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Trial record 11 of 39 for:    ALECTINIB

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX)

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ClinicalTrials.gov Identifier: NCT02075840
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Results First Posted : March 15, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Alectinib
Drug: Crizotinib
Enrollment 303
Recruitment Details The study recruited treatment-naive participants with Anaplastic Lymphoma Kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) in 29 countries from August 2014 to January 2016.
Pre-assignment Details A total of 303 participants were randomized at the time of clinical cut-off (CCO) date on 9 February 2017 and included in the intent-to-treat (ITT) population; 152 participants in the alectinib arm and 151 participants in the crizotinib arm.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Period Title: Overall Study
Started 152 151
Completed 0 0
Not Completed 152 151
Reason Not Completed
Withdrawal by Subject             13             22
Reason not specified             1             0
Adverse Event             0             2
Death             35             40
Lost to Follow-up             3             2
Physician Decision             1             3
Ongoing at CCOD             99             82
Arm/Group Title Alectinib Crizotinib Total
Hide Arm/Group Description Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. Total of all reporting groups
Overall Number of Baseline Participants 152 151 303
Hide Baseline Analysis Population Description
Analysis was performed on intent to treat (ITT) population which included all randomized participants in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 151 participants 303 participants
56.3  (12.0) 53.8  (13.5) 55.1  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 151 participants 303 participants
Female
84
  55.3%
87
  57.6%
171
  56.4%
Male
68
  44.7%
64
  42.4%
132
  43.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 151 participants 303 participants
Ethnicity - Hispanic or Latino 8 8 16
Ethinicity - Not Hispanic or Latino 138 136 274
Ethnicity - Not Stated 6 7 13
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 151 participants 303 participants
Race - American Indian or Alaska Native 4 0 4
Race - Asian 69 69 138
Race - Black or African American 0 4 4
Race - Native Hawaiian or other Pacific Islander 1 1 2
Race - White 76 75 151
Race - Unknown 2 2 4
1.Primary Outcome
Title Progression-Free Survival (PFS) by Investigator Assessment
Hide Description PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
Time Frame Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(17.7 to NA)
11.1
(9.1 to 13.1)
[1]
The median PFS had not been reached in the alectinib arm at the time of data cutoff date (9 Feb 2017).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio, stratified
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.34 to 0.65
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With PFS Event by Investigator Assessment
Hide Description PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
Time Frame Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Measure Type: Number
Unit of Measure: Percentage of Participants
40.8 67.5
3.Secondary Outcome
Title PFS Independent Review Committee (IRC)-Assessed
Hide Description PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
Time Frame Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (95% Confidence Interval)
Unit of Measure: months
25.7 [1] 
(19.9 to NA)
10.4
(7.7 to 14.6)
[1]
The upper limit of the CI could not be estimated in the alectinib arm at the time of data cutoff date (9 Feb 2017).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.36 to 0.70
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With PFS Event by IRC
Hide Description PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
Time Frame Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Measure Type: Number
Unit of Measure: Percentage of Participants
41.4 60.9
5.Secondary Outcome
Title Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria
Hide Description CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.
Time Frame Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Measure Type: Number
Unit of Measure: Percentage of Participants
11.8 45.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments IRC, RECIST v1.1 Stratified Analysis (by race (Asian vs non-Asian) and CNS metastases at baseline by IRC)
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cause-Specific Hazard Ratio
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
0.10 to 0.28
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria
Hide Description CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.
Time Frame Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Measure Type: Number
Unit of Measure: Percentage of Participants
10.5 35.8
7.Secondary Outcome
Title Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria
Hide Description ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
82.9
(75.95 to 88.51)
75.5
(67.84 to 82.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0936
Comments Stratified analysis
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Overall Response Rates
Estimated Value 7.40
Confidence Interval (2-Sided) 95%
-1.71 to 16.50
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators
Hide Description DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
Time Frame First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
11.1
(7.9 to 13.0)
[1]
The median DOR was not estimable [95% CI: NE] in the alectinib arm due to the low number of contributing events of disease progression or death.
9.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) was defined as the time from randomization to death from any cause.
Time Frame From randomization until death (up to 43 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median time to OS event was not reached in participants in either treatment arm at the time of data cutoff (9 Feb 2017).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2405
Comments Stratified analysis
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.48 to 1.20
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With OS Event
Hide Description Overall survival (OS) was defined as the time from randomization to death from any cause.
Time Frame From randomization until death (up to 43 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Measure Type: Number
Unit of Measure: Percentage of Participants
23.0 26.5
11.Secondary Outcome
Title Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria
Hide Description CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure (number of participants with measurable/non-measurable CNS lesions at baseline).
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Measurable CNS lesions at baseline Number Analyzed 21 participants 22 participants
81.0
(58.09 to 94.55)
50.0
(28.22 to 71.78)
Measurable and non-measurable CNS lesions Number Analyzed 64 participants 58 participants
59.4
(46.37 to 71.49)
25.9
(15.26 to 39.04)
12.Secondary Outcome
Title CNS DOR IRC-assessed According to RECIST v1.1 Criteria
Hide Description CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
Time Frame First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 21 22
Median (95% Confidence Interval)
Unit of Measure: months
17.3 [1] 
(14.8 to NA)
5.5
(2.1 to 17.3)
[1]
The upper limit of the CI for CNS DOR could not be estimated at time of the data cutoff for participants in the alectinib arm.
