Trial Outcomes & Findings for A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer (NCT NCT03456076)

NCT ID: NCT03456076

Last Updated: 2026-01-30

Results Overview

DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 257 participants
• Primary outcome timeframe: Approximately 58 months
• Results posted on: 2026-01-30

Participant Flow

Participant milestones

Measure	Alectinib Participants received 600 mg oral alectinib twice daily (BID) for 2 years	Platinum-Based Chemotherapy Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
Overall Study STARTED	130	127
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	130	127

Reasons for withdrawal

Measure	Alectinib Participants received 600 mg oral alectinib twice daily (BID) for 2 years	Platinum-Based Chemotherapy Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
Overall Study Withdrawal by Subject	5	9
Overall Study Protocol deviation	0	1
Overall Study Lost to Follow-up	0	1
Overall Study Death	2	5
Overall Study Study ongoing	123	111

Baseline Characteristics

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Alectinib n=130 Participants Participants received 600 mg oral alectinib twice daily (BID) for 2 years	Platinum-Based Chemotherapy n=127 Participants Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).	Total n=257 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 12.5 • n=35 Participants	56.6 years STANDARD_DEVIATION 11.3 • n=4328 Participants	54.9 years STANDARD_DEVIATION 12.0 • n=8687 Participants
Sex: Female, Male Female	75 Participants n=35 Participants	59 Participants n=4328 Participants	134 Participants n=8687 Participants
Sex: Female, Male Male	55 Participants n=35 Participants	68 Participants n=4328 Participants	123 Participants n=8687 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	127 Participants n=35 Participants	122 Participants n=4328 Participants	249 Participants n=8687 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=35 Participants	5 Participants n=4328 Participants	7 Participants n=8687 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Asian	72 Participants n=35 Participants	71 Participants n=4328 Participants	143 Participants n=8687 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Black or African American	1 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants
Race (NIH/OMB) White	55 Participants n=35 Participants	52 Participants n=4328 Participants	107 Participants n=8687 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=35 Participants	4 Participants n=4328 Participants	6 Participants n=8687 Participants

PRIMARY outcome

Timeframe: Approximately 58 months

Population: The ITT population consisted of all randomized participants, whether or not the participant received the assigned treatment. The Stage II-IIIa population consisted of all participants in the ITT population with Stage II-IIIa NSCLC.

DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first

Outcome measures

Measure	Alectinib n=15 Participants Participants received 600 mg oral alectinib twice daily (BID) for 2 years	Platinum-Based Chemotherapy n=50 Participants Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
Disease-free Survival (DFS), as Assessed by the Investigator Stage II-IIIA population	NA months The number of events is too low to estimate this parameter.	44.4 months Interval 27.8 to There was insufficient follow-up time to estimate the upper limit.
Disease-free Survival (DFS), as Assessed by the Investigator ITT population	NA months The number of events is too low to estimate this parameter.	41.3 months Interval 28.5 to There was insufficient follow-up time to estimate the upper limit.

SECONDARY outcome

Timeframe: From the date of randomization until death due to any cause up to approximately 8 years

Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI.

OS, defined as the time from randomization to death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)

Population: The safety-evaluable population consisted of all participants who received at least one dose of study treatment, with participants assigned to treatment groups according to the treatment received. All participants who received any dose of alectinib are included in the alectinib treatment arm.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.

