Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline,or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.

The Safety Set consists of all participants that received study drug in the core study and had at least one post-baseline safety assessment.

Flare rate was calculated as the number of new flares over the period of observation in years. New flares occurred before first study medication dose in extension 3 study were considered.

Modified Analysis Set (MAS) consisted of all participants randomized in the core studies and received both treatments according to their exposure.

Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild).

Modified Analysis Set (MAS) consisted of all Full Analysis Set (FAS) participants. The FAS consisted of all enrolled participants who have received at least one dose of study medication. This outcome measure was assessed only in the subset of participants who had re-treatment with at least one dose of canakinumab.