Trial Outcomes & Findings for A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer (NCT NCT03596866)

NCT ID: NCT03596866

Last Updated: 2025-09-12

Results Overview

PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by BIRC, or death due to any cause, whichever occurs first, in the full analysis set. PFS was censored for participants without documented disease progression or death at the last valid tumor response assessment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 248 participants
• Primary outcome timeframe: Up to 33.8 months
• Results posted on: 2025-09-12

Participant Flow

Participants took part in the study at various investigative sites globally from 19 April 2019 to 18 September 2024.

Participants with anaplastic lymphoma kinase positive (ALK+) non-small-cell lung cancer (NSCLC) who had progressed on crizotinib were administered either brigatinib or alectinib in this study.

Participant milestones

Measure	Brigatinib Participants were administered brigatinib 90 milligrams (mg), tablets, orally, once daily (QD) for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib Participants were administered alectinib 600 mg, capsules, orally, twice daily (BID) until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Overall Study STARTED	125	123
Overall Study COMPLETED	3	6
Overall Study NOT COMPLETED	122	117

Reasons for withdrawal

Measure	Brigatinib Participants were administered brigatinib 90 milligrams (mg), tablets, orally, once daily (QD) for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib Participants were administered alectinib 600 mg, capsules, orally, twice daily (BID) until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Overall Study Site terminated by Sponsor	64	65
Overall Study Death	37	24
Overall Study Withdrawal by Subject	4	6
Overall Study Missing	0	6
Overall Study Lost to Follow-up	2	3
Overall Study Protocol Violation	1	0
Overall Study Reason Not Specified	14	13

Baseline Characteristics

A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

Baseline characteristics by cohort

Measure	Brigatinib n=125 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 33.8 months.	Alectinib n=123 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity, or up to 33.8 months.	Total n=248 Participants Total of all reporting groups
Age, Continuous	53.0 years STANDARD_DEVIATION 12.17 • n=93 Participants	52.9 years STANDARD_DEVIATION 13.53 • n=4 Participants	53 years STANDARD_DEVIATION 12.84 • n=27 Participants
Sex: Female, Male Female	67 Participants n=93 Participants	68 Participants n=4 Participants	135 Participants n=27 Participants
Sex: Female, Male Male	58 Participants n=93 Participants	55 Participants n=4 Participants	113 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=93 Participants	14 Participants n=4 Participants	21 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	116 Participants n=93 Participants	106 Participants n=4 Participants	222 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	74 Participants n=93 Participants	66 Participants n=4 Participants	140 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	50 Participants n=93 Participants	52 Participants n=4 Participants	102 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 33.8 months

Population: FAS included all participants randomized to each regimen regardless of whether they were ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they received study drug or adhered to the assigned dose.

PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by BIRC, or death due to any cause, whichever occurs first, in the full analysis set. PFS was censored for participants without documented disease progression or death at the last valid tumor response assessment.

Outcome measures

Measure	Brigatinib n=125 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=123 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Progression-free Survival (PFS) as Assessed by Blinded Independent Review Committee (BIRC) Per RECIST v1.1	19.253 months Interval 15.671 to The upper limit of 95% confidence interval (CI) was not estimable due to censoring.	19.187 months Interval 12.879 to The upper limit of 95% CI was not estimable due to censoring.

SECONDARY outcome

Timeframe: Up to 64 months

Population: FAS included all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose.

OS is defined as the time interval from the date of randomization until death due to any cause in the full analysis set. OS was censored on the date of last contact for those participants who are alive.

Outcome measures

Measure	Brigatinib n=125 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=123 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Overall Survival (OS)	NA months Interval 38.472 to The median and upper limit of 95% CI was not estimable due to low number of participants with events.	NA months The median and 95% CI was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 33.8 months

Population: FAS included all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose.

PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by investigator, or death due to any cause, whichever occurs first, in the full analysis set. PFS was censored for participants without documented disease progression or death at the last valid tumor response assessment.

Outcome measures

Measure	Brigatinib n=125 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=123 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
PFS as Assessed by Investigator Per RECIST v1.1	16.789 months Interval 10.94 to 19.417	16.591 months Interval 13.602 to 27.565

SECONDARY outcome

Timeframe: Up to 33.8 months

Population: FAS included all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose.