Outcome measures

Measure	Alectinib n=128 Participants Participants received 600 mg oral alectinib twice daily (BID) for 2 years	Platinum-Based Chemotherapy n=120 Participants Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
Percentage of Participants With Adverse Events (AEs) Related AE	93.8 Percentage of participants	89.2 Percentage of participants
Percentage of Participants With Adverse Events (AEs) At least one AE	98.4 Percentage of participants	93.3 Percentage of participants
Percentage of Participants With Adverse Events (AEs) AE with fatal outcome	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Adverse Events (AEs) Grade 3-5 AE	29.7 Percentage of participants	30.8 Percentage of participants
Percentage of Participants With Adverse Events (AEs) Serious AE (SAE)	13.3 Percentage of participants	8.3 Percentage of participants
Percentage of Participants With Adverse Events (AEs) SAE leading to treatment withdrawal	0.8 Percentage of participants	3.3 Percentage of participants
Percentage of Participants With Adverse Events (AEs) SAE leading to dose modification/interruption	5.5 Percentage of participants	3.3 Percentage of participants
Percentage of Participants With Adverse Events (AEs) Related SAE	1.6 Percentage of participants	6.7 Percentage of participants
Percentage of Participants With Adverse Events (AEs) AE leading to treatment withdrawal	5.5 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With Adverse Events (AEs) AE leading to dose modification/interruption	43.0 Percentage of participants	22.5 Percentage of participants
Percentage of Participants With Adverse Events (AEs) Related AE leading to treatment withdrawal	5.5 Percentage of participants	11.7 Percentage of participants
Percentage of Participants With Adverse Events (AEs) Related AE leading to dose mod./interruption	38.3 Percentage of participants	21.7 Percentage of participants

SECONDARY outcome

Timeframe: Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)

Population: The safety-evaluable population consisted of all participants who received at least one dose of study treatment, with participants assigned to treatment groups according to the treatment received. All participants who received any dose of alectinib are included in the alectinib treatment arm.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.

Outcome measures

Measure	Alectinib n=128 Participants Participants received 600 mg oral alectinib twice daily (BID) for 2 years	Platinum-Based Chemotherapy n=120 Participants Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms Neutrophil count decreased	0 Percentage of participants	10.0 Percentage of participants
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms Blood creatinine phosphokinase increased	6.3 Percentage of participants	0.8 Percentage of participants
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms White blood cell count decreased	0 Percentage of participants	3.3 Percentage of participants
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms Nausea	0 Percentage of participants	4.2 Percentage of participants
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms Appendicitis	3.1 Percentage of participants	0 Percentage of participants
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms Neutropenia	0 Percentage of participants	8.3 Percentage of participants
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms Asthenia	0 Percentage of participants	2.5 Percentage of participants

SECONDARY outcome

Timeframe: Predose (2 hours) Week 3 - Week 96

Population: The PK-evaluable population consisted of all participants who received at least one dose of alectinib and who had at least one post-baseline PK sample available. This population did not include participants from the platinum-based chemotherapy arm, who did not receive alectinib.

Outcome measures

Measure	Alectinib n=124 Participants Participants received 600 mg oral alectinib twice daily (BID) for 2 years	Platinum-Based Chemotherapy Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
Plasma Concentration of Alectinib Week 96	478 ng/mL Geometric Coefficient of Variation 106.4	—
Plasma Concentration of Alectinib Week 9	593 ng/mL Geometric Coefficient of Variation 91.4	—
Plasma Concentration of Alectinib Week 12	581 ng/mL Geometric Coefficient of Variation 94.9	—
Plasma Concentration of Alectinib Week 24	619 ng/mL Geometric Coefficient of Variation 93.2	—
Plasma Concentration of Alectinib Week 36	639 ng/mL Geometric Coefficient of Variation 54.1	—
Plasma Concentration of Alectinib Week 48	551 ng/mL Geometric Coefficient of Variation 90.1	—
Plasma Concentration of Alectinib Week 60	588 ng/mL Geometric Coefficient of Variation 58.9	—
Plasma Concentration of Alectinib Week 72	527 ng/mL Geometric Coefficient of Variation 96.5	—
Plasma Concentration of Alectinib Week 84	515 ng/mL Geometric Coefficient of Variation 91.1	—
Plasma Concentration of Alectinib Week 3	382 ng/mL Geometric Coefficient of Variation 276.2	—
Plasma Concentration of Alectinib Week 6	611 ng/mL Geometric Coefficient of Variation 70.6	—

SECONDARY outcome

Timeframe: Predose (2 hours) Week 3 - Week 96

Population: The PK-evaluable population consisted of all participants who received at least one dose of alectinib and who had at least one post-baseline PK sample available. This population did not include participants from the platinum-based chemotherapy arm, who did not receive alectinib.

