Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Subject Initials * {{-- --}}

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Patients with confirmed diagnosis of hypertriglyceridemia *

Yes No

Presenting Signs and Symptoms *

Clinical Diagnosis *

Duration of current illness *

Concomitant medication for current medical illness (If Any)

Medication	Dose	Frequency	Duration

Medications being used for other concomitant diseases

Disease	Duration	Medication	Dose	Frequency

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Omega-3 Fatty Acids prescribed*

Yes No

Brand Name *

Formulation * {{-- --}}

Dose *

Frequency *

Taking the O3FA since * {{-- --}}

Now prescribed O3FA for how much duration

Percentage of O3FA in the prescribed brand/formulation

Other medications prescribed for T/t for other comorbidities

Medication	Dose	Frequency	Duration

Date of Assessment *

Total Duration of Therapy (days) *

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Adverse events noted due to study medication *

Yes No

ADVERSE EVENT(S)
AE. No	Adverse Event Term	Date of onset (DD/MM/YYYY)	Severity	Action Taken	Treatment given	Relationship with Study Drug	Outcome	Serious Adverse Event
1					Yes No			Yes No
2					Yes No			Yes No
3					Yes No			Yes No
4					Yes No			Yes No
Severity: 1- Mild; 2- Moderate; 3- Severe; +Action Taken: 1- No Change in IP, 2- IP Temporarily Interrupted, 3- IP Permanently Discontinued, 4- Other, specify *If 'Treatment given 'is ticked as 'Yes' then relevant information should be captured on Prior and concomitant Medication Form.Relationship: 1= Related, 2= Not Related ++Outcome: 1 = Resolved, 2= Recovered/ Resolved with Sequelae, 3= Recovering/ Resolving, 4=Not Recovered/ Not Resolved, 5= Fatal/ result in death, 6= Unknown

Reports	Assessment 1	Assessment 2
Triglyceride (mg/dL)
Total cholesterol (mg/dL)
LDL (mg/dL)
HDL (mg/dL)
VLDL (mg/dL)
LDL/HDL (mg/dL)
FBS (mg/dL)
PPBS (mg/dL)
HBA1C (%)
RFT
S. Cr (mg/dL)
Specify Others (if any)

03FA

ASSESSMENT 1 - START OF THERAPY

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE and MEDICATION

VITALS

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2 - FIRST FOLLOW- UP VISIT

DATE OF ASSESSMENT

VITALS

ADVERSE EVENTS

LABORATORY PARAMETERS