| Pre-Treatment | Treatment | Follow-Up | Early Termination | |||
---|---|---|---|---|---|---|---|
Tests & Procedures | Recruitment | Enrollment/ Baseline | Day 1 | Day 5 | Week 2 Day 14 (+/− 3 days) | Week 4 Day 28 (+/−  3 days) | (collect only if patient allows/agrees) |
Pre-Screen | X | Â | Â | Â | Â | Â | Â |
Informed Consent | X | Â | Â | Â | Â | Â | Â |
Eligibility Screen | Â | X | Â | Â | Â | Â | Â |
aHistory and physical exam | Â | X | Â | Â | Â | Â | Â |
aPregnancy Test (if applicable) | Â | X | Â | Â | Â | Â | Â |
Patient Diary (provided to patient) |  |  | X | X Day 1–5 |  |  |  |
b Brief Pain Inventory | Â | X | X | Â | X | X | X |
Functional Living Index - Emesis | Â | X | X | Â | X | X | X |
PRO-CTCAE & QoL EORTC QLQ-C15-PAL | Â | Â | X | Â | X | X | X |
Treatment Related Data | Â | Â | X | Â | Â | Â | Â |
HCP-reported baseline and follow up form (Medications and Toxicity) | Â | X | Â | Â | X | X | X |