{"description":"Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.","eventGroups":[{"deathsNumAffected":16,"deathsNumAtRisk":31,"description":"Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.\n\nPaclitaxel: Given IV","id":"EG000","otherNumAffected":31,"otherNumAtRisk":31,"seriousNumAffected":1,"seriousNumAtRisk":31,"title":"Treatment (Paclitaxel)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":31}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":31}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":31}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Cardiovascular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":31}],"term":"Constitutional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":31}],"term":"Dermatologic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":31}],"term":"Gastrointestinal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Genitourinary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31}],"term":"Hepatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Infection / fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":31}],"term":"Neurologic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31}],"term":"Metabolic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31}],"term":"Musculoskeletal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31}],"term":"Ocular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":31}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC (2.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31}],"term":"Pulmonary"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Muscle weakness lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Febrile neutropenia"}],"timeFrame":"For the duration of treatment and follow-up"}