{"description":"Safety population: All patients who received any amount of rituximab or any vaccine.","eventGroups":[{"description":"Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.","id":"EG000","otherNumAffected":51,"otherNumAtRisk":68,"seriousNumAffected":3,"seriousNumAtRisk":68,"title":"Rituximab + Methotrexate (Group A) - Treatment Period"},{"description":"Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.","id":"EG001","otherNumAffected":19,"otherNumAtRisk":32,"seriousNumAffected":2,"seriousNumAtRisk":32,"title":"Methotrexate (Group B) - Treatment Period"},{"description":"Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.","id":"EG002","otherNumAffected":7,"otherNumAtRisk":52,"seriousNumAffected":2,"seriousNumAtRisk":52,"title":"Group A - Optional Extension Re-treatment Period"},{"description":"Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.","id":"EG003","otherNumAffected":13,"otherNumAtRisk":26,"seriousNumAffected":2,"seriousNumAtRisk":26,"title":"Group B - Optional Extension Re-treatment Period"},{"description":"Patients received no treatment during the Safety Follow-up Period.","id":"EG004","otherNumAffected":19,"otherNumAtRisk":68,"seriousNumAffected":3,"seriousNumAtRisk":68,"title":"Group A - Safety Follow-up Period"},{"description":"Patients received no treatment during the Safety Follow-up Period.","id":"EG005","otherNumAffected":11,"otherNumAtRisk":32,"seriousNumAffected":1,"seriousNumAtRisk":32,"title":"Group B - Safety Follow-up Period"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":68},{"groupId":"EG001","numAffected":2,"numAtRisk":32},{"groupId":"EG002","numAffected":1,"numAtRisk":52},{"groupId":"EG003","numAffected":4,"numAtRisk":26},{"groupId":"EG004","numAffected":8,"numAtRisk":68},{"groupId":"EG005","numAffected":6,"numAtRisk":32}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":2,"numAtRisk":52},{"groupId":"EG003","numAffected":3,"numAtRisk":26},{"groupId":"EG004","numAffected":7,"numAtRisk":68},{"groupId":"EG005","numAffected":2,"numAtRisk":32}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":2,"numAtRisk":26},{"groupId":"EG004","numAffected":2,"numAtRisk":68},{"groupId":"EG005","numAffected":3,"numAtRisk":32}],"term":"Rheumatoid arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":32},{"groupId":"EG002","numAffected":2,"numAtRisk":52},{"groupId":"EG003","numAffected":2,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":68},{"groupId":"EG001","numAffected":3,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":68},{"groupId":"EG001","numAffected":2,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":68},{"groupId":"EG001","numAffected":2,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Throat irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":3,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":2,"numAtRisk":52},{"groupId":"EG003","numAffected":2,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":6,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":3,"numAtRisk":68},{"groupId":"EG005","numAffected":3,"numAtRisk":32}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":3,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Ear pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":2,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":68},{"groupId":"EG001","numAffected":2,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Feeling hot"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":2,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Genital herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":1,"numAtRisk":68},{"groupId":"EG005","numAffected":2,"numAtRisk":32}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Bursitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":2,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":3,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Respiratory tract congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":2,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":68},{"groupId":"EG001","numAffected":3,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":68},{"groupId":"EG001","numAffected":2,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":3,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Flushing"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Rheumatoid arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":1,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Ovarian cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":1,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Amaurosis fugax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":1,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":1,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":1,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Ovarian cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":1,"numAtRisk":26},{"groupId":"EG004","numAffected":0,"numAtRisk":68},{"groupId":"EG005","numAffected":1,"numAtRisk":32}],"term":"Thyroid cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":1,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":68},{"groupId":"EG001","numAffected":0,"numAtRisk":32},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":26},{"groupId":"EG004","numAffected":1,"numAtRisk":68},{"groupId":"EG005","numAffected":0,"numAtRisk":32}],"term":"Bipolar disorder"}],"timeFrame":"Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks)."}