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):
Two years recurrence rate (proportion of patients with recurrence/total of patients). Measurement time: 2 years
Key secondary outcomes:
Related with efectivity
1. Recurrence rate per year (proportion of patients with recurrence/total of patients). Measurement time: Follow up every year until 2 years after recruitment.
2. Relapse-free time (time in which a new lesion is not detected since inclusion in the trial, measured in months). Measurement time: Follow up every year until 2 years after recruitment.
Related with Safety
3. Adverse Events-AE (Occurrence of any AE (1. yes / 2. no), Description of the AE (Name of the EA), Duration of the AE (Differences between the start and end date of the AE), Intensity of the AE (1. Light, 2. Moderate, 3. Severe, 4. Very severe, 5. Death), Severity (1. Serious / 2. Not serious), Result (1. Recovered, 2. Improved, 3. Persists or Sequelae), Attitude towards treatment (1. No change, 2. Dose modification, 3. Temporary interruption or 4. Definitive interruption), Causal relationship (1. Very Probable / certain / definitive, 2. Probable, 3. Possible, 4. Unlikely, 5. Unrelated, 6. Unknown), Lot of CIMAvax EGF Vaccine (The number of administered vaccine lot)). Measurement Time: Follow up every month until 2 years after recruitment.