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 Iron-deficiency Anemia *

Yes No

Signs and Symptoms *

Clinical Diagnosis *

Any underlying cause of IDA *

Duration of current illness *

Concomitant medication for current medical illness (If Any)

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

Syrup Hemfer (Ferrous Glycine Sulfate 50 mg) of Alkem Laboratories Limited prescribed *

Yes No

Any other oral iron supplements prescribed *

Yes No

Specify brand/genetic name (If yes)

Dose *

Frequency *

Duration *

Other medications prescribed for T/t of iron deficiency anemia

Medication	Dose	Frequency	Duration

Date of Assessment *

Total Duration of Therapy *

Signs and Symptoms (if any)

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

@php $labels = [ 'Hb (gm/dL)', 'RBC(Millions/cumm)', 'CRP (mg/dL)', 'Hct', 'MCV (fl)', 'MCH (pg/cell)', 'MCHC (gm/dL)', 'Iron Indices', 'Serum Iron (mcg/dL)', 'Ferritin (ng/mL)', 'TIBC (mcg/dL)', 'Transferrin (mcg/dL)', 'Transferrin saturation (%)', 'Soluble transferrin receptor', ]; $i = 38; @endphp @foreach ($labels as $label) @php $i++; @endphp @endforeach

Reports	Assessment 1	Assessment 2
{{ $label }}
Specify Others (if any)

Reports	Assessment 1	Assessment 2
Hb (gm/dL)
RBC(Millions/cumm)
CRP (mg/dL)
Hct
MCV (fl)
MCH (pg/cell)
MCHC (gm/dL)
Iron Indices
Serum Iron (mcg/dL)
Ferritin (ng/mL)
TIBC (mcg/dL)
Transferrin (mcg/dL)
Transferrin saturation (%)
Soluble transferrin receptor
Specify Others (if any)

FGS Protocol

ASSESSMENT 1 - START OF THERAPY

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE and MEDICATION

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2

DATE OF ASSESSMENT

CLINICAL DATA

ADVERSE EVENTS

LABORATORY PARAMETERS