Outcome measures

Measure	Alectinib n=124 Participants Participants received 600 mg oral alectinib twice daily (BID) for 2 years	Platinum-Based Chemotherapy Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
Plasma Concentration of Alectinib Metabolite M4 Week 3	178 ng/mL Geometric Coefficient of Variation 111.7	—
Plasma Concentration of Alectinib Metabolite M4 Week 6	214 ng/mL Geometric Coefficient of Variation 86.3	—
Plasma Concentration of Alectinib Metabolite M4 Week 9	213 ng/mL Geometric Coefficient of Variation 78.9	—
Plasma Concentration of Alectinib Metabolite M4 Week 12	205 ng/mL Geometric Coefficient of Variation 94.7	—
Plasma Concentration of Alectinib Metabolite M4 Week 24	237 ng/mL Geometric Coefficient of Variation 73.2	—
Plasma Concentration of Alectinib Metabolite M4 Week 36	238 ng/mL Geometric Coefficient of Variation 50.7	—
Plasma Concentration of Alectinib Metabolite M4 Week 48	209 ng/mL Geometric Coefficient of Variation 51.7	—
Plasma Concentration of Alectinib Metabolite M4 Week 72	213 ng/mL Geometric Coefficient of Variation 62.6	—
Plasma Concentration of Alectinib Metabolite M4 Week 84	198 ng/mL Geometric Coefficient of Variation 65.4	—
Plasma Concentration of Alectinib Metabolite M4 Week 96	191 ng/mL Geometric Coefficient of Variation 76.8	—
Plasma Concentration of Alectinib Metabolite M4 Week 60	217 ng/mL Geometric Coefficient of Variation 49.7	—

Adverse Events

Alectinib

Serious events: 17 serious events

Other events: 124 other events

Deaths: 2 deaths

Platinum-Based Chemotherapy

Serious events: 10 serious events

Other events: 110 other events

Deaths: 5 deaths

Serious adverse events

Measure	Alectinib n=128 participants at risk Participants received 600 mg oral alectinib twice daily (BID) for 2 years	Platinum-Based Chemotherapy n=120 participants at risk Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Cardiac disorders Acute myocardial infarction	1.6% 2/128 • Number of events 2 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Abdominal pain	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Colitis	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Gastritis erosive	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Ileus paralytic	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Nausea	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	1.7% 2/120 • Number of events 2 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Regurgitation	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Vomiting	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
General disorders Fatigue	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Infections and infestations Appendicitis	3.1% 4/128 • Number of events 4 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Infections and infestations Influenza	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Infections and infestations Lower respiratory tract infection	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Infections and infestations Pneumonia	2.3% 3/128 • Number of events 3 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Infections and infestations Pneumonia viral	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Infections and infestations Urinary tract infection	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Infections and infestations Urosepsis	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Neutrophil count decreased	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	1.7% 2/120 • Number of events 2 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Reproductive system and breast disorders Uterine prolapse	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Vascular disorders Embolism	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.

