Trial Outcomes & Findings for A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) (NCT NCT01871805)

Last Updated: 2018-08-21

Results Overview

The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (\>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must have Grade 3 AST/ALT for 7 days or Grade 4 AST/ALT to be considered a DLT), and adverse events (AEs) that required suspension of treatment for a total of \>=7 days which the Investigator could not rule out as been related to alectinib.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

134 participants

Primary outcome timeframe

Throughout Cycle 1 of Phase I (21 days)

Results posted on

2018-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Alectinib 300 mg (Fasted): Phase I Participants received single dose of 20 or 40 milligrams (mg) alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg twice daily (BID) dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase II Participants received 150 mg alectinib capsules orally to make a dose of 600 mg BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Phase I STARTED	7	7	13	7	13	0
Phase I COMPLETED	0	0	0	0	0	0
Phase I NOT COMPLETED	7	7	13	7	13	0
Phase II STARTED	0	0	0	0	0	87
Phase II COMPLETED	0	0	0	0	0	0
Phase II NOT COMPLETED	0	0	0	0	0	87

Reasons for withdrawal

Reasons for withdrawal
Measure	Alectinib 300 mg (Fasted): Phase I Participants received single dose of 20 or 40 milligrams (mg) alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg twice daily (BID) dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase II Participants received 150 mg alectinib capsules orally to make a dose of 600 mg BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Phase I Death	7	4	6	2	9	0
Phase I Alive in Survival Follow-up	0	2	4	5	4	0
Phase I Lost to Follow-up	0	1	3	0	0	0
Phase II Death	0	0	0	0	0	45
Phase II Alive in Survival Follow-up	0	0	0	0	0	29
Phase II Lost to Follow-up	0	0	0	0	0	13

Baseline Characteristics

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alectinib 300 mg (Fasted): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) n=13 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) n=13 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase II n=87 Participants Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Total n=134 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants	7 Participants n=4 Participants	10 Participants n=21 Participants	71 Participants n=8 Participants	113 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	16 Participants n=8 Participants	21 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants	48 Participants n=8 Participants	68 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	39 Participants n=8 Participants	66 Participants n=8 Participants

PRIMARY outcome

Timeframe: Throughout Cycle 1 of Phase I (21 days)

Population: Phase I safety population

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) n=13 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) n=13 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Number of Participants With Dose Limiting Toxicities (DLTs): Phase I	0 participants	0 participants	0 participants	0 participants	2 participants	—	—	—	—

PRIMARY outcome

Timeframe: Throughout Cycle 1 of Phase I (21 days)

Population: Phase I safety population

RP2D was defined as the highest dose with acceptable toxicity as determined from Phase I of the study.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=47 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Recommended Phase II Dose (RP2D): Phase I	600 mg	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 up to 194 weeks (assessed at every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter) (1 cycle = 21 days)

Population: Phase II Response evaluable (RE) population comprised all Phase II participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.

Percentage of participants with objective response as assessed by IRC was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of complete response (CR) or partial response (PR) based on the RECIST v1.1 criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% confidence interval (CI).

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=67 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Independent Review Committee (IRC): Phase II	52.2 percentage of participants Interval 39.67 to 64.6	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase I RE population comprised all Phase I participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.

Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=13 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I n=34 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I	69.2 percentage of participants Interval 38.57 to 90.91	55.9 percentage of participants Interval 37.89 to 72.81	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase I RE population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=9 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I n=19 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Duration of Response (DOR) According to RECIST v1.1 by Investigator: Phase I	12.2 months Interval 4.9 to 20.9	11.0 months Interval 6.3 to 14.8	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II RE population

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=87 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II	52.9 percentage of participants Interval 41.87 to 63.67	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II RE population

Disease control rate assessed according to RECIST v1.1 was defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD) lasting for at least 12 weeks, after the first dose of alectinib. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. 95% CI for rate was constructed using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=87 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Percentage of Participants With Disease Control According to RECIST v1.1 by Investigator: Phase II	66.7 percentage of participants Interval 55.75 to 76.42	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II safety population

Percentage of participants with disease progression according to RECIST v1.1 by IRC is defined as the participants with at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=87 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Percentage of Participants With Disease Progression According to RECIST v1.1 by IRC or Death : Phase II	66.7 percentage of participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II safety population

PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST v1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=87 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Progression-Free Survival (PFS) According to RECIST v1.1 by IRC: Phase II	8.2 months Interval 6.3 to 12.6	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II safety population

Percentage of participants with disease progression according to RECIST v1.1 by investigator is defined as the participants with at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=87 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Percentage of Participants With Disease Progression According to RECIST v1.1 by Investigator or Death : Phase II	70.1 percentage of participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II RE population

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=87 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
PFS According to RECIST v1.1 by Investigator: Phase II	8.4 months Interval 5.5 to 12.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to death (any cause) (maximum follow up 284 weeks)

Population: Phase II safety population

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=87 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Percentage of Participants Who Died Due to Any Cause: Phase II	51.7 percentage of participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to death (any cause) (maximum follow up 284 weeks)

Population: Phase II safety population

OS was defined as the time between date of first dose and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants without any follow-up information were censored at the date of first dose. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=87 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Overall Survival (OS) Time: Phase II	27.9 months Interval 17.2 to Upper limit of 95% CI was not estimable due to low number of events and longer observation time.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II RE population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=35 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
DOR According to RECIST v1.1 by IRC: Phase II	14.9 months Interval 6.9 to Upper limit of 95% CI was not estimable due to low number of events and longer observation time.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II RE population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=46 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
DOR According to RECIST v1.1 by Investigator: Phase II	13.3 months Interval 8.8 to 18.2	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II safety population. 'Overall Number of Participants Analyzed' = participants with measurable CNS lesions at baseline based on RECIST v1.1 according to IRC.

COR rate (CORR) was defined as the percentage of participants who had a CR or PR of the baseline central nervous system (CNS) lesions, based on RECIST v.1.1. CNS responses according to RECIST v1.1 did not have to be confirmed. CR was defined as disappearance of all CNS lesions. PR was defined as \>=30% decrease in the sum of diameters of measurable CNS lesions (taking as reference the baseline sum of diameters). 95% CI was computed using the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=16 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Percentage of Participants With Central Nervous System Objective Response (COR) According to RECIST v1.1 by IRC: Phase II	75.0 percentage of participants Interval 47.62 to 92.73	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II safety population. 'Overall Number of Participants Analyzed' = participants with measurable CNS lesions at baseline according to RANO criteria by IRC.

