{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"14"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"description":"adverse events, physical examination and biological changes during the whole clinical trial.","groups":[{"description":"0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles","id":"OG000","title":"IPH2101 0.2 mg/kg"},{"description":"2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles","id":"OG001","title":"IPH2101 2 mg/kg"}],"paramType":"NUMBER","populationDescription":"The safety population included all subjects who received at least 1 dose of IPH2101","reportingStatus":"POSTED","timeFrame":"Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months","title":"Safety Assessment","type":"SECONDARY","unitOfMeasure":"Patients with any AE"}