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1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.30","value":"-3.0"},{"groupId":"OG001","spread":"5.98","value":"-2.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"title":"Cycle 10 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.05","value":"-3.6"},{"groupId":"OG001","spread":"6.23","value":"-2.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"title":"Cycle 12 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.82","value":"-3.3"},{"groupId":"OG001","spread":"5.57","value":"-2.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"Cycle 14 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.87","value":"-3.3"},{"groupId":"OG001","spread":"5.77","value":"-2.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"title":"Cycle 16 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.26","value":"-3.7"},{"groupId":"OG001","spread":"4.30","value":"-2.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Cycle 18 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.24","value":"-3.3"},{"groupId":"OG001","spread":"4.62","value":"-2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"17"}],"units":"Participants"}],"title":"Cycle 20 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.95","value":"-3.2"},{"groupId":"OG001","spread":"4.82","value":"-2.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"13"}],"units":"Participants"}],"title":"Cycle 22 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.97","value":"-3.1"},{"groupId":"OG001","spread":"9.31","value":"2.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Cycle 24 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.87","value":"-3.2"},{"groupId":"OG001","spread":"3.81","value":"-0.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"Cycle 26 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.53","value":"-3.0"},{"groupId":"OG001","spread":"7.65","value":"0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"title":"Cycle 28 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.00","value":"-4.8"},{"groupId":"OG001","spread":"3.20","value":"1.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"title":"Cycle 30 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.14","value":"-5.0"},{"groupId":"OG001","spread":"9.19","value":"7.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Cycle 32 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.42","value":"-2.3"},{"groupId":"OG001","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Cycle 34 Day 1"},{"categories":[{"measurements":[{"groupId":"OG001","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Cycle 36 Day 1"},{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Cycle 38 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.49","value":"0.8"},{"groupId":"OG001","spread":"7.45","value":"-0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"60"}],"units":"Participants"}],"title":"End of Treatment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"147"}],"units":"Participants"}],"description":"BDI-II (Mood Assessment) is a 21 item self-reported scale, with each item rated by participants on a 4-point scale (ranging from 0-3). The scale includes items capturing mood, (loss of pleasure, sadness, and irritability), suicidal ideation, and cognitive signs (punitive thoughts, self-criticism, self-dislike pessimism, poor concentration) as well as somatic signs (appetite, sleep, fatigue, libido). Scores were obtained by adding up the total points from the series of answers. The total score ranged from 0 to 63, with higher total scores indicating more severe depressive symptoms. The standardized cutoffs are as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.","dispersionType":"Standard Deviation","groups":[{"description":"Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.","id":"OG000","title":"Lorlatinib"},{"description":"Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.","id":"OG001","title":"Crizotinib"}],"paramType":"MEAN","populationDescription":"\"Number of Participants Analyzed\" included all participants in the safety analysis population within each treatment group. \"Number Analyzed\" included all participants with at least a baseline and postbaseline assessment at the visit.","reportingStatus":"POSTED","timeFrame":"Baseline, Cycle 2 Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C8D1, C10D1, C12D1, C14D1, C16D1, C18D1, C20D1, C22D1, C24D1, C26D1, C28D1, C30D1, C32D1, C34D1, C36D1, C38D1 and End of Treatment","title":"Change From Baseline in Total Scores of Beck Depression Inventory (BDI)-II (Mood Assessment) Across Time","type":"SECONDARY","unitOfMeasure":"Units on a scale"}