastrium
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Pain in the Periumbical Region
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Pain in the Right Upper Quadrant
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Pain in the Left Upper Quadrant
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Pain in the Left Lower Quadrant
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Pain in the Right Lower Quadrant
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Pain in the Right Flank
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Pain in the Left Flank
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Pain in the Back
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Other Symptoms
Item
Specify symptom
text
Symptom
Code List
Specify symptom
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Nausea
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Vomiting
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Fever
Temperature
Item
Temperature
float
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Biochemistry
Record lab results in corresponding categories below
Item
Record lab results in corresponding categories below
text
Item Group
Alkaline phosphatase
Was lab test performed?
Item
Was lab test performed?
boolean
Lab Test Result
Item
Lab Test Result
text
Lab Unit
Item
Lab Unit
text
Other lab unit, specify
Item
Other lab unit, specify
text
Lab LLN
Item
Lab LLN
text
Lab ULN
Item
Lab ULN
text
Item Group
Total bilirubin
Was lab test performed?
Item
Was lab test performed?
boolean
Lab Test Result
Item
Lab Test Result
text
Lab Unit
Item
Lab Unit
text
Other lab unit, specify
Item
Other lab unit, specify
text
Lab LLN
Item
Lab LLN
text
Lab ULN
Item
Lab ULN
text
Item Group
Direct bilirubin
Was lab test performed?
Item
Was lab test performed?
boolean
Lab Test Result
Item
Lab Test Result
text
Lab Unit
Item
Lab Unit
text
Other lab unit, specify
Item
Other lab unit, specify
text
Lab LLN
Item
Lab LLN
text
Lab ULN
Item
Lab ULN
text
Item Group
Creatinine
Was lab test performed?
Item
Was lab test performed?
boolean
Lab Test Result
Item
Lab Test Result
text
Lab Unit
Item
Lab Unit
text
Other lab unit, specify
Item
Other lab unit, specify
text
Lab LLN
Item
Lab LLN
text
Lab ULN
Item
Lab ULN
text
Item Group
Other lab test
Specify test
Item
Specify test
text
Lab Test Result
Item
Lab Test Result
text
Lab Unit
Item
Lab Unit
text
Other lab unit, specify
Item
Other lab unit, specify
text
Lab LLN
Item
Lab LLN
text
Lab ULN
Item
Lab ULN
text
Were additional Lab-Results Biochemistry evaluations performed?
Item
Were additional Lab-Results Biochemistry evaluations performed?
boolean
Item Group
Diagnostic Studies - Pancreatitis
Was Abdominal Ultrasound performed?
Item
Was Abdominal Ultrasound performed?
boolean
Date of abdominal ultrasound
Item
Date of abdominal ultrasound
date
Item
If Yes, record the result
text
If Yes, record the result
Code List
If Yes, record the result
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Are there any evidence of cholelithiasis?
text
Are there any evidence of cholelithiasis?
Code List
Are there any evidence of cholelithiasis?
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Was an additional Abdominal Ultrasound performed?
Item
Was an additional Abdominal Ultrasound performed?
boolean
Item Group
Abdominal CT Scan
Was an abdominal CT Scan performed?
Item
Was an abdominal CT Scan performed?
boolean
If Yes, Date of Abdominal CT
Item
If Yes, Date of Abdominal CT
date
Item
Record overall results
text
Record overall results
Code List
Record overall results
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
If Abnormal, what are the diagnostic findings?
text
If Abnormal, what are the diagnostic findings?
Code List
If Abnormal, what are the diagnostic findings?
CL Item
Unknown (1)
CL Item
Cholelithiasis (2)
CL Item
Pancreatic fluid collection (3)
CL Item
Pseudocysts (4)
CL Item
Edema of the small bowel mesentery (5)
CL Item
Pancreatic necrosis (6)
CL Item
Focal edema of the pancreas (7)
CL Item
Other (8)
Specify other
Item
Specify other
text
Was an additional Abdominal CT Scan performed?