CORR was defined as the percentage of participants who had a CR or PR according to RANO criteria of the baseline CNS lesions. As per RANO criteria, CR was defined as disappearance of all enhancing measurable and non-measurable disease, and no new lesions along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and stable or improved non enhancing T2/FLAIR lesions; PR was defined as 50% or more decrease in sum of the products of the diameters (SPD) of measurable enhancing measurable lesions, no new lesion along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and no progression of non-measurable disease (enhancing and non-enhancing T2/FLAIR lesions. Clopper-Pearson method was used to calculate 95% CI.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=11 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Percentage of Participants With COR According to Response Assessment in Neuro-Oncology (RANO) Criteria by IRC: Phase II	54.5 percentage of participants Interval 23.38 to 83.25	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

CDOR was defined for CNS responders as the time from the first observation of a CNS response of CR or PR until first observation of CNS progression or death from any cause. An analysis by IRC using RECIST v1.1 was performed. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. CR was defined as disappearance of all CNS lesions. PR was defined as \>=30% decrease in the sum of diameters of measurable CNS lesions (taking as reference the baseline sum of diameters). The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=12 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
CNS Duration of Response (CDOR) According to RECIST v1.1 by IRC: Phase II	11.1 months Interval 5.8 to Upper limit of 95% CI was not estimable due to low number of events and longer observation time.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

CDOR was defined as the time from the first observation of a CNS response of CR or PR according to RANO criteria until first observation of CNS progression or death from any cause. An analysis by RANO criteria was performed. Definitions of CR or PR as per RANO was included in description of Outcome Measure 17. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease) and clear worsening of neurological status with respect to the previous timepoint. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=6 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
CDOR According to RANO Criteria by IRC: Phase II	12.1 months Interval 11.1 to Upper limit of 95% CI was not estimable due to low number of events and longer observation time.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RECIST v1.1. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=16 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II	0 percentage of participants Interval 0.0 to 20.59	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

Population: Data were not estimable due to low number of responders and longer observation time.

CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RANO criteria. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 (1 cycle = 21 days)

Population: Phase I pharmacokinetic (PK) evaluable population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=3 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I n=1 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) n=3 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) n=6 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) n=6 Participants Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) n=6 Participants Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Maximum Observed Plasma Concentration (Cmax) After Single Dose of Alectinib: Phase I	73.5 nanograms per milliliter (ng/mL) Standard Deviation 12.4	87.7 nanograms per milliliter (ng/mL)	45.3 nanograms per milliliter (ng/mL) Standard Deviation 9.24	142.00 nanograms per milliliter (ng/mL) Standard Deviation 71.4	158.0 nanograms per milliliter (ng/mL) Standard Deviation 67.2	186.0 nanograms per milliliter (ng/mL) Standard Deviation 43.1	257.0 nanograms per milliliter (ng/mL) Standard Deviation 83.1	186.0 nanograms per milliliter (ng/mL) Standard Deviation 120.0	295.0 nanograms per milliliter (ng/mL) Standard Deviation 131.0

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 (1 cycle = 21 days)

Population: Phase I PK evaluable population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=6 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) n=5 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=6 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) n=5 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) n=7 Participants Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=4 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Cmax After Multiple Dose of Alectinib: Phase I	259 ng/mL Standard Deviation 79.0	618 ng/mL Standard Deviation 165	765 ng/mL Standard Deviation 176	670 ng/mL Standard Deviation 360	733 ng/mL Standard Deviation 98.0	1140 ng/mL Standard Deviation 448	1200 ng/mL Standard Deviation 311	—	—

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 (1 cycle = 21 days)

Population: Phase I PK evaluable population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

AUCinf = AUC from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0- t) plus AUC (t-inf).

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=3 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I n=1 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) n=3 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) n=6 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) n=6 Participants Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) n=6 Participants Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I	1360 hour*ng/mL Standard Deviation 436	858 hour*ng/mL	1030 hour*ng/mL Standard Deviation 481	3280 hour*ng/mL Standard Deviation 2240	3310 hour*ng/mL Standard Deviation 1110	3190 hour*ng/mL Standard Deviation 1510	4090 hour*ng/mL Standard Deviation 1680	3730 hour*ng/mL Standard Deviation 2310	7790 hour*ng/mL Standard Deviation 6210

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 (1 cycle = 21 days)

Population: Phase I PK evaluable population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=6 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I n=7 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) n=5 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=6 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) n=5 Participants Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) n=7 Participants Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=4 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
AUC From Time Zero to Last Measurable Concentration (AUClast) After Multiple Dose of Alectinib: Phase I	1800 hour*ng/mL Standard Deviation 562	4510 hour*ng/mL Standard Deviation 1700	5970 hour*ng/mL Standard Deviation 1140	5300 hour*ng/mL Standard Deviation 3180	5780 hour*ng/mL Standard Deviation 1020	9800 hour*ng/mL Standard Deviation 4660	9500 hour*ng/mL Standard Deviation 2670	—	—

SECONDARY outcome

Timeframe: Pre-dose (0 hour) on Day 1 of Cycles 2, Cycle 3, Cycle 4, Cycle 5 (1 cycle = 21 days)

Population: Phase II PK evaluable population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=61 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Ctrough After Multiple Dose of Alectinib: Phase II Cycle 2 Day 1	473 ng/mL Standard Deviation 277	—	—	—	—	—	—	—	—
Ctrough After Multiple Dose of Alectinib: Phase II Cycle 3 Day 1	521 ng/mL Standard Deviation 272	—	—	—	—	—	—	—	—
Ctrough After Multiple Dose of Alectinib: Phase II Cycle 4 Day 1	538 ng/mL Standard Deviation 279	—	—	—	—	—	—	—	—
Ctrough After Multiple Dose of Alectinib: Phase II Cycle 5 Day 1	538 ng/mL Standard Deviation 226	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)

Population: Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.

EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to lie between 0-100 scale; for each of the symptom scales, higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below (e.g. Global health status/QoL \[quality of life\]) represents absolute data at baseline. QoL=quality of life