13.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Baseline up to 28 months in the crizotinib arm and up to 30 months in the alectinib arm
Hide Outcome Measure Data
Hide Analysis Population Description
Safety (SAF) population included all participants who received at least one dose of any study drug.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Measure Type: Number
Unit of Measure: Percentage of Participants
97.0 97.0
14.Secondary Outcome
Title Area Under The Concentration-Time Curve (AUC) of Alectinib
Hide Description [Not Specified]
Time Frame Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.
Arm/Group Title Alectinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 144
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*ng/mL
Baseline Number Analyzed 10 participants
713
(104.9%)
Treatment - week 4 Number Analyzed 9 participants
5030
(47.2%)
15.Secondary Outcome
Title Maximum Concentration (Cmax) of Alectinib
Hide Description [Not Specified]
Time Frame Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.
Arm/Group Title Alectinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 144
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram/milliliter (ng/mL)
Baseline Number Analyzed 10 participants
211
(55.5%)
Treatment - week 4 Number Analyzed 9 participants
717
(46.8%)
16.Secondary Outcome
Title Time to Reach Cmax (Tmax) of Alectinib
Hide Description [Not Specified]
Time Frame Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.
Arm/Group Title Alectinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 144
Median (Full Range)
Unit of Measure: hours
Baseline Number Analyzed 10 participants
6.03
(1.98 to 12.00)
Treatment - week 4 Number Analyzed 9 participants
4.02
(2.00 to 8.00)
17.Secondary Outcome
Title AUC of Alectinib Metabolite
Hide Description [Not Specified]
Time Frame Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.
Arm/Group Title Alectinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 144
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*ng/mL
Baseline Number Analyzed 10 participants
142
(191.7%)
Treatment - week 4 Number Analyzed 9 participants
2230
(37.0%)
18.Secondary Outcome
Title Cmax of Alectinib Metabolite
Hide Description [Not Specified]
Time Frame Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.
Arm/Group Title Alectinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 144
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram/milliliter (ng/mL)
Baseline Number Analyzed 10 participants
56.2
(80.1%)
Treatment - week 4 Number Analyzed 9 participants
321
(32.0%)
19.Secondary Outcome
Title Tmax of Alectinib Metabolite
Hide Description [Not Specified]
Time Frame Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.
Arm/Group Title Alectinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 144
Median (Full Range)
Unit of Measure: hours
Baseline Number Analyzed 10 participants
8.00
(5.98 to 12.00)
Treatment - week 4 Number Analyzed 9 participants
6.00
(2.00 to 10.00)
20.Secondary Outcome
Title Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30)
Hide Description The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
Time Frame Baseline, every 4 weeks until disease progression (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (95% Confidence Interval)
Unit of Measure: months
Fatigue
NA [1] 
(NA to NA)
NA [1] 
(9.4 to NA)
Dyspnea
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median deterioration not reached at CCOD
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments Fatigue
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2079
Comments [Not Specified]
Method Log Rank
Comments Stratified analysis
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.46 to 1.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments Dyspnea
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1137
Comments Stratified analysis
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.66
Confidence Interval (2-Sided) 95%
0.88 to 3.15
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30)
Hide Description The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
Time Frame Baseline, every 4 weeks until disease progression (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Measure Type: Number
Unit of Measure: Percentage of Participants
Fatigue 21.7 25.2
Dyspnea 17.1 9.9
22.Secondary Outcome
Title Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
Hide Description The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
Time Frame Baseline, every 4 weeks until disease progression (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (95% Confidence Interval)
Unit of Measure: months
Coughing
NA [1] 
(24.0 to NA)
NA [1] 
(NA to NA)
Dyspnea
22.8 [2] 
(11.8 to NA)
NA [1] 
(21.0 to NA)
Pain in arm and shoulder
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Pain in chest
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Composite score (c, p in c, d)
12.7 [2] 
(5.0 to NA)
21.0 [2] 
(9.8 to NA)
[1]
Median deterioration not reached at CCOD
[2]
Upper limit of the CI not reached at CCOD
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments Coughing
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7042
Comments Stratified analysis
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.44 to 1.74
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments Dyspnea
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0285
Comments Stratified analysis
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
1.05 to 2.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments Pain in arm and shoulder
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2377
Comments Stratified analysis
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.43
Confidence Interval (2-Sided) 95%
0.79 to 2.61
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments Pain in chest
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0796
Comments Stratified analysis
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.24 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Alectinib, Crizotinib
Comments Composite score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6435
Comments Stratified analysis
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.72 to 1.68
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
Hide Description The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
Time Frame Baseline, every 4 weeks until disease progression (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Measure Type: Number
Unit of Measure: Percentage of Participants
Coughing 11 11
Dyspnea 28 16
Pain in arm and shoulder 18 12
Pain in chest 7 11
Composite score (c, p in c, d) 32 28
24.Secondary Outcome
Title Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score
Hide Description The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Time Frame Baseline, every 4 weeks until disease progression (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (Full Range)
Unit of Measure: Score on a scale
Baseline Number Analyzed 100 participants 97 participants
66.67
(8.3 to 100.0)
66.67
(0.0 to 100.0)
Treatment - week 4 Number Analyzed 95 participants 89 participants
66.67
(0.0 to 100.0)
66.67
(16.7 to 100.0)
Treatment - week 8 Number Analyzed 89 participants 84 participants
75.0
(16.7 to 100.0)
75.0
(16.7 to 100.0)
Treatment - week 12 Number Analyzed 75 participants 78 participants
75.0
(25.0 to 100.0)
75.0
(33.3 to 100.0)
Treatment - week 16 Number Analyzed 79 participants 73 participants
75.0
(16.7 to 100.0)
83.33
(16.7 to 100.0)
Treatment - week 20 Number Analyzed 73 participants 67 participants
75.0
(16.7 to 100.0)
75.0
(16.7 to 100.0)
Treatment - week 24 Number Analyzed 77 participants 71 participants
75.0
(16.7 to 100.0)
83.33
(8.3 to 100.0)
Treatment - week 28 Number Analyzed 67 participants 62 participants
75.0
(33.3 to 100.0)
75.0
(33.3 to 100.0)
Treatment - week 32 Number Analyzed 73 participants 65 participants
75.0
(33.3 to 100.0)
66.67
(8.3 to 100.0)
Treatment - week 36 Number Analyzed 64 participants 61 participants
79.17
(16.7 to 100.0)
66.67
(16.7 to 100.0)
Treatment - week 40 Number Analyzed 74 participants 50 participants
75.0
(16.7 to 100.0)
83.33
(33.3 to 100.0)
Treatment - week 44 Number Analyzed 62 participants 47 participants
83.33
(16.7 to 100.0)
83.33
(16.7 to 100.0)
Treatment - week 48 Number Analyzed 67 participants 47 participants
66.67
(25.0 to 100.0)
83.33
(41.7 to 100.0)
Treatment - week 52 Number Analyzed 58 participants 44 participants
83.33
(16.7 to 100.0)
75.00
(41.7 to 100.0)
Treatment - week 56 Number Analyzed 61 participants 48 participants
75.0
(16.7 to 100.0)
75.0
(41.7 to 100.0)
Treatment - week 60 Number Analyzed 47 participants 39 participants
75.0
(33.3 to 100.0)
75.0
(50.0 to 100.0)
Treatment - week 64 Number Analyzed 55 participants 39 participants
75.0
(33.3 to 100.0)
83.33
(41.7 to 100.0)
Treatment - week 68 Number Analyzed 49 participants 34 participants
75.0
(33.3 to 100.0)
79.17
(33.3 to 100.0)
Treatment - week 72 Number Analyzed 54 participants 34 participants
75.0
(33.3 to 100.0)
75.00
(8.3 to 100.0)
Treatment - week 76 Number Analyzed 42 participants 29 participants
75.0
(41.7 to 100.0)
75.0
(16.7 to 100.0)
Treatment - week 80 Number Analyzed 43 participants 23 participants
75.0
(33.3 to 100.0)
75.0
(33.3 to 100.0)
Treatment - week 84 Number Analyzed 33 participants 19 participants
83.33
(41.7 to 100.0)
66.67
(33.3 to 100.0)
Treatment - week 88 Number Analyzed 36 participants 16 participants
75.0
(33.3 to 100.0)
66.67
(33.3 to 100.0)
Treatment - week 92 Number Analyzed 30 participants 13 participants
70.83
(33.3 to 100.0)
75.0
(50.0 to 100.0)
Treatment - week 96 Number Analyzed 22 participants 11 participants
66.67
(33.3 to 100.0)
66.67
(33.3 to 100.0)
Treatment - week 100 Number Analyzed 18 participants 10 participants
66.67
(25.0 to 100.0)
75.0
(33.3 to 100.0)
Treatment - week 104 Number Analyzed 15 participants 7 participants
66.67
(50.0 to 100.0)
66.67
(50.0 to 100.0)
Treatment - week 108 Number Analyzed 11 participants 7 participants
66.67
(50.0 to 100.0)
75.0
(33.3 to 100.0)
Treatment - week 112 Number Analyzed 9 participants 4 participants
75.0
(50.0 to 100.0)
75.0
(33.3 to 100.0)
Treatment - week 116 Number Analyzed 4 participants 2 participants
70.83
(41.7 to 100.0)
91.67
(83.3 to 100.0)
Treatment - week 120 Number Analyzed 3 participants 151 participants
83.3
(50.0 to 100.0)
NA [1] 
(NA to NA)
[1]
Not evaluable at week 120
25.Secondary Outcome
Title HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing
Hide Description The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Time Frame Baseline, every 4 weeks until disease progression (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (Full Range)
Unit of Measure: Score on a scale
Baseline Number Analyzed 100 participants 96 participants
33.33
(0.0 to 100.0)
33.33
(0.0 to 100.0)
Treatment - week 4 Number Analyzed 95 participants 89 participants
33.33
(0.0 to 100.0)
33.33
(0.0 to 100.0)
Treatment - week 8 Number Analyzed 89 participants 84 participants
33.33
(0.0 to 66.7)
33.33
(0.0 to 100.0)
Treatment - week 12 Number Analyzed 75 participants 78 participants
33.33
(0.0 to 100.0)
0.0
(0.0 to 66.7)
Treatment - week 16 Number Analyzed 79 participants 73 participants
0.0
(0.0 to 100.0)
0.0
(0.0 to 66.7)
Treatment - week 20 Number Analyzed 73 participants 67 participants
33.33
(0.0 to 100.0)
0.0
(0.0 to 66.7)
Treatment - week 24 Number Analyzed 77 participants 71 participants
33.33
(0.0 to 100.0)
33.33
(0.0 to 100.0)
Treatment - week 28 Number Analyzed 67 participants 62 participants
33.33
(0.0 to 100.0)
16.67
(0.0 to 100.0)
Treatment - week 32 Number Analyzed 73 participants 65 participants
33.33
(0.0 to 100.0)
33.33
(0.0 to 100.0)
Treatment - week 36 Number Analyzed 64 participants 61 participants
0.0
(0.0 to 100.0)
0.0
(0.0 to 66.7)
Treatment - week 40 Number Analyzed 74 participants 50 participants
33.33
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - week 44 Number Analyzed 62 participants 47 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - week 48 Number Analyzed 67 participants 47 participants
33.33
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - week 52 Number Analyzed 58 participants 44 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - week 56 Number Analyzed 61 participants 48 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 100.0)
Treatment - week 60 Number Analyzed 47 participants 39 participants
33.33
(0.0 to 100.0)
0.0
(0.0 to 66.7)
Treatment - week 64 Number Analyzed 55 participants 39 participants
33.33
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - week 68 Number Analyzed 49 participants 34 participants
33.33
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - week 72 Number Analyzed 54 participants 34 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - week 76 Number Analyzed 42 participants 29 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - week 80 Number Analyzed 43 participants 23 participants
33.33
(0.0 to 66.7)
0.0
(0.0 to 33.33)
Treatment - week 84 Number Analyzed 33 participants 19 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.33)
Treatment - week 88 Number Analyzed 36 participants 16 participants
33.33
(0.0 to 100.0)
0.0
(0.0 to 33.33)
Treatment - week 92 Number Analyzed 30 participants 13 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - week 96 Number Analyzed 22 participants 11 participants
16.67
(0.0 to 66.7)
0.0
(0.0 to 33.33)
Treatment - week 100 Number Analyzed 18 participants 10 participants
0.0
(0.0 to 100.0)
0.0
(0.0 to 33.3)
Treatment - week 104 Number Analyzed 15 participants 7 participants
33.33
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - week 108 Number Analyzed 11 participants 7 participants
33.33
(0.0 to 66.7)
33.33
(0.0 to 33.33)
Treatment - week 112 Number Analyzed 9 participants 4 participants
33.33
(0.0 to 33.33)
0.0
(0.0 to 33.33)
Treatment - week 116 Number Analyzed 4 participants 2 participants
33.33
(0.0 to 33.33)
16.67
(0.0 to 33.33)
Treatment - week 120 Number Analyzed 3 participants 0 participants
33.33
(33.33 to 33.33)
26.Secondary Outcome
Title HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea
Hide Description The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Time Frame Baseline, every 4 weeks until disease progression (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (Full Range)
Unit of Measure: Score on a scale
Baseline Number Analyzed 100 participants 96 participants
22.22
(0.0 to 100.0)
22.22
(0.0 to 100.0)
Treatment - Week 4 Number Analyzed 95 participants 89 participants
22.22
(0.0 to 100.0)
22.22
(0.0 to 88.9)
Treatment - Week 8 Number Analyzed 89 participants 84 participants
22.22
(0.0 to 66.7)
11.11
(0.0 to 66.7)
Treatment - Week 12 Number Analyzed 75 participants 78 participants
22.22
(0.0 to 66.7)
11.11
(0.0 to 66.7)
Treatment - Week 16 Number Analyzed 79 participants 73 participants
22.22
(0.0 to 77.8)
11.11
(0.0 to 88.9)
Treatment - Week 20 Number Analyzed 73 participants 67 participants
22.22
(0.0 to 88.9)
11.11
(0.0 to 66.7)
Treatment - Week 24 Number Analyzed 77 participants 71 participants
22.22
(0.0 to 77.8)
11.11
(0.0 to 77.8)
Treatment - Week 28 Number Analyzed 67 participants 62 participants
11.11
(0.0 to 44.4)
11.11
(0.0 to 100.0)
Treatment - Week 32 Number Analyzed 73 participants 65 participants
22.22
(0.0 to 66.7)
11.11
(0.0 to 88.9)
Treatment - Week 36 Number Analyzed 64 participants 61 participants
16.67
(0.0 to 77.8)
11.11
(0.0 to 66.7)
Treatment - Week 40 Number Analyzed 74 participants 50 participants
11.11
(0.0 to 55.6)
5.56
(0.0 to 66.7)
Treatment - Week 44 Number Analyzed 62 participants 47 participants
11.11
(0.0 to 88.9)
11.11
(0.0 to 77.8)
Treatment - Week 48 Number Analyzed 67 participants 47 participants
22.22
(0.0 to 55.6)
11.11
(0.0 to 44.4)
Treatment - Week 52 Number Analyzed 58 participants 44 participants
22.22
(0.0 to 44.4)
11.11
(0.0 to 66.7)
Treatment - Week 56 Number Analyzed 61 participants 48 participants
22.22
(0.0 to 77.8)
11.11
(0.0 to 77.8)
Treatment - Week 60 Number Analyzed 47 participants 39 participants
22.22
(0.0 to 77.8)
0.0
(0.0 to 55.6)
Treatment - Week 64 Number Analyzed 55 participants 39 participants
22.22
(0.0 to 66.7)
11.11
(0.0 to 66.7)
Treatment - Week 68 Number Analyzed 49 participants 34 participants
22.22
(0.0 to 77.8)
11.11
(0.0 to 55.6)
Treatment - Week 72 Number Analyzed 54 participants 34 participants
22.22
(0.0 to 66.7)
11.11
(0.0 to 44.4)
Treatment - Week 76 Number Analyzed 42 participants 29 participants
11.11
(0.0 to 66.7)
11.11
(0.0 to 55.6)
Treatment - Week 80 Number Analyzed 43 participants 23 participants
22.22
(0.0 to 66.7)
11.11
(0.0 to 55.6)
Treatment - Week 84 Number Analyzed 33 participants 19 participants
11.11
(0.0 to 66.7)
11.11
(0.0 to 44.4)
Treatment - Week 88 Number Analyzed 36 participants 16 participants
22.22
(0.0 to 55.6)
22.22
(0.0 to 33.3)
Treatment - Week 92 Number Analyzed 30 participants 13 participants
22.22
(0.0 to 44.4)
22.22
(0.0 to 77.8)
Treatment - Week 96 Number Analyzed 22 participants 11 participants
22.22
(0.0 to 66.7)
22.22
(0.0 to 44.4)
Treatment - Week 100 Number Analyzed 18 participants 10 participants
22.22
(0.0 to 55.6)
27.78
(0.0 to 44.4)
Treatment - Week 104 Number Analyzed 15 participants 7 participants
11.11
(0.0 to 66.7)
11.11
(0.0 to 33.3)
Treatment - Week 108 Number Analyzed 11 participants 7 participants
22.22
(0.0 to 66.7)
11.11
(0.0 to 33.3)
Treatment - Week 112 Number Analyzed 9 participants 4 participants
11.11
(11.11 to 44.4)
27.78
(0.0 to 33.3)
Treatment - Week 116 Number Analyzed 4 participants 2 participants
16.67
(11.1 to 22.2)
16.67
(0.0 to 33.3)
Treatment - Week 120 Number Analyzed 3 participants 0 participants
22.22
(11.1 to 33.3)
27.Secondary Outcome
Title HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest
Hide Description The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Time Frame Baseline, every 4 weeks until disease progression (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (Full Range)
Unit of Measure: Score on a scale
Baseline Number Analyzed 100 participants 96 participants
33.33
(0.0 to 100.0)
0.0
(0.0 to 100.0)
Treatment - Week 4 Number Analyzed 95 participants 89 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 8 Number Analyzed 89 participants 84 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 66.7)
Treatment - Week 12 Number Analyzed 75 participants 78 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 16 Number Analyzed 79 participants 73 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 66.7)
Treatment - Week 20 Number Analyzed 73 participants 67 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 24 Number Analyzed 77 participants 71 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 66.7)
Treatment - Week 28 Number Analyzed 67 participants 62 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 33.3)
Treatment - Week 32 Number Analyzed 73 participants 65 participants
0.00
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 36 Number Analyzed 64 participants 61 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 40 Number Analyzed 74 participants 50 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 44 Number Analyzed 62 participants 47 participants
0.0
(0.0 to 100.0)
0.0
(0.0 to 66.7)
Treatment - Week 48 Number Analyzed 67 participants 47 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 52 Number Analyzed 58 participants 44 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 56 Number Analyzed 61 participants 48 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 33.3)
Treatment - Week 60 Number Analyzed 47 participants 39 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 66.7)
Treatment - Week 64 Number Analyzed 55 participants 39 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 68 Number Analyzed 49 participants 34 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 72 Number Analyzed 54 participants 34 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 33.3)
Treatment - Week 76 Number Analyzed 42 participants 29 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 80 Number Analyzed 43 participants 23 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 33.3)
Treatment - Week 84 Number Analyzed 33 participants 19 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 33.3)
Treatment - Week 88 Number Analyzed 36 participants 16 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 92 Number Analyzed 30 participants 13 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 33.3)
Treatment - Week 96 Number Analyzed 22 participants 11 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 100 Number Analyzed 18 participants 10 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 104 Number Analyzed 15 participants 7 participants
33.33
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 108 Number Analyzed 11 participants 7 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 112 Number Analyzed 9 participants 4 participants
0.0
(0.0 to 66.7)
16.67
(0.0 to 33.3)
Treatment - Week 116 Number Analyzed 4 participants 2 participants
0.0
(0.0 to 33.3)
16.67
(0.0 to 33.3)
Treatment - Week 120 Number Analyzed 3 participants 0 participants
0.0
(0.0 to 66.7)
28.Secondary Outcome
Title HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder
Hide Description The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Time Frame Baseline, every 4 weeks until disease progression (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Overall Number of Participants Analyzed 152 151
Median (Full Range)
Unit of Measure: Score on a scale
Baseline Number Analyzed 100 participants 96 participants
0.0
(0.0 to 100.0)
0.0
(0.0 to 100.0)
Treatment - Week 4 Number Analyzed 95 participants 89 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 100.0)
Treatment - Week 8 Number Analyzed 89 participants 84 participants
0.0
(0.0 to 100.0)
0.0
(0.0 to 66.7)
Treatment - Week 12 Number Analyzed 75 participants 78 participants
0.0
(0.0 to 100.0)
0.0
(0.0 to 66.7)
Treatment - Week 16 Number Analyzed 79 participants 73 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 20 Number Analyzed 73 participants 67 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 24 Number Analyzed 77 participants 71 participants
0.0
(0.0 to 33.3)
0.0
(0.0 to 66.7)
Treatment - Week 28 Number Analyzed 67 participants 62 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 32 Number Analyzed 73 participants 65 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 100.0)
Treatment - Week 36 Number Analyzed 64 participants 61 participants
0.0
(0.0 to 100.0)
0.0
(0.0 to 66.7)
Treatment - Week 40 Number Analyzed 74 participants 50 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 100.0)
Treatment - Week 44 Number Analyzed 62 participants 47 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 100.0)
Treatment - Week 48 Number Analyzed 67 participants 47 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 52 Number Analyzed 58 participants 44 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 56 Number Analyzed 61 participants 48 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 60 Number Analyzed 47 participants 39 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 64 Number Analyzed 55 participants 39 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 68 Number Analyzed 49 participants 34 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 72 Number Analyzed 54 participants 34 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 76 Number Analyzed 42 participants 29 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 80 Number Analyzed 43 participants 23 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 84 Number Analyzed 33 participants 19 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 88 Number Analyzed 36 participants 16 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 92 Number Analyzed 30 participants 13 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 100.0)
