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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01871805
Recruitment Status : Completed
First Posted : June 7, 2013
Results First Posted : February 12, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Intervention Drug: Alectinib
Enrollment 134
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alectinib 300 mg (Fasted): Phase I Alectinib 460 mg (Fed): Phase I Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Alectinib 760 mg (Fed): Phase I Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
Period Title: Phase I
Started 7 7 13 7 13 0
Completed 0 0 0 0 0 0
Not Completed 7 7 13 7 13 0
Reason Not Completed
Death             7             4             6             2             9             0
Alive in Survival Follow-up             0             2             4             5             4             0
Lost to Follow-up             0             1             3             0             0             0
Period Title: Phase II
Started 0 0 0 0 0 87
Completed 0 0 0 0 0 0
Not Completed 0 0 0 0 0 87
Reason Not Completed
Death             0             0             0             0             0             45
Alive in Survival Follow-up             0             0             0             0             0             29
Lost to Follow-up             0             0             0             0             0             13
Arm/Group Title Alectinib 300 mg (Fasted): Phase I Alectinib 460 mg (Fed): Phase I Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Alectinib 760 mg (Fed): Phase I Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Alectinib 600 mg (Fed): Phase II Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 7 7 13 7 13 87 134
Hide Baseline Analysis Population Description
Safety population included all participants who received any dose of alectinib.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 13 participants 7 participants 13 participants 87 participants 134 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
6
  85.7%
12
  92.3%
7
 100.0%
10
  76.9%
71
  81.6%
113
  84.3%
>=65 years
0
   0.0%
1
  14.3%
1
   7.7%
0
   0.0%
3
  23.1%
16
  18.4%
21
  15.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 13 participants 7 participants 13 participants 87 participants 134 participants
Female
2
  28.6%
4
  57.1%
3
  23.1%
2
  28.6%
9
  69.2%
48
  55.2%
68
  50.7%
Male
5
  71.4%
3
  42.9%
10
  76.9%
5
  71.4%
4
  30.8%
39
  44.8%
66
  49.3%
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs): Phase I
Hide Description 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.
Time Frame Throughout Cycle 1 of Phase I (21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I safety population
Arm/Group Title Alectinib 300 mg (Fasted): Phase I Alectinib 460 mg (Fed): Phase I Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Alectinib 760 mg (Fed): Phase I Alectinib 900 mg (Fed): Phase I (20/40/150 mg)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 7 7 13 7 13
Measure Type: Number
Unit of Measure: participants
0 0 0 0 2
2.Primary Outcome
Title Recommended Phase II Dose (RP2D): Phase I
Hide Description RP2D was defined as the highest dose with acceptable toxicity as determined from Phase I of the study.
Time Frame Throughout Cycle 1 of Phase I (21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I safety population
Arm/Group Title Alectinib: Phase I
Hide Arm/Group Description:
Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 600, 760, or 900 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.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: mg
600
3.Primary Outcome
Title 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
Hide Description 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).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.2
(39.67 to 64.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alectinib 600 mg (Fed): Phase II
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0056
Comments Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.
Method Exact Clopper-Pearson CI, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Alectinib Other Than 600 mg (Fasted/Fed): Phase I
Hide Arm/Group Description:
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.
Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 760, or 900 mg on Cycle 1 Day -3 and then received 300, 460, 760, or 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Overall Number of Participants Analyzed 13 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
69.2
(38.57 to 90.91)
55.9
(37.89 to 72.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alectinib 600 mg (Fed): Phase I (20/40/150 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0251
Comments Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.
Method Exact Clopper-Pearson CI, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alectinib Other Than 600 mg (Fasted/Fed): Phase I
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0203
Comments Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.
Method Exact Clopper-Pearson CI, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Duration of Response (DOR) According to RECIST v1.1 by Investigator: Phase I
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I RE population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Alectinib Other Than 600 mg (Fasted/Fed): Phase I
Hide Arm/Group Description:
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.
Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 760, or 900 mg on Cycle 1 Day -3 and then received 300, 460, 760, or 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Overall Number of Participants Analyzed 9 19
Median (95% Confidence Interval)
Unit of Measure: months
12.2
(4.9 to 20.9)
11.0
(6.3 to 14.8)
6.Secondary Outcome
Title Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II RE population
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.9
(41.87 to 63.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alectinib 600 mg (Fed): Phase II
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.
Method Exact Clopper-Pearson CI, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Disease Control According to RECIST v1.1 by Investigator: Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II RE population
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66.7
(55.75 to 76.42)
8.Secondary Outcome
Title Percentage of Participants With Disease Progression According to RECIST v1.1 by IRC or Death : Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II safety population
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 87
Measure Type: Number
Unit of Measure: percentage of participants
66.7
9.Secondary Outcome
Title Progression-Free Survival (PFS) According to RECIST v1.1 by IRC: Phase II
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II safety population
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 87
Median (95% Confidence Interval)
Unit of Measure: months
8.2
(6.3 to 12.6)
10.Secondary Outcome
Title Percentage of Participants With Disease Progression According to RECIST v1.1 by Investigator or Death : Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II safety population
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 87
Measure Type: Number
Unit of Measure: percentage of participants
70.1
11.Secondary Outcome
Title PFS According to RECIST v1.1 by Investigator: Phase II
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II RE population
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 87
Median (95% Confidence Interval)
Unit of Measure: months
8.4
(5.5 to 12.7)
12.Secondary Outcome
Title Percentage of Participants Who Died Due to Any Cause: Phase II
Hide Description [Not Specified]
Time Frame Baseline up to death (any cause) (maximum follow up 284 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II safety population
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 87
Measure Type: Number
Unit of Measure: percentage of participants
51.7
13.Secondary Outcome
Title Overall Survival (OS) Time: Phase II
Hide Description 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.
Time Frame Baseline up to death (any cause) (maximum follow up 284 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II safety population
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 87
Median (95% Confidence Interval)
Unit of Measure: months
27.9 [1] 
(17.2 to NA)
[1]
Upper limit of 95% CI was not estimable due to low number of events and longer observation time.
14.Secondary Outcome
Title DOR According to RECIST v1.1 by IRC: Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II RE population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 35
Median (95% Confidence Interval)
Unit of Measure: months
14.9 [1] 
(6.9 to NA)
[1]
Upper limit of 95% CI was not estimable due to low number of events and longer observation time.
15.Secondary Outcome
Title DOR According to RECIST v1.1 by Investigator: Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II RE population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 46
Median (95% Confidence Interval)
Unit of Measure: months
13.3
(8.8 to 18.2)
16.Secondary Outcome
Title Percentage of Participants With Central Nervous System Objective Response (COR) According to RECIST v1.1 by IRC: Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants with measurable CNS lesions at baseline based on RECIST v1.1 according to IRC.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.0
(47.62 to 92.73)
17.Secondary Outcome
Title Percentage of Participants With COR According to Response Assessment in Neuro-Oncology (RANO) Criteria by IRC: Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants with measurable CNS lesions at baseline according to RANO criteria by IRC.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.5
(23.38 to 83.25)
18.Secondary Outcome
Title CNS Duration of Response (CDOR) According to RECIST v1.1 by IRC: Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: months
11.1 [1] 
(5.8 to NA)
[1]
Upper limit of 95% CI was not estimable due to low number of events and longer observation time.
19.Secondary Outcome
Title CDOR According to RANO Criteria by IRC: Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 6
Median (95% Confidence Interval)
Unit of Measure: months
12.1 [1] 
(11.1 to NA)
[1]
Upper limit of 95% CI was not estimable due to low number of events and longer observation time.
20.Secondary Outcome
Title Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.00 to 20.59)
21.Secondary Outcome
Title Percentage of Participants With CNS Progression According to RANO Criteria by IRC: Phase II
Hide Description 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).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not estimable due to low number of responders and longer observation time.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) After Single Dose of Alectinib: Phase I
Hide Description [Not Specified]
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I Alectinib 240 mg Once and 300 mg BID (Fed): Phase I Alectinib 300 mg (Fasted): Phase I Alectinib 460 mg (Fed): Phase I Alectinib 600 mg (Fed): Phase I (20/40 mg) Alectinib 600 mg (Fed): Phase I (150 mg) Alectinib 760 mg (Fed): Phase I Alectinib 900 mg (Fed): Phase I (20/40 mg) Alectinib 900 mg (Fed): Phase I (150 mg)
Hide Arm/Group Description:
Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 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.
Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 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.
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 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.
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.
Participants received single dose of 20 or 40 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.
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.
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.
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.
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 Number of Participants Analyzed 3 1 3 7 6 6 7 7 6
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
73.5  (12.4) 87.7 45.3  (9.24) 142.00  (71.4) 158.0  (67.2) 186.0  (43.1) 257.0  (83.1) 186.0  (120.0) 295.0  (131.0)
23.Secondary Outcome
Title Cmax After Multiple Dose of Alectinib: Phase I
Hide Description [Not Specified]
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Alectinib 300 mg (Fasted): Phase I Alectinib 460 mg (Fed): Phase I Alectinib 600 mg (Fed): Phase I (20/40 mg) Alectinib 600 mg (Fed): Phase I (150 mg) Alectinib 760 mg (Fed): Phase I Alectinib 900 mg (Fed): Phase I (20/40 mg) Alectinib 900 mg (Fed): Phase I (150 mg)
Hide Arm/Group Description:
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.
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.
Participants received single dose of 20 or 40 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.
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.
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.
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.
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 Number of Participants Analyzed 6 7 5 6 5 7 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
259  (79.0) 618  (165) 765  (176) 670  (360) 733  (98.0) 1140  (448) 1200  (311)
24.Secondary Outcome
Title Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I
Hide Description AUCinf = AUC from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0- t) plus AUC (t-inf).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I Alectinib 240 mg Once and 300 mg BID (Fed): Phase I Alectinib 300 mg (Fasted): Phase I Alectinib 460 mg (Fed): Phase I Alectinib 600 mg (Fed): Phase I (20/40 mg) Alectinib 600 mg (Fed): Phase I (150 mg) Alectinib 760 mg (Fed): Phase I Alectinib 900 mg (Fed): Phase I (20/40 mg) Alectinib 900 mg (Fed): Phase I (150 mg)
Hide Arm/Group Description:
Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 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.
Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 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.
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 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.
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.
Participants received single dose of 20 or 40 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.
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.
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.
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.
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 Number of Participants Analyzed 3 1 3 7 6 6 7 7 6
Mean (Standard Deviation)
Unit of Measure: hour*ng/mL
1360  (436) 858 1030  (481) 3280  (2240) 3310  (1110) 3190  (1510) 4090  (1680) 3730  (2310) 7790  (6210)
25.Secondary Outcome
Title AUC From Time Zero to Last Measurable Concentration (AUClast) After Multiple Dose of Alectinib: Phase I
Hide Description [Not Specified]
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Alectinib 300 mg (Fasted): Phase I Alectinib 460 mg (Fed): Phase I Alectinib 600 mg (Fed): Phase I (20/40 mg) Alectinib 600 mg (Fed): Phase I (150 mg) Alectinib 760 mg (Fed): Phase I Alectinib 900 mg (Fed): Phase I (20/40 mg) Alectinib 900 mg (Fed): Phase I (150 mg)
Hide Arm/Group Description:
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.