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=79 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 96	0.00 units on a scale Standard Deviation 22.05	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 99	-16.67 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 105	-16.67 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Baseline	53.59 units on a scale Standard Deviation 24.27	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 6	15.89 units on a scale Standard Deviation 25.66	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 12	18.83 units on a scale Standard Deviation 23.41	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 18	15.65 units on a scale Standard Deviation 23.73	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 24	15.65 units on a scale Standard Deviation 20.77	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 30	13.03 units on a scale Standard Deviation 19.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 33	-5.56 units on a scale Standard Deviation 9.62	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 36	12.28 units on a scale Standard Deviation 20.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 39	4.17 units on a scale Standard Deviation 5.89	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 42	10.19 units on a scale Standard Deviation 19.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 45	-10.42 units on a scale Standard Deviation 12.50	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 48	11.11 units on a scale Standard Deviation 19.06	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 51	12.50 units on a scale Standard Deviation 17.68	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 54	9.95 units on a scale Standard Deviation 16.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 57	-3.33 units on a scale Standard Deviation 21.73	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 60	10.28 units on a scale Standard Deviation 19.54	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 63	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 66	15.06 units on a scale Standard Deviation 17.80	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 69	12.50 units on a scale Standard Deviation 15.96	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 72	8.33 units on a scale Standard Deviation 18.12	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Last visit	7.99 units on a scale Standard Deviation 21.27	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Baseline	69.96 units on a scale Standard Deviation 24.43	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 6	4.69 units on a scale Standard Deviation 17.44	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 90	4.17 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 75	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 78	10.32 units on a scale Standard Deviation 16.44	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 81	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 84	10.90 units on a scale Standard Deviation 14.98	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 87	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Global health status/QoL: Week 93	-29.17 units on a scale Standard Deviation 41.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Baseline	73.49 units on a scale Standard Deviation 21.40	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 6	7.99 units on a scale Standard Deviation 18.75	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Baseline	36.29 units on a scale Standard Deviation 33.63	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 6	-12.50 units on a scale Standard Deviation 33.47	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 12	-14.81 units on a scale Standard Deviation 32.48	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 18	-13.07 units on a scale Standard Deviation 33.55	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 24	-6.35 units on a scale Standard Deviation 31.44	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 27	8.33 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 30	-5.13 units on a scale Standard Deviation 33.37	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 33	5.56 units on a scale Standard Deviation 9.62	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 36	-6.14 units on a scale Standard Deviation 34.31	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 39	-8.33 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 42	-5.09 units on a scale Standard Deviation 23.17	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 45	8.33 units on a scale Standard Deviation 21.52	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 48	-4.55 units on a scale Standard Deviation 17.81	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 51	-25.00 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 54	-0.52 units on a scale Standard Deviation 24.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 57	0.00 units on a scale Standard Deviation 39.09	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 60	0.56 units on a scale Standard Deviation 14.17	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 63	-5.56 units on a scale Standard Deviation 9.62	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 66	-5.13 units on a scale Standard Deviation 23.46	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 69	-4.17 units on a scale Standard Deviation 15.96	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 72	-5.07 units on a scale Standard Deviation 28.62	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 75	-8.33 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 78	1.59 units on a scale Standard Deviation 15.73	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 81	-8.33 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 84	-5.13 units on a scale Standard Deviation 19.70	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 87	-5.56 units on a scale Standard Deviation 9.62	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 90	-8.33 units on a scale Standard Deviation 25.20	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 93	25.00 units on a scale Standard Deviation 35.36	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 96	-11.11 units on a scale Standard Deviation 53.58	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Pain: Last visit	-9.36 units on a scale Standard Deviation 29.92	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Baseline	33.33 units on a scale Standard Deviation 30.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 6	-12.17 units on a scale Standard Deviation 32.96	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea : Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 12	-10.69 units on a scale Standard Deviation 32.54	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 18	-12.67 units on a scale Standard Deviation 30.78	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 24	-7.50 units on a scale Standard Deviation 25.58	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 30	-7.89 units on a scale Standard Deviation 26.21	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 33	0.00 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 27	3.33 units on a scale Standard Deviation 4.71	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 30	2.22 units on a scale Standard Deviation 17.39	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 33	0.00 units on a scale Standard Deviation 13.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 42	6.85 units on a scale Standard Deviation 18.89	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 60	7.56 units on a scale Standard Deviation 22.67	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 63	-6.67 units on a scale Standard Deviation 11.55	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 90	7.50 units on a scale Standard Deviation 18.32	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 93	-26.67 units on a scale Standard Deviation 28.28	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 99	-6.67 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 12	12.65 units on a scale Standard Deviation 32.69	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 18	12.42 units on a scale Standard Deviation 31.94	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 24	8.73 units on a scale Standard Deviation 27.85	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 30	9.83 units on a scale Standard Deviation 24.70	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 33	-33.33 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 36	9.65 units on a scale Standard Deviation 24.70	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 39	-33.33 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 42	6.48 units on a scale Standard Deviation 28.81	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning Week 45	-20.83 units on a scale Standard Deviation 15.96	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 48	10.94 units on a scale Standard Deviation 24.54	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 51	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 54	7.29 units on a scale Standard Deviation 24.30	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 57	-13.33 units on a scale Standard Deviation 18.26	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 60	8.89 units on a scale Standard Deviation 27.24	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 63	-5.56 units on a scale Standard Deviation 9.62	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 66	8.97 units on a scale Standard Deviation 29.90	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 69	-16.67 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 72	7.97 units on a scale Standard Deviation 27.46	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 78	9.52 units on a scale Standard Deviation 28.66	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 84	5.13 units on a scale Standard Deviation 31.46	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 87	-11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 90	-4.17 units on a scale Standard Deviation 19.42	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 93	-41.67 units on a scale Standard Deviation 35.36	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 96	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 99	-16.67 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Last visit	9.36 units on a scale Standard Deviation 34.47	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 12	11.01 units on a scale Standard Deviation 17.04	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 18	13.44 units on a scale Standard Deviation 21.17	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 24	10.37 units on a scale Standard Deviation 16.75	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 27	-4.17 units on a scale Standard Deviation 5.89	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 30	9.40 units on a scale Standard Deviation 20.34	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 33	-30.56 units on a scale Standard Deviation 26.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 36	7.89 units on a scale Standard Deviation 19.85	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 39	-4.17 units on a scale Standard Deviation 5.89	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 42	7.41 units on a scale Standard Deviation 18.12	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning Week 45	-6.25 units on a scale Standard Deviation 7.98	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 48	6.73 units on a scale Standard Deviation 15.23	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 51	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 54	3.49 units on a scale Standard Deviation 13.40	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 57	-6.67 units on a scale Standard Deviation 18.07	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 60	3.33 units on a scale Standard Deviation 14.12	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 63	-11.11 units on a scale Standard Deviation 34.69	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 66	5.45 units on a scale Standard Deviation 14.52	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 69	-8.33 units on a scale Standard Deviation 26.35	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 72	5.07 units on a scale Standard Deviation 21.43	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 75	8.33 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 78	-1.19 units on a scale Standard Deviation 19.77	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 81	4.17 units on a scale Standard Deviation 5.89	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 84	1.28 units on a scale Standard Deviation 19.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 87	-11.11 units on a scale Standard Deviation 34.69	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 90	1.04 units on a scale Standard Deviation 8.26	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 93	-12.50 units on a scale Standard Deviation 17.68	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 96	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Emotional functioning: Last visit	4.76 units on a scale Standard Deviation 19.