{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.1762","value":"-8.754"},{"groupId":"OG001","spread":"21.0819","value":"-11.111"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Endocrine scale: chg from BL @ wk 72 (n=33,11)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.0000","value":"0.000"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Endocrine scale: chg from BL @ wk 120 (n=2,0)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.3083","value":"-2.727"},{"groupId":"OG001","spread":"10.0101","value":"2.424"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"G.I. scale: chg from BL @ wk 72 (n=33,11)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.0000","value":"-13.333"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"G.I. scale: chg from BL @ wk 120 (n=2,0)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.9563","value":"-8.995"},{"groupId":"OG001","spread":"11.1111","value":"0.000"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"title":"Treatment scale: chg from BL @ wk 72 (n=21,5)"},{"categories":[{"measurements":[{"comment":"Only one participant analyzed","groupId":"OG000","spread":"NA","value":"-16.667"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Treatment scale: chg from BL @ wk 120 (n=1,0)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.3985","value":"-7.576"},{"groupId":"OG001","spread":"21.1217","value":"-7.576"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Social function scale: chg from BL @ wk 72 (n=33,11)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.0000","value":"11.111"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Social function scale: chg from BL @ wk 120 (n=2,0)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.9289","value":"-6.061"},{"groupId":"OG001","spread":"33.7765","value":"1.010"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Diseases rel. worries scale: chg from BL @ wk 72 (n=33,11)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.4270","value":"33.333"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Diseases rel. worries scale: chg from BL @ wk 120 (n=2,0)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"33.4594","value":"-5.051"},{"groupId":"OG001","spread":"36.0041","value":"-16.667"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"title":"Muscle/Bone pain symptom: chg from BL @ wk 72 (n=33,10)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.5702","value":"-16.667"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Muscle/Bone pain symptom: chg from BL @ wk 120 (n=2,0)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"40.3031","value":"6.349"},{"groupId":"OG001","spread":"17.8174","value":"14.286"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"title":"Sexual function: chg from BL @ wk 72 (n=21,7)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"70.7107","value":"50.000"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Sexual function: chg from BL @ wk 120 (n=2,0)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.0309","value":"-4.040"},{"groupId":"OG001","spread":"30.8139","value":"-12.121"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Information/Communication: chg from BL @ wk 72 (n=33,11)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.0000","value":"0.000"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Information/Communication: chg from BL @ wk 120 (n=2,0)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.1766","value":"-4.040"},{"groupId":"OG001","spread":"17.9787","value":"-3.030"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Body image: chg from BL @ wk 72 (n=33,11)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.5702","value":"16.667"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Body image: chg from BL @ wk 120 (n=2,0)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"111"}],"units":"Participants"}],"description":"The Quality of Life GI Neuroendocrine Tumor survey (QLQ GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"Safety Analysis Set (SAF). Values at Inclusion were taken from last non-missing value prior to randomization (the only scheduled pre-randomization assessment was at the Baseline visit). Calculations at each visit included only participants with scores at the visit and Inclusion.","reportingStatus":"POSTED","timeFrame":"Inclusion (Baseline) (BL), Week 72, Week 120","title":"Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}