Item
Was an additional Abdominal CT Scan performed?
boolean
Item Group
MRI
Was MRI performed?
Item
Was MRI performed?
boolean
Date of MRI
Item
Date of MRI
date
Item
Results of MRI
text
Results of MRI
Code List
Results of MRI
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
If Abnormal, what was the diagnostic finding?
integer
If Abnormal, what was the diagnostic finding?
Code List
If Abnormal, what was the diagnostic finding?
CL Item
Unknown (1)
CL Item
Cholelithiasis (2)
CL Item
Pancreatic fluid collection (3)
CL Item
Pseudocysts (4)
CL Item
Edema of the small bowel mesentery (5)
CL Item
Pancreatic necrosis (6)
CL Item
Focal edema of the pancreas (7)
CL Item
Diffuse edema of the pancreas (8)
CL Item
Other (9)
Was additional MRI performed?
Item
Was additional MRI performed?
boolean
Item Group
New Thyroid Nodules
Date of evaluation at which new nodule appeared
Item
Date of evaluation at which new nodule appeared
date
AE/SAE Reference Number
Item
AE/SAE Reference Number
integer
Item
Type
text
Type
Code List
Type
CL Item
Solitary nodule (1)
CL Item
Multinodular (2)
Item
Location
text
Location
Code List
Location
CL Item
Right upper lobe (1)
CL Item
Left upper lobe (2)
CL Item
Right lower lobe (3)
CL Item
Left lower lobe (4)
CL Item
Isthmus (5)
Item Group
Bidimensional Measurement
length
Item
length
float
width
Item
width
float
Item Group
Thyroid Nodules AE Details
Was an action taken?
Item
Was an action taken?
boolean
Item
If Yes, please check all that apply
text
If Yes, please check all that apply
Code List
If Yes, please check all that apply
CL Item
Ultrasound (1)
CL Item
RIU (2)
CL Item
Technetium scan (3)
CL Item
Physical exam (4)
CL Item
Fine needle aspirate (5)
CL Item
Surgery (6)
CL Item
Thyroid function tests (7)
Item
If Diagnostic Method was Fine Needle aspirate, please provide pathology results
text
If Diagnostic Method was Fine Needle aspirate, please provide pathology results
Code List
If Diagnostic Method was Fine Needle aspirate, please provide pathology results
CL Item
Non-diagnostic (1)
CL Item
Benign (2)
CL Item
Malignant, thyroid cancer (3)
Item
If Malignant, thyroid cancer, check all that apply
text
If Malignant, thyroid cancer, check all that apply
Code List
If Malignant, thyroid cancer, check all that apply
CL Item
Papillary (1)
CL Item
Follicular (2)
CL Item
Metastatic (3)
CL Item
Medullary (4)
CL Item
Aplastic (5)
Was an action taken due to fine needle aspirate pathology result?
Item
Was an action taken due to fine needle aspirate pathology result?
boolean
If Yes, please provide details:
Item
If Yes, please provide details:
text
Item Group
Thyroid function tests
Record the details below
Item
Record the details below
boolean
Item Group
Free T4
Result
Item
Result
text
Unit
Item
Unit
text
LLN
Item
LLN
text
ULN
Item
ULN
text
Item Group
T4
Result
Item
Result
text
Unit
Item
Unit
text
LLN
Item
LLN
text
ULN
Item
ULN
text
Item Group
TSH
Result
Item
Result
text
Unit
Item
Unit
text
LLN
Item
LLN
text
ULN
Item
ULN
text
Item Group
Free T3
Result
Item
Result
text
Unit
Item
Unit
text
LLN
Item
LLN
text
ULN
Item
ULN
text
Item Group
T3 Uptake
Result
Item
Result
text
Unit
Item
Unit
text
LLN
Item
LLN
text
ULN
Item
ULN
text
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