Alkem

Subject Initials *

Investigator *

Centre *

Date of Assessment *

OPD *

Age (in Years) *

Gender *

Male Female

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

Specify others (if available)

Clinical Signs and Symptoms*

Signs and Symptoms*

Clinical Diagnosis *

History of Current illness*

Duration of current illness *

Previous antibiotics used (if any)

Any Bacterial Species isolated *

Yes No

Details, if yes

Culture & Sensitivity results (if available)

Urine analysis: Routine & microscopy (if available)

Cefixime prescribed *

Yes No

Brand Name *

Marketing company *

Dose *

Frequency *

Duration *

Other medications prescribed for T/t

Medication	Dose	Frequency	Duration

Concomitant Disease *

Medications being used for other concomitant diseases

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

Date of Assessment *

Total Duration of Therapy (days) *

Duration of Hospital Stay (if applicable) (days)

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

Specify others (if available)

Signs and Symptoms (if any)

Cure Improvement Worsening Mortality

Any secondary infections during hospital stay (details if yes)

Relapse of infection (details if yes)

Any Bacterial Species isolated (If possible/if available)

Yes No

Details, if yes

Sensitivity results (if available)

Urine analysis: Routine & microscopy (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)
Specify others (if available)

Cefixime

ASSESSMENT 1 - START OF THERAPY

DEMOGRAPHICS and ANTHROPOMETRY

VITALS

MEDICAL AND SURGICAL HISTORY

MICROBIOLOGICAL DATA

TREATMENT OF CURRENT MEDICAL ILLNESS

CONCOMITANT DISEASE and MEDICATION

ASSESSMENT 2 - FOLLOW UP VISIT

DATE OF ASSESSMENT

VITALS

CLINICAL DATA

MICROBIOLOGICAL DATA

LABORATORY PARAMETER

ADVERSE EVENTS