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.
Participants received single dose of 20 or 40 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.
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.
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.
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.
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 Number of Participants Analyzed 6 7 5 6 5 7 4
Mean (Standard Deviation)
Unit of Measure: hour*ng/mL
1800  (562) 4510  (1700) 5970  (1140) 5300  (3180) 5780  (1020) 9800  (4660) 9500  (2670)
26.Secondary Outcome
Title Ctrough After Multiple Dose of Alectinib: Phase II
Hide Description [Not Specified]
Time Frame Pre-dose (0 hour) on Day 1 of Cycles 2, Cycle 3, Cycle 4, Cycle 5 (1 cycle = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 2 Day 1 Number Analyzed 61 participants
473  (277)
Cycle 3 Day 1 Number Analyzed 51 participants
521  (272)
Cycle 4 Day 1 Number Analyzed 52 participants
538  (279)
Cycle 5 Day 1 Number Analyzed 45 participants
538  (226)
27.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II
Hide Description 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
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
Global health status/QoL: Baseline Number Analyzed 79 participants
53.59  (24.27)
Global health status/QoL: Week 6 Number Analyzed 64 participants
15.89  (25.66)
Global health status/QoL: Week 9 Number Analyzed 1 participants
0.00
Global health status/QoL: Week 12 Number Analyzed 54 participants
18.83  (23.41)
Global health status/QoL: Week 15 Number Analyzed 1 participants
0.00
Global health status/QoL: Week 18 Number Analyzed 49 participants
15.65  (23.73)
Global health status/QoL: Week 21 Number Analyzed 1 participants
0.00
Global health status/QoL: Week 24 Number Analyzed 41 participants
15.65  (20.77)
Global health status/QoL: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Global health status/QoL: Week 30 Number Analyzed 39 participants
13.03  (19.57)
Global health status/QoL: Week 33 Number Analyzed 3 participants
-5.56  (9.62)
Global health status/QoL: Week 36 Number Analyzed 38 participants
12.28  (20.57)
Global health status/QoL: Week 39 Number Analyzed 2 participants
4.17  (5.89)
Global health status/QoL: Week 42 Number Analyzed 36 participants
10.19  (19.33)
Global health status/QoL: Week 45 Number Analyzed 4 participants
-10.42  (12.50)
Global health status/QoL: Week 48 Number Analyzed 33 participants
11.11  (19.06)
Global health status/QoL: Week 51 Number Analyzed 2 participants
12.50  (17.68)
Global health status/QoL: Week 54 Number Analyzed 31 participants
9.95  (16.86)
Global health status/QoL: Week 57 Number Analyzed 5 participants
-3.33  (21.73)
Global health status/QoL: Week 60 Number Analyzed 30 participants
10.28  (19.54)
Global health status/QoL: Week 63 Number Analyzed 3 participants
11.11  (19.25)
Global health status/QoL: Week 66 Number Analyzed 26 participants
15.06  (17.80)
Global health status/QoL: Week 69 Number Analyzed 4 participants
12.50  (15.96)
Global health status/QoL: Week 72 Number Analyzed 23 participants
8.33  (18.12)
Global health status/QoL: Week 75 Number Analyzed 2 participants
16.67  (23.57)
Global health status/QoL: Week 78 Number Analyzed 21 participants
10.32  (16.44)
Global health status/QoL: Week 81 Number Analyzed 2 participants
16.67  (23.57)
Global health status/QoL: Week 84 Number Analyzed 13 participants
10.90  (14.98)
Global health status/QoL: Week 87 Number Analyzed 3 participants
11.11  (19.25)
Global health status/QoL: Week 90 Number Analyzed 8 participants
4.17  (11.79)
Global health status/QoL: Week 93 Number Analyzed 2 participants
-29.17  (41.25)
Global health status/QoL: Week 96 Number Analyzed 3 participants
0.00  (22.05)
Global health status/QoL: Week 99 Number Analyzed 1 participants
-16.67
Global health status/QoL: Week 105 Number Analyzed 1 participants
-16.67
Global health status/QoL: Week 111 Number Analyzed 1 participants
0.00
Global health status/QoL: Week 117 Number Analyzed 1 participants
0.00
Global health status/QoL: Last visit Number Analyzed 73 participants
7.99  (21.27)
Physical functioning: Baseline Number Analyzed 79 participants
69.96  (24.43)
Physical functioning: Week 6 Number Analyzed 64 participants
4.69  (17.44)
Physical functioning: Week 9 Number Analyzed 1 participants
0.00
Physical functioning: Week 12 Number Analyzed 54 participants
4.20  (22.37)
Physical functioning: Week 15 Number Analyzed 1 participants
0.00
Physical functioning: Week 18 Number Analyzed 51 participants
7.58  (18.23)
Physical functioning: Week 21 Number Analyzed 1 participants
0.00
Physical functioning: Week 24 Number Analyzed 42 participants
4.13  (16.33)
Physical functioning: Week 27 Number Analyzed 2 participants
3.33  (4.71)
Physical functioning: Week 30 Number Analyzed 39 participants
2.22  (17.39)
Physical functioning: Week 33 Number Analyzed 3 participants
0.00  (13.33)
Physical functioning: Week 36 Number Analyzed 38 participants
4.21  (18.10)
Physical functioning: Week 39 Number Analyzed 2 participants
3.33  (14.14)
Physical functioning: Week 42 Number Analyzed 36 participants
6.85  (18.89)
Physical functioning: Week 45 Number Analyzed 4 participants
-3.33  (22.11)
Physical functioning: Week 48 Number Analyzed 33 participants
5.25  (16.81)
Physical functioning: Week 51 Number Analyzed 2 participants
0.00  (18.86)
Physical functioning: Week 54 Number Analyzed 32 participants
6.67  (18.32)
Physical functioning: Week 57 Number Analyzed 5 participants
0.00  (20.55)
Physical functioning: Week 60 Number Analyzed 30 participants
7.56  (22.67)
Physical functioning: Week 63 Number Analyzed 3 participants
-6.67  (11.55)
Physical functioning: Week 66 Number Analyzed 26 participants
8.97  (19.13)
Physical functioning: Week 69 Number Analyzed 4 participants
8.33  (16.67)
Physical functioning: Week 72 Number Analyzed 23 participants
4.20  (22.70)
Physical functioning: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Physical functioning: Week 78 Number Analyzed 21 participants
6.98  (19.83)
Physical functioning: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Physical functioning: Week 84 Number Analyzed 13 participants
3.08  (21.71)
Physical functioning: Week 87 Number Analyzed 3 participants
-6.67  (11.55)
Physical functioning: Week 90 Number Analyzed 8 participants
7.50  (18.32)
Physical functioning: Week 93 Number Analyzed 2 participants
-26.67  (28.28)
Physical functioning: Week 96 Number Analyzed 3 participants
33.33  (11.55)
Physical functioning: Week 99 Number Analyzed 1 participants
-6.67
Physical functioning: Week 105 Number Analyzed 1 participants
0.00
Physical functioning: Week 111 Number Analyzed 1 participants
0.00
Physical functioning: Week 117 Number Analyzed 1 participants
0.00
Physical functioning: Last visit Number Analyzed 73 participants
2.28  (21.64)
Role functioning: Baseline Number Analyzed 79 participants
58.86  (34.06)
Role functioning: Week 6 Number Analyzed 64 participants
14.84  (32.00)
Role functioning: Week 9 Number Analyzed 1 participants
0.00
Role functioning: Week 12 Number Analyzed 54 participants
12.65  (32.69)
Role functioning: Week 15 Number Analyzed 1 participants
0.00
Role functioning: Week 18 Number Analyzed 51 participants
12.42  (31.94)
Role functioning: Week 21 Number Analyzed 1 participants
0.00
Role functioning: Week 24 Number Analyzed 42 participants
8.73  (27.85)
Role functioning: Week 27 Number Analyzed 2 participants
-8.33  (11.79)
Role functioning: Week 30 Number Analyzed 39 participants
9.83  (24.70)
Role functioning: Week 33 Number Analyzed 3 participants
-33.33  (33.33)
Role functioning: Week 36 Number Analyzed 38 participants
9.65  (24.70)
Role functioning: Week 39 Number Analyzed 2 participants
-33.33  (0.00)
Role functioning: Week 42 Number Analyzed 36 participants
6.48  (28.81)
Role functioning Week 45 Number Analyzed 4 participants
-20.83  (15.96)
Role functioning: Week 48 Number Analyzed 32 participants
10.94  (24.54)
Role functioning: Week 51 Number Analyzed 2 participants
-16.67  (23.57)
Role functioning: Week 54 Number Analyzed 32 participants
7.29  (24.30)
Role functioning: Week 57 Number Analyzed 5 participants
-13.33  (18.26)
Role functioning: Week 60 Number Analyzed 30 participants
8.89  (27.24)
Role functioning: Week 63 Number Analyzed 3 participants
-5.56  (9.62)
Role functioning: Week 66 Number Analyzed 26 participants
8.97  (29.90)
Role functioning: Week 69 Number Analyzed 4 participants
-16.67  (33.33)
Role functioning: Week 72 Number Analyzed 23 participants
7.97  (27.46)
Role functioning: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Role functioning: Week 78 Number Analyzed 21 participants
9.52  (28.66)
Role functioning: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Role functioning: Week 84 Number Analyzed 13 participants
5.13  (31.46)
Role functioning: Week 87 Number Analyzed 3 participants
-11.11  (19.25)
Role functioning: Week 90 Number Analyzed 8 participants
-4.17  (19.42)
Role functioning: Week 93 Number Analyzed 2 participants
-41.67  (35.36)
Role functioning: Week 96 Number Analyzed 3 participants
11.11  (19.25)
