{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"105"},{"groupId":"OG001","value":"90"}]}],"title":"Adverse Events (AEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"31"}]}],"title":"Serious Adverse Events (SAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"}]}],"title":"Deaths during treatment period"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"}]}],"title":"Deaths during follow-up period"}],"denoms":[{"counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"112"}],"units":"Participants"}],"description":"The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters.","groups":[{"description":"* 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died.\n* Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi).\n* Concomitant amino acids were given with each administration for kidney protection.\n* 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.\n* In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.","id":"OG000","title":"177Lu-DOTA0-Tyr3-Octreotate"},{"description":"* 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.\n* In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.","id":"OG001","title":"Octreotide LAR"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Analysis Set (SAF).","reportingStatus":"POSTED","timeFrame":"From informed consent signature through study completion reached at final safety cutoff date on 18July2021, assessed up to approximately 101 Months","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}