Alkem

Subject Initials *

Investigator *

Centre *

Date of Assessment *

OPD *

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

Specify others (if available)

History of present illness *

H/o of viral fever drug use Any other details

Signs and Symptoms*

Itching *

	Absent	Present	Mild	Moderate	Severe
Itching

No. of Hives (Mark details if available)

Clinical Diagnosis *

Duration of current illness *

Previous medicines used (if any)

Bilastine prescribed *

Yes No

Brand Name *

Marketing company *

Dose *

Frequency *

Duration *

Other medications prescribed for T/t

Medication	Dose	Frequency	Duration

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

Date of Assessment *

Total Duration of Therapy (days) *

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

Specify others (if available)

Signs and Symptoms (if any)

Cure Improvement Worsening

Itching *

	Absent	Present	Mild	Moderate	Severe
Itching

No. of Hives (Mark details 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

Tests	Assessment 1 Result	Assessment 2 Result
RBC (millions/cumm)
WBC (cumm)
Platelets (cumm)
CRP (mg/L)
ESR (mm/hr)
Serum IgE (IU/ml)
anti-IgE (IU/ml)
Specify others (if available)

Bilastine

ASSESSMENT 1 - BASELINE VISIT

DEMOGRAPHICS and ANTHROPOMETRY

VITALS

MEDICAL HISTORY

TREATMENT OF CURRENT MEDICAL ILLNESS

CONCOMITANT DISEASE and MEDICATION

ASSESSMENT 2 - FOLLOW UP VISIT

DATE OF ASSESSMENT

VITALS

CLINICAL DATA

LABORATORY PARAMETER

ADVERSE EVENTS