Treatment - Week 96 Number Analyzed 22 participants 11 participants
33.33
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 100 Number Analyzed 18 participants 10 participants
33.33
(0.0 to 66.7)
0.0
(0.0 to 66.7)
Treatment - Week 104 Number Analyzed 15 participants 7 participants
33.33
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 108 Number Analyzed 11 participants 7 participants
0.0
(0.0 to 66.7)
0.0
(0.0 to 33.3)
Treatment - Week 112 Number Analyzed 9 participants 4 participants
0.0
(0.0 to 66.7)
16.67
(0.0 to 33.33)
Treatment - Week 116 Number Analyzed 4 participants 2 participants
16.67
(0.0 to 33.33)
16.67
(0.0 to 33.33)
Treatment - Week 120 Number Analyzed 3 participants 0 participants
33.33
(33.33 to 33.33)
Time Frame Baseline up to 43 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
All-Cause Mortality
Alectinib Crizotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   35/152 (23.03%)   40/151 (26.49%) 
Show Serious Adverse Events Hide Serious Adverse Events
Alectinib Crizotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   44/152 (28.95%)   45/151 (29.80%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/152 (1.32%)  0/151 (0.00%) 
Cardiac disorders     
Acute Myocardial Infarction * 1  0/152 (0.00%)  1/151 (0.66%) 
Atrial Fibrillation * 1  0/152 (0.00%)  1/151 (0.66%) 
Cardiac Arrest * 1  1/152 (0.66%)  1/151 (0.66%) 
Myocardial Infarction * 1  0/152 (0.00%)  1/151 (0.66%) 
Sinus Bradycardia * 1  0/152 (0.00%)  1/151 (0.66%) 
Cardiac Tamponade * 1  1/152 (0.66%)  0/151 (0.00%) 
Pericardial Effusion * 1  1/152 (0.66%)  0/151 (0.00%) 
Eye disorders     
Vision Blurred * 1  0/152 (0.00%)  1/151 (0.66%) 
Gastrointestinal disorders     
Nausea * 1  0/152 (0.00%)  3/151 (1.99%) 
Vomiting * 1  0/152 (0.00%)  2/151 (1.32%) 
Gastrointestinal Disorder * 1  0/152 (0.00%)  1/151 (0.66%) 
Ileus * 1  0/152 (0.00%)  1/151 (0.66%) 
Oesophagitis * 1  0/152 (0.00%)  1/151 (0.66%) 
General disorders     
Pyrexia * 1  1/152 (0.66%)  3/151 (1.99%) 
Asthenia * 1  0/152 (0.00%)  1/151 (0.66%) 
Chest Discomfort * 1  0/152 (0.00%)  1/151 (0.66%) 
Hyperthermia Malignant * 1  0/152 (0.00%)  1/151 (0.66%) 
Multiple Organ Dysfunction Syndrome * 1  0/152 (0.00%)  1/151 (0.66%) 
Sudden Death * 1  0/152 (0.00%)  1/151 (0.66%) 
Chest Pain * 1  1/152 (0.66%)  0/151 (0.00%) 
Death * 1  1/152 (0.66%)  0/151 (0.00%) 
Oedema * 1  1/152 (0.66%)  0/151 (0.00%) 
Oedema Peripheral * 1  0/152 (0.00%)  1/151 (0.66%) 
Hepatobiliary disorders     
Cholelithiasis * 1  0/152 (0.00%)  1/151 (0.66%) 
Drug−Induced Liver Injury * 1  1/152 (0.66%)  1/151 (0.66%) 
Hepatic Haematoma * 1  0/152 (0.00%)  1/151 (0.66%) 
Hepatic Haemorrhage * 1  1/152 (0.66%)  0/151 (0.00%) 
Hepatotoxicity * 1  1/152 (0.66%)  0/151 (0.00%) 
Cholecystitis Acute * 1  1/152 (0.66%)  0/151 (0.00%) 
Infections and infestations     
Pneumonia * 1  5/152 (3.29%)  4/151 (2.65%) 
Lung Infection * 1  3/152 (1.97%)  0/151 (0.00%) 
Bronchitis * 1  2/152 (1.32%)  0/151 (0.00%) 
Urinary Tract Infection * 1  2/152 (1.32%)  0/151 (0.00%) 
Bacteraemia * 1  1/152 (0.66%)  0/151 (0.00%) 
Cellulitis * 1  1/152 (0.66%)  0/151 (0.00%) 
Herpes Zoster * 1  1/152 (0.66%)  0/151 (0.00%) 
Infection * 1  1/152 (0.66%)  0/151 (0.00%) 
Influenza * 1  1/152 (0.66%)  0/151 (0.00%) 
Sepsis * 1  1/152 (0.66%)  1/151 (0.66%) 
Skin Infection * 1  1/152 (0.66%)  0/151 (0.00%) 
Upper Respiratory Tract Infection * 1  1/152 (0.66%)  0/151 (0.00%) 
Acinetobacter Infection * 1  0/152 (0.00%)  1/151 (0.66%) 
Appendicitis * 1  0/152 (0.00%)  1/151 (0.66%) 
Necrotising Fasciitis * 1  0/152 (0.00%)  1/151 (0.66%) 
Oesophageal Candidiasis * 1  0/152 (0.00%)  1/151 (0.66%) 
Pneumonia Klebsiella * 1  0/152 (0.00%)  1/151 (0.66%) 
Injury, poisoning and procedural complications     
Forearm Fracture * 1  0/152 (0.00%)  1/151 (0.66%) 
Thoracic Vertebral Fracture * 1  1/152 (0.66%)  0/151 (0.00%) 
Investigations     
Blood Creatinine Increased * 1  2/152 (1.32%)  0/151 (0.00%) 
Alanine Aminotransferase Increased * 1  1/152 (0.66%)  4/151 (2.65%) 
Aspartate Aminotransferase Increased * 1  1/152 (0.66%)  1/151 (0.66%) 
Human Chorionic Gonadotropin Increased * 1  1/152 (0.66%)  0/151 (0.00%) 
Metabolism and nutrition disorders     
Hyponatraemia * 1  1/152 (0.66%)  1/151 (0.66%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/152 (0.00%)  1/151 (0.66%) 
Back Pain * 1  1/152 (0.66%)  0/151 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ovarian Cancer * 1  0/152 (0.00%)  1/151 (0.66%) 
Nervous system disorders     
Aphasia * 1  0/152 (0.00%)  1/151 (0.66%) 
Cerebral Haemorrhage * 1  0/152 (0.00%)  1/151 (0.66%) 
Dizziness * 1  1/152 (0.66%)  1/151 (0.66%) 
Epilepsy * 1  0/152 (0.00%)  1/151 (0.66%) 
Hemiparesis * 1  0/152 (0.00%)  1/151 (0.66%) 
Seizure * 1  0/152 (0.00%)  1/151 (0.66%) 
