{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":".428","upperLimit":".631","value":".530"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"}],"units":"Participants"}],"description":"The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.","dispersionType":"95% Confidence Interval","groups":[{"description":"The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging","id":"OG000","title":"Full Analysis Set (FAS)"}],"paramType":"NUMBER","populationDescription":"Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who:\n\n• Were evaluated under both normal light/palpation and NIR fluorescent light imaging","reportingStatus":"POSTED","timeFrame":"1 day","title":"Clinically Significant Events (CSE)","type":"PRIMARY","unitOfMeasure":"proportion of participants"}