Table 3.
Assessment Time-point | Data points collected | Comments |
---|---|---|
Baseline |
Patient and cancer demographics FP chemotherapy data DPYD genotype status |
FP containing regimens Chemotherapy indication |
Post-first FP dose |
Patient metrics FP dose and adjustments FP related toxicities Hospitalisations, ICU admissions, treatment-related death |
G3-4 toxicities Time in hospital Time in ICU G5 toxicity-related deaths Dose reduction data |
Subsequent FP administration (capped at 60 days post-first dose) |
Patient metrics FP dose and adjustments FP related toxicities Hospitalisations, ICU admissions, treatment-related death |
G3-4 toxicities Time in in hospital Time in ICU G5 toxicity-related deaths Dose reduction data |
No fixed time point | Patient and clinician semi-structured interviews |
Exploration of patient/clinician experience of genotyping process Clinician satisfaction with education/support resources, facilitators/barriers to ongoing use |
Follow-up | Cancer outcomes reports at 6-month intervals up to 5 years post-FP |
Disease-free survival (DFS) Progression-free survival (PFS) Overall survival (OS) All cause mortality |