A Phase 2 interventional study of PF-02341066 in Carcinoma, Non-Small-Cell Lung, sponsored by Pfizer. Completed at 279 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-13.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.
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Exclusion Criteria:
Drug: PF-02341066
PF-02341066, 250 mg BID, will be administered orally on a continuous schedule
Objective Response Rate
The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.
Time frame: 6 years
Percentage of Participants With Adverse Events
Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 4.0).
Time frame: 6 years
Duration of Response (DR)
DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death - first date of CR or PR that was subsequently confirmed + 1)/30.4.
Time frame: 6 years
Time to Tumor Response (TTR)
TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.
Time frame: 6 years
Disease Control Rate (DCR)
DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.
Time frame: 6 years
Progression Free Survival (PFS)
PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.
Time frame: 6 years
Overall Survival (OS)
OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death - date of Cycle 1 Day 1 dose + 1)/30.4.
Time frame: 6 years
Probability of Survival
Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.
Time frame: 6 years
Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182
Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.
Time frame: 6 years
Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)
Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.
Time frame: 6 years
Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)
The frequency of the candidate gene alleles, HLA-DQA1\*02:01, HLA-DQB1\*02:02, HLA-DRB1\*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B\*57:01 and HLA-DRB1\*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of ≤1xULN and at least one on-treatment ALT assessment of \>3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of ≤1xULN.
Time frame: 6 years
QTc Prolongation in Participants
The percentage of participants with maximum post-dose QTcF/QTcB (\<450, 450 - \<480, 480 - \<500, and ≥500 msec) were evaluated.
Time frame: 6 years
Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.
The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
Time frame: 6 years
Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores
The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
Time frame: 6 years
Mean Change From Baseline of QLQ-LC13 Scale Scores
The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
Time frame: 6 years
Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)
The participants who responded to the question: "Have you experienced any visual disturbances?" Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question.
Time frame: 6 years
Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale
The EQ-5D descriptive system measured a patient's health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.
Time frame: 6 years
A total of 1069 participants entered the study out of which 3 participants were withdrawn from the study before receiving study treatment because they were not eligible and were mistakenly entered into the interactive voice response system. Only 1066 participants received greater than or equal to 1 dose of crizotinib.
| Milestone | Crizotinib 250 mg BID |
|---|---|
| Started | 1066 |
| Completed | 244 |
| Not completed | 822 |
| Withdrew: Withdrawal by subject | 69 |
| Withdrew: Lost to follow-up | 22 |
| Withdrew: Death | 726 |
| Withdrew: Other reasons | 5 |
DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death - first date of CR or PR that was subsequently confirmed + 1)/30.4.
| Months | Crizotinib 250 mg BID |
|---|---|
| ALK Positive by IUO, N=491 | 11.8 (10.4 to 12.8) |
| ALK Positive by non-IUO only, N=64 | 9.5 (6.9 to 15.2) |
TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.
| Weeks | Crizotinib 250 mg BID |
|---|---|
| ALK Positive by IUO (n=491) | 6.1 (2.7 to 164) |
| ALK Positive by non-IUO only (n=64) | 6.3 (4.7 to 65.9) |
DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.
| Percentage of participants | Crizotinib 250 mg BID |
|---|---|
| ALK Positive by IUO at Week 6, N=908 | 81.7 (79.0 to 84.2) |
| ALK Positive by IUO at Week 12, N=908 | 70.8 (67.7 to 73.8) |
| ALK Positive by non-IUO at Week 6, N=158 | 69.6 (61.8 to 76.7) |
| ALK Positive by non-IUO at Week 12, N=158 | 61.4 (53.3 to 69.0) |
PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.
| Months | Crizotinib 250 mg BID |
|---|---|
| ALK Positive by IUO , N= 908 | 8.4 (7.1 to 9.7) |
| ALK Positive by non-IUO only , N=158 | 6.9 (5.6 to 9.4) |
OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death - date of Cycle 1 Day 1 dose + 1)/30.4.
| Months | Crizotinib 250 mg BID |
|---|---|
| ALK-positive by IUO (N= 908) | 21.8 (19.4 to 24.0) |
| ALK-positive by non-IUO (N= 158) | 16.9 (13.4 to 21.5) |
Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.