Role functioning: Week 99 Number Analyzed 1 participants
-16.67
Role functioning: Week 105 Number Analyzed 1 participants
0.00
Role functioning: Week 111 Number Analyzed 1 participants
0.00
Role functioning: Week 117 Number Analyzed 1 participants
0.00
Role functioning: Last visit Number Analyzed 73 participants
9.36  (34.47)
Emotional functioning: Baseline Number Analyzed 79 participants
73.49  (21.40)
Emotional functioning: Week 6 Number Analyzed 64 participants
7.99  (18.75)
Emotional functioning: Week 9 Number Analyzed 1 participants
0.00
Emotional functioning: Week 12 Number Analyzed 54 participants
11.01  (17.04)
Emotional functioning: Week 15 Number Analyzed 1 participants
0.00
Emotional functioning: Week 18 Number Analyzed 49 participants
13.44  (21.17)
Emotional functioning: Week 21 Number Analyzed 1 participants
0.00
Emotional functioning: Week 24 Number Analyzed 41 participants
10.37  (16.75)
Emotional functioning: Week 27 Number Analyzed 2 participants
-4.17  (5.89)
Emotional functioning: Week 30 Number Analyzed 39 participants
9.40  (20.34)
Emotional functioning: Week 33 Number Analyzed 3 participants
-30.56  (26.79)
Emotional functioning: Week 36 Number Analyzed 38 participants
7.89  (19.85)
Emotional functioning: Week 39 Number Analyzed 2 participants
-4.17  (5.89)
Emotional functioning: Week 42 Number Analyzed 36 participants
7.41  (18.12)
Emotional functioning Week 45 Number Analyzed 4 participants
-6.25  (7.98)
Emotional functioning: Week 48 Number Analyzed 33 participants
6.73  (15.23)
Emotional functioning: Week 51 Number Analyzed 2 participants
0.00  (0.00)
Emotional functioning: Week 54 Number Analyzed 31 participants
3.49  (13.40)
Emotional functioning: Week 57 Number Analyzed 5 participants
-6.67  (18.07)
Emotional functioning: Week 60 Number Analyzed 30 participants
3.33  (14.12)
Emotional functioning: Week 63 Number Analyzed 3 participants
-11.11  (34.69)
Emotional functioning: Week 66 Number Analyzed 26 participants
5.45  (14.52)
Emotional functioning: Week 69 Number Analyzed 4 participants
-8.33  (26.35)
Emotional functioning: Week 72 Number Analyzed 23 participants
5.07  (21.43)
Emotional functioning: Week 75 Number Analyzed 2 participants
8.33  (11.79)
Emotional functioning: Week 78 Number Analyzed 21 participants
-1.19  (19.77)
Emotional functioning: Week 81 Number Analyzed 2 participants
4.17  (5.89)
Emotional functioning: Week 84 Number Analyzed 13 participants
1.28  (19.79)
Emotional functioning: Week 87 Number Analyzed 3 participants
-11.11  (34.69)
Emotional functioning: Week 90 Number Analyzed 8 participants
1.04  (8.26)
Emotional functioning: Week 93 Number Analyzed 2 participants
-12.50  (17.68)
Emotional functioning: Week 96 Number Analyzed 3 participants
11.11  (19.25)
Emotional functioning: Week 99 Number Analyzed 1 participants
0.00
Emotional functioning: Week 105 Number Analyzed 1 participants
0.00
Emotional functioning: Week 111 Number Analyzed 1 participants
0.00
Emotional functioning: Week 117 Number Analyzed 1 participants
0.00
Emotional functioning: Last visit Number Analyzed 73 participants
4.76  (19.86)
Cognitive functioning: Baseline Number Analyzed 79 participants
77.85  (24.13)
Cognitive functioning: Week 6 Number Analyzed 64 participants
2.34  (20.76)
Cognitive functioning: Week 9 Number Analyzed 1 participants
0.00
Cognitive functioning: Week 12 Number Analyzed 54 participants
2.78  (15.44)
Cognitive functioning: Week 15 Number Analyzed 1 participants
0.00
Cognitive functioning: Week 18 Number Analyzed 49 participants
2.04  (15.82)
Cognitive functioning: Week 21 Number Analyzed 1 participants
0.00
Cognitive functioning: Week 24 Number Analyzed 41 participants
-3.25  (16.34)
Cognitive functioning: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Cognitive functioning: Week 30 Number Analyzed 39 participants
-1.28  (17.68)
Cognitive functioning: Week 33 Number Analyzed 3 participants
-27.78  (25.46)
Cognitive functioning: Week 36 Number Analyzed 38 participants
-2.63  (13.16)
Cognitive functioning: Week 39 Number Analyzed 2 participants
-25.00  (35.36)
Cognitive functioning: Week 42 Number Analyzed 36 participants
-0.46  (14.08)
Cognitive functioning Week 45 Number Analyzed 4 participants
-4.17  (51.59)
Cognitive functioning: Week 48 Number Analyzed 33 participants
-6.06  (21.58)
Cognitive functioning: Week 51 Number Analyzed 2 participants
-33.33  (0.00)
Cognitive functioning: Week 54 Number Analyzed 31 participants
-7.53  (22.29)
Cognitive functioning: Week 57 Number Analyzed 5 participants
0.00  (31.18)
Cognitive functioning: Week 60 Number Analyzed 30 participants
-6.11  (21.66)
Cognitive functioning: Week 63 Number Analyzed 3 participants
11.11  (19.25)
Cognitive functioning: Week 66 Number Analyzed 26 participants
-8.97  (22.23)
Cognitive functioning: Week 69 Number Analyzed 4 participants
4.17  (8.33)
Cognitive functioning: Week 72 Number Analyzed 23 participants
-7.97  (20.64)
Cognitive functioning: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Cognitive functioning: Week 78 Number Analyzed 21 participants
-9.52  (25.59)
Cognitive functioning: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Cognitive functioning: Week 84 Number Analyzed 13 participants
-3.85  (20.59)
Cognitive functioning: Week 87 Number Analyzed 3 participants
-11.11  (19.25)
Cognitive functioning: Week 90 Number Analyzed 8 participants
-8.33  (15.43)
Cognitive functioning: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Cognitive functioning: Week 96 Number Analyzed 3 participants
-22.22  (19.25)
Cognitive functioning: Week 99 Number Analyzed 1 participants
0.00
Cognitive functioning: Week 105 Number Analyzed 1 participants
0.00
Cognitive functioning: Week 111 Number Analyzed 1 participants
0.00
Cognitive functioning: Week 117 Number Analyzed 1 participants
0.00
Cognitive functioning: Last visit Number Analyzed 73 participants
-4.79  (24.45)
Social functioning: Baseline Number Analyzed 79 participants
60.55  (35.32)
Social functioning: Week 6 Number Analyzed 64 participants
11.20  (23.20)
Social functioning: Week 9 Number Analyzed 1 participants
0.00
Social functioning: Week 12 Number Analyzed 54 participants
10.19  (27.93)
Social functioning: Week 15 Number Analyzed 1 participants
0.00
Social functioning: Week 18 Number Analyzed 49 participants
13.27  (25.45)
Social functioning: Week 21 Number Analyzed 1 participants
0.00
Social functioning: Week 24 Number Analyzed 41 participants
8.54  (26.38)
Social functioning: Week 27 Number Analyzed 2 participants
16.67  (23.57)
Social functioning: Week 30 Number Analyzed 39 participants
14.53  (31.11)
Social functioning: Week 33 Number Analyzed 3 participants
5.56  (25.46)
Social functioning: Week 36 Number Analyzed 38 participants
9.21  (32.35)
Social functioning: Week 39 Number Analyzed 2 participants
-8.33  (11.79)
Social functioning: Week 42 Number Analyzed 36 participants
8.80  (30.47)
Social functioning: Week 45 Number Analyzed 4 participants
4.17  (20.97)
Social functioning: Week 48 Number Analyzed 33 participants
16.16  (29.31)
Social functioning: Week 51 Number Analyzed 2 participants
-8.33  (11.79)
Social functioning: Week 54 Number Analyzed 31 participants
12.37  (28.53)
Social functioning: Week 57 Number Analyzed 5 participants
3.33  (18.26)
Social functioning: Week 60 Number Analyzed 30 participants
8.33  (25.43)
Social functioning: Week 63 Number Analyzed 3 participants
0.00  (33.33)
Social functioning: Week 66 Number Analyzed 26 participants
5.77  (31.95)
Social functioning: Week 69 Number Analyzed 4 participants
20.83  (25.00)
Social functioning: Week 72 Number Analyzed 23 participants
11.59  (23.80)
Social functioning: Week 75 Number Analyzed 2 participants
16.67  (23.57)
Social functioning: Week 78 Number Analyzed 21 participants
12.70  (23.51)
Social functioning: Week 81 Number Analyzed 2 participants
16.67  (23.57)
Social functioning: Week 84 Number Analyzed 13 participants
8.97  (29.36)
Social functioning: Week 87 Number Analyzed 3 participants
27.78  (25.46)
Social functioning: Week 90 Number Analyzed 8 participants
14.58  (16.52)
Social functioning: Week 93 Number Analyzed 2 participants
-8.33  (82.50)
Social functioning: Week 96 Number Analyzed 3 participants
16.67  (16.67)
Social functioning: Week 99 Number Analyzed 1 participants
0.00
Social functioning: Week 105 Number Analyzed 1 participants
0.00
Social functioning: Week 111 Number Analyzed 1 participants
0.00
Social functioning: Week 117 Number Analyzed 1 participants
0.00
Social functioning: Last visit Number Analyzed 73 participants
3.20  (30.39)
Fatigue: Baseline Number Analyzed 79 participants
45.57  (27.02)
Fatigue: Week 6 Number Analyzed 64 participants
-10.94  (25.70)
Fatigue: Week 9 Number Analyzed 1 participants
-11.11
Fatigue: Week 12 Number Analyzed 54 participants
-11.11  (27.73)
Fatigue: Week 15 Number Analyzed 1 participants
0.00
Fatigue: Week 18 Number Analyzed 51 participants
-12.85  (24.88)
Fatigue: Week 21 Number Analyzed 1 participants
0.00
Fatigue: Week 24 Number Analyzed 42 participants
-10.05  (22.06)
Fatigue: Week 27 Number Analyzed 2 participants
5.56  (7.86)
Fatigue: Week 30 Number Analyzed 39 participants