Other adverse events

Measure	Alectinib n=128 participants at risk Participants received 600 mg oral alectinib twice daily (BID) for 2 years	Platinum-Based Chemotherapy n=120 participants at risk Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
Blood and lymphatic system disorders Anaemia	23.4% 30/128 • Number of events 45 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	25.8% 31/120 • Number of events 45 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders Leukopenia	0.78% 1/128 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	7.5% 9/120 • Number of events 14 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders Neutropenia	1.6% 2/128 • Number of events 2 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	15.8% 19/120 • Number of events 34 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Cardiac disorders Bradycardia	7.8% 10/128 • Number of events 12 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Constipation	42.2% 54/128 • Number of events 62 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	25.0% 30/120 • Number of events 34 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Diarrhoea	12.5% 16/128 • Number of events 17 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	8.3% 10/120 • Number of events 14 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Nausea	7.8% 10/128 • Number of events 12 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	72.5% 87/120 • Number of events 174 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders Vomiting	7.0% 9/128 • Number of events 12 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	25.0% 30/120 • Number of events 62 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
General disorders Asthenia	10.9% 14/128 • Number of events 17 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	15.8% 19/120 • Number of events 29 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
General disorders Fatigue	14.1% 18/128 • Number of events 18 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	12.5% 15/120 • Number of events 21 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
General disorders Malaise	4.7% 6/128 • Number of events 6 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	13.3% 16/120 • Number of events 24 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
General disorders Oedema peripheral	10.2% 13/128 • Number of events 17 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
General disorders Pyrexia	5.5% 7/128 • Number of events 9 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	3.3% 4/120 • Number of events 4 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Infections and infestations COVID-19	28.9% 37/128 • Number of events 38 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Infections and infestations Upper respiratory tract infection	7.0% 9/128 • Number of events 17 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Infections and infestations Urinary tract infection	8.6% 11/128 • Number of events 18 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 2 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Alanine aminotransferase increased	33.6% 43/128 • Number of events 60 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	9.2% 11/120 • Number of events 13 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Aspartate aminotransferase increased	41.4% 53/128 • Number of events 77 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	5.0% 6/120 • Number of events 8 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Bilirubin conjugated increased	8.6% 11/128 • Number of events 21 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Blood alkaline phosphatase increased	25.0% 32/128 • Number of events 48 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	3.3% 4/120 • Number of events 6 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Blood bilirubin increased	33.6% 43/128 • Number of events 73 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Blood creatine phosphokinase increased	43.0% 55/128 • Number of events 74 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Blood creatinine increased	14.8% 19/128 • Number of events 26 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	5.0% 6/120 • Number of events 7 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Blood lactate dehydrogenase increased	7.0% 9/128 • Number of events 13 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	5.0% 6/120 • Number of events 10 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Gamma-glutamyltransferase increased	3.1% 4/128 • Number of events 4 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	5.8% 7/120 • Number of events 7 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Neutrophil count decreased	2.3% 3/128 • Number of events 7 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	16.7% 20/120 • Number of events 48 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Platelet count decreased	2.3% 3/128 • Number of events 4 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	5.0% 6/120 • Number of events 12 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations Weight increased	13.3% 17/128 • Number of events 25 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Investigations White blood cell count decreased	1.6% 2/128 • Number of events 4 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	19.2% 23/120 • Number of events 44 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders Decreased appetite	5.5% 7/128 • Number of events 7 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	29.2% 35/120 • Number of events 53 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders Hyperuricaemia	9.4% 12/128 • Number of events 21 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	1.7% 2/120 • Number of events 3 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	7.8% 10/128 • Number of events 10 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	1.7% 2/120 • Number of events 2 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders Back pain	5.5% 7/128 • Number of events 7 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.83% 1/120 • Number of events 1 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders Myalgia	28.1% 36/128 • Number of events 44 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	1.7% 2/120 • Number of events 2 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders Pain in extremity	5.5% 7/128 • Number of events 7 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	1.7% 2/120 • Number of events 2 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Nervous system disorders Dizziness	7.0% 9/128 • Number of events 10 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	9.2% 11/120 • Number of events 15 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Nervous system disorders Dysgeusia	10.2% 13/128 • Number of events 18 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	2.5% 3/120 • Number of events 4 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Nervous system disorders Headache	10.9% 14/128 • Number of events 15 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	6.7% 8/120 • Number of events 9 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders Cough	14.8% 19/128 • Number of events 20 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	3.3% 4/120 • Number of events 4 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.2% 13/128 • Number of events 14 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	2.5% 3/120 • Number of events 3 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/128 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	7.5% 9/120 • Number of events 13 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders Productive cough	5.5% 7/128 • Number of events 7 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	0.00% 0/120 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders Alopecia	2.3% 3/128 • Number of events 3 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	5.8% 7/120 • Number of events 7 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders Pruritus	6.2% 8/128 • Number of events 8 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	2.5% 3/120 • Number of events 3 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders Rash	14.1% 18/128 • Number of events 21 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	5.8% 7/120 • Number of events 9 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
Vascular disorders Hypertension	3.1% 4/128 • Number of events 7 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.	5.0% 6/120 • Number of events 8 • Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER