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 acute painful conditions attributable to: Trauma, Tendinitis, Myalgia, Low back ache, Sprains, Pulled muscle, Soft tissue injury, Dental pain, Dental procedure/surgery *

Yes No

Clinical Diagnosis *

Duration of current illness *

Previous analgesics used (if any)

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

10-point NRS score for Pain Intensity

Physician Global Assessment Scale (Physician GAS) for Pain Severity

No Pain (0) Mild Pain (1) Moderate Pain (2) Severe Pain (3)

Patient Global Assessment Scale (Patient GAS) for Pain Severity

No Pain (0) Mild Pain (1) Moderate Pain (2) Severe Pain (3)

Laboratory Investigations (if available)

Reports	Value

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Nimesulide & Paracetamol tablets (100mg + 325mg) *

Yes No

Brand Name *

Marketing Company Name *

Dose *

Frequency *

Duration *

Other medications prescribed for T/t

Medication	Dose	Frequency	Duration

Date of Assessment *

Total Duration of Therapy (days (7±3 days)) *

10-point NRS score for Pain Intensity

Physician Global Assessment Scale (Physician GAS) for Pain Severity

No Pain (0) Mild Pain (1) Moderate Pain (2) Severe Pain (3)

Patient Global Assessment Scale (Patient GAS) for Pain Severity

No Pain (0) Mild Pain (1) Moderate Pain (2) Severe Pain (3)

Laboratory Investigations (if available)

Reports	Value

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Need of rescue analgesics beside nimesulide-paracetamol *

Yes No

Rescue analgesics medications prescribed for T/t (if yes)

Medication	Dose	Frequency	Duration

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

Nimesulide Paracetamol RWE

ASSESSMENT 1 - START OF THERAPY

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE and MEDICATION

PAIN INTENSITY AND SEVERITY

VITALS

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2 - POST TREATMENT FOLLOW_UP

DATE OF ASSESSMENT

PAIN INTENSITY AND SEVERITY

VITALS

TREATMENT OF CURRENT MEDICAL ILLNESS

ADVERSE EVENTS