| Percentage of probability | Crizotinib 250 mg BID |
|---|---|
| ALK positive by IUO at 6 Months | 81.7 (79.0 to 84.0) |
| ALK positive by non IUO at 6 Months | 77.5 (70.1 to 83.3) |
| ALK positive by IUO at 12 Months | 66.5 (63.3 to 69.5) |
| ALK positive by non IUO at 12 Months | 62.4 (54.3 to 69.6) |
Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.
| ng/mL | Crizotinib (PF-02341066) | PF-06260182 |
|---|---|---|
| Cycle 1 Day 1 (N= 13, 13) | 1.95 ± 55 | 0.00601 ± 167 |
| Cycle 2 Day 1 (N=447, 431) | 279 ± 46 | 76.2 ± 79 |
| Cycle 3 Day 1 (N=398, 385) | 297 ± 44 | 80.8 ± 58 |
| Cycle 5 Day 1 (N=297, 290) | 294 ± 48 | 81.4 ± 61 |
Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.
| Percentage of cells | Crizotinib 250 mg BID |
|---|---|
| Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population) | 60.0 ± 21.18 |
The frequency of the candidate gene alleles, HLA-DQA1\*02:01, HLA-DQB1\*02:02, HLA-DRB1\*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B\*57:01 and HLA-DRB1\*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of ≤1xULN and at least one on-treatment ALT assessment of \>3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of ≤1xULN.
| Percentage of participants | Crizotinib 250 mg BID-ALT Cases | Crizotinib 250 mg BID-ALT Controls |
|---|---|---|
| HLA-DQA1*02:01 | 20.3 | 20.0 |
| HLA-DQB1*02:02 | 17.6 | 16.5 |
| HLA-DRB1*07:01 | 20.3 | 20.0 |
| TNXB/rs12153855 | 10.8 | 16.5 |
| HLA-B*57:01 | 2.7 | 4.3 |
| HLA-DRB1*15:01 | 17.6 | 20.9 |
The percentage of participants with maximum post-dose QTcF/QTcB (\<450, 450 - \<480, 480 - \<500, and ≥500 msec) were evaluated.
| Percentage of participants | Crizotinib 250 mg BID |
|---|---|
| Maximum QTcF Interval (<450) | 89.8 |
| Maximum QTcF Interval (450-<480) | 7.7 |
| Maximum QTcF Interval (480 - <500) | 1.0 |
| Maximum QTcF Interval (≥500) | 1.5 |
| Maximum QTcB Interval (<450) | 74.3 |
| Maximum QTcB Interval (450-<480) | 21.2 |
| Maximum QTcB Interval (480-<500) | 2.4 |
| Maximum QTcB Interval (≥500) | 2.1 |
The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
| Units on a scale | Crizotinib 250 mg BID |
|---|---|
| CYCLE2/DAY1 (n=929) | 7.9 ± 22.2 |
| CYCLE3/DAY1 (n=872) | 10.6 ± 23.7 |
| CYCLE4/DAY1 (n=828) | 12.2 ± 24.9 |
| CYCLE5/DAY1 (n=806) | 11.5 ± 23.9 |
| CYCLE6/DAY1 (n=774) | 11.9 ± 24.8 |
| CYCLE7/DAY1 (n=734) | 12.3 ± 24.7 |
| CYCLE8/DAY1 (n=699) | 12.3 ± 24.1 |
| CYCLE9/DAY1 (n=665) | 11.8 ± 23.5 |
| CYCLE10/DAY1 (n=631) | 11.5 ± 23.6 |
| CYCLE11/DAY1 (n=570) | 10.4 ± 23.9 |
