Skip to main content
. 2024 Mar 7;13:e50513. doi: 10.2196/50513

Table 2.

Study calendar.

Screening visit, from 7 to 30 days Enrollment visit, day 0 Treatment days 1-7 Follow-up visit, day 8 (+3-day window)
Required assessments
Informed consent ✓
Medical historya ✓
Height and weight ✓
Physical examination ✓ ✓
Vital signs ✓ ✓
ECOGb performance status ✓ ✓ ✓
EKGc ✓ ✓
Blood chemistriesd ✓ ✓
Hemoglobin, absolute neutrophil count, and platelets ✓ ✓
Urine pregnancy ✓ ✓
Medication assessmente ✓ ✓ ✓
Adverse event assessment ✓ ✓
Questionnaires
Physician questionnaire ✓
Study coordinator questionnaire ✓ ✓
Patient questionnaire (VASf, BPIg, PROMISh, and COMPATi) ✓ ✓ ✓
Medication diary ✓ ✓ ✓

aMedical history and establishment of suspected or definite chronic pancreatitis diagnosis may occur at any time before trial entry.

bECOG: Eastern Cooperative Oncology Group.

cEKG: electrocardiogram.

dWill include at a minimum: electrolytes, glucose, blood urea nitrogen, creatinine and creatinine clearance, calcium, and hepatic function panel.

eWill include detailed use of rescue pain medications and opioids use.

fVAS: Visual Analog Score.

gBPI: Brief Pain Inventory.

hPROMIS: Patient-Reported Outcomes Measurement Information System.

iCOMPAT: Comprehensive Pain Assessment Tool for Chronic Pancreatitis.