{"eventGroups":[{"deathsNumAffected":9,"deathsNumAtRisk":10,"description":"One ARG1-vaccine every third week for 45 weeks.\n\nARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide","id":"EG000","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":3,"seriousNumAtRisk":10,"title":"ARG1-18,19,20 Peptide Vaccine"}],"frequencyThreshold":"1","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":10}],"term":"Fatique"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":10}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Xerostomia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10}],"term":"Granuloma at injection site"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Facial paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Hypothyroidsm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Only grade 1-2. Six of the seven patients had an increase in transaminases during treatment, however, they all had corresponding progression of metastatic lesion in the liver.","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":10}],"term":"Transaminase elevation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":10}],"term":"Alkaline phosphate increased"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"not related to study drug","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"not related to study drug","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"not related to study drug","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Facial paralysis"}],"timeFrame":"Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)"}