| CYCLE12/DAY1 (n=411) | 10.1 ± 21.6 |
| CYCLE13/DAY1 (n=512) | 11.0 ± 24.0 |
| CYCLE14/DAY1 (n=353) | 10.4 ± 21.5 |
| CYCLE15/DAY1 (n=462) | 9.5 ± 23.9 |
| CYCLE16/DAY1 (n=294) | 7.4 ± 23.2 |
| CYCLE17/DAY1 (n=419) | 8.0 ± 24.3 |
| CYCLE18/DAY1 (n=247) | 7.8 ± 22.0 |
| CYCLE19/DAY1 (n=376) | 7.8 ± 23.1 |
| CYCLE20/DAY1 (n=222) | 9.1 ± 22.4 |
| CYCLE21/DAY1 (n=340) | 7.8 ± 22.5 |
| CYCLE22/DAY1 (n=179) | 5.9 ± 23.7 |
| CYCLE23/DAY1 (n=305) | 6.7 ± 24.0 |
| CYCLE24/DAY1 (n=154) | 6.4 ± 25.0 |
| CYCLE25/DAY1 (n=293) | 4.7 ± 23.3 |
| CYCLE26/DAY1 (n=127) | 8.3 ± 24.7 |
| CYCLE27/DAY1 (n=269) | 5.9 ± 23.2 |
| CYCLE28/DAY1 (n=120) | 6.7 ± 24.2 |
| CYCLE29/DAY1 (n=247) | 5.7 ± 23.3 |
| CYCLE30/DAY1 (n=105) | 6.4 ± 24.9 |
| End of treatment (n=450) | -1.0 ± 27.2 |
The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
| Units on a scale | Crizotinib 250 mg BID |
|---|---|
| Physical Functioning (Cycle 2/Day 1) (n=936) | 4.3 ± 17.1 |
| Physical Functioning (Cycle 3/Day 1) (n=879) | 6.6 ± 18.6 |
| Physical Functioning (Cycle 4/Day 1) (n=836) | 8.2 ± 19.1 |
| Physical Functioning (Cycle 5/Day 1) (n=810) | 8.8 ± 18.8 |
| Physical Functioning (Cycle 6/Day 1) (n=778) | 9.5 ± 18.6 |
| Physical Functioning (Cycle 7/Day 1) (n=739) | 10.0 ± 19.3 |
| Physical Functioning (Cycle 8/Day 1) (n= 704) | 10.1 ± 18.8 |
| Physical Functioning (Cycle 9/Day 1) (n= 673) | 10.5 ± 18.2 |
| Physical Functioning (Cycle 10/Day 1) (n= 637) | 9.5 ± 17.9 |
| Physical Functioning (Cycle 11/Day 1) (n=577) | 9.1 ± 17.9 |
| Physical Functioning (Cycle 12/Day 1) (n=412) | 8.2 ± 17.3 |
| Physical Functioning (Cycle 13/Day 1) (n=517) | 8.7 ± 18.1 |
| Physical Functioning (Cycle 14/Day 1) (n=358) | 8.2 ± 16.5 |
| Physical Functioning (Cycle 15/Day 1) (n=466) | 7.3 ± 19.2 |
| Physical Functioning (Cycle 16/Day 1) (n=295) | 6.3 ± 19.1 |
| Physical Functioning (Cycle 17/Day 1) (n=424) | 6.0 ± 18.9 |
| Physical Functioning (Cycle 18/Day 1) (n=250) | 6.1 ± 18.4 |
| Physical Functioning (Cycle 19/Day 1) (n=380) | 6.6 ± 16.8 |
| Physical Functioning (Cycle 20/Day 1) (n=224) | 5.1 ± 16.8 |
| Physical Functioning (Cycle 21/Day 1) (n=346) | 5.7 ± 17.6 |
| Physical Functioning (Cycle 22/Day 1) (n=182) | 3.8 ± 17.0 |
| Physical Functioning (Cycle 23/Day 1) (n=311) | 3.7 ± 17.1 |
| Physical Functioning (Cycle 24/Day 1) (n=156) | 2.4 ± 18.9 |
| Physical Functioning (Cycle 25/Day 1) (n=296) | 4.0 ± 18.0 |
| Physical Functioning (Cycle 26/Day 1) (n=129) | 5.3 ± 18.1 |
| Physical Functioning (Cycle 27/Day 1) (n=275) | 3.8 ± 16.1 |
| Physical Functioning (Cycle 28/Day 1) (n=121) | 3.6 ± 20.4 |