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Baseline	77.85 units on a scale Standard Deviation 24.13	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 6	2.34 units on a scale Standard Deviation 20.76	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 12	2.78 units on a scale Standard Deviation 15.44	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 18	2.04 units on a scale Standard Deviation 15.82	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 24	-3.25 units on a scale Standard Deviation 16.34	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 30	-1.28 units on a scale Standard Deviation 17.68	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 33	-27.78 units on a scale Standard Deviation 25.46	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 36	-2.63 units on a scale Standard Deviation 13.16	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 39	-25.00 units on a scale Standard Deviation 35.36	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 42	-0.46 units on a scale Standard Deviation 14.08	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning Week 45	-4.17 units on a scale Standard Deviation 51.59	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 48	-6.06 units on a scale Standard Deviation 21.58	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 51	-33.33 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 54	-7.53 units on a scale Standard Deviation 22.29	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 57	0.00 units on a scale Standard Deviation 31.18	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 60	-6.11 units on a scale Standard Deviation 21.66	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 63	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 66	-8.97 units on a scale Standard Deviation 22.23	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 69	4.17 units on a scale Standard Deviation 8.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 72	-7.97 units on a scale Standard Deviation 20.64	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 78	-9.52 units on a scale Standard Deviation 25.59	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 84	-3.85 units on a scale Standard Deviation 20.59	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 87	-11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 90	-8.33 units on a scale Standard Deviation 15.43	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 96	-22.22 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Cognitive functioning: Last visit	-4.79 units on a scale Standard Deviation 24.45	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Baseline	60.55 units on a scale Standard Deviation 35.32	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 6	11.20 units on a scale Standard Deviation 23.20	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 12	10.19 units on a scale Standard Deviation 27.93	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 18	13.27 units on a scale Standard Deviation 25.45	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 24	8.54 units on a scale Standard Deviation 26.38	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 27	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 30	14.53 units on a scale Standard Deviation 31.11	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 33	5.56 units on a scale Standard Deviation 25.46	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 36	9.21 units on a scale Standard Deviation 32.35	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 39	-8.33 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 42	8.80 units on a scale Standard Deviation 30.47	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 45	4.17 units on a scale Standard Deviation 20.97	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 48	16.16 units on a scale Standard Deviation 29.31	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 51	-8.33 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 54	12.37 units on a scale Standard Deviation 28.53	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 57	3.33 units on a scale Standard Deviation 18.26	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 60	8.33 units on a scale Standard Deviation 25.43	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 63	0.00 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 66	5.77 units on a scale Standard Deviation 31.95	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 69	20.83 units on a scale Standard Deviation 25.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 72	11.59 units on a scale Standard Deviation 23.80	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 75	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 78	12.70 units on a scale Standard Deviation 23.51	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 81	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 84	8.97 units on a scale Standard Deviation 29.36	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 87	27.78 units on a scale Standard Deviation 25.46	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 90	14.58 units on a scale Standard Deviation 16.52	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 93	-8.33 units on a scale Standard Deviation 82.50	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 96	16.67 units on a scale Standard Deviation 16.67	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Social functioning: Last visit	3.20 units on a scale Standard Deviation 30.39	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Baseline	45.57 units on a scale Standard Deviation 27.02	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 6	-10.94 units on a scale Standard Deviation 25.70	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 12	-11.11 units on a scale Standard Deviation 27.73	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 18	-12.85 units on a scale Standard Deviation 24.88	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 24	-10.05 units on a scale Standard Deviation 22.06	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 27	5.56 units on a scale Standard Deviation 7.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 30	-9.97 units on a scale Standard Deviation 23.47	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 33	14.81 units on a scale Standard Deviation 6.42	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 36	-10.23 units on a scale Standard Deviation 25.75	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 39	5.56 units on a scale Standard Deviation 7.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 42	-9.26 units on a scale Standard Deviation 21.50	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 45	0.00 units on a scale Standard Deviation 24.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 48	-11.11 units on a scale Standard Deviation 22.93	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 51	0.00 units on a scale Standard Deviation 47.14	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 54	-7.64 units on a scale Standard Deviation 18.39	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 57	4.44 units on a scale Standard Deviation 16.85	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 60	-7.78 units on a scale Standard Deviation 21.27	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 63	7.41 units on a scale Standard Deviation 23.13	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 66	-7.69 units on a scale Standard Deviation 20.07	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 69	-8.33 units on a scale Standard Deviation 10.64	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 72	-8.21 units on a scale Standard Deviation 22.28	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 75	-5.56 units on a scale Standard Deviation 7.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 78	-6.35 units on a scale Standard Deviation 23.19	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 81	-5.56 units on a scale Standard Deviation 7.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 84	-9.40 units on a scale Standard Deviation 18.62	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 87	0.00 units on a scale Standard Deviation 11.11	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 90	-8.33 units on a scale Standard Deviation 17.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 93	33.33 units on a scale Standard Deviation 31.43	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 96	-18.52 units on a scale Standard Deviation 6.42	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Last visit	-6.85 units on a scale Standard Deviation 21.65	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Baseline	15.61 units on a scale Standard Deviation 20.73	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 6	-6.77 units on a scale Standard Deviation 19.63	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 12	-8.02 units on a scale Standard Deviation 21.66	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 18	-9.15 units on a scale Standard Deviation 19.81	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 27	-8.33 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 30	-5.98 units on a scale Standard Deviation 17.31	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 33	11.11 units on a scale Standard Deviation 25.46	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 36	-7.46 units on a scale Standard Deviation 17.63	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 39	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 42	-8.80 units on a scale Standard Deviation 18.47	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 48	-9.38 units on a scale Standard Deviation 19.37	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 51	8.33 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 54	-8.85 units on a scale Standard Deviation 19.85	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 57	6.67 units on a scale Standard Deviation 14.91	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 60	-6.67 units on a scale Standard Deviation 17.29	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 63	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 66	-7.05 units on a scale Standard Deviation 20.10	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 69	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 72	-5.80 units on a scale Standard Deviation 19.85	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 78	-5.56 units on a scale Standard Deviation 13.26	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 87	5.56 units on a scale Standard Deviation 9.62	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 90	2.08 units on a scale Standard Deviation 13.91	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Last visit	-6.85 units on a scale Standard Deviation 20.38	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 36	-7.21 units on a scale Standard Deviation 27.37	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 39	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 42	-5.71 units on a scale Standard Deviation 27.40	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 45	0.00 units on a scale Standard Deviation 27.22	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 48	-6.25 units on a scale Standard Deviation 28.63	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 54	-7.29 units on a scale Standard Deviation 23.55	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 60	-1.11 units on a scale Standard Deviation 22.29	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 63	-11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 66	-8.97 units on a scale Standard Deviation 24.14	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 69	-8.33 units on a scale Standard Deviation 16.67	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 72	-1.45 units on a scale Standard Deviation 32.53	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 75	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 78	-4.76 units on a scale Standard Deviation 21.82	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 81	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 84	0.00 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 87	-11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 90	8.33 units on a scale Standard Deviation 29.55	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 93	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 96	-11.11 units on a scale Standard Deviation 38.49	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 99	33.33 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Baseline	31.22 units on a scale Standard Deviation 30.82	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 6	-9.38 units on a scale Standard Deviation 29.38	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 12	-9.26 units on a scale Standard Deviation 34.52	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 18	-3.27 units on a scale Standard Deviation 37.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 30	-9.40 units on a scale Standard Deviation 33.29	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 33	44.44 units on a scale Standard Deviation 50.92	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 36	-8.77 units on a scale Standard Deviation 40.03	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 39	83.33 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 42	-5.56 units on a scale Standard Deviation 25.82	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 45	41.67 units on a scale Standard Deviation 31.91	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 48	-3.13 units on a scale Standard Deviation 29.77	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 51	50.00 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 54	-2.08 units on a scale Standard Deviation 28.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 57	40.00 units on a scale Standard Deviation 43.46	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 60	-1.11 units on a scale Standard Deviation 28.34	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 63	0.00 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 66	-5.33 units on a scale Standard Deviation 32.89	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 69	0.00 units on a scale Standard Deviation 27.22	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 72	0.00 units on a scale Standard Deviation 26.59	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 78	1.59 units on a scale Standard Deviation 22.30	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 84	0.00 units on a scale Standard Deviation 36.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 87	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 90	0.00 units on a scale Standard Deviation 30.