{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"140"}]}],"title":"AEs (all-causality)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"133"}]}],"title":"AEs (treatment-related)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"39"}]}],"title":"SAEs (all-causality)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"7"}]}],"title":"SAEs (treatment-related)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"79"}]}],"title":"Maximum Grade 3 or 4 AEs (all-causality)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"52"}]}],"title":"Maximum Grade 3 or 4 AEs (treatment-related)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"}]}],"title":"Maximum Grade 5 AEs (all-causality)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Maximum Grade 5 AEs (treatment-related)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]}],"title":"AEs causing study discontinuation (all-causality)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"AEs causing study discontinuation (treatment-related)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"13"}]}],"title":"AEs causing study treatment discontinuation (all-causality)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"}]}],"title":"AEs causing study treatment discontinuation (treatment-related)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"71"}]}],"title":"AEs causing dose reduction or temporary discontinuation (all-causality)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"54"}]}],"title":"AEs causing dose reduction or temporary discontinuation (treatment-related)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"142"}],"units":"Participants"}],"description":"An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs in the table below were treatment-emergent AEs. Grade 3 and 4 AEs in the table below indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. Treatment-related AEs were determined by investigators.","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":"The safety analysis population included all participants who received at least 1 dose of study drug. Participants were classified according to the treatment assigned at randomization unless the incorrect treatment(s) were received throughout the dosing period, in which case participants were classified according to the first study treatment received.","reportingStatus":"POSTED","timeFrame":"From time of Study Start up to 33 months","title":"Number of Participants With Treatment-Emergent Adverse Events (AEs; All-Causality and Treatment-Related)","type":"SECONDARY","unitOfMeasure":"Participants"}