| Physical Functioning (Cycle 29/Day 1) (n=251) | 3.7 ± 15.8 |
| Physical Functioning (Cycle 30/Day 1) (n=109) | 2.8 ± 21.9 |
| Physical Functioning (End of treatment) (n=451) | 0.1 ± 25.0 |
| Cognitive functioning (Cycle 2/Day 1) (n=930) | 1.0 ± 18.4 |
| Cognitive Functioning (Cycle 3/Day 1) (n=874) | 2.1 ± 19.4 |
| Cognitive Functioning (Cycle 4/Day 1) (n=829) | 2.1 ± 18.6 |
| Cognitive Functioning (Cycle 5/Day 1) (n=806) | 2.3 ± 18.4 |
| Cognitive Functioning (Cycle 6/Day 1) (n=773) | 2.5 ± 18.2 |
| Cognitive Functioning (Cycle 7/Day 1) (n=734) | 3.2 ± 18.6 |
| Cognitive Functioning (Cycle 8/Day 1) (n=699) | 3.3 ± 18.5 |
| Cognitive Functioning (Cycle 9/Day 1) (n=667) | 3.0 ± 18.4 |
| Cognitive Functioning (Cycle 10/Day 1) (n=632) | 2.7 ± 19.0 |
| Cognitive Functioning (Cycle 11/Day 1) (n=571) | 3.0 ± 18.5 |
| Cognitive Functioning (Cycle 12/Day 1) (n=411) | 1.5 ± 17.1 |
| Cognitive Functioning (Cycle 13/Day 1) (n=512) | 2.0 ± 19.3 |
| Cognitive Functioning (Cycle 14/Day 1) (n=352) | 1.2 ± 17.8 |
| Cognitive Functioning (Cycle 15/Day 1) (n=462) | 1.3 ± 19.7 |
| Cognitive Functioning (Cycle 16/Day 1) (n=294) | -0.1 ± 18.1 |
| Cognitive Functioning (Cycle 17/Day 1) (n=419) | 0.0 ± 19.4 |
| Cognitive Functioning (Cycle 18/Day 1) (n=247) | 0.1 ± 19.2 |
| Cognitive Functioning (Cycle 19/Day 1) (n=376) | 0.1 ± 19.2 |
| Cognitive Functioning (Cycle 20/Day 1) (n=222) | 0.9 ± 18.1 |
| Cognitive Functioning (Cycle 21/Day 1) (n=340) | -0.1 ± 17.8 |
| Cognitive Functioning (Cycle 22/Day 1) (n=179) | -1.1 ± 17.5 |
| Cognitive Functioning (Cycle 23/Day 1) (n=305) | -0.3 ± 17.6 |
| Cognitive Functioning (Cycle 24/Day 1) (n=154) | -3.6 ± 21.2 |
| Cognitive Functioning (Cycle 25/Day 1) (n=293) | -1.3 ± 18.1 |
| Cognitive Functioning (Cycle 26/Day 1) (n=127) | -0.3 ± 20.2 |
| Cognitive Functioning (Cycle 27/Day 1) (n=269) | -0.9 ± 17.7 |
| Cognitive Functioning (Cycle 28/Day 1) (n=120) | -0.6 ± 20.7 |
| Cognitive Functioning (Cycle 29/Day 1) (n=247) | -0.2 ± 16.0 |
| Cognitive Functioning (Cycle 30/Day 1) (n=106) | -2.5 ± 23.7 |
| Cognitive Functioning (End of treatment) (n=449) | -2.3 ± 21.7 |
| Emotional Functioning (Cycle 2/Day 1) (n=928) | 5.5 ± 18.4 |
| Emotional Functioning (Cycle 3/Day 1) (n=873) | 6.8 ± 18.8 |
| Emotional Functioning (Cycle 4/Day 1) (n=827) | 8.2 ± 18.3 |
| Emotional Functioning (Cycle 5/Day 1) (n=804) | 7.8 ± 18.3 |
| Emotional Functioning (Cycle 6/Day 1) (n=772) | 8.6 ± 18.0 |
| Emotional Functioning (Cycle 7/Day 1) (n=731) | 8.3 ± 18.3 |