-9.97  (23.47)
Fatigue: Week 33 Number Analyzed 3 participants
14.81  (6.42)
Fatigue: Week 36 Number Analyzed 38 participants
-10.23  (25.75)
Fatigue: Week 39 Number Analyzed 2 participants
5.56  (7.86)
Fatigue: Week 42 Number Analyzed 36 participants
-9.26  (21.50)
Fatigue: Week 45 Number Analyzed 4 participants
0.00  (24.00)
Fatigue: Week 48 Number Analyzed 32 participants
-11.11  (22.93)
Fatigue: Week 51 Number Analyzed 2 participants
0.00  (47.14)
Fatigue: Week 54 Number Analyzed 32 participants
-7.64  (18.39)
Fatigue: Week 57 Number Analyzed 5 participants
4.44  (16.85)
Fatigue: Week 60 Number Analyzed 30 participants
-7.78  (21.27)
Fatigue: Week 63 Number Analyzed 3 participants
7.41  (23.13)
Fatigue: Week 66 Number Analyzed 26 participants
-7.69  (20.07)
Fatigue: Week 69 Number Analyzed 4 participants
-8.33  (10.64)
Fatigue: Week 72 Number Analyzed 23 participants
-8.21  (22.28)
Fatigue: Week 75 Number Analyzed 2 participants
-5.56  (7.86)
Fatigue: Week 78 Number Analyzed 21 participants
-6.35  (23.19)
Fatigue: Week 81 Number Analyzed 2 participants
-5.56  (7.86)
Fatigue: Week 84 Number Analyzed 13 participants
-9.40  (18.62)
Fatigue: Week 87 Number Analyzed 3 participants
0.00  (11.11)
Fatigue: Week 90 Number Analyzed 8 participants
-8.33  (17.57)
Fatigue: Week 93 Number Analyzed 2 participants
33.33  (31.43)
Fatigue: Week 96 Number Analyzed 3 participants
-18.52  (6.42)
Fatigue: Week 99 Number Analyzed 1 participants
0.00
Fatigue: Week 105 Number Analyzed 1 participants
0.00
Fatigue: Week 111 Number Analyzed 1 participants
0.00
Fatigue: Week 117 Number Analyzed 1 participants
0.00
Fatigue: Last visit Number Analyzed 73 participants
-6.85  (21.65)
Nausea and vomiting: Baseline Number Analyzed 79 participants
15.61  (20.73)
Nausea and vomiting: Week 6 Number Analyzed 64 participants
-6.77  (19.63)
Nausea and vomiting: Week 9 Number Analyzed 1 participants
0.00
Nausea and vomiting: Week 12 Number Analyzed 54 participants
-8.02  (21.66)
Nausea and vomiting: Week 15 Number Analyzed 1 participants
0.00
Nausea and vomiting: Week 18 Number Analyzed 51 participants
-9.15  (19.81)
Nausea and vomiting: Week 21 Number Analyzed 1 participants
0.00
Nausea and vomiting: Week 24 Number Analyzed 42 participants
-9.13  (18.48)
Nausea and vomiting: Week 27 Number Analyzed 2 participants
-8.33  (11.79)
Nausea and vomiting: Week 30 Number Analyzed 39 participants
-5.98  (17.31)
Nausea and vomiting: Week 33 Number Analyzed 3 participants
11.11  (25.46)
Nausea and vomiting: Week 36 Number Analyzed 38 participants
-7.46  (17.63)
Nausea and vomiting: Week 39 Number Analyzed 2 participants
16.67  (23.57)
Nausea and vomiting: Week 42 Number Analyzed 36 participants
-8.80  (18.47)
Nausea and vomiting: Week 45 Number Analyzed 4 participants
4.17  (8.33)
Nausea and vomiting: Week 48 Number Analyzed 32 participants
-9.38  (19.37)
Nausea and vomiting: Week 51 Number Analyzed 2 participants
8.33  (11.79)
Nausea and vomiting: Week 54 Number Analyzed 32 participants
-8.85  (19.85)
Nausea and vomiting: Week 57 Number Analyzed 5 participants
6.67  (14.91)
Nausea and vomiting: Week 60 Number Analyzed 30 participants
-6.67  (17.29)
Nausea and vomiting: Week 63 Number Analyzed 3 participants
11.11  (19.25)
Nausea and vomiting: Week 66 Number Analyzed 26 participants
-7.05  (20.10)
Nausea and vomiting: Week 69 Number Analyzed 4 participants
0.00  (0.00)
Nausea and vomiting: Week 72 Number Analyzed 23 participants
-5.80  (19.85)
Nausea and vomiting: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Nausea and vomiting: Week 78 Number Analyzed 21 participants
-5.56  (13.26)
Nausea and vomiting: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Nausea and vomiting: Week 84 Number Analyzed 13 participants
-6.41  (12.80)
Nausea and vomiting: Week 87 Number Analyzed 3 participants
5.56  (9.62)
Nausea and vomiting: Week 90 Number Analyzed 8 participants
2.08  (13.91)
Nausea and vomiting: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Nausea and vomiting: Week 96 Number Analyzed 3 participants
0.00  (16.67)
Nausea and vomiting: Week 99 Number Analyzed 1 participants
0.00
Nausea and vomiting: Week 105 Number Analyzed 1 participants
0.00
Nausea and vomiting: Week 111 Number Analyzed 1 participants
0.00
Nausea and vomiting: Week 117 Number Analyzed 1 participants
0.00
Nausea and vomiting: Last visit Number Analyzed 73 participants
-6.85  (20.38)
Pain: Baseline Number Analyzed 79 participants
36.29  (33.63)
Pain: Week 6 Number Analyzed 64 participants
-12.50  (33.47)
Pain: Week 9 Number Analyzed 1 participants
0.00
Pain: Week 12 Number Analyzed 54 participants
-14.81  (32.48)
Pain: Week 15 Number Analyzed 1 participants
0.00
Pain: Week 18 Number Analyzed 51 participants
-13.07  (33.55)
Pain: Week 21 Number Analyzed 1 participants
0.00
Pain: Week 24 Number Analyzed 42 participants
-6.35  (31.44)
Pain: Week 27 Number Analyzed 2 participants
8.33  (11.79)
Pain: Week 30 Number Analyzed 39 participants
-5.13  (33.37)
Pain: Week 33 Number Analyzed 3 participants
5.56  (9.62)
Pain: Week 36 Number Analyzed 38 participants
-6.14  (34.31)
Pain: Week 39 Number Analyzed 2 participants
-8.33  (11.79)
Pain: Week 42 Number Analyzed 36 participants
-5.09  (23.17)
Pain: Week 45 Number Analyzed 4 participants
8.33  (21.52)
Pain: Week 48 Number Analyzed 33 participants
-4.55  (17.81)
Pain: Week 51 Number Analyzed 2 participants
-25.00  (11.79)
Pain: Week 54 Number Analyzed 32 participants
-0.52  (24.86)
Pain: Week 57 Number Analyzed 5 participants
0.00  (39.09)
Pain: Week 60 Number Analyzed 30 participants
0.56  (14.17)
Pain: Week 63 Number Analyzed 3 participants
-5.56  (9.62)
Pain: Week 66 Number Analyzed 26 participants
-5.13  (23.46)
Pain: Week 69 Number Analyzed 4 participants
-4.17  (15.96)
Pain: Week 72 Number Analyzed 23 participants
-5.07  (28.62)
Pain: Week 75 Number Analyzed 2 participants
-8.33  (11.79)
Pain: Week 78 Number Analyzed 21 participants
1.59  (15.73)
Pain: Week 81 Number Analyzed 2 participants
-8.33  (11.79)
Pain: Week 84 Number Analyzed 13 participants
-5.13  (19.70)
Pain: Week 87 Number Analyzed 3 participants
-5.56  (9.62)
Pain: Week 90 Number Analyzed 8 participants
-8.33  (25.20)
Pain: Week 93 Number Analyzed 2 participants
25.00  (35.36)
Pain: Week 96 Number Analyzed 3 participants
-11.11  (53.58)
Pain: Week 99 Number Analyzed 1 participants
0.00
Pain: Week 105 Number Analyzed 1 participants
0.00
Pain: Week 111 Number Analyzed 1 participants
0.00
Pain: Week 117 Number Analyzed 1 participants
0.00
Pain: Last visit Number Analyzed 73 participants
-9.36  (29.92)
Dyspnoea: Baseline Number Analyzed 78 participants
33.33  (30.86)
Dyspnoea: Week 6 Number Analyzed 63 participants
-12.17  (32.96)
Dyspnoea : Week 9 Number Analyzed 1 participants
0.00
Dyspnoea: Week 12 Number Analyzed 53 participants
-10.69  (32.54)
Dyspnoea: Week 15 Number Analyzed 1 participants
0.00
Dyspnoea: Week 18 Number Analyzed 50 participants
-12.67  (30.78)
Dyspnoea: Week 21 Number Analyzed 1 participants
0.00
Dyspnoea: Week 24 Number Analyzed 40 participants
-7.50  (25.58)
Dyspnoea: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Dyspnoea: Week 30 Number Analyzed 38 participants
-7.89  (26.21)
Dyspnoea: Week 33 Number Analyzed 3 participants
0.00  (33.33)
Dyspnoea: Week 36 Number Analyzed 37 participants
-7.21  (27.37)
Dyspnoea: Week 39 Number Analyzed 2 participants
-16.67  (23.57)
Dyspnoea: Week 42 Number Analyzed 35 participants
-5.71  (27.40)
Dyspnoea: Week 45 Number Analyzed 4 participants
0.00  (27.22)
Dyspnoea: Week 48 Number Analyzed 32 participants
-6.25  (28.63)
Dyspnoea: Week 51 Number Analyzed 2 participants
0.00  (0.00)
Dyspnoea: Week 54 Number Analyzed 32 participants
-7.29  (23.55)
Dyspnoea: Week 57 Number Analyzed 5 participants
-6.67  (14.91)
Dyspnoea: Week 60 Number Analyzed 30 participants
-1.11  (22.29)
Dyspnoea: Week 63 Number Analyzed 3 participants
-11.11  (19.25)
Dyspnoea: Week 66 Number Analyzed 26 participants
-8.97  (24.14)
Dyspnoea: Week 69 Number Analyzed 4 participants
-8.33  (16.67)
Dyspnoea: Week 72 Number Analyzed 23 participants
-1.45  (32.53)
Dyspnoea: Week 75 Number Analyzed 2 participants
-16.67  (23.57)
Dyspnoea: Week 78 Number Analyzed 21 participants
-4.76  (21.82)
Dyspnoea: Week 81 Number Analyzed 2 participants
-16.67  (23.57)
Dyspnoea: Week 84 Number Analyzed 13 participants
0.00  (23.57)
Dyspnoea: Week 87 Number Analyzed 3 participants
-11.11  (19.25)
Dyspnoea: Week 90 Number Analyzed 8 participants
8.33  (29.55)
Dyspnoea: Week 93 Number Analyzed 2 participants
16.67  (23.57)
Dyspnoea: Week 96 Number Analyzed 3 participants
-11.11  (38.49)
Dyspnoea: Week 99 Number Analyzed 1 participants
33.33
Dyspnoea: Week 105 Number Analyzed 1 participants
0.00
Dyspnoea: Week 111 Number Analyzed 1 participants
0.00
Dyspnoea: Week 117 Number Analyzed 1 participants
0.00
Dyspnoea: Last visit Number Analyzed 72 participants
-4.63  (33.71)
Insomnia: Baseline Number Analyzed 79 participants
31.22  (30.82)
Insomnia: Week 6 Number Analyzed 64 participants
-9.38  (29.38)
Insomnia: Week 9 Number Analyzed 1 participants
0.00
Insomnia: Week 12 Number Analyzed 54 participants
-9.26  (34.52)
Insomnia: Week 15 Number Analyzed 1 participants