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 96	22.22 units on a scale Standard Deviation 38.49	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Baseline	29.96 units on a scale Standard Deviation 33.16	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 6	-16.67 units on a scale Standard Deviation 30.28	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 12	-18.52 units on a scale Standard Deviation 36.44	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 18	-20.26 units on a scale Standard Deviation 33.39	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 24	-19.84 units on a scale Standard Deviation 29.50	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 27	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 33	-44.44 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 36	-14.91 units on a scale Standard Deviation 27.62	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 39	-50.00 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 42	-16.67 units on a scale Standard Deviation 32.37	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 45	-8.33 units on a scale Standard Deviation 41.94	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 48	-20.83 units on a scale Standard Deviation 34.65	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 51	-33.33 units on a scale Standard Deviation 47.14	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 54	-18.75 units on a scale Standard Deviation 32.72	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 57	-20.00 units on a scale Standard Deviation 29.81	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 60	-20.00 units on a scale Standard Deviation 31.07	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 63	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 66	-23.08 units on a scale Standard Deviation 33.69	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 69	-16.67 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 72	-23.19 units on a scale Standard Deviation 30.87	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 78	-20.63 units on a scale Standard Deviation 30.69	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 87	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 90	-20.83 units on a scale Standard Deviation 39.59	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 96	-55.56 units on a scale Standard Deviation 50.92	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Last visit	-13.70 units on a scale Standard Deviation 33.72	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Baseline	20.25 units on a scale Standard Deviation 26.38	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 6	9.90 units on a scale Standard Deviation 30.68	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 12	1.85 units on a scale Standard Deviation 31.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 15	33.33 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 24	2.38 units on a scale Standard Deviation 29.81	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 27	33.33 units on a scale Standard Deviation 47.14	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 30	5.13 units on a scale Standard Deviation 27.08	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 33	11.11 units on a scale Standard Deviation 50.92	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 36	5.26 units on a scale Standard Deviation 21.26	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 39	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 42	9.26 units on a scale Standard Deviation 24.70	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 48	1.04 units on a scale Standard Deviation 26.07	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 51	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 54	6.45 units on a scale Standard Deviation 23.44	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 57	26.67 units on a scale Standard Deviation 43.46	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 60	6.67 units on a scale Standard Deviation 22.15	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 63	44.44 units on a scale Standard Deviation 38.49	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 66	12.82 units on a scale Standard Deviation 26.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 69	-8.33 units on a scale Standard Deviation 16.67	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 72	4.35 units on a scale Standard Deviation 25.23	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 75	33.33 units on a scale Standard Deviation 47.14	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 78	7.94 units on a scale Standard Deviation 17.97	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 81	33.33 units on a scale Standard Deviation 47.14	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 84	7.69 units on a scale Standard Deviation 19.97	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 87	22.22 units on a scale Standard Deviation 38.49	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 93	33.33 units on a scale Standard Deviation 47.14	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 96	-11.11 units on a scale Standard Deviation 50.92	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 99	33.33 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Last visit	8.68 units on a scale Standard Deviation 31.93	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Baseline	13.25 units on a scale Standard Deviation 23.01	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 6	-7.41 units on a scale Standard Deviation 25.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 12	-6.29 units on a scale Standard Deviation 23.62	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 18	-5.56 units on a scale Standard Deviation 25.11	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 24	-4.17 units on a scale Standard Deviation 28.43	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 27	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 30	-8.55 units on a scale Standard Deviation 23.84	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 33	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 39	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 42	-6.48 units on a scale Standard Deviation 26.21	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 51	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 54	-6.25 units on a scale Standard Deviation 26.01	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 57	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 60	-1.11 units on a scale Standard Deviation 32.14	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 66	-7.69 units on a scale Standard Deviation 30.27	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 69	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 72	-7.25 units on a scale Standard Deviation 28.35	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 78	-6.67 units on a scale Standard Deviation 25.59	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 84	2.78 units on a scale Standard Deviation 26.43	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 87	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 90	9.52 units on a scale Standard Deviation 16.27	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 96	33.33 units on a scale Standard Deviation 47.14	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Last visit	-2.31 units on a scale Standard Deviation 28.15	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Baseline	30.80 units on a scale Standard Deviation 33.24	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 6	-2.60 units on a scale Standard Deviation 21.66	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 12	-4.32 units on a scale Standard Deviation 23.39	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 18	-4.76 units on a scale Standard Deviation 21.52	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 24	-2.44 units on a scale Standard Deviation 26.24	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 30	-6.84 units on a scale Standard Deviation 23.17	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 33	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 36	-6.14 units on a scale Standard Deviation 27.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 39	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 42	-6.48 units on a scale Standard Deviation 20.81	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 45	8.33 units on a scale Standard Deviation 16.67	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 51	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 54	-2.15 units on a scale Standard Deviation 27.13	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 57	6.67 units on a scale Standard Deviation 14.91	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 63	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 66	-2.56 units on a scale Standard Deviation 28.16	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 69	-8.33 units on a scale Standard Deviation 16.67	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 78	0.00 units on a scale Standard Deviation 34.96	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 84	12.82 units on a scale Standard Deviation 34.80	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 87	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 90	-4.17 units on a scale Standard Deviation 21.36	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 93	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 96	22.22 units on a scale Standard Deviation 38.49	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Last visit	1.83 units on a scale Standard Deviation 32.82	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 12	4.20 units on a scale Standard Deviation 22.37	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 18	7.58 units on a scale Standard Deviation 18.23	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 24	4.13 units on a scale Standard Deviation 16.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 36	4.21 units on a scale Standard Deviation 18.10	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 39	3.33 units on a scale Standard Deviation 14.14	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 45	-3.33 units on a scale Standard Deviation 22.11	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 48	5.25 units on a scale Standard Deviation 16.81	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 51	0.00 units on a scale Standard Deviation 18.86	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 54	6.67 units on a scale Standard Deviation 18.32	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 57	0.00 units on a scale Standard Deviation 20.55	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 66	8.97 units on a scale Standard Deviation 19.13	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 69	8.33 units on a scale Standard Deviation 16.67	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 72	4.20 units on a scale Standard Deviation 22.70	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 78	6.98 units on a scale Standard Deviation 19.83	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 84	3.08 units on a scale Standard Deviation 21.71	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 87	-6.67 units on a scale Standard Deviation 11.55	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Week 96	33.33 units on a scale Standard Deviation 11.55	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Physical functioning: Last visit	2.28 units on a scale Standard Deviation 21.64	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Baseline	58.86 units on a scale Standard Deviation 34.06	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 6	14.84 units on a scale Standard Deviation 32.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Role functioning: Week 27	-8.33 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 9	-11.11 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Fatigue: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 24	-9.13 units on a scale Standard Deviation 18.48	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 45	4.17 units on a scale Standard Deviation 8.33	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 84	-6.41 units on a scale Standard Deviation 12.80	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Nausea and vomiting: Week 96	0.00 units on a scale Standard Deviation 16.67	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 51	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 57	-6.67 units on a scale Standard Deviation 14.91	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Dyspnoea: Last visit	-4.63 units on a scale Standard Deviation 33.71	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Week 24	-3.17 units on a scale Standard Deviation 36.67	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Insomnia: Last visit	-1.83 units on a scale Standard Deviation 35.09	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 30	-13.68 units on a scale Standard Deviation 23.84	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 84	-25.64 units on a scale Standard Deviation 36.40	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Appetite loss: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 18	4.58 units on a scale Standard Deviation 25.84	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 45	50.00 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Constipation: Week 90	8.33 units on a scale Standard Deviation 15.43	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 36	-7.89 units on a scale Standard Deviation 23.80	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 45	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 48	-3.03 units on a scale Standard Deviation 28.09	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Diarrhoea: Week 63	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 48	-8.08 units on a scale Standard Deviation 23.61	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 60	-3.33 units on a scale Standard Deviation 22.06	—	—	—	—	—	—	—	—
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II Financial difficulties: Week 72	5.80 units on a scale Standard Deviation 25.92	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)