| Emotional Functioning (Cycle 8/Day 1) (n=697) | 9.2 ± 18.9 |
| Emotional Functioning (Cycle 9/Day 1) (n=665) | 8.7 ± 18.6 |
| Emotional Functioning (Cycle 10/Day 1) (n=630) | 8.5 ± 18.9 |
| Emotional Functioning (Cycle 11/Day 1) (n=571) | 8.5 ± 17.6 |
| Emotional Functioning (Cycle 12/Day 1) (n=410) | 8.4 ± 17.6 |
| Emotional Functioning (Cycle 13/Day 1) (n=511) | 8.5 ± 19.1 |
| Emotional Functioning (Cycle 14/Day 1) (n=352) | 7.9 ± 16.6 |
| Emotional Functioning (Cycle 15/Day 1) (n=461) | 8.3 ± 18.7 |
| Emotional Functioning (Cycle 16/Day 1) (n=293) | 7.5 ± 16.8 |
| Emotional Functioning (Cycle 17/Day 1) (n=418) | 6.9 ± 19.2 |
| Emotional Functioning (Cycle 18/Day 1) (n=246) | 7.5 ± 17.2 |
| Emotional Functioning (Cycle 19/Day 1) (n=376) | 7.4 ± 18.3 |
| Emotional Functioning (Cycle 20/Day 1) (n=221) | 7.4 ± 17.6 |
| Emotional Functioning (Cycle 21/Day 1) (n=340) | 6.7 ± 17.5 |
| Emotional Functioning (Cycle 22/Day 1) (n=178) | 5.2 ± 17.9 |
| Emotional Functioning (Cycle 23/Day 1) (n=305) | 6.6 ± 17.6 |
| Emotional Functioning (Cycle 24/Day 1) (n=153) | 4.4 ± 19.5 |
| Emotional Functioning (Cycle 25/Day 1) (n=293) | 6.2 ± 17.4 |
| Emotional Functioning (Cycle 26/Day 1) (n=126) | 7.5 ± 18.9 |
| Emotional Functioning (Cycle 27/Day 1) (n=269) | 6.3 ± 17.6 |
| Emotional Functioning (Cycle 28/Day 1) (n=119) | 4.1 ± 19.2 |
| Emotional Functioning (Cycle 29/Day 1) (n=247) | 5.9 ± 17.7 |
| Emotional Functioning (Cycle 30/Day 1) (n=105) | 3.2 ± 21.5 |
| Emotional Functioning (End of treatment) (n=448) | 1.9 ± 22.3 |
| Role Functioning (Cycle 2/Day 1) (n=935) | 4.2 ± 25.0 |
| Role Functioning (Cycle 3/Day 1) (n=879) | 7.3 ± 27.8 |
| Role Functioning (Cycle 4/Day 1) (n=835) | 9.3 ± 28.7 |
| Role Functioning (Cycle 5/Day 1) (n=809) | 9.5 ± 28.4 |
| Role Functioning (Cycle 6/Day 1) (n=778) | 10.5 ± 28.7 |
| Role Functioning (Cycle 7/Day 1) (n=738) | 10.4 ± 30.2 |
| Role Functioning (Cycle 8/Day 1) (n=702) | 10.8 ± 28.5 |
| Role Functioning (Cycle 9/Day 1) (n=671) | 10.9 ± 28.1 |
| Role Functioning (Cycle 10/Day 1) (n=635) | 10.8 ± 28.8 |
| Role Functioning (Cycle 11/Day 1) (n=576) | 10.0 ± 29.0 |
| Role Functioning (Cycle 12/Day 1) (n=413) | 8.4 ± 28.0 |
| Role Functioning (Cycle 13/Day 1) (n=516) | 9.0 ± 28.8 |
| Role Functioning (Cycle 14/Day 1) (n=358) | 8.4 ± 26.5 |
| Role Functioning (Cycle 15/Day 1) (n=465) | 8.8 ± 28.7 |
| Role Functioning (Cycle 16/Day 1) (n=296) | 6.0 ± 28.3 |
| Role Functioning (Cycle 17/Day 1) (n=424) | 6.1 ± 30.4 |
| Role Functioning (Cycle 18/Day 1) (n=250) | 5.2 ± 27.8 |
