Trial Outcomes & Findings for A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) (NCT NCT02838420)

NCT ID: NCT02838420

Last Updated: 2026-01-09

Results Overview

PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by the investigators, or to death from any cause, whichever occurred first.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 187 participants
• Primary outcome timeframe: From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 40 months)
• Results posted on: 2026-01-09

Participant Flow

Asian adult participants with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC) were enrolled at 21 study sites in 3 countries - China, Korea, and Thailand.

Participant milestones

Measure	Alectinib Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Crizotinib Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Study STARTED	125	62
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	125	62

Reasons for withdrawal

Measure	Alectinib Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Crizotinib Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Study Ongoing in Study	113	45
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	3	4
Overall Study Death	8	13

Baseline Characteristics

A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Measure	Alectinib n=125 Participants Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Crizotinib n=62 Participants Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.	Total n=187 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Age, Continuous	50.5 Years STANDARD_DEVIATION 11.3 • n=8 Participants	51.1 Years STANDARD_DEVIATION 12.6 • n=7 Participants	50.7 Years STANDARD_DEVIATION 11.7 • n=15 Participants
Sex: Female, Male Female	61 Participants n=8 Participants	28 Participants n=7 Participants	89 Participants n=15 Participants
Sex: Female, Male Male	64 Participants n=8 Participants	34 Participants n=7 Participants	98 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	124 Participants n=8 Participants	60 Participants n=7 Participants	184 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=8 Participants	2 Participants n=7 Participants	3 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Asian	125 Participants n=8 Participants	62 Participants n=7 Participants	187 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) White	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants

PRIMARY outcome

Timeframe: From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 40 months)

Population: The primary analysis population for efficacy was the intent-to-treat (ITT) population, defined as all randomized participants.

PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by the investigators, or to death from any cause, whichever occurred first.

Outcome measures

Measure	Alectinib n=125 Participants Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Crizotinib n=62 Participants Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1	NA Months Interval 20.3 to Median and upper bound of 95% CI could not be estimated as PFS had not been reached at the time of data cutoff for the primary end point.	11.1 Months Interval 9.1 to 13.0

SECONDARY outcome

Timeframe: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by an independent review committee, or to death from any cause, whichever occurred first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, until death (up to overall period of approximately 40 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to overall period of approximately 40 months

Population: The safety population was defined as all participants who received at least one dose of study drug.

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. Preexisting conditions which worsen during a study are also considered as adverse events.

Outcome measures

Measure	Alectinib n=125 Participants Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Crizotinib n=62 Participants Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events Serious Adverse Events	15.2 Percentage of Participants	25.8 Percentage of Participants
Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events Non-Serious Adverse Events	99.2 Percentage of Participants	100.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 4 predose (within 2 hours before administration of study drug)

Population: The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm.

AUC was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.

Outcome measures

Measure	Alectinib n=20 Participants Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Crizotinib Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite Alectinib Baseline	1590 Hours*nanogram/milliliter (hr*ng/mL) Standard Deviation 852	—
Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite M4 Baseline	471 Hours*nanogram/milliliter (hr*ng/mL) Standard Deviation 243	—
Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite Alectinib Week 4	7760 Hours*nanogram/milliliter (hr*ng/mL) Standard Deviation 3270	—
Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite M4 Week 4	2890 Hours*nanogram/milliliter (hr*ng/mL) Standard Deviation 1130	—

SECONDARY outcome

Timeframe: Baseline and Week 4 predose (within 2 hours before administration of study drug)

Population: The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm.

Cmax was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.

Outcome measures

Measure	Alectinib n=20 Participants Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Crizotinib Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Maximum Plasma Concentration Observed (Cmax) of Alectinib and Its Metabolite Alectinib Baseline	255 Nanograms/milliliter (ng/mL) Standard Deviation 130	—
Maximum Plasma Concentration Observed (Cmax) of Alectinib and Its Metabolite M4 Baseline	71.4 Nanograms/milliliter (ng/mL) Standard Deviation 33.5	—
Maximum Plasma Concentration Observed (Cmax) of Alectinib and Its Metabolite Alectinib Week 4	861 Nanograms/milliliter (ng/mL) Standard Deviation 332	—
Maximum Plasma Concentration Observed (Cmax) of Alectinib and Its Metabolite M4 Week 4	306 Nanograms/milliliter (ng/mL) Standard Deviation 111	—

SECONDARY outcome

Timeframe: Baseline and Week 4 predose (within 2 hours before administration of study drug)

Population: The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm.

Tmax was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.

Outcome measures

Measure	Alectinib n=20 Participants Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Crizotinib Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Time to Cmax (Tmax) of Alectinib and Its Metabolite M4 Week 4	4.11 Hour (hr) Standard Deviation 3.06	—
Time to Cmax (Tmax) of Alectinib and Its Metabolite Alectinib Baseline	5.61 Hour (hr) Standard Deviation 3.02	—
Time to Cmax (Tmax) of Alectinib and Its Metabolite M4 Baseline	8.19 Hour (hr) Standard Deviation 2.30	—
Time to Cmax (Tmax) of Alectinib and Its Metabolite Alectinib Week 4	4.30 Hour (hr) Standard Deviation 2.45	—

