Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Subject Initials *

OPD/IPD *

OPD IPD

Gender *

Male Female

Age (in Years) *

Height (in cm) *

Weight (in Kg) *

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)

{{-- @for ($i = 1; $i <= 4; $i++) @for ($j = 1; $j <= 5; $j++) @endfor @endfor --}} @for ($i = 1; $i <= 4; $i++) @for ($j = 1; $j <= 5; $j++) @endfor @endfor

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

RBC

WBC

Platelets

CRP

ESR

Specify Others (if any)

Co-Amoxiclav 625 tablets prescribed *

Yes No

Brand Name *

Marketing Company Name *

Dose *

Frequency *

Duration *

Other medications prescribed for T/t

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Medication	Dose	Frequency	Duration

Date of Assessment *

Total Duration of Therapy (days) *

Any Bacterial Species isolated

Yes No

Sensitivity results (if available)

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Hb

RBC

WBC

Platelets

CRP

ESR

Specify Others (if any)

Clinical Signs and Symptoms (if any)

Cure Improvement Worsening Mortality

Adverse events noted due to study medication *

Yes No

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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
{{ $j++ }}					Yes No			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

Date of Assessment

Total Duration of Therapy (days)

Any Bacterial Species isolated

Yes No

Sensitivity results (if available)

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Hb

RBC

WBC

Platelets

CRP

ESR

Specify Others (if any)

Clinical Signs and Symptoms (if any)

Cure Improvement Worsening Mortality

Adverse events noted due to study medication

Yes No

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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
{{ $j++ }}					Yes No			Yes No

Amoxiclav URTI RWE

ASSESSMENT 1 - BASELINE VISIT - DAY 0

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE and MEDICATION

MICROBIOLOGICAL DATA

VITALS

LABORATORY PARAMETERS (Reports & Value)

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2 - FIRST FOLLOW-UP VISIT - DAY 7±2

DATE OF ASSESSMENT

MICROBIOLOGICAL DATA

VITALS

LABORATORY PARAMETERS (Reports & Value)

CLINICAL DATA

ADVERSE EVENTS

ASSESSMENT 3 - SECOND FOLLOW-UP VISIT - DAY 14±2

DATE OF ASSESSMENT

MICROBIOLOGICAL DATA

VITALS

LABORATORY PARAMETERS (Reports & Value)

CLINICAL DATA

ADVERSE EVENTS