{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"138"}],"units":"Participants"}],"title":"Change of QTcF ≥60 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"41"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"138"}],"units":"Participants"}],"title":"30 msec ≤ Change of QTcF <60 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"81"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"138"}],"units":"Participants"}],"title":"Change of QTcF <30 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"15"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"141"}],"units":"Participants"}],"title":"Change of QTcB ≥60 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"26"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"141"}],"units":"Participants"}],"title":"30 msec ≤ Change of QTcB <60 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"100"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"141"}],"units":"Participants"}],"title":"Change of QTcB <30 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"140"}],"units":"Participants"}],"title":"PR change ≥50% if absolute baseline value was <200 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"140"}],"units":"Participants"}],"title":"PR change ≥25% if absolute baseline value was ≥200 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"141"}],"units":"Participants"}],"title":"QRS change ≥50% if absolute baseline value was <100 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"141"}],"units":"Participants"}],"title":"QRS change ≥25% if absolute baseline value was ≥100 msec"}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"142"}],"units":"Participants"}],"description":"Baseline was defined as the last assessment performed on or prior to date of the first dose of study treatment. Triplicate ECGs were collected in the study and the average of the replicate assessments were used for summary analysis. The pre-defined criteria of ECG data were as follows: change from baseline in QTcF ≥60 msec, ≥30 msec but \\<60 msec, \\<30 msec; change from baseline in QTcB ≥60 msec, ≥30 msec but \\<60 msec, \\<30 msec; PR change ≥50% if absolute baseline value was \\<200 msec; PR change ≥25% if absolute baseline value was ≥200 msec; QRS change ≥50% if absolute baseline value was \\<100 msec; QRS change ≥25% if absolute baseline value was ≥100 msec.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"\"Number of Participants Analyzed\" included all participants in the safety analysis population. \"Number Analyzed\" included all participants in the safety analysis population with evaluable data against the pre-defined criteria.","reportingStatus":"POSTED","timeFrame":"From Baseline up to 33 months","title":"Number of Participant With Maximum Increase From Baseline in Electrocardiogram (ECG) Data Meeting Pre-defined Criteria","type":"SECONDARY","unitOfMeasure":"Participants"}