{"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":"FG000","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":"FG001","title":"Octreotide LAR"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"64"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"17"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"10"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"9"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"1"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"117"},{"groupId":"FG001","numSubjects":"114"}],"comment":"All patients who received a randomization number, regardless of receiving study medication were included in the Randomized Set","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"117"},{"groupId":"FG001","numSubjects":"114"}],"comment":"All randomized participant were analyzed according to randomized treatment, regardless of the actual treatment received.","type":"Full Analysis Set (FAS)"},{"achievements":[{"groupId":"FG000","numSubjects":"111"},{"groupId":"FG001","numSubjects":"112"}],"comment":"All randomized patients who received at least one dose of active study medication. In the SAF, patients were analyzed based on actual treatment received.","type":"Safety Analysis Set (SAF)"},{"achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"99"}],"type":"FAS-Entered Long-term Follow-up"},{"achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"13"}],"comment":"refers to completion of a minimum of 72 weeks of treatment.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"67"},{"groupId":"FG001","numSubjects":"101"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"69"},{"groupId":"FG001","numSubjects":"64"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"10"}],"type":"Consent withdrawal"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"FAS-Entered long-term follow-up","groupId":"FG000","numSubjects":"101"},{"comment":"FAS-Entered long-term follow-up","groupId":"FG001","numSubjects":"99"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"19"}],"comment":"Study ended 5 years from randomization of last participant or 158 deaths in the study achieved","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"80"}],"type":"NOT COMPLETED"}],"title":"Long-term Follow-Up Period"}],"recruitmentDetails":"The study was conducted in 41 sites across 8 countries."}