ORR is defined as the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR), using RECIST v1.1 after the initiation of study treatment. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Measure	Brigatinib n=125 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=123 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Objective Response Rate (ORR) as Assessed by BIRC and Investigator Per RECIST v1.1 BIRC Assessed	52.0 percentage of participants Interval 42.9 to 61.0	61.0 percentage of participants Interval 51.8 to 69.6
Objective Response Rate (ORR) as Assessed by BIRC and Investigator Per RECIST v1.1 Investigator Assessed	40.8 percentage of participants Interval 32.1 to 49.9	56.1 percentage of participants Interval 46.9 to 65.0

SECONDARY outcome

Timeframe: Up to 33.8 months

Population: FAS=all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose. N=number of participants with data available for analysis. n=number of participants with data available for analysis at specified categories.

DOR is defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the progressive disease (PD) is objectively documented or death, as assessed by the investigator and BIRC, using RECIST v1.1. Participants who did not progress or died, were censored at the last tumor assessment date prior to receiving subsequent anticancer therapy.

Outcome measures

Measure	Brigatinib n=78 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=88 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Duration of Response (DOR) as Assessed by BIRC and Investigator Per RECIST v1.1 BIRC Assessed	17.544 months Interval 14.784 to The upper limit of 95% CI was not estimable due to low number of participants with events.	20.205 months Interval 12.649 to The upper limit of 95% CI was not estimable due to low number of participants with events.
Duration of Response (DOR) as Assessed by BIRC and Investigator Per RECIST v1.1 Investigator Assessed	17.511 months Interval 11.335 to 23.031	19.614 months Interval 14.226 to The upper limit of 95% CI was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 33.8 months

Population: FAS=all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose. N=number of participants with data available for analysis. n=number of participants with data available for analysis at specified categories.

Time to response is defined as the time interval from randomization until the initial observation of CR or PR, as assessed by the investigator and BIRC, using RECIST v1.1. Time to response will be summarized using descriptive statistics in participants with confirmed objective response.

Outcome measures

Measure	Brigatinib n=78 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=88 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Time to Response as Assessed by Investigator and BIRC Per RECIST v1.1 BIRC Assessed	1.873 months Interval 1.64 to 16.49	1.840 months Interval 1.41 to 16.56
Time to Response as Assessed by Investigator and BIRC Per RECIST v1.1 Investigator Assessed	1.873 months Interval 1.61 to 14.0	1.873 months Interval 1.41 to 10.87

SECONDARY outcome

Timeframe: Up to 33.8 months

Population: Measurable iCNS disease population included all participants in the full analysis population determined by the BIRC to have had at least 1 measurable iCNS tumor lesion.

Confirmed iORR, as assessed by the BIRC, is defined as the percentage of the participants who have achieved CR or PR in the central nervous system (CNS) per a modification RECIST v1.1 after the initiation of study treatment in participants with CNS metastases at baseline. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Measure	Brigatinib n=30 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=31 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Confirmed Intracranial Objective Response Rate (iORR) as Assessed by BIRC Per Modified RECIST v1.1	73.3 percentage of participants Interval 54.1 to 87.7	67.7 percentage of participants Interval 48.6 to 83.3

SECONDARY outcome

Timeframe: Up to 33.8 months

Population: Measurable iCNS disease population included all participants in the full analysis population determined by the BIRC to have had at least 1 measurable iCNS tumor lesion. Overall number analyzed is the number of participants with data available for analysis.

iDOR, as assessed by the BIRC per modified RECIST v1.1, is defined as the time interval from the time that the measurement criteria are first met for CR or PR in the CNS (whichever is first recorded) until the first date that the PD in the CNS is objectively documented or death. Participants who did not progress or died, were censored at the last iCNS tumor assessment date prior to receiving subsequent anticancer therapy.

Outcome measures

Measure	Brigatinib n=22 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=21 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Intracranial Duration of Response (iDOR) as Assessed by the BIRC Per Modified RECIST v1.1	17.413 months Interval 7.425 to The upper limit of 95% CI was not estimable due to low number of participants with events.	NA months Interval 5.552 to The median and upper limit of 95% CI were not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: 6, 12, 18 and 24 months

Population: FAS included all participants randomized to each regimen regardless of whether they are ALK+ by an FDA approved test (Vysis ALK Break Apart FISH Probe Kit, Ventana ALK (D5F3) CDx Assay, Foundation Medicine's FoundationOne CDx) or a local test other than FISH and immunohistochemistry, or whether they receive study drug or adhere to the assigned dose.

