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 Anaemia *

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

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Ferric Carboxymaltose (FCM) of Alkem Laboratories Limited prescribed*

Yes No

Dose *

Frequency *

Duration of infusion *

Gap between 2 doses, if applicable

Date of Assessment *

Total No. of Infusions given *

Duration from the last infusion *

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Signs and Symptoms (if any)

Physician's Efficacy Assessment *

Very good Good Average Poor

Reports	Assessment 1	Assessment 2
Hb (gm/dL)
RBC(Millions/cumm)
CRP (mg/dL)
Hct (cumm)
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)

Adverse events noted due to study medication *

Yes No {{-- Yes --}}

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

Hemfer FCM

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

CLINICAL DATA

LABORATORY PARAMETERS

ADVERSE EVENTS