EORTC QLQ-LC13 consisted of 13 questions for dyspnea (3 items) and 10 single items (cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm/shoulder, other pain). Questions used 4-point scale (1 'Not at all' to 4 'Very much'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below represents absolute data at baseline.

Outcome measures

Outcome measures
Measure	Alectinib 300 mg (Fasted): Phase I n=79 Participants Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (20/40 mg) Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I (150 mg) Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 33	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 36	-1.75 units on a scale Standard Deviation 7.54	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 39	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 42	0.00 units on a scale Standard Deviation 7.97	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 57	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 60	-1.15 units on a scale Standard Deviation 6.19	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 63	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 69	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 78	-1.67 units on a scale Standard Deviation 7.45	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 84	-2.56 units on a scale Standard Deviation 9.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 87	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Baseline	5.06 units on a scale Standard Deviation 16.09	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 6	-1.11 units on a scale Standard Deviation 13.68	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 12	0.64 units on a scale Standard Deviation 13.99	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 18	-2.04 units on a scale Standard Deviation 17.22	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 24	-0.85 units on a scale Standard Deviation 17.91	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 30	2.56 units on a scale Standard Deviation 11.81	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 33	22.22 units on a scale Standard Deviation 38.49	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 36	1.75 units on a scale Standard Deviation 15.40	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 39	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 42	-0.93 units on a scale Standard Deviation 9.71	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 45	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 48	7.07 units on a scale Standard Deviation 26.03	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 51	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 54	1.08 units on a scale Standard Deviation 13.56	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 57	0.00 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 60	-1.15 units on a scale Standard Deviation 14.04	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 63	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 66	-2.56 units on a scale Standard Deviation 13.07	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 69	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 72	4.55 units on a scale Standard Deviation 18.67	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 78	1.67 units on a scale Standard Deviation 7.45	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 84	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 87	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 90	4.17 units on a scale Standard Deviation 11.79	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 96	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Last visit	-0.46 units on a scale Standard Deviation 15.21	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Baseline	4.64 units on a scale Standard Deviation 11.61	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 6	-1.67 units on a scale Standard Deviation 11.36	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 12	-0.64 units on a scale Standard Deviation 10.42	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 24	0.83 units on a scale Standard Deviation 11.91	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 27	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 30	3.42 units on a scale Standard Deviation 14.90	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 33	0.00 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 36	-0.88 units on a scale Standard Deviation 5.41	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 42	-0.93 units on a scale Standard Deviation 12.56	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 45	0.00 units on a scale Standard Deviation 27.22	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 48	2.02 units on a scale Standard Deviation 16.54	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 51	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 54	-1.08 units on a scale Standard Deviation 13.56	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 63	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 66	-1.28 units on a scale Standard Deviation 14.85	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 69	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 78	0.00 units on a scale Standard Deviation 10.81	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 84	2.56 units on a scale Standard Deviation 9.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 87	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 90	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 96	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Baseline	13.08 units on a scale Standard Deviation 22.28	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 6	6.11 units on a scale Standard Deviation 17.88	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 18	2.72 units on a scale Standard Deviation 22.40	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 24	4.17 units on a scale Standard Deviation 20.24	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 27	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 36	0.00 units on a scale Standard Deviation 18.98	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 39	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 42	1.85 units on a scale Standard Deviation 21.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 45	8.33 units on a scale Standard Deviation 16.67	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 48	2.02 units on a scale Standard Deviation 23.48	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 51	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 54	6.45 units on a scale Standard Deviation 26.41	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 60	2.30 units on a scale Standard Deviation 23.45	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 63	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 66	1.28 units on a scale Standard Deviation 24.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 69	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 72	2.90 units on a scale Standard Deviation 28.27	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 84	12.82 units on a scale Standard Deviation 37.36	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 87	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 90	16.67 units on a scale Standard Deviation 17.82	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Last visit	1.37 units on a scale Standard Deviation 22.52	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Baseline	11.69 units on a scale Standard Deviation 25.80	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 6	-1.13 units on a scale Standard Deviation 22.29	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 18	-4.96 units on a scale Standard Deviation 25.04	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 24	-2.56 units on a scale Standard Deviation 27.98	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 30	-3.51 units on a scale Standard Deviation 27.72	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 39	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 48	-5.21 units on a scale Standard Deviation 22.58	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 51	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 54	-6.45 units on a scale Standard Deviation 15.91	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 57	-6.67 units on a scale Standard Deviation 14.91	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 66	-2.67 units on a scale Standard Deviation 27.08	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 78	-8.33 units on a scale Standard Deviation 26.21	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 81	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 84	-2.56 units on a scale Standard Deviation 25.32	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 87	-11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 90	4.17 units on a scale Standard Deviation 21.36	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 96	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Last visit	-5.16 units on a scale Standard Deviation 27.97	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Baseline	21.52 units on a scale Standard Deviation 28.26	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 6	-16.67 units on a scale Standard Deviation 29.75	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 18	-8.84 units on a scale Standard Deviation 27.87	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 24	-8.33 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 30	-3.42 units on a scale Standard Deviation 22.68	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 33	-11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 36	-6.14 units on a scale Standard Deviation 26.68	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 39	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 45	-8.33 units on a scale Standard Deviation 41.94	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 48	-6.06 units on a scale Standard Deviation 19.46	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 51	-33.33 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 57	-13.33 units on a scale Standard Deviation 38.01	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 60	-3.45 units on a scale Standard Deviation 16.29	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 63	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 66	-2.56 units on a scale Standard Deviation 18.67	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 69	-25.00 units on a scale Standard Deviation 31.91	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 72	-2.90 units on a scale Standard Deviation 28.27	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 78	0.00 units on a scale Standard Deviation 18.73	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 81	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 84	-5.13 units on a scale Standard Deviation 22.96	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 93	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Last visit	-8.80 units on a scale Standard Deviation 26.83	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Baseline	16.88 units on a scale Standard Deviation 28.18	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 6	-7.22 units on a scale Standard Deviation 25.37	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 18	-4.86 units on a scale Standard Deviation 24.78	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 24	-10.83 units on a scale Standard Deviation 27.62	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 27	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 30	-3.42 units on a scale Standard Deviation 23.93	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 33	-11.11 units on a scale Standard Deviation 38.49	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 36	-5.26 units on a scale Standard Deviation 33.36	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 39	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 42	-5.56 units on a scale Standard Deviation 25.82	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 45	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 48	-6.06 units on a scale Standard Deviation 21.17	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 51	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 54	-1.08 units on a scale Standard Deviation 25.07	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 57	0.00 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 63	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 66	-3.85 units on a scale Standard Deviation 27.21	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 69	-16.67 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 72	-4.35 units on a scale Standard Deviation 28.96	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 78	-8.77 units on a scale Standard Deviation 24.45	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 84	7.69 units on a scale Standard Deviation 38.86	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 87	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 90	4.17 units on a scale Standard Deviation 21.36	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 93	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 96	0.00 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Last visit	0.00 units on a scale Standard Deviation 29.92	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Baseline	44.00 units on a scale Standard Deviation 36.42	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 6	-16.96 units on a scale Standard Deviation 42.78	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 12	-11.59 units on a scale Standard Deviation 41.70	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 18	-19.26 units on a scale Standard Deviation 41.74	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 24	-19.30 units on a scale Standard Deviation 36.87	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 30	-18.52 units on a scale Standard Deviation 37.75	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 33	0.00 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 36	-18.52 units on a scale Standard Deviation 36.90	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 39	0.00 units on a scale Standard Deviation 94.28	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 42	-16.16 units on a scale Standard Deviation 37.38	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 45	-8.33 units on a scale Standard Deviation 56.93	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 48	-12.22 units on a scale Standard Deviation 34.45	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 51	0.00 units on a scale Standard Deviation 47.14	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 54	-14.94 units on a scale Standard Deviation 38.41	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 57	-13.33 units on a scale Standard Deviation 38.01	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 60	-15.38 units on a scale Standard Deviation 34.29	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 63	-44.44 units on a scale Standard Deviation 38.49	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 66	-10.61 units on a scale Standard Deviation 39.02	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 69	-8.33 units on a scale Standard Deviation 41.94	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 72	-15.00 units on a scale Standard Deviation 33.29	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 75	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 78	-5.26 units on a scale Standard Deviation 27.81	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 81	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 84	-12.12 units on a scale Standard Deviation 22.47	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 87	-22.22 units on a scale Standard Deviation 38.49	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 90	0.00 units on a scale Standard Deviation 36.51	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Baseline	30.85 units on a scale Standard Deviation 27.13	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 6	-8.24 units on a scale Standard Deviation 22.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 12	-7.64 units on a scale Standard Deviation 20.65	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 18	-11.35 units on a scale Standard Deviation 21.67	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 24	-7.41 units on a scale Standard Deviation 21.68	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 30	-4.09 units on a scale Standard Deviation 20.41	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 33	-11.11 units on a scale Standard Deviation 11.11	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 36	-5.41 units on a scale Standard Deviation 21.69	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 39	-5.56 units on a scale Standard Deviation 7.86	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 42	-8.64 units on a scale Standard Deviation 20.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 45	-2.78 units on a scale Standard Deviation 27.78	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 48	-7.74 units on a scale Standard Deviation 24.77	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 51	-27.78 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 54	-5.02 units on a scale Standard Deviation 19.63	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 60	-7.28 units on a scale Standard Deviation 19.54	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 63	3.70 units on a scale Standard Deviation 16.97	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 66	-6.22 units on a scale Standard Deviation 25.27	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 69	-13.89 units on a scale Standard Deviation 29.22	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 72	-6.76 units on a scale Standard Deviation 26.96	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 75	-5.56 units on a scale Standard Deviation 7.86	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 93	33.33 units on a scale Standard Deviation 47.14	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 96	-33.33 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Last visit	-12.56 units on a scale Standard Deviation 37.96	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 93	22.22 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 99	11.11 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Baseline	33.76 units on a scale Standard Deviation 27.47	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 12	-12.82 units on a scale Standard Deviation 27.34	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 36	-8.77 units on a scale Standard Deviation 28.67	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 39	-50.00 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 42	-0.93 units on a scale Standard Deviation 27.01	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 45	-8.33 units on a scale Standard Deviation 50.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 48	-4.04 units on a scale Standard Deviation 35.12	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 51	-33.33 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 54	-8.33 units on a scale Standard Deviation 25.40	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 57	-20.00 units on a scale Standard Deviation 29.81	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 60	-2.30 units on a scale Standard Deviation 29.45	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 63	0.00 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 66	-5.13 units on a scale Standard Deviation 27.80	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 69	-25.00 units on a scale Standard Deviation 31.91	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 75	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 78	-6.67 units on a scale Standard Deviation 35.21	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 81	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 84	-15.38 units on a scale Standard Deviation 29.24	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 90	-8.33 units on a scale Standard Deviation 29.55	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 93	16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 96	-44.44 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Last visit	-5.48 units on a scale Standard Deviation 32.87	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 6	-1.11 units on a scale Standard Deviation 6.03	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 18	-1.36 units on a scale Standard Deviation 6.66	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 30	0.00 units on a scale Standard Deviation 13.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 27	5.56 units on a scale Standard Deviation 7.86	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 57	-2.22 units on a scale Standard Deviation 16.48	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 78	-8.19 units on a scale Standard Deviation 22.48	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 81	-5.56 units on a scale Standard Deviation 7.86	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 84	-9.40 units on a scale Standard Deviation 16.26	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 87	7.41 units on a scale Standard Deviation 23.13	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 90	-5.56 units on a scale Standard Deviation 17.82	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 96	-51.85 units on a scale Standard Deviation 23.13	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dyspnoea: Last visit	-6.44 units on a scale Standard Deviation 23.45	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 6	-13.89 units on a scale Standard Deviation 31.47	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 18	-13.61 units on a scale Standard Deviation 24.46	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 24	-9.17 units on a scale Standard Deviation 31.11	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 30	-1.75 units on a scale Standard Deviation 24.44	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 33	-22.22 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 72	-7.25 units on a scale Standard Deviation 28.35	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 87	0.00 units on a scale Standard Deviation 33.33	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Coughing: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Baseline	1.27 units on a scale Standard Deviation 6.41	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 12	-1.28 units on a scale Standard Deviation 6.47	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 24	-1.67 units on a scale Standard Deviation 7.36	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 45	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 48	-1.01 units on a scale Standard Deviation 5.80	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 51	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 54	1.08 units on a scale Standard Deviation 10.48	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 66	-1.28 units on a scale Standard Deviation 6.54	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 72	2.90 units on a scale Standard Deviation 22.28	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 90	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 96	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Hemoptysis: Last visit	-0.91 units on a scale Standard Deviation 7.80	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Sore mouth: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 18	-1.36 units on a scale Standard Deviation 11.70	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 39	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 57	6.67 units on a scale Standard Deviation 27.89	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 60	-3.57 units on a scale Standard Deviation 13.88	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 72	1.45 units on a scale Standard Deviation 15.82	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 105	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 111	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Dysphagia: Last visit	2.74 units on a scale Standard Deviation 17.35	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 12	1.28 units on a scale Standard Deviation 20.83	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 15	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 30	4.27 units on a scale Standard Deviation 24.40	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 33	11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 57	6.67 units on a scale Standard Deviation 27.89	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 78	-3.33 units on a scale Standard Deviation 21.36	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 81	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Peripheral neuropathy: Week 96	55.56 units on a scale Standard Deviation 38.49	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 12	1.31 units on a scale Standard Deviation 31.24	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 21	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 33	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 36	0.90 units on a scale Standard Deviation 32.85	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 42	-2.78 units on a scale Standard Deviation 20.12	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 45	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 60	-4.60 units on a scale Standard Deviation 19.36	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 63	-11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 69	-8.33 units on a scale Standard Deviation 16.67	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 72	-3.03 units on a scale Standard Deviation 33.98	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Alopecia: Week 117	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 12	-11.54 units on a scale Standard Deviation 23.69	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 27	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 42	-6.48 units on a scale Standard Deviation 19.22	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 54	-4.30 units on a scale Standard Deviation 20.62	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 75	-16.67 units on a scale Standard Deviation 23.57	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 87	-11.11 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 90	-12.50 units on a scale Standard Deviation 24.80	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 96	-22.22 units on a scale Standard Deviation 19.25	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in chest: Week 99	0.00 units on a scale	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 12	-5.77 units on a scale Standard Deviation 30.05	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 60	-2.30 units on a scale Standard Deviation 26.62	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in arm or shoulder: Week 75	0.00 units on a scale Standard Deviation 0.00	—	—	—	—	—	—	—	—
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II Pain in other parts: Week 9	0.00 units on a scale	—	—	—	—	—	—	—	—