Time to iPD as assessed by the BIRC,is defined as time interval from date of randomization until first date at which iPD is objectively documented via a modification of RECIST v1.1 without prior systemic progression (PD) or death. Time to iPD was analyzed within a competing risk framework (with systemic progression and death as the competing risks) by estimating the cumulative incidence function (CIF) within each arm. The CIF is a function of time, and indicates the probability of an event (e.g. iPD without prior PD or death) occurring by the specified time. The estimated CIFs were analyzed using Grey's Test and the estimated probability of CIFs is reported at pre-specified landmark times (6, 12, 18 and 24 months).

Outcome measures

Measure	Brigatinib n=125 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=123 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Cumulative Incidence of Intracranial Disease Progression (iPD) as Assessed by BIRC Per Modified RECIST v1.1 6 months	0.115 probability Interval 0.064 to 0.182	0.076 probability Interval 0.037 to 0.133
Cumulative Incidence of Intracranial Disease Progression (iPD) as Assessed by BIRC Per Modified RECIST v1.1 12 months	0.218 probability Interval 0.144 to 0.302	0.171 probability Interval 0.107 to 0.247
Cumulative Incidence of Intracranial Disease Progression (iPD) as Assessed by BIRC Per Modified RECIST v1.1 18 months	0.305 probability Interval 0.211 to 0.404	0.209 probability Interval 0.135 to 0.293
Cumulative Incidence of Intracranial Disease Progression (iPD) as Assessed by BIRC Per Modified RECIST v1.1 24 months	0.388 probability Interval 0.274 to 0.5	0.248 probability Interval 0.161 to 0.344

SECONDARY outcome

Timeframe: Up to 33.8 months

Population: The patient-reported outcome (PRO) analysis set included all participants with baseline and at least 1 post-baseline PRO measurement in the full analysis set. Overall number analyzed is the number of participants with data available for analysis of this outcome measure at end of treatment visit.

EORTC QLQ-C30 incorporates 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status scale, higher scores represent better quality of life (QOL); for the symptom scales, lower scores represent better QOL.

Outcome measures

Measure	Brigatinib n=37 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=41 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Health-Related Quality of Life (HRQOL) From European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 v3.0) Score	86.15 score on a scale Interval 35.9 to 100.0	84.74 score on a scale Interval 36.6 to 100.0

SECONDARY outcome

Timeframe: Up to 33.8 months

Population: The PRO analysis set included all participants with baseline and at least 1 post-baseline PRO measurement in the full analysis set. Overall number analyzed is the number of participants with data available for analysis of this outcome measure at end of treatment visit.

HRQOL scores were assessed with European Organization for Research and Treatment (EORTC), its lung cancer module QLQ-LC13. QLQ-LC13 contains 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Subscales were scored on a range of 0 to 100. Higher symptom score = greater degree of symptom severity.

