Alkem

Patient No *

Patient Initials *

Date of Enrollment *

Investigator *

Site *

Patient Initials *

Age (in Years) *

Gender *

Male Female Other

Diagnosis of APD and/or dyspepsia *

Comorbidities *

Concomitant medications *

Presence and severity of APD symptoms (e.g., heartburn, regurgitation) *

Presence and severity of dyspeptic symptoms (e.g., abdominal pain, bloating) *

Brand Name *

Dosage *

Frequency *

Duration *

Improvement in APD Symptoms *

Yes No

Improvement in Dyspeptic Symptoms *

Yes No

Adverse Events *

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

Additional Notes

Outcomes (PRO) Scale APD Symptom Severity * Heartburn * Regurgitation * Chest Pain *	Rating in following options* None Mild Moderate Severe
Dyspeptic Symptom Severity Abdominal Pain * Bloating * Early Satiety *	Treatment Satisfaction * Overall satisfaction with PPI and domperidone combination therapy Very satisfied Satisfied Neutral Dissatisfied Very dissatisfied
Quality of Life (QoL) * Impact of APD and dyspepsia on daily activities No impact Mild impact Moderate impact Severe impact

Baseline Characteristics