{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34"}]}],"title":"Overall number of baseline subjects"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Serious Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"}]}],"title":"Non-Serious Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Death (all causes)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Death (from Adverse Events)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"}],"units":"Participants"}],"description":"Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.","groups":[{"description":"NEOD001, 24 mg/kg IV every 28 days for 22 months","id":"OG000","title":"NEOD001 24 mg/kg"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"From initiation of study drug through the last study visit or up to 30 days after date of last dose, whichever came first, assessed up to 24 months","title":"Long-term Safety and Tolerability of NEOD001","type":"PRIMARY","unitOfMeasure":"Participants"}