Outcome measures

Measure	Brigatinib n=37 Participants Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=40 Participants Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
HRQOL From EORTC QLQ- Lung Cancer (LC) 13 End of Treatment: Dyspnoea	22.22 score on a scale Interval 0.0 to 88.9	11.11 score on a scale Interval 0.0 to 88.9
HRQOL From EORTC QLQ- Lung Cancer (LC) 13 End of Treatment: Coughing	33.33 score on a scale Interval 0.0 to 100.0	33.33 score on a scale Interval 0.0 to 66.7
HRQOL From EORTC QLQ- Lung Cancer (LC) 13 End of Treatment: Haemoptysis	0.00 score on a scale Interval 0.0 to 33.3	0.00 score on a scale Interval 0.0 to 66.7
HRQOL From EORTC QLQ- Lung Cancer (LC) 13 End of Treatment: Sore mouth	0.00 score on a scale Interval 0.0 to 100.0	0.00 score on a scale Interval 0.0 to 66.7
HRQOL From EORTC QLQ- Lung Cancer (LC) 13 End of Treatment: Dysphagia	0.00 score on a scale Interval 0.0 to 100.0	0.00 score on a scale Interval 0.0 to 66.7
HRQOL From EORTC QLQ- Lung Cancer (LC) 13 End of Treatment: Peripheral neuropathy	0.00 score on a scale Interval 0.0 to 66.7	0.00 score on a scale Interval 0.0 to 100.0
HRQOL From EORTC QLQ- Lung Cancer (LC) 13 End of Treatment: Alopecia	0.00 score on a scale Interval 0.0 to 33.3	0.00 score on a scale Interval 0.0 to 100.0
HRQOL From EORTC QLQ- Lung Cancer (LC) 13 End of Treatment: Pain in chest	0.00 score on a scale Interval 0.0 to 66.7	0.00 score on a scale Interval 0.0 to 100.0
HRQOL From EORTC QLQ- Lung Cancer (LC) 13 End of Treatment: Pain in arm or shoulder	0.00 score on a scale Interval 0.0 to 66.7	0.00 score on a scale Interval 0.0 to 100.0
HRQOL From EORTC QLQ- Lung Cancer (LC) 13 End of Treatment: Pain in other parts	0.00 score on a scale Interval 0.0 to 66.7	0.00 score on a scale Interval 0.0 to 100.0

Adverse Events

Brigatinib

Serious events: 38 serious events

Other events: 122 other events

Deaths: 37 deaths

Alectinib

Serious events: 24 serious events

Other events: 118 other events

Deaths: 25 deaths

Serious adverse events

Measure	Brigatinib n=125 participants at risk Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=122 participants at risk Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Gastrointestinal disorders Abdominal pain lower	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Alanine aminotransferase increased	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Blood and lymphatic system disorders Anaemia	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	1.6% 2/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Infections and infestations Appendicitis	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Cardiac disorders Atrial fibrillation	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Nervous system disorders Brain oedema	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/67 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	1.5% 1/68 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Bronchoscopy	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Infections and infestations COVID-19	1.6% 2/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Infections and infestations COVID-19 pneumonia	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	1.6% 2/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Cardiac disorders Cardiac tamponade	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Psychiatric disorders Cardiovascular somatic symptom disorder	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Nervous system disorders Cerebral haemorrhage	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	1.5% 1/67 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/68 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma recurrent	1.5% 1/67 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/68 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Chest discomfort	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Hepatobiliary disorders Cholecystitis acute	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Psychiatric disorders Confusional state	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Nervous system disorders Dizziness	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.0% 5/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Enteritis	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.00% 0/67 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	1.5% 1/68 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Gastritis erosive	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Hyperpyrexia	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Vascular disorders Hypertension	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Metabolism and nutrition disorders Hypophagia	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	4.0% 5/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Nervous system disorders Ischaemic stroke	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to ovary	0.00% 0/67 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	1.5% 1/68 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Multiple organ dysfunction syndrome	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Blood and lymphatic system disorders Neutropenia	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Nodule	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	2.4% 3/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Pancreatitis acute	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Pelvic mass	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Cardiac disorders Pericardial effusion	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 2/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Infections and infestations Pneumonia	1.6% 2/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	2.5% 3/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Injury, poisoning and procedural complications Radiation necrosis	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.4% 3/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Nervous system disorders Seizure	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Infections and infestations Sepsis	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Subileus	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Swelling face	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Nervous system disorders Syncope	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Cardiac disorders Tachycardia	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Infections and infestations Upper respiratory tract infection	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Vomiting	0.00% 0/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.82% 1/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.

