Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
- Tumor recurrence (defined as the appearance of tumorous lesion in the first year post-surgery [if it occurs in the first 6 months is considered early recurrence, after 6 months, late recurrence]). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months).
Key secondary outcomes:
- Time to recurrence (days, months). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months). - Occurrence of complications (Yes, No, type, severity, causal relationship to study treatment). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months). - Adverse events (Event number; Type; Frequency: Yes, No; Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events; Duration: hours, days, months; Causal relationship: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death; Treatment indicated: type and dosage of medication, treatment time). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months).