{"description":"The occurrence of adverse drug reactions (ADRs) not including not-related (S)AEs was sought by non-directive questioning of the patient at each visit during the study. Only Adverse events with a suspected relationship to EP2006 were collected.","eventGroups":[{"description":"Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Number 1496 refers to the total number of patients who received at least one dose of study medication EP2006.","id":"EG000","otherNumAffected":36,"otherNumAtRisk":1496,"seriousNumAffected":4,"seriousNumAtRisk":1496,"title":"EP2006"}],"frequencyThreshold":"0.5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":1496,"numEvents":33}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1496,"numEvents":21}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":1496,"numEvents":11}],"term":"Myalgia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1496,"numEvents":1}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1496,"numEvents":1}],"term":"Vulvul abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1496,"numEvents":1}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1496,"numEvents":1}],"term":"Loss of consciousness"}],"timeFrame":"Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days"}