{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Severe toxicity was defined, according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0), as 1)an Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly related Grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) should persist for 48 hours despite therapy in order to be taken into account and as 2)an ASCI related or possibly related Grade 2 or higher allergic reaction occurring within 24 hours of the dose administration. All active follow-up visits and procedures were stopped, hence this follow-up analysis was not performed as initially planned.","groups":[{"description":"Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.","id":"OG000","title":"NY-ESO 1 Group"}],"populationDescription":"The analysis was to be performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the ASCI treatment. All active follow-up visits and procedures were stopped, hence this follow-up analysis was not performed as initially planned.","reportingStatus":"POSTED","timeFrame":"During the one year follow-up period (i.e. from Month 49 until Month 61)","title":"Number of Patients With Severe Toxicities During the Follow-up Period","type":"PRIMARY"}