Adverse Events

Alectinib 300 mg (Fasted): Phase I

Serious events: 1 serious events

Other events: 7 other events

Deaths: 7 deaths

Alectinib 460 mg (Fed): Phase I

Serious events: 2 serious events

Other events: 7 other events

Deaths: 4 deaths

Alectinib 600 mg (Fed): Phase I

Serious events: 6 serious events

Other events: 12 other events

Deaths: 6 deaths

Alectinib 760 mg (Fed): Phase I

Serious events: 0 serious events

Other events: 7 other events

Deaths: 2 deaths

Alectinib 900 mg (Fed): Phase I

Serious events: 1 serious events

Other events: 13 other events

Deaths: 9 deaths

Alectinib 600 mg (Fed): Phase II

Serious events: 21 serious events

Other events: 85 other events

Deaths: 45 deaths

Serious adverse events

Serious adverse events
Measure	Alectinib 300 mg (Fasted): Phase I n=7 participants at risk Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I n=7 participants at risk Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I n=13 participants at risk Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=7 participants at risk Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I n=13 participants at risk Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase II n=87 participants at risk Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Infections and infestations Bronchitis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Pneumonia bacterial	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Cardiac disorders Pericardial effusion	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Nausea	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Vomiting	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Procedural pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Renal and urinary disorders Renal failure	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Brain oedema	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Cerebral ventricle dilatation	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Embolic stroke	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Haemorrhage intracranial	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Hemiparesis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Influenza	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Lung infection	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Staphylococcal sepsis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Intestinal obstruction	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hyperammonaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Vascular disorders Haemorrhage	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Hepatobiliary disorders Bile duct obstruction	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Pneumonia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Gastroenteritis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Overdose	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Radiation necrosis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Stroke-like migraine attacks after radiation therapy	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Seizure	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Cerebrovascular accident	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Headache	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Vascular disorders Embolism	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Fatigue	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Non-cardiac chest pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Death	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Ear and labyrinth disorders Vertigo	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	1.1% 1/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population

Other adverse events

Other adverse events
Measure	Alectinib 300 mg (Fasted): Phase I n=7 participants at risk Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 460 mg (Fed): Phase I n=7 participants at risk Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase I n=13 participants at risk Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 760 mg (Fed): Phase I n=7 participants at risk Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 900 mg (Fed): Phase I n=13 participants at risk Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	Alectinib 600 mg (Fed): Phase II n=87 participants at risk Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
General disorders Fatigue	57.1% 4/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	71.4% 5/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	53.8% 7/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	41.4% 36/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Oedema peripheral	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	25.3% 22/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	10.3% 9/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Pyrexia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	5.7% 5/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Asthenia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Chest discomfort	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Chest pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	5.7% 5/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Face oedema	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Gait disturbance	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Injection site haemorrhage	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Injection site reaction	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Mucosal inflammation	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Non-cardiac chest pain	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Myalgia	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	57.1% 4/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	26.4% 23/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Arthralgia	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	13.8% 12/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	38.5% 5/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	13.8% 12/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Musculoskeletal pain	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	8.0% 7/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Muscular weakness	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	5.7% 5/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Muscle fatigue	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Blood creatine phosphokinase increased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	57.1% 4/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	57.1% 4/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.0% 20/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Alanine aminotransferase increased	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	18.4% 16/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Aspartate aminotransferase increased	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	20.7% 18/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Blood bilirubin increased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	11.5% 10/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Blood creatinine increased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	30.8% 4/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	5.7% 5/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Blood alkaline phosphatase increased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	13.8% 12/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Electrocardiogram PR Prolongation	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Neutrophil count decreased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations White blood cell count decreased	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Blood lactate dehydrogenase increased	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Blood triglycerides increased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Gamma-glutamyltransferase increased	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Haemoglobin decreased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Activated partial thromboplastin time prolonged	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	9.2% 8/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Blood cholesterol increased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Blood phosphorus increased	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Ejection fraction decreased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Heart rate irregular	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations International normalised ratio increased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Neutrophil count	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Platelet count decreased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Weight decreased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	6.9% 6/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Weight increased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	19.5% 17/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Constipation	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	39.1% 34/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Nausea	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	25.3% 22/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	24.1% 21/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Vomiting	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	16.1% 14/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Abdominal discomfort	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Abdominal distension	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Abdominal pain upper	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Dry mouth	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	5.7% 5/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Flatulence	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Abdominal pain lower	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Dental caries	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Haemorrhoids	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Oral disorder	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Stomatitis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Headache	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	30.8% 4/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.7% 25/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Dysgeusia	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	9.2% 8/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Dizziness	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	13.8% 12/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Burning sensation	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Hypoaesthesia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Neuropathy peripheral	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	9.2% 8/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	5.7% 5/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Amnesia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Aura	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Brain oedema	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Memory impairment	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Narcolepsy	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Paraesthesia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Sinus headache	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Upper respiratory tract infection	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	16.1% 14/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Urinary tract infection	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	10.3% 9/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Pneumonia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	6.9% 6/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Oral herpes	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Tooth infection	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Viral upper respiratory tract infection	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	5.7% 5/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Conjunctivitis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Fungal skin infection	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Gastroenteritis viral	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Rash pustular	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Rhinitis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Sinusitis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Viral infection	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	6.9% 6/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.9% 13/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	6.9% 6/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	11.5% 10/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Decreased appetite	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	10.3% 9/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Fluid retention	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	6.9% 6/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Cough	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	57.1% 4/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	21.8% 19/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	20.7% 18/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Dysphonia	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Haemoptysis	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	6.9% 6/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	6.9% 6/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Skin and subcutaneous tissue disorders Rash	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	23.1% 3/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	9.2% 8/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Skin and subcutaneous tissue disorders Photosensitivity reaction	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	11.5% 10/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Skin and subcutaneous tissue disorders Dry skin	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	8.0% 7/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Blood and lymphatic system disorders Anaemia	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	42.9% 3/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	30.8% 4/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	19.5% 17/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Blood and lymphatic system disorders Leukopenia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	6.9% 6/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Blood and lymphatic system disorders Neutropenia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Cardiac disorders Sinus bradycardia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	30.8% 4/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	6.9% 6/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Cardiac disorders Atrial fibrillation	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Cardiac disorders Atrioventricular block	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Cardiac disorders Bradycardia	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	9.2% 8/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Cardiac disorders Bundle branch block left	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Cardiac disorders Cardiomyopathy	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Cardiac disorders Coronary artery disease	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Cardiac disorders Diastolic dysfunction	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Psychiatric disorders Insomnia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.9% 13/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Psychiatric disorders Anxiety	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Psychiatric disorders Depression	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Psychiatric disorders Panic attack	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Eye disorders Visual impairment	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Eye disorders Eye irritation	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Eye disorders Eyelid oedema	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Eye disorders Periorbital oedema	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Eye disorders Vision blurred	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	8.0% 7/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Eye disorders Vitreous floaters	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Excoriation	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Fall	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	5.7% 5/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Post lumbar puncture syndrome	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Radiation injury	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Thermal burn	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Renal and urinary disorders Pollakiuria	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Renal and urinary disorders Dysuria	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Renal and urinary disorders Haematuria	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Renal and urinary disorders Micturition urgency	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Renal and urinary disorders Renal cyst	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Ear and labyrinth disorders Tinnitus	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Ear and labyrinth disorders Vertigo	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	28.6% 2/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	15.4% 2/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	8.0% 7/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Vascular disorders Flushing	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Vascular disorders Haematoma	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Vascular disorders Hot flush	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Vascular disorders Thrombophlebitis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Endocrine disorders Hypothyroidism	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Social circumstances Tanning	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Cardiac disorders Ventricular extrasystoles	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Ear and labyrinth disorders Hypoacusis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Faecaloma	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Gingival swelling	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Noninfective gingivitis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Gastrointestinal disorders Oesophagitis	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Axillary pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Influenza like illness	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Oedema	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
General disorders Peripheral swelling	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Babesiosis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Influenza	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Infections and infestations Onychomycosis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Animal bite	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Blood testosterone decreased	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Electrocardiogram abnormal	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Investigations Prothrombin time prolonged	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Dizziness postural	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Seizure	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Nervous system disorders Tremor	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Renal and urinary disorders Hypertonic bladder	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	7.7% 1/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	14.3% 1/7 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/13 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population	0.00% 0/87 • Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks) Safety population

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: [email protected]

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