{"description":"Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.","eventGroups":[{"description":"Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\\^9/L could reinitiate romiplostim for up to 8 weeks.","id":"EG000","otherNumAffected":50,"otherNumAtRisk":75,"seriousNumAffected":17,"seriousNumAtRisk":75,"title":"Romiplostim"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":75}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":75}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":75}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":75}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":75}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":75}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":75}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":75}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":75}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":75}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":75}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":75}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Idiopathic Thrombocytopenic Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Atrial Fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Faecaloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Tendon Rupture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Transaminases Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Non-Hodgkin's Lymphoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Papillary Thyroid Cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Reversible Ischaemic Neurological Deficit"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Delirium Tremens"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Renal Failure Acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Pleuritic Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Dapsone Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75}],"term":"Peripheral Vascular Disorder"}],"timeFrame":"From first dose date of romiplostim to end of study (up to 24 months)."}