{"description":"All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":203,"description":"Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.","id":"EG000","otherNumAffected":183,"otherNumAtRisk":203,"seriousNumAffected":60,"seriousNumAtRisk":203,"title":"Romiplostim"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":203}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":203}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":203}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":203}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":203}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":203}],"term":"Gingival bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":203}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":203}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":203}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":203}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":203}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":203}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":203}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":203}],"term":"Ear infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":203}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":203}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":75,"numAtRisk":203}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":203}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":203}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":203}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":203}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":203}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":203}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":203}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":203}],"term":"Skin laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":203}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":203}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":203}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":78,"numAtRisk":203}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":203}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":77,"numAtRisk":203}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":203}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":203}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":203}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":203}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":203}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":203}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":203}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":203}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":203}],"term":"Limb injury"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Evans syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Haemorrhagic disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":203}],"term":"Immune thrombocytopenic purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Lymphadenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":203}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Thrombocytopenic purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Gingival bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Tooth impacted"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Cytomegalovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Gastroenteritis rotavirus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Otitis externa"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Otitis media acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Peritonsillar abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Pilonidal cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Staphylococcal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Head injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Road traffic accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Arthroscopy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Blood urine present"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":203}],"term":"Neutralising antibodies positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":203}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Haemarthrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Mixed connective tissue disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Systemic lupus erythematosus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"B-cell lymphoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Suicidal ideation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Lupus nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Gynaecomastia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Menorrhagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Metrorrhagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Polymenorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Varicocele"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":203}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Status asthmaticus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Haemorrhage subcutaneous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203}],"term":"Haemorrhage"}],"timeFrame":"SAEs were collected from Screening through end-of-study follow-up (up to 38 months). Nonserious AEs were collected from first to last dose of study drug during the treatment period (up to 36 months)."}