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disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"abdominal cramps"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":34,"numEvents":8},{"groupId":"EG001","numAffected":7,"numAtRisk":32,"numEvents":7}],"term":"constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":34,"numEvents":5},{"groupId":"EG001","numAffected":6,"numAtRisk":32,"numEvents":6}],"term":"cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"cramps in the calf"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":34,"numEvents":36},{"groupId":"EG001","numAffected":21,"numAtRisk":32,"numEvents":23}],"term":"diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":32,"numEvents":3}],"term":"dysuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":34,"numEvents":37},{"groupId":"EG001","numAffected":26,"numAtRisk":32,"numEvents":42}],"term":"edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":34,"numEvents":7},{"groupId":"EG001","numAffected":6,"numAtRisk":32,"numEvents":6}],"term":"exanthema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":34,"numEvents":35},{"groupId":"EG001","numAffected":31,"numAtRisk":32,"numEvents":45}],"term":"fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":34,"numEvents":13},{"groupId":"EG001","numAffected":10,"numAtRisk":32,"numEvents":11}],"term":"headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":34,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"heartburn / reflux"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":32,"numEvents":4}],"term":"hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":34,"numEvents":35},{"groupId":"EG001","numAffected":22,"numAtRisk":32,"numEvents":28}],"term":"hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34,"numEvents":3},{"groupId":"EG001","numAffected":7,"numAtRisk":32,"numEvents":7}],"term":"hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":34,"numEvents":8},{"groupId":"EG001","numAffected":4,"numAtRisk":32,"numEvents":4}],"term":"increase of CRP"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":32,"numEvents":4}],"term":"increase of bilirubin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"increase of creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":34,"numEvents":20},{"groupId":"EG001","numAffected":13,"numAtRisk":32,"numEvents":25}],"term":"increase of liver enzymes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":34,"numEvents":52},{"groupId":"EG001","numAffected":24,"numAtRisk":32,"numEvents":42}],"term":"nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":34,"numEvents":32},{"groupId":"EG001","numAffected":20,"numAtRisk":32,"numEvents":32}],"term":"vomiting"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":32,"numEvents":0}],"term":"atypical pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"cardiac arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":32,"numEvents":0}],"term":"cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"staphyloccocus epidermidis sepsis"}],"timeFrame":"Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study."}