Adverse Events

Alectinib

Serious events: 19 serious events

Other events: 124 other events

Deaths: 8 deaths

Crizotinib

Serious events: 16 serious events

Other events: 62 other events

Deaths: 13 deaths

Serious adverse events

Measure	Alectinib n=125 participants at risk Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Crizotinib n=62 participants at risk Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Infections and infestations Lung infection	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	3.2% 2/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Infections and infestations Pneumonia	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	3.2% 2/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Infections and infestations Appendicitis	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Infections and infestations Bronchitis	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Infections and infestations Escherichia sepsis	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Infections and infestations Upper respiratory tract infection	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Infections and infestations Wound infection	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood uric acid increased	2.4% 3/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood creatine phosphokinase increased	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	3.2% 2/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Alanine aminotransferase increased	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood bilirubin increased	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	4.8% 3/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Nervous system disorders Brain ooedema	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Nervous system disorders Cerebral infarction	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Nervous system disorders Intracranial pressure increased	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Nervous system disorders Paraplegia	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Nervous system disorders Spinal cord compression	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Cardiac disorders Bradycardia	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	3.2% 2/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Cardiac disorders Pericardial effusion	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
General disorders Death	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
General disorders Fatigue	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
General disorders Pyrexia	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	3.2% 2/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Injury, poisoning and procedural complications Post procedural ooedema	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Injury, poisoning and procedural complications Rib fracture	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Injury, poisoning and procedural complications Wound dehiscence	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Blood and lymphatic system disorders Anaemia	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypokalaemia	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Psychiatric disorders Suicide attempt	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Renal and urinary disorders Acute kidney injury	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Surgical and medical procedures Abortion induced	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Vascular disorders Venous thrombosis	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.

Other adverse events

Measure	Alectinib n=125 participants at risk Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Crizotinib n=62 participants at risk Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Investigations Aspartate aminotransferase increased	52.0% 65/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	50.0% 31/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Alanine aminotransferase increased	41.6% 52/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	54.8% 34/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood creatine phosphokinase increased	44.0% 55/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	29.0% 18/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood bilirubin increased	48.8% 61/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	3.2% 2/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood alkaline phosphatase increased	26.4% 33/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	12.9% 8/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
General disorders Chest pain	8.0% 10/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	12.9% 8/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
General disorders Oedema peripheral	6.4% 8/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	16.1% 10/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood creatinine increased	20.0% 25/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	24.2% 15/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Bilirubin conjugated increased	26.4% 33/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	3.2% 2/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Weight increased	18.4% 23/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	3.2% 2/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Gamma-glutamyltransferase increased	4.0% 5/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	27.4% 17/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Haemoglobin decreased	14.4% 18/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	4.8% 3/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations White blood cell count decreased	4.8% 6/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	24.2% 15/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood lactate dehydrogenase increased	8.8% 11/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	11.3% 7/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Neutrophil count decreased	3.2% 4/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	19.4% 12/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood bilirubin unconjugated increased	11.2% 14/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	0.00% 0/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood thyroid stimulating hormone increased	9.6% 12/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Electrocardiogram QT prolonged	3.2% 4/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	11.3% 7/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood albumin decreased	3.2% 4/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	8.1% 5/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Blood creatine phosphokinase MB increased	3.2% 4/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	8.1% 5/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Weight decreased	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	8.1% 5/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Investigations Protein total decreased	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	6.5% 4/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Constipation	36.0% 45/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	50.0% 31/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Diarrhoea	12.8% 16/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	50.0% 31/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Nausea	6.4% 8/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	33.9% 21/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Vomiting	5.6% 7/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	35.5% 22/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
General disorders Fatigue	8.8% 11/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	14.5% 9/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
General disorders Pyrexia	8.8% 11/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	14.5% 9/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
General disorders Chest discomfort	8.0% 10/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	4.8% 3/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
General disorders Asthenia	4.8% 6/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	8.1% 5/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
General disorders Oedema	7.2% 9/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	3.2% 2/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Cardiac disorders Sinus bradycardia	29.6% 37/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	17.7% 11/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Cardiac disorders Bradycardia	9.6% 12/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	8.1% 5/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Infections and infestations Upper respiratory tract infection	18.4% 23/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	9.7% 6/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Infections and infestations Nasopharyngitis	12.0% 15/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	4.8% 3/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Infections and infestations Urinary tract infection	6.4% 8/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Infections and infestations Lung infection	1.6% 2/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	6.5% 4/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Blood and lymphatic system disorders Anaemia	30.4% 38/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	22.6% 14/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Blood and lymphatic system disorders Neutropenia	0.00% 0/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	8.1% 5/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Cough	21.6% 27/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	17.7% 11/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.6% 12/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	8.1% 5/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Productive cough	5.6% 7/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	4.8% 3/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Decreased appetite	4.8% 6/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	35.5% 22/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypoalbuminaemia	4.8% 6/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	12.9% 8/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypokalaemia	8.0% 10/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	6.5% 4/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hyponatraemia	3.2% 4/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	14.5% 9/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypoproteinaemia	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	6.5% 4/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Back pain	8.8% 11/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	16.1% 10/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.6% 12/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	4.8% 3/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Pain in extremity	7.2% 9/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	9.7% 6/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Myalgia	8.8% 11/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	3.2% 2/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Skin and subcutaneous tissue disorders Rash	16.8% 21/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	4.8% 3/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Skin and subcutaneous tissue disorders Pruritis	9.6% 12/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	8.1% 5/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Nervous system disorders Dizziness	5.6% 7/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	21.0% 13/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Nervous system disorders Headache	5.6% 7/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	16.1% 10/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Nervous system disorders Dysgeusia	0.80% 1/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	16.1% 10/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Hepatobiliary disorders Liver injury	11.2% 14/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	6.5% 4/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Hepatobiliary disorders Hepatic function abnormal	7.2% 9/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	6.5% 4/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Psychiatric disorders Insomnia	5.6% 7/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	9.7% 6/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Eye disorders Vision blurred	1.6% 2/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	14.5% 9/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
Renal and urinary disorders Haematuria	6.4% 8/125 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.	1.6% 1/62 • Up to approximately 40 months The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 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