0.00
Insomnia: Week 18 Number Analyzed 51 participants
-3.27  (37.86)
Insomnia: Week 21 Number Analyzed 1 participants
0.00
Insomnia: Week 24 Number Analyzed 42 participants
-3.17  (36.67)
Insomnia: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Insomnia: Week 30 Number Analyzed 39 participants
-9.40  (33.29)
Insomnia: Week 33 Number Analyzed 3 participants
44.44  (50.92)
Insomnia: Week 36 Number Analyzed 38 participants
-8.77  (40.03)
Insomnia: Week 39 Number Analyzed 2 participants
83.33  (23.57)
Insomnia: Week 42 Number Analyzed 36 participants
-5.56  (25.82)
Insomnia: Week 45 Number Analyzed 4 participants
41.67  (31.91)
Insomnia: Week 48 Number Analyzed 32 participants
-3.13  (29.77)
Insomnia: Week 51 Number Analyzed 2 participants
50.00  (23.57)
Insomnia: Week 54 Number Analyzed 32 participants
-2.08  (28.00)
Insomnia: Week 57 Number Analyzed 5 participants
40.00  (43.46)
Insomnia: Week 60 Number Analyzed 30 participants
-1.11  (28.34)
Insomnia: Week 63 Number Analyzed 3 participants
0.00  (33.33)
Insomnia: Week 66 Number Analyzed 25 participants
-5.33  (32.89)
Insomnia: Week 69 Number Analyzed 4 participants
0.00  (27.22)
Insomnia: Week 72 Number Analyzed 23 participants
0.00  (26.59)
Insomnia: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Insomnia: Week 78 Number Analyzed 21 participants
1.59  (22.30)
Insomnia: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Insomnia: Week 84 Number Analyzed 13 participants
0.00  (36.00)
Insomnia: Week 87 Number Analyzed 3 participants
11.11  (19.25)
Insomnia: Week 90 Number Analyzed 8 participants
0.00  (30.86)
Insomnia: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Insomnia: Week 96 Number Analyzed 3 participants
22.22  (38.49)
Insomnia: Week 99 Number Analyzed 1 participants
0.00
Insomnia: Week 105 Number Analyzed 1 participants
0.00
Insomnia: Week 111 Number Analyzed 1 participants
0.00
Insomnia: Week 117 Number Analyzed 1 participants
0.00
Insomnia: Last visit Number Analyzed 73 participants
-1.83  (35.09)
Appetite loss: Baseline Number Analyzed 79 participants
29.96  (33.16)
Appetite loss: Week 6 Number Analyzed 64 participants
-16.67  (30.28)
Appetite loss: Week 9 Number Analyzed 1 participants
0.00
Appetite loss: Week 12 Number Analyzed 54 participants
-18.52  (36.44)
Appetite loss: Week 15 Number Analyzed 1 participants
0.00
Appetite loss: Week 18 Number Analyzed 51 participants
-20.26  (33.39)
Appetite loss: Week 21 Number Analyzed 1 participants
0.00
Appetite loss: Week 24 Number Analyzed 42 participants
-19.84  (29.50)
Appetite loss: Week 27 Number Analyzed 2 participants
-16.67  (23.57)
Appetite loss: Week 30 Number Analyzed 39 participants
-13.68  (23.84)
Appetite loss: Week 33 Number Analyzed 3 participants
-44.44  (19.25)
Appetite loss: Week 36 Number Analyzed 38 participants
-14.91  (27.62)
Appetite loss: Week 39 Number Analyzed 2 participants
-50.00  (23.57)
Appetite loss: Week 42 Number Analyzed 36 participants
-16.67  (32.37)
Appetite loss: Week 45 Number Analyzed 4 participants
-8.33  (41.94)
Appetite loss: Week 48 Number Analyzed 32 participants
-20.83  (34.65)
Appetite loss: Week 51 Number Analyzed 2 participants
-33.33  (47.14)
Appetite loss: Week 54 Number Analyzed 32 participants
-18.75  (32.72)
Appetite loss: Week 57 Number Analyzed 5 participants
-20.00  (29.81)
Appetite loss: Week 60 Number Analyzed 30 participants
-20.00  (31.07)
Appetite loss: Week 63 Number Analyzed 3 participants
0.00  (0.00)
Appetite loss: Week 66 Number Analyzed 26 participants
-23.08  (33.69)
Appetite loss: Week 69 Number Analyzed 4 participants
-16.67  (33.33)
Appetite loss: Week 72 Number Analyzed 23 participants
-23.19  (30.87)
Appetite loss: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Appetite loss: Week 78 Number Analyzed 21 participants
-20.63  (30.69)
Appetite loss: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Appetite loss: Week 84 Number Analyzed 13 participants
-25.64  (36.40)
Appetite loss: Week 87 Number Analyzed 3 participants
11.11  (19.25)
Appetite loss: Week 90 Number Analyzed 8 participants
-20.83  (39.59)
Appetite loss: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Appetite loss: Week 96 Number Analyzed 3 participants
-55.56  (50.92)
Appetite loss: Week 99 Number Analyzed 1 participants
0.00
Appetite loss: Week 105 Number Analyzed 1 participants
0.00
Appetite loss: Week 111 Number Analyzed 1 participants
0.00
Appetite loss: Week 117 Number Analyzed 1 participants
0.00
Appetite loss: Last visit Number Analyzed 73 participants
-13.70  (33.72)
Constipation: Baseline Number Analyzed 79 participants
20.25  (26.38)
Constipation: Week 6 Number Analyzed 64 participants
9.90  (30.68)
Constipation: Week 9 Number Analyzed 1 participants
0.00
Constipation: Week 12 Number Analyzed 54 participants
1.85  (31.33)
Constipation: Week 15 Number Analyzed 1 participants
33.33
Constipation: Week 18 Number Analyzed 51 participants
4.58  (25.84)
Constipation: Week 21 Number Analyzed 1 participants
0.00
Constipation: Week 24 Number Analyzed 42 participants
2.38  (29.81)
Constipation: Week 27 Number Analyzed 2 participants
33.33  (47.14)
Constipation: Week 30 Number Analyzed 39 participants
5.13  (27.08)
Constipation: Week 33 Number Analyzed 3 participants
11.11  (50.92)
Constipation: Week 36 Number Analyzed 38 participants
5.26  (21.26)
Constipation: Week 39 Number Analyzed 2 participants
16.67  (23.57)
Constipation: Week 42 Number Analyzed 36 participants
9.26  (24.70)
Constipation: Week 45 Number Analyzed 4 participants
50.00  (19.25)
Constipation: Week 48 Number Analyzed 32 participants
1.04  (26.07)
Constipation: Week 51 Number Analyzed 2 participants
-16.67  (23.57)
Constipation: Week 54 Number Analyzed 31 participants
6.45  (23.44)
Constipation: Week 57 Number Analyzed 5 participants
26.67  (43.46)
Constipation: Week 60 Number Analyzed 30 participants
6.67  (22.15)
Constipation: Week 63 Number Analyzed 3 participants
44.44  (38.49)
Constipation: Week 66 Number Analyzed 26 participants
12.82  (26.79)
Constipation: Week 69 Number Analyzed 4 participants
-8.33  (16.67)
Constipation: Week 72 Number Analyzed 23 participants
4.35  (25.23)
Constipation: Week 75 Number Analyzed 2 participants
33.33  (47.14)
Constipation: Week 78 Number Analyzed 21 participants
7.94  (17.97)
Constipation: Week 81 Number Analyzed 2 participants
33.33  (47.14)
Constipation: Week 84 Number Analyzed 13 participants
7.69  (19.97)
Constipation: Week 87 Number Analyzed 3 participants
22.22  (38.49)
Constipation: Week 90 Number Analyzed 8 participants
8.33  (15.43)
Constipation: Week 93 Number Analyzed 2 participants
33.33  (47.14)
Constipation: Week 96 Number Analyzed 3 participants
-11.11  (50.92)
Constipation: Week 99 Number Analyzed 1 participants
33.33
Constipation: Week 105 Number Analyzed 1 participants
0.00
Constipation: Week 111 Number Analyzed 1 participants
0.00
Constipation: Week 117 Number Analyzed 1 participants
0.00
Constipation: Last visit Number Analyzed 73 participants
8.68  (31.93)
Diarrhoea: Baseline Number Analyzed 78 participants
13.25  (23.01)
Diarrhoea: Week 6 Number Analyzed 63 participants
-7.41  (25.00)
Diarrhoea: Week 9 Number Analyzed 1 participants
0.00
Diarrhoea: Week 12 Number Analyzed 53 participants
-6.29  (23.62)
Diarrhoea: Week 15 Number Analyzed 1 participants
0.00
Diarrhoea: Week 18 Number Analyzed 48 participants
-5.56  (25.11)
Diarrhoea: Week 21 Number Analyzed 1 participants
0.00
Diarrhoea: Week 24 Number Analyzed 40 participants
-4.17  (28.43)
Diarrhoea: Week 27 Number Analyzed 2 participants
-16.67  (23.57)
Diarrhoea: Week 30 Number Analyzed 39 participants
-8.55  (23.84)
Diarrhoea: Week 33 Number Analyzed 2 participants
-16.67  (23.57)
Diarrhoea: Week 36 Number Analyzed 38 participants
-7.89  (23.80)
Diarrhoea: Week 39 Number Analyzed 1 participants
0.00
Diarrhoea: Week 42 Number Analyzed 36 participants
-6.48  (26.21)
Diarrhoea: Week 45 Number Analyzed 3 participants
0.00  (0.00)
Diarrhoea: Week 48 Number Analyzed 33 participants
-3.03  (28.09)
Diarrhoea: Week 51 Number Analyzed 1 participants
0.00
Diarrhoea: Week 54 Number Analyzed 32 participants
-6.25  (26.01)
Diarrhoea: Week 57 Number Analyzed 4 participants
0.00  (0.00)
Diarrhoea: Week 60 Number Analyzed 30 participants
-1.11  (32.14)
Diarrhoea: Week 63 Number Analyzed 3 participants
0.00  (0.00)
Diarrhoea: Week 66 Number Analyzed 26 participants
-7.69  (30.27)
Diarrhoea: Week 69 Number Analyzed 3 participants
11.11  (19.25)
Diarrhoea: Week 72 Number Analyzed 23 participants
-7.25  (28.35)
Diarrhoea: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Diarrhoea: Week 78 Number Analyzed 20 participants
-6.67  (25.59)
Diarrhoea: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Diarrhoea: Week 84 Number Analyzed 12 participants
2.78  (26.43)
Diarrhoea: Week 87 Number Analyzed 3 participants
11.11  (19.25)
Diarrhoea: Week 90 Number Analyzed 7 participants
9.52  (16.27)
Diarrhoea: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Diarrhoea: Week 96 Number Analyzed 2 participants
33.33  (47.14)
Diarrhoea: Week 99 Number Analyzed 1 participants
0.00
Diarrhoea: Week 105 Number Analyzed 1 participants
0.00
Diarrhoea: Week 111 Number Analyzed 1 participants
0.00
Diarrhoea: Week 117 Number Analyzed 1 participants
0.00
Diarrhoea: Last visit Number Analyzed 72 participants
-2.31  (28.15)
Financial difficulties: Baseline Number Analyzed 79 participants
30.80  (33.24)
Financial difficulties: Week 6 Number Analyzed 64 participants
-2.60  (21.66)
Financial difficulties: Week 9 Number Analyzed 1 participants
0.00
Financial difficulties: Week 12 Number Analyzed 54 participants
-4.32  (23.39)
Financial difficulties: Week 15 Number Analyzed 1 participants
0.00
Financial difficulties: Week 18 Number Analyzed 49 participants
-4.76  (21.52)
Financial difficulties: Week 21 Number Analyzed 1 participants
0.00
Financial difficulties: Week 24 Number Analyzed 41 participants
-2.44  (26.24)
Financial difficulties: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Financial difficulties: Week 30 Number Analyzed 39 participants
-6.84  (23.17)
Financial difficulties: Week 33 Number Analyzed 3 participants
11.11  (19.25)
Financial difficulties: Week 36 Number Analyzed 38 participants
-6.14  (27.79)
Financial difficulties: Week 39 Number Analyzed 2 participants
16.67  (23.57)
Financial difficulties: Week 42 Number Analyzed 36 participants
-6.48  (20.81)
Financial difficulties: Week 45 Number Analyzed 4 participants
8.33  (16.67)
Financial difficulties: Week 48 Number Analyzed 33 participants
-8.08  (23.61)
Financial difficulties: Week 51 Number Analyzed 2 participants
16.67  (23.57)
Financial difficulties: Week 54 Number Analyzed 31 participants
-2.15  (27.13)
Financial difficulties: Week 57 Number Analyzed 5 participants
6.67  (14.91)
Financial difficulties: Week 60 Number Analyzed 30 participants
-3.33  (22.06)
Financial difficulties: Week 63 Number Analyzed 3 participants
0.00  (0.00)
Financial difficulties: Week 66 Number Analyzed 26 participants
-2.56  (28.16)
Financial difficulties: Week 69 Number Analyzed 4 participants
-8.33  (16.67)
Financial difficulties: Week 72 Number Analyzed 23 participants
5.80  (25.92)
Financial difficulties: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Financial difficulties: Week 78 Number Analyzed 21 participants
0.00  (34.96)
Financial difficulties: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Financial difficulties: Week 84 Number Analyzed 13 participants
12.82  (34.80)
Financial difficulties: Week 87 Number Analyzed 3 participants
0.00  (0.00)
Financial difficulties: Week 90 Number Analyzed 8 participants
-4.17  (21.36)
Financial difficulties: Week 93 Number Analyzed 2 participants
-16.67  (23.57)
Financial difficulties: Week 96 Number Analyzed 3 participants
22.22  (38.49)
Financial difficulties: Week 99 Number Analyzed 1 participants
0.00
Financial difficulties: Week 105 Number Analyzed 1 participants
0.00
Financial difficulties: Week 111 Number Analyzed 1 participants
0.00
Financial difficulties: Week 117 Number Analyzed 1 participants
0.00
Financial difficulties: Last visit Number Analyzed 73 participants
1.83  (32.82)
28.Secondary Outcome
Title Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Alectinib 600 mg (Fed): Phase II
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
Dyspnoea: Baseline Number Analyzed 76 participants
30.85  (27.13)
Dyspnoea: Week 6 Number Analyzed 58 participants
-8.24  (22.57)
Dyspnoea: Week 9 Number Analyzed 1 participants
0.00
Dyspnoea: Week 12 Number Analyzed 48 participants
-7.64  (20.65)
Dyspnoea: Week 15 Number Analyzed 1 participants
0.00
Dyspnoea: Week 18 Number Analyzed 47 participants
-11.35  (21.67)
Dyspnoea: Week 21 Number Analyzed 1 participants
0.00
Dyspnoea: Week 24 Number Analyzed 39 participants
-7.41  (21.68)
Dyspnoea: Week 27 Number Analyzed 2 participants
5.56  (7.86)
Dyspnoea: Week 30 Number Analyzed 38 participants
-4.09  (20.41)
Dyspnoea: Week 33 Number Analyzed 3 participants
-11.11  (11.11)
Dyspnoea: Week 36 Number Analyzed 37 participants
-5.41  (21.69)
Dyspnoea: Week 39 Number Analyzed 2 participants
-5.56  (7.86)
Dyspnoea: Week 42 Number Analyzed 36 participants
-8.64  (20.25)
Dyspnoea: Week 45 Number Analyzed 4 participants
-2.78  (27.78)
Dyspnoea: Week 48 Number Analyzed 33 participants
-7.74  (24.77)
Dyspnoea: Week 51 Number Analyzed 2 participants
-27.78  (23.57)
Dyspnoea: Week 54 Number Analyzed 31 participants
-5.02  (19.63)
Dyspnoea: Week 57 Number Analyzed 5 participants
-2.22  (16.48)
Dyspnoea: Week 60 Number Analyzed 29 participants
-7.28  (19.54)
Dyspnoea: Week 63 Number Analyzed 3 participants
3.70  (16.97)
Dyspnoea: Week 66 Number Analyzed 25 participants
-6.22  (25.27)
Dyspnoea: Week 69 Number Analyzed 4 participants
-13.89  (29.22)
Dyspnoea: Week 72 Number Analyzed 23 participants
-6.76  (26.96)
Dyspnoea: Week 75 Number Analyzed 2 participants
-5.56  (7.86)
Dyspnoea: Week 78 Number Analyzed 19 participants
-8.19  (22.48)
Dyspnoea: Week 81 Number Analyzed 2 participants
-5.56  (7.86)
Dyspnoea: Week 84 Number Analyzed 13 participants
-9.40  (16.26)
Dyspnoea: Week 87 Number Analyzed 3 participants
7.41  (23.13)
Dyspnoea: Week 90 Number Analyzed 8 participants
-5.56  (17.82)
Dyspnoea: Week 93 Number Analyzed 2 participants
22.22  (0.00)
Dyspnoea: Week 96 Number Analyzed 3 participants
-51.85  (23.13)
Dyspnoea: Week 99 Number Analyzed 1 participants
11.11
Dyspnoea: Week 105 Number Analyzed 1 participants
0.00
Dyspnoea: Week 111 Number Analyzed 1 participants
0.00
Dyspnoea: Week 117 Number Analyzed 1 participants
0.00
Dyspnoea: Last visit Number Analyzed 69 participants
-6.44  (23.45)
Coughing: Baseline Number Analyzed 79 participants
33.76  (27.47)
Coughing: Week 6 Number Analyzed 60 participants
-13.89  (31.47)
Coughing: Week 9 Number Analyzed 1 participants
0.00
Coughing: Week 12 Number Analyzed 52 participants
-12.82  (27.34)
Coughing: Week 15 Number Analyzed 1 participants
0.00
Coughing: Week 18 Number Analyzed 49 participants
-13.61  (24.46)
Coughing: Week 21 Number Analyzed 1 participants
0.00
Coughing: Week 24 Number Analyzed 40 participants
-9.17  (31.11)
Coughing: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Coughing: Week 30 Number Analyzed 38 participants
-1.75  (24.44)
Coughing: Week 33 Number Analyzed 3 participants
-22.22  (19.25)
Coughing: Week 36 Number Analyzed 38 participants
-8.77  (28.67)
Coughing: Week 39 Number Analyzed 2 participants
-50.00  (23.57)
Coughing: Week 42 Number Analyzed 36 participants
-0.93  (27.01)
Coughing: Week 45 Number Analyzed 4 participants
-8.33  (50.00)
Coughing: Week 48 Number Analyzed 33 participants
-4.04  (35.12)
Coughing: Week 51 Number Analyzed 2 participants
-33.33  (0.00)
Coughing: Week 54 Number Analyzed 32 participants
-8.33  (25.40)
Coughing: Week 57 Number Analyzed 5 participants
-20.00  (29.81)
Coughing: Week 60 Number Analyzed 29 participants
-2.30  (29.45)
Coughing: Week 63 Number Analyzed 3 participants
0.00  (33.33)
Coughing: Week 66 Number Analyzed 26 participants
-5.13  (27.80)
Coughing: Week 69 Number Analyzed 4 participants
-25.00  (31.91)
Coughing: Week 72 Number Analyzed 23 participants
-7.25  (28.35)
Coughing: Week 75 Number Analyzed 2 participants
-16.67  (23.57)
Coughing: Week 78 Number Analyzed 20 participants
-6.67  (35.21)
Coughing: Week 81 Number Analyzed 2 participants
-16.67  (23.57)
Coughing: Week 84 Number Analyzed 13 participants
-15.38  (29.24)
Coughing: Week 87 Number Analyzed 3 participants
0.00  (33.33)
Coughing: Week 90 Number Analyzed 8 participants
-8.33  (29.55)
Coughing: Week 93 Number Analyzed 2 participants
16.67  (23.57)
Coughing: Week 96 Number Analyzed 3 participants
-44.44  (19.25)
Coughing: Week 99 Number Analyzed 1 participants
0.00
Coughing: Week 105 Number Analyzed 1 participants
0.00
Coughing: Week 111 Number Analyzed 1 participants
0.00
Coughing: Week 117 Number Analyzed 1 participants
0.00
Coughing: Last visit Number Analyzed 73 participants
-5.48  (32.87)
Hemoptysis: Baseline Number Analyzed 79 participants
1.27  (6.41)
Hemoptysis: Week 6 Number Analyzed 60 participants
-1.11  (6.03)
Hemoptysis: Week 9 Number Analyzed 1 participants
0.00
Hemoptysis: Week 12 Number Analyzed 52 participants
-1.28  (6.47)
Hemoptysis: Week 15 Number Analyzed 1 participants
0.00
Hemoptysis: Week 18 Number Analyzed 49 participants
-1.36  (6.66)
Hemoptysis: Week 21 Number Analyzed 1 participants
0.00
Hemoptysis: Week 24 Number Analyzed 40 participants
-1.67  (7.36)
Hemoptysis: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Hemoptysis: Week 30 Number Analyzed 39 participants
0.00  (13.25)
Hemoptysis: Week 33 Number Analyzed 3 participants
0.00  (0.00)
Hemoptysis: Week 36 Number Analyzed 38 participants
-1.75  (7.54)
Hemoptysis: Week 39 Number Analyzed 2 participants
0.00  (0.00)
Hemoptysis: Week 42 Number Analyzed 36 participants
0.00  (7.97)
Hemoptysis: Week 45 Number Analyzed 4 participants
0.00  (0.00)
Hemoptysis: Week 48 Number Analyzed 33 participants
-1.01  (5.80)
Hemoptysis: Week 51 Number Analyzed 2 participants
0.00  (0.00)
Hemoptysis: Week 54 Number Analyzed 31 participants
1.08  (10.48)
Hemoptysis: Week 57 Number Analyzed 5 participants
0.00  (0.00)
Hemoptysis: Week 60 Number Analyzed 29 participants
-1.15  (6.19)
Hemoptysis: Week 63 Number Analyzed 3 participants
0.00  (0.00)
Hemoptysis: Week 66 Number Analyzed 26 participants
-1.28  (6.54)
Hemoptysis: Week 69 Number Analyzed 4 participants
0.00  (0.00)
Hemoptysis: Week 72 Number Analyzed 23 participants
2.90  (22.28)
Hemoptysis: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Hemoptysis: Week 78 Number Analyzed 20 participants
-1.67  (7.45)
Hemoptysis: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Hemoptysis: Week 84 Number Analyzed 13 participants
-2.56  (9.25)
Hemoptysis: Week 87 Number Analyzed 3 participants
0.00  (0.00)
Hemoptysis: Week 90 Number Analyzed 8 participants
0.00  (0.00)
Hemoptysis: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Hemoptysis: Week 96 Number Analyzed 3 participants
0.00  (0.00)
Hemoptysis: Week 99 Number Analyzed 1 participants
0.00
Hemoptysis: Week 105 Number Analyzed 1 participants
0.00
Hemoptysis: Week 111 Number Analyzed 1 participants
0.00
Hemoptysis: Week 117 Number Analyzed 1 participants
0.00
Hemoptysis: Last visit Number Analyzed 73 participants
-0.91  (7.80)
Sore mouth: Baseline Number Analyzed 79 participants
5.06  (16.09)
Sore mouth: Week 6 Number Analyzed 60 participants
-1.11  (13.68)
Sore mouth: Week 9 Number Analyzed 1 participants
0.00
Sore mouth: Week 12 Number Analyzed 52 participants
0.64  (13.99)
Sore mouth: Week 15 Number Analyzed 1 participants
0.00
Sore mouth: Week 18 Number Analyzed 49 participants
-2.04  (17.22)
Sore mouth: Week 21 Number Analyzed 1 participants
0.00
Sore mouth: Week 24 Number Analyzed 39 participants
-0.85  (17.91)
Sore mouth: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Sore mouth: Week 30 Number Analyzed 39 participants
2.56  (11.81)
Sore mouth: Week 33 Number Analyzed 3 participants
22.22  (38.49)
Sore mouth: Week 36 Number Analyzed 38 participants
1.75  (15.40)
Sore mouth: Week 39 Number Analyzed 2 participants
16.67  (23.57)
Sore mouth: Week 42 Number Analyzed 36 participants
-0.93  (9.71)
Sore mouth: Week 45 Number Analyzed 4 participants
0.00  (0.00)
Sore mouth: Week 48 Number Analyzed 33 participants
7.07  (26.03)
Sore mouth: Week 51 Number Analyzed 2 participants
0.00  (0.00)
Sore mouth: Week 54 Number Analyzed 31 participants
1.08  (13.56)
Sore mouth: Week 57 Number Analyzed 5 participants
0.00  (23.57)
Sore mouth: Week 60 Number Analyzed 29 participants
-1.15  (14.04)
Sore mouth: Week 63 Number Analyzed 3 participants
0.00  (0.00)
Sore mouth: Week 66 Number Analyzed 26 participants
-2.56  (13.07)
Sore mouth: Week 69 Number Analyzed 4 participants
0.00  (0.00)
Sore mouth: Week 72 Number Analyzed 22 participants
4.55  (18.67)
Sore mouth: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Sore mouth: Week 78 Number Analyzed 20 participants
1.67  (7.45)
Sore mouth: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Sore mouth: Week 84 Number Analyzed 13 participants
0.00  (0.00)
Sore mouth: Week 87 Number Analyzed 3 participants
0.00  (0.00)
Sore mouth: Week 90 Number Analyzed 8 participants
4.17  (11.79)
Sore mouth: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Sore mouth: Week 96 Number Analyzed 3 participants
11.11  (19.25)
Sore mouth: Week 99 Number Analyzed 1 participants
0.00
Sore mouth: Week 105 Number Analyzed 1 participants
0.00
Sore mouth: Week 111 Number Analyzed 1 participants
0.00
Sore mouth: Week 117 Number Analyzed 1 participants
0.00
Sore mouth: Last visit Number Analyzed 73 participants
-0.46  (15.21)
Dysphagia: Baseline Number Analyzed 79 participants
4.64  (11.61)
Dysphagia: Week 6 Number Analyzed 60 participants
-1.67  (11.36)
Dysphagia: Week 9 Number Analyzed 1 participants
0.00
Dysphagia: Week 12 Number Analyzed 52 participants
-0.64  (10.42)
Dysphagia: Week 15 Number Analyzed 1 participants
0.00
Dysphagia: Week 18 Number Analyzed 49 participants
-1.36  (11.70)
Dysphagia: Week 21 Number Analyzed 1 participants
0.00
Dysphagia: Week 24 Number Analyzed 40 participants
0.83  (11.91)
Dysphagia: Week 27 Number Analyzed 2 participants
16.67  (23.57)
Dysphagia: Week 30 Number Analyzed 39 participants
3.42  (14.90)
Dysphagia: Week 33 Number Analyzed 3 participants
0.00  (33.33)
Dysphagia: Week 36 Number Analyzed 38 participants
-0.88  (5.41)
Dysphagia: Week 39 Number Analyzed 2 participants
-16.67  (23.57)
Dysphagia: Week 42 Number Analyzed 36 participants
-0.93  (12.56)
Dysphagia: Week 45 Number Analyzed 4 participants
0.00  (27.22)
Dysphagia: Week 48 Number Analyzed 33 participants
2.02  (16.54)
Dysphagia: Week 51 Number Analyzed 2 participants
-16.67  (23.57)
Dysphagia: Week 54 Number Analyzed 31 participants
-1.08  (13.56)
Dysphagia: Week 57 Number Analyzed 5 participants
6.67  (27.89)
Dysphagia: Week 60 Number Analyzed 28 participants
-3.57  (13.88)
Dysphagia: Week 63 Number Analyzed 3 participants
11.11  (19.25)
Dysphagia: Week 66 Number Analyzed 26 participants
-1.28  (14.85)
Dysphagia: Week 69 Number Analyzed 4 participants
0.00  (0.00)
Dysphagia: Week 72 Number Analyzed 23 participants
1.45  (15.82)
Dysphagia: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Dysphagia: Week 78 Number Analyzed 20 participants
0.00  (10.81)
Dysphagia: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Dysphagia: Week 84 Number Analyzed 13 participants
2.56  (9.25)
Dysphagia: Week 87 Number Analyzed 3 participants
0.00  (0.00)
Dysphagia: Week 90 Number Analyzed 8 participants
0.00  (0.00)
Dysphagia: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Dysphagia: Week 96 Number Analyzed 3 participants
0.00  (0.00)
Dysphagia: Week 99 Number Analyzed 1 participants
0.00
Dysphagia: Week 105 Number Analyzed 1 participants
0.00
Dysphagia: Week 111 Number Analyzed 1 participants
0.00
Dysphagia: Week 117 Number Analyzed 1 participants
0.00
Dysphagia: Last visit Number Analyzed 73 participants
2.74  (17.35)
Peripheral neuropathy: Baseline Number Analyzed 79 participants
13.08  (22.28)
Peripheral neuropathy: Week 6 Number Analyzed 60 participants
6.11  (17.88)
Peripheral neuropathy: Week 9 Number Analyzed 1 participants
0.00
Peripheral neuropathy: Week 12 Number Analyzed 52 participants
1.28  (20.83)
Peripheral neuropathy: Week 15 Number Analyzed 1 participants
0.00
Peripheral neuropathy: Week 18 Number Analyzed 49 participants
2.72  (22.40)
Peripheral neuropathy: Week 21 Number Analyzed 1 participants
0.00
Peripheral neuropathy: Week 24 Number Analyzed 40 participants
4.17  (20.24)
Peripheral neuropathy: Week 27 Number Analyzed 2 participants
-16.67  (23.57)
Peripheral neuropathy: Week 30 Number Analyzed 39 participants
4.27  (24.40)
Peripheral neuropathy: Week 33 Number Analyzed 3 participants
11.11  (19.25)
Peripheral neuropathy: Week 36 Number Analyzed 38 participants
0.00  (18.98)
Peripheral neuropathy: Week 39 Number Analyzed 2 participants
0.00  (0.00)
Peripheral neuropathy: Week 42 Number Analyzed 36 participants
1.85  (21.00)
Peripheral neuropathy: Week 45 Number Analyzed 4 participants
8.33  (16.67)
Peripheral neuropathy: Week 48 Number Analyzed 33 participants
2.02  (23.48)
Peripheral neuropathy: Week 51 Number Analyzed 2 participants
0.00  (0.00)
Peripheral neuropathy: Week 54 Number Analyzed 31 participants
6.45  (26.41)
Peripheral neuropathy: Week 57 Number Analyzed 5 participants
6.67  (27.89)
Peripheral neuropathy: Week 60 Number Analyzed 29 participants
2.30  (23.45)
Peripheral neuropathy: Week 63 Number Analyzed 3 participants
0.00  (0.00)
Peripheral neuropathy: Week 66 Number Analyzed 26 participants
1.28  (24.00)
Peripheral neuropathy: Week 69 Number Analyzed 4 participants
0.00  (0.00)
Peripheral neuropathy: Week 72 Number Analyzed 23 participants
2.90  (28.27)
Peripheral neuropathy: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Peripheral neuropathy: Week 78 Number Analyzed 20 participants
-3.33  (21.36)
Peripheral neuropathy: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Peripheral neuropathy: Week 84 Number Analyzed 13 participants
12.82  (37.36)
Peripheral neuropathy: Week 87 Number Analyzed 3 participants
0.00  (0.00)
Peripheral neuropathy: Week 90 Number Analyzed 8 participants
16.67  (17.82)
Peripheral neuropathy: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Peripheral neuropathy: Week 96 Number Analyzed 3 participants
55.56  (38.49)
Peripheral neuropathy: Week 99 Number Analyzed 1 participants
0.00
Peripheral neuropathy: Week 105 Number Analyzed 1 participants
0.00
Peripheral neuropathy: Week 111 Number Analyzed 1 participants
0.00
Peripheral neuropathy: Week 117 Number Analyzed 1 participants
0.00
Peripheral neuropathy: Last visit Number Analyzed 73 participants
1.37  (22.52)
Alopecia: Baseline Number Analyzed 77 participants
11.69  (25.80)
Alopecia: Week 6 Number Analyzed 59 participants
-1.13  (22.29)
Alopecia: Week 9 Number Analyzed 1 participants
0.00
Alopecia: Week 12 Number Analyzed 51 participants
1.31  (31.24)
Alopecia: Week 15 Number Analyzed 1 participants
0.00
Alopecia: Week 18 Number Analyzed 47 participants
-4.96  (25.04)
Alopecia: Week 21 Number Analyzed 1 participants
0.00
Alopecia: Week 24 Number Analyzed 39 participants
-2.56  (27.98)
Alopecia: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Alopecia: Week 30 Number Analyzed 38 participants
-3.51  (27.72)
Alopecia: Week 33 Number Analyzed 3 participants
0.00  (0.00)
Alopecia: Week 36 Number Analyzed 37 participants
