Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Subject Initials *

OPD *

IPD *

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Adult Patients with confirmed case of URTIs presented to the OPD or admitted to the IPD *

Yes No

Clinical Signs and Symptoms *

Clinical Diagnosis *

Duration of current illness *

Previous antibiotics used (if any)

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

Any Bacterial Species isolated

Yes No

Sensitivity results (if available)

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Hb (gm%)

RBC (cumm)

WBC (cumm)

Platelets (cumm)

CRP (mg/dl)

ESR

Specify Others (if any)

Cefpodoxime prescribed *

Yes No

Brand Name *

Marketing Company Name *

Dose *

Frequency *

Duration *

Other medications prescribed for T/t

Medication	Dose	Frequency	Duration

Date of Assessment *

Duration of Hospital Stay (days) (if hospitalized)

Total Duration of Therapy (days) *

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Hb (gm%)

RBC (cumm)

WBC (cumm)

Platelets (cumm)

CRP (mg/dl)

ESR

Specify Others (if any)

Any Bacterial Species isolated?(if available)

Yes No

Sensitivity results (if available)

Clinical Signs and Symptoms (if any)

Cure Improvement Worsening Mortality

Any secondary infections during hospital stay (details if yes)

Relapse of infection (details if yes)

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

Cefpodoxime Adult

ASSESSMENT 1 - BASELINE VISIT

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE and MEDICATION

MICROBIOLOGICAL DATA (if available)

VITALS

LABORATORY PARAMETERS (if available)

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2 - FOLLOW-UP VISIT

DATE OF ASSESSMENT

VITALS

LABORATORY PARAMETERS (if available)

MICROBIOLOGICAL DATA (if available)

CLINICAL DATA

ADVERSE EVENTS