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(14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":725},{"groupId":"EG001","numAffected":1,"numAtRisk":725},{"groupId":"EG002","numAffected":0,"numAtRisk":635},{"groupId":"EG003","numAffected":0,"numAtRisk":651}],"term":"Catheterisation venous"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":725},{"groupId":"EG001","numAffected":1,"numAtRisk":725},{"groupId":"EG002","numAffected":0,"numAtRisk":635},{"groupId":"EG003","numAffected":0,"numAtRisk":651}],"term":"Thrombophlebitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":725},{"groupId":"EG001","numAffected":2,"numAtRisk":725},{"groupId":"EG002","numAffected":0,"numAtRisk":635},{"groupId":"EG003","numAffected":0,"numAtRisk":651}],"term":"Thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":725},{"groupId":"EG001","numAffected":0,"numAtRisk":725},{"groupId":"EG002","numAffected":1,"numAtRisk":635},{"groupId":"EG003","numAffected":0,"numAtRisk":651}],"term":"Anal fissure"}],"timeFrame":"Period from time of informed consent signature until 21 days post study drugs (Day 1 of the last cycle). Upon Investigator's judgment, all non resolved, non serious Adverse Events (AEs) beyond this date could have been followed for an additional 14 days"}