0.90  (32.85)
Alopecia: Week 39 Number Analyzed 2 participants
0.00  (0.00)
Alopecia: Week 42 Number Analyzed 36 participants
-2.78  (20.12)
Alopecia: Week 45 Number Analyzed 4 participants
0.00  (0.00)
Alopecia: Week 48 Number Analyzed 32 participants
-5.21  (22.58)
Alopecia: Week 51 Number Analyzed 2 participants
0.00  (0.00)
Alopecia: Week 54 Number Analyzed 31 participants
-6.45  (15.91)
Alopecia: Week 57 Number Analyzed 5 participants
-6.67  (14.91)
Alopecia: Week 60 Number Analyzed 29 participants
-4.60  (19.36)
Alopecia: Week 63 Number Analyzed 3 participants
-11.11  (19.25)
Alopecia: Week 66 Number Analyzed 25 participants
-2.67  (27.08)
Alopecia: Week 69 Number Analyzed 4 participants
-8.33  (16.67)
Alopecia: Week 72 Number Analyzed 22 participants
-3.03  (33.98)
Alopecia: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Alopecia: Week 78 Number Analyzed 20 participants
-8.33  (26.21)
Alopecia: Week 81 Number Analyzed 2 participants
-16.67  (23.57)
Alopecia: Week 84 Number Analyzed 13 participants
-2.56  (25.32)
Alopecia: Week 87 Number Analyzed 3 participants
-11.11  (19.25)
Alopecia: Week 90 Number Analyzed 8 participants
4.17  (21.36)
Alopecia: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Alopecia: Week 96 Number Analyzed 3 participants
0.00  (0.00)
Alopecia: Week 99 Number Analyzed 1 participants
0.00
Alopecia: Week 105 Number Analyzed 1 participants
0.00
Alopecia: Week 111 Number Analyzed 1 participants
0.00
Alopecia: Week 117 Number Analyzed 1 participants
0.00
Alopecia: Last visit Number Analyzed 71 participants
-5.16  (27.97)
Pain in chest: Baseline Number Analyzed 79 participants
21.52  (28.26)
Pain in chest: Week 6 Number Analyzed 60 participants
-16.67  (29.75)
Pain in chest: Week 9 Number Analyzed 1 participants
0.00
Pain in chest: Week 12 Number Analyzed 52 participants
-11.54  (23.69)
Pain in chest: Week 15 Number Analyzed 1 participants
0.00
Pain in chest: Week 18 Number Analyzed 49 participants
-8.84  (27.87)
Pain in chest: Week 21 Number Analyzed 1 participants
0.00
Pain in chest: Week 24 Number Analyzed 40 participants
-8.33  (23.57)
Pain in chest: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Pain in chest: Week 30 Number Analyzed 39 participants
-3.42  (22.68)
Pain in chest: Week 33 Number Analyzed 3 participants
-11.11  (19.25)
Pain in chest: Week 36 Number Analyzed 38 participants
-6.14  (26.68)
Pain in chest: Week 39 Number Analyzed 2 participants
-16.67  (23.57)
Pain in chest: Week 42 Number Analyzed 36 participants
-6.48  (19.22)
Pain in chest: Week 45 Number Analyzed 4 participants
-8.33  (41.94)
Pain in chest: Week 48 Number Analyzed 33 participants
-6.06  (19.46)
Pain in chest: Week 51 Number Analyzed 2 participants
-33.33  (0.00)
Pain in chest: Week 54 Number Analyzed 31 participants
-4.30  (20.62)
Pain in chest: Week 57 Number Analyzed 5 participants
-13.33  (38.01)
Pain in chest: Week 60 Number Analyzed 29 participants
-3.45  (16.29)
Pain in chest: Week 63 Number Analyzed 2 participants
-16.67  (23.57)
Pain in chest: Week 66 Number Analyzed 26 participants
-2.56  (18.67)
Pain in chest: Week 69 Number Analyzed 4 participants
-25.00  (31.91)
Pain in chest: Week 72 Number Analyzed 23 participants
-2.90  (28.27)
Pain in chest: Week 75 Number Analyzed 2 participants
-16.67  (23.57)
Pain in chest: Week 78 Number Analyzed 20 participants
0.00  (18.73)
Pain in chest: Week 81 Number Analyzed 2 participants
-16.67  (23.57)
Pain in chest: Week 84 Number Analyzed 13 participants
-5.13  (22.96)
Pain in chest: Week 87 Number Analyzed 3 participants
-11.11  (19.25)
Pain in chest: Week 90 Number Analyzed 8 participants
-12.50  (24.80)
Pain in chest: Week 93 Number Analyzed 2 participants
16.67  (23.57)
Pain in chest: Week 96 Number Analyzed 3 participants
-22.22  (19.25)
Pain in chest: Week 99 Number Analyzed 1 participants
0.00
Pain in chest: Week 105 Number Analyzed 1 participants
0.00
Pain in chest: Week 111 Number Analyzed 1 participants
0.00
Pain in chest: Week 117 Number Analyzed 1 participants
0.00
Pain in chest: Last visit Number Analyzed 72 participants
-8.80  (26.83)
Pain in arm or shoulder: Baseline Number Analyzed 79 participants
16.88  (28.18)
Pain in arm or shoulder: Week 6 Number Analyzed 60 participants
-7.22  (25.37)
Pain in arm or shoulder: Week 9 Number Analyzed 1 participants
0.00
Pain in arm or shoulder: Week 12 Number Analyzed 52 participants
-5.77  (30.05)
Pain in arm or shoulder: Week 15 Number Analyzed 1 participants
0.00
Pain in arm or shoulder: Week 18 Number Analyzed 48 participants
-4.86  (24.78)
Pain in arm or shoulder: Week 21 Number Analyzed 1 participants
0.00
Pain in arm or shoulder: Week 24 Number Analyzed 40 participants
-10.83  (27.62)
Pain in arm or shoulder: Week 27 Number Analyzed 2 participants
-16.67  (23.57)
Pain in arm or shoulder: Week 30 Number Analyzed 39 participants
-3.42  (23.93)
Pain in arm or shoulder: Week 33 Number Analyzed 3 participants
-11.11  (38.49)
Pain in arm or shoulder: Week 36 Number Analyzed 38 participants
-5.26  (33.36)
Pain in arm or shoulder: Week 39 Number Analyzed 2 participants
-16.67  (23.57)
Pain in arm or shoulder: Week 42 Number Analyzed 36 participants
-5.56  (25.82)
Pain in arm or shoulder: Week 45 Number Analyzed 4 participants
0.00  (0.00)
Pain in arm or shoulder: Week 48 Number Analyzed 33 participants
-6.06  (21.17)
Pain in arm or shoulder: Week 51 Number Analyzed 2 participants
-16.67  (23.57)
Pain in arm or shoulder: Week 54 Number Analyzed 31 participants
-1.08  (25.07)
Pain in arm or shoulder: Week 57 Number Analyzed 5 participants
0.00  (23.57)
Pain in arm or shoulder: Week 60 Number Analyzed 29 participants
-2.30  (26.62)
Pain in arm or shoulder: Week 63 Number Analyzed 3 participants
0.00  (0.00)
Pain in arm or shoulder: Week 66 Number Analyzed 26 participants
-3.85  (27.21)
Pain in arm or shoulder: Week 69 Number Analyzed 4 participants
-16.67  (33.33)
Pain in arm or shoulder: Week 72 Number Analyzed 23 participants
-4.35  (28.96)
Pain in arm or shoulder: Week 75 Number Analyzed 2 participants
0.00  (0.00)
Pain in arm or shoulder: Week 78 Number Analyzed 19 participants
-8.77  (24.45)
Pain in arm or shoulder: Week 81 Number Analyzed 2 participants
0.00  (0.00)
Pain in arm or shoulder: Week 84 Number Analyzed 13 participants
7.69  (38.86)
Pain in arm or shoulder: Week 87 Number Analyzed 3 participants
0.00  (0.00)
Pain in arm or shoulder: Week 90 Number Analyzed 8 participants
4.17  (21.36)
Pain in arm or shoulder: Week 93 Number Analyzed 2 participants
0.00  (0.00)
Pain in arm or shoulder: Week 96 Number Analyzed 3 participants
0.00  (33.33)
Pain in arm or shoulder: Week 99 Number Analyzed 1 participants
0.00
Pain in arm or shoulder: Week 105 Number Analyzed 1 participants
0.00
Pain in arm or shoulder: Week 111 Number Analyzed 1 participants
0.00
Pain in arm or shoulder: Week 117 Number Analyzed 1 participants
0.00
Pain in arm or shoulder: Last visit Number Analyzed 73 participants
0.00  (29.92)
Pain in other parts: Baseline Number Analyzed 75 participants
44.00  (36.42)
Pain in other parts: Week 6 Number Analyzed 57 participants
-16.96  (42.78)
Pain in other parts: Week 9 Number Analyzed 1 participants
0.00
Pain in other parts: Week 12 Number Analyzed 46 participants
-11.59  (41.70)
Pain in other parts: Week 15 Number Analyzed 1 participants
0.00
Pain in other parts: Week 18 Number Analyzed 45 participants
-19.26  (41.74)
Pain in other parts: Week 21 Number Analyzed 1 participants
0.00
Pain in other parts: Week 24 Number Analyzed 38 participants
-19.30  (36.87)
Pain in other parts: Week 27 Number Analyzed 2 participants
0.00  (0.00)
Pain in other parts: Week 30 Number Analyzed 36 participants
-18.52  (37.75)
Pain in other parts: Week 33 Number Analyzed 3 participants
0.00  (33.33)
Pain in other parts: Week 36 Number Analyzed 36 participants
-18.52  (36.90)
Pain in other parts: Week 39 Number Analyzed 2 participants
0.00  (94.28)
Pain in other parts: Week 42 Number Analyzed 33 participants
-16.16  (37.38)
Pain in other parts: Week 45 Number Analyzed 4 participants
-8.33  (56.93)
Pain in other parts: Week 48 Number Analyzed 30 participants
-12.22  (34.45)
Pain in other parts: Week 51 Number Analyzed 2 participants
0.00  (47.14)
Pain in other parts: Week 54 Number Analyzed 29 participants
-14.94  (38.41)
Pain in other parts: Week 57 Number Analyzed 5 participants
-13.33  (38.01)
Pain in other parts: Week 60 Number Analyzed 26 participants
-15.38  (34.29)
Pain in other parts: Week 63 Number Analyzed 3 participants
-44.44  (38.49)
Pain in other parts: Week 66 Number Analyzed 22 participants
-10.61  (39.02)
Pain in other parts: Week 69 Number Analyzed 4 participants
-8.33  (41.94)
Pain in other parts: Week 72 Number Analyzed 20 participants
-15.00  (33.29)
Pain in other parts: Week 75 Number Analyzed 2 participants
-16.67  (23.57)
Pain in other parts: Week 78 Number Analyzed 19 participants
-5.26  (27.81)
Pain in other parts: Week 81 Number Analyzed 2 participants
-16.67  (23.57)
Pain in other parts: Week 84 Number Analyzed 11 participants
-12.12  (22.47)
Pain in other parts: Week 87 Number Analyzed 3 participants
-22.22  (38.49)
Pain in other parts: Week 90