{"description":"Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.","eventGroups":[{"description":"Participants received weekly subcutaneous placebo for 24 weeks.","id":"EG000","otherNumAffected":19,"otherNumAtRisk":19,"seriousNumAffected":1,"seriousNumAtRisk":19,"title":"Placebo"},{"description":"Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\\^9/L.","id":"EG001","otherNumAffected":41,"otherNumAtRisk":42,"seriousNumAffected":10,"seriousNumAtRisk":42,"title":"Romiplostim"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Increased Tendency To Bruise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Iron Deficiency Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Ear Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Conjunctival Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Scleral Discolouration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":5,"numAtRisk":42}],"term":"Abdominal Pain Upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":5,"numAtRisk":42}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19},{"groupId":"EG001","numAffected":10,"numAtRisk":42}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Faeces Discoloured"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Gastrointestinal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19},{"groupId":"EG001","numAffected":8,"numAtRisk":42}],"term":"Gingival Bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Lip Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Loose Tooth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19},{"groupId":"EG001","numAffected":11,"numAtRisk":42}],"term":"Mouth Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Mouth Ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":19},{"groupId":"EG001","numAffected":8,"numAtRisk":42}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Oral Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Tooth Socket Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19},{"groupId":"EG001","numAffected":11,"numAtRisk":42}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":19},{"groupId":"EG001","numAffected":7,"numAtRisk":42}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Injection Site Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Injection Site Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Localised Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Nodule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Non-Cardiac Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Peripheral Swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":9,"numAtRisk":42}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Vessel Puncture Site Bruise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Oral Herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Pharyngitis Streptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Sinusitis Bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Tooth Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":19},{"groupId":"EG001","numAffected":16,"numAtRisk":42}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Viral Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Viral Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Animal Bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Animal Scratch"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Arthropod Bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Burns Second Degree"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":19},{"groupId":"EG001","numAffected":21,"numAtRisk":42}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Head Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Lip Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Muscle Strain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Post Procedural Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":6,"numAtRisk":42}],"term":"Scratch"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Skin Abrasion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Sunburn"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Thermal Burn"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Tooth Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Wound Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19},{"groupId":"EG001","numAffected":5,"numAtRisk":42}],"term":"Platelet Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Weight Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Decreased Appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Polydipsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Bone Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Joint Range Of Motion Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Limb Discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19},{"groupId":"EG001","numAffected":5,"numAtRisk":42}],"term":"Pain In Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Temporomandibular Joint Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":19},{"groupId":"EG001","numAffected":17,"numAtRisk":42}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Tension Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Depressed Mood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Mood Altered"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Stress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Dysmenorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Menorrhagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Metrorrhagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":8,"numAtRisk":42}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":19},{"groupId":"EG001","numAffected":20,"numAtRisk":42}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":5,"numAtRisk":42}],"term":"Nasal Congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Nasal Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":11,"numAtRisk":42}],"term":"Oropharyngeal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Rhinitis Allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":7,"numAtRisk":42}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Dry Skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":19},{"groupId":"EG001","numAffected":10,"numAtRisk":42}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":6,"numAtRisk":42}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Rash Vesicular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Scab"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Skin Lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Skin Mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Tooth Extraction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Pallor"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Thrombocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Bronchiolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Animal Bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Petit Mal Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Nephrotic Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":19},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Petechiae"}],"timeFrame":"From the first dose of study drug until 4 weeks after last dose; 28 weeks."}