Haemorrhage Intracranial * 1  1/152 (0.66%)  0/151 (0.00%) 
Hypoglycaemic Coma * 1  1/152 (0.66%)  0/151 (0.00%) 
Psychiatric disorders     
Confusional State * 1  1/152 (0.66%)  2/151 (1.32%) 
Disorientation * 1  1/152 (0.66%)  0/151 (0.00%) 
Renal and urinary disorders     
Renal Impairment * 1  0/152 (0.00%)  1/151 (0.66%) 
Acute Kidney Injury * 1  4/152 (2.63%)  0/151 (0.00%) 
Urinary Retention * 1  1/152 (0.66%)  0/151 (0.00%) 
Reproductive system and breast disorders     
Uterine Polyp * 1  1/152 (0.66%)  0/151 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis * 1  2/152 (1.32%)  4/151 (2.65%) 
Pneumothorax * 1  2/152 (1.32%)  0/151 (0.00%) 
Dyspnoea * 1  2/152 (1.32%)  1/151 (0.66%) 
Pulmonary Embolism * 1  2/152 (1.32%)  3/151 (1.99%) 
Bronchopleural Fistula * 1  1/152 (0.66%)  0/151 (0.00%) 
Haemoptysis * 1  1/152 (0.66%)  1/151 (0.66%) 
Pleural Effusion * 1  1/152 (0.66%)  1/151 (0.66%) 
Pulmonary Haemorrhage * 1  1/152 (0.66%)  0/151 (0.00%) 
Respiratory Failure * 1  1/152 (0.66%)  1/151 (0.66%) 
Interstitial Lung Disease * 1  0/152 (0.00%)  1/151 (0.66%) 
Skin and subcutaneous tissue disorders     
Rash * 1  1/152 (0.66%)  0/151 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis * 1  0/152 (0.00%)  2/151 (1.32%) 
Lymphoedema * 1  0/152 (0.00%)  1/151 (0.66%) 
Orthostatic Hypotension * 1  0/152 (0.00%)  1/151 (0.66%) 
Thrombosis * 1  0/152 (0.00%)  1/151 (0.66%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alectinib Crizotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   136/152 (89.47%)   140/151 (92.72%) 
Blood and lymphatic system disorders     
Anaemia * 1  29/152 (19.08%)  7/151 (4.64%) 
Neutropenia * 1  4/152 (2.63%)  11/151 (7.28%) 
Cardiac disorders     
Bradycardia * 1  8/152 (5.26%)  14/151 (9.27%) 
Sinus Bradycardia * 1  8/152 (5.26%)  7/151 (4.64%) 
Eye disorders     
Visual Impairment * 1  2/152 (1.32%)  18/151 (11.92%) 
Vision Blurred * 1  3/152 (1.97%)  10/151 (6.62%) 
Photopsia * 1  0/152 (0.00%)  9/151 (5.96%) 
Gastrointestinal disorders     
Constipation * 1  52/152 (34.21%)  49/151 (32.45%) 
Nausea * 1  21/152 (13.82%)  70/151 (46.36%) 
Diarrohea * 1  18/152 (11.84%)  68/151 (45.03%) 
Vomiting * 1  11/152 (7.24%)  57/151 (37.75%) 
Abdominal Pain * 1  9/152 (5.92%)  7/151 (4.64%) 
Dyspepsia * 1  5/152 (3.29%)  12/151 (7.95%) 
Abdominal Pain Upper * 1  8/152 (5.26%)  6/151 (3.97%) 
Dysphagia * 1  1/152 (0.66%)  8/151 (5.30%) 
General disorders     
Oedema Peripheral * 1  26/152 (17.11%)  41/151 (27.15%) 
Fatigue * 1  29/152 (19.08%)  25/151 (16.56%) 
Asthenia * 1  11/152 (7.24%)  11/151 (7.28%) 
Pyrexia * 1  7/152 (4.61%)  9/151 (5.96%) 
Chest Pain * 1  9/152 (5.92%)  5/151 (3.31%) 
Infections and infestations     
Upper Respiratory Tract Infection * 1  13/152 (8.55%)  13/151 (8.61%) 
Urinary Tract Infection * 1  10/152 (6.58%)  7/151 (4.64%) 
Investigations     
Alanine Aminotransferase Increased * 1  22/152 (14.47%)  42/151 (27.81%) 
Aspartate Aminotransferase Increased * 1  20/152 (13.16%)  37/151 (24.50%) 
Blood Bilirubin Increased * 1  23/152 (15.13%)  2/151 (1.32%) 
Blood Creatinine Increased * 1  11/152 (7.24%)  6/151 (3.97%) 
Blood Creatine Phosphokinase Increased * 1  8/152 (5.26%)  7/151 (4.64%) 
Weight Increased * 1  15/152 (9.87%)  0/151 (0.00%) 
Blood Alkaline Phosphatase Increased * 1  6/152 (3.95%)  8/151 (5.30%) 
Gamma−Glutamyltransferase Increased * 1  1/152 (0.66%)  10/151 (6.62%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  14/152 (9.21%)  14/151 (9.27%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  17/152 (11.18%)  10/151 (6.62%) 
Myalgia * 1  24/152 (15.79%)  3/151 (1.99%) 
Back Pain * 1  12/152 (7.89%)  7/151 (4.64%) 
Pain In Extremity * 1  6/152 (3.95%)  10/151 (6.62%) 
Musculoskeletal Pain * 1  11/152 (7.24%)  3/151 (1.99%) 
Nervous system disorders     
Dysgeusia * 1  4/152 (2.63%)  29/151 (19.21%) 
Dizziness * 1  12/152 (7.89%)  20/151 (13.25%) 
Headache * 1  11/152 (7.24%)  13/151 (8.61%) 
Paraesthesia * 1  3/152 (1.97%)  8/151 (5.30%) 
Psychiatric disorders     
Insomnia * 1  15/152 (9.87%)  9/151 (5.96%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  11/152 (7.24%)  9/151 (5.96%) 
Dyspnoea * 1  8/152 (5.26%)  6/151 (3.97%) 
Productive Cough * 1  8/152 (5.26%)  1/151 (0.66%) 
Skin and subcutaneous tissue disorders     
Rash * 1  16/152 (10.53%)  14/151 (9.27%) 
Alopecia * 1  1/152 (0.66%)  11/151 (7.28%) 
Photosensitivity Reaction * 1  8/152 (5.26%)  0/151 (0.00%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02075840     History of Changes
Other Study ID Numbers: BO28984
2013-004133-33 ( EudraCT Number )
First Submitted: February 27, 2014
First Posted: March 3, 2014
Results First Submitted: February 6, 2018
Results First Posted: March 15, 2018
Last Update Posted: October 10, 2019