Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Patients on NSAID therapy *

Yes No

Indication of NSAID therapy *

NSAID details: Name (Brand/generic) *

Dose *

Frequency *

Duration

Does the patient has GI symptoms *

Yes No

Details if Yes

abdominal pain dyspepsia gastroesophageal reflux symptoms nausea vomiting bloating diarrhea constipation

Pantoprazole prescribed *

Yes No

Brand Name *

Dose *

Frequency *

Duration *

Add details of medications beside NSAIDS and Pantoprazole

Disease	Duration	Medication	Dose	Frequency

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Hb (gm/dL)

RBC (millions/cumm)

WBC (cumm)

Platelets (cumm)

CRP (mg/L)

Bilirubin (T/D/I) (mg/dL)

SGPT (U/L)

SGOT (U/L)

ALP (U/L)

Protein (T/A/G) (g/dL)

S.Cr (mg/dL)

BUN (mg/dL)

eGFR (mL/min/1.73m²)

Specify others (if available)

Date of Assessment *

Total Duration of Therapy (days) *

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Hb (gm/dL)

RBC (millions/cumm)

WBC (cumm)

Platelets (cumm)

CRP (mg/L)

Bilirubin (T/D/I) (mg/dL)

SGPT (U/L)

SGOT (U/L)

ALP (U/L)

Protein (T/A/G) (g/dL)

S.Cr (mg/dL)

BUN (mg/dL)

eGFR (mL/min/1.73m²)

Specify others (if available)

Is NSAID therapy ingoing

Yes No

Details

Does patient have GI symptoms

Yes No

Details if Yes

abdominal pain dyspepsia gastroesophageal reflux symptoms nausea vomiting bloating diarrhea constipation

Pantoprazole therapy ongoing

Yes No

Details

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

Pantoprazole

ASSESSMENT 1 - START OF THERAPY

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

OTHER CONCOMITANT DISEASES AND MEDICATIONS

VITALS

LABORATORY PARAMETER (test & Results)

ASSESSMENT 2 - FOLLOW-UP VISIT

DATE OF ASSESSMENT

VITALS

LABORATORY PARAMETER (test & Results)

CLINICAL DATA

ADVERSE EVENTS