Other adverse events

Measure	Brigatinib n=125 participants at risk Participants were administered brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 63.47 months.	Alectinib n=122 participants at risk Participants were administered alectinib 600 mg, capsules, orally, BID until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months.
Gastrointestinal disorders Abdominal pain	4.8% 6/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	5.7% 7/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Alanine aminotransferase increased	47.2% 59/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	38.5% 47/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Alpha hydroxybutyrate dehydrogenase increased	6.4% 8/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	0.00% 0/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Amylase increased	20.8% 26/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	11.5% 14/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Blood and lymphatic system disorders Anaemia	21.6% 27/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	36.9% 45/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	12.0% 15/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	15.6% 19/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Aspartate aminotransferase increased	56.8% 71/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	41.8% 51/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Asthenia	12.0% 15/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	6.6% 8/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Musculoskeletal and connective tissue disorders Back pain	10.4% 13/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	13.1% 16/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Bilirubin conjugated increased	1.6% 2/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	8.2% 10/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood alkaline phosphatase increased	12.8% 16/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	20.5% 25/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood bilirubin increased	5.6% 7/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	32.0% 39/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood bilirubin unconjugated increased	1.6% 2/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	5.7% 7/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood cholesterol increased	6.4% 8/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	2.5% 3/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood creatine phosphokinase MB increased	5.6% 7/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	2.5% 3/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood creatine phosphokinase increased	73.6% 92/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	32.0% 39/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood creatinine increased	12.8% 16/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	17.2% 21/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood glucose increased	7.2% 9/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	2.5% 3/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood insulin increased	11.2% 14/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	7.4% 9/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood lactate dehydrogenase increased	20.0% 25/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	10.7% 13/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Blood urea increased	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	7.4% 9/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Infections and infestations COVID-19	10.4% 13/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	10.7% 13/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Constipation	11.2% 14/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	28.7% 35/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Respiratory, thoracic and mediastinal disorders Cough	12.8% 16/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	21.3% 26/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Metabolism and nutrition disorders Decreased appetite	12.8% 16/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	4.1% 5/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Diarrhoea	12.8% 16/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	17.2% 21/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Nervous system disorders Dizziness	8.0% 10/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	6.6% 8/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Dyspepsia	5.6% 7/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	1.6% 2/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.0% 15/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	9.8% 12/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Fatigue	8.8% 11/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	15.6% 19/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Gamma-glutamyltransferase increased	6.4% 8/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	1.6% 2/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Nervous system disorders Headache	18.4% 23/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	17.2% 21/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Metabolism and nutrition disorders Hypercholesterolaemia	6.4% 8/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	1.6% 2/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Metabolism and nutrition disorders Hyperglycaemia	10.4% 13/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	9.0% 11/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Vascular disorders Hypertension	30.4% 38/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	4.1% 5/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Metabolism and nutrition disorders Hypertriglyceridaemia	7.2% 9/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	4.1% 5/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Metabolism and nutrition disorders Hyperuricaemia	9.6% 12/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	13.9% 17/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	5.6% 7/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	5.7% 7/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Metabolism and nutrition disorders Hypokalaemia	6.4% 8/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	9.8% 12/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Metabolism and nutrition disorders Hyponatraemia	8.0% 10/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	6.6% 8/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Influenza like illness	7.2% 9/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	7.4% 9/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Psychiatric disorders Insomnia	5.6% 7/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	4.9% 6/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Lipase increased	23.2% 29/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	18.9% 23/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 7/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	2.5% 3/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Musculoskeletal and connective tissue disorders Myalgia	6.4% 8/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	16.4% 20/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Infections and infestations Nasopharyngitis	2.4% 3/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	5.7% 7/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Nausea	14.4% 18/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	9.0% 11/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Neutrophil count decreased	2.4% 3/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	5.7% 7/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Oedema peripheral	3.2% 4/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	18.9% 23/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	6.4% 8/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	4.9% 6/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Skin and subcutaneous tissue disorders Photosensitivity reaction	6.4% 8/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	1.6% 2/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Respiratory, thoracic and mediastinal disorders Productive cough	2.4% 3/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	6.6% 8/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Skin and subcutaneous tissue disorders Pruritus	7.2% 9/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	9.0% 11/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
General disorders Pyrexia	3.2% 4/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	5.7% 7/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Skin and subcutaneous tissue disorders Rash	15.2% 19/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	9.8% 12/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Infections and infestations Upper respiratory tract infection	3.2% 4/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	6.6% 8/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Gastrointestinal disorders Vomiting	10.4% 13/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	9.8% 12/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Weight decreased	8.8% 11/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	2.5% 3/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations Weight increased	4.8% 6/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	9.8% 12/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.
Investigations White blood cell count decreased	0.80% 1/125 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.	5.7% 7/122 • Up to approximately 5 years 4 months All-cause Mortality: FAS. Serious and Other Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. As per planned analysis, data for adverse events was collected per treatment groups (brigatinib and alectinib) irrespective of the dosing regimen and is presented accordingly.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place