| Role Functioning (Cycle 19/Day 1) (n=380) | 8.0 ± 27.5 |
| Role Functioning (Cycle 20/Day 1) (n=224) | 5.8 ± 25.1 |
| Role Functioning (Cycle 21/Day 1) (n=346) | 5.3 ± 27.1 |
| Role Functioning (Cycle 22/Day 1) (n=182) | 4.1 ± 26.7 |
| Role Functioning (Cycle 23/Day 1) (n=311) | 3.2 ± 27.9 |
| Role Functioning (Cycle 24/Day 1) (n=157) | 2.7 ± 29.5 |
| Role Functioning (Cycle 25/Day 1) (n=297) | 2.2 ± 27.2 |
| Role Functioning (Cycle 26/Day 1) (n=129) | 6.1 ± 28.0 |
| Role Functioning (Cycle 27/Day 1) (n=275) | 2.4 ± 27.6 |
| Role Functioning (Cycle 28/Day 1) (n=121) | 1.5 ± 30.0 |
| Role Functioning (Cycle 29/Day 1)(n=251) | 1.6 ± 24.6 |
| Role Functioning (Cycle 30/Day 1) (n=109) | 1.1 ± 34.0 |
| Role Functioning (End of treatment) (n=451) | -1.6 ± 31.9 |
| Social Functioning (Cycle 2/Day 1) (n=928) | 6.8 ± 25.9 |
| Social Functioning (Cycle 3/Day 1) (n=872) | 9.1 ± 26.2 |
| Social Functioning (Cycle 4/Day 1) (n=828) | 10.4 ± 27.2 |
| Social Functioning (Cycle 5/Day 1) (n=805) | 10.6 ± 26.7 |
| Social Functioning (Cycle 6/Day 1) (n=773) | 11.1 ± 27.0 |
| Social Functioning (Cycle 7/Day 1) (n=733) | 12.1 ± 26.5 |
| Social Functioning (Cycle 8/Day 1) (n=698) | 12.3 ± 26.4 |
| Social Functioning (Cycle 9/Day 1) (n=666) | 12.0 ± 26.4 |
| Social Functioning (Cycle 10/Day 1) (n=631) | 11.8 ± 26.1 |
| Social Functioning (Cycle 11/Day 1) (n=570) | 12.1 ± 27.3 |
| Social Functioning (Cycle 12/Day 1) (n=410) | 10.3 ± 26.3 |
| Social Functioning (Cycle 13/Day 1) (n=512) | 10.6 ± 27.3 |
| Social Functioning (Cycle 14/Day 1) (n=352) | 10.4 ± 25.1 |
| Social Functioning (Cycle 15/Day 1) (n=462) | 10.1 ± 28.1 |
| Social Functioning (Cycle 16/Day 1) (n=293) | 9.0 ± 26.4 |
| Social Functioning (Cycle 17/Day 1) (n=418) | 8.8 ± 26.9 |
| Social Functioning (Cycle 18/Day 1) (n=246) | 6.6 ± 25.4 |
| Social Functioning (Cycle 19/Day 1) (n=376) | 8.0 ± 25.6 |
| Social Functioning (Cycle 20/Day 1) (n=221) | 5.7 ± 23.9 |
| Social Functioning (Cycle 21/Day 1) (n=340) | 6.7 ± 26.6 |
| Social Functioning (Cycle 22/Day 1) (n=178) | 5.3 ± 22.7 |
| Social Functioning (Cycle 23/Day 1) (n=305) | 7.0 ± 24.9 |
| Social Functioning (Cycle 24/Day 1) (n=153) | 3.6 ± 26.5 |
| Social Functioning (Cycle 25/Day 1) (n=293) | 4.4 ± 25.8 |
| Social Functioning (Cycle 26/Day 1) (n=126) | 5.2 ± 26.6 |
| Social Functioning (Cycle 27/Day 1) (n=269) | 5.3 ± 26.4 |
| Social Functioning (Cycle 28/Day 1) (n=119) | 2.1 ± 31.4 |
| Social Functioning (Cycle 29/Day 1) (n=247) | 6.6 ± 24.1 |
| Social Functioning (Cycle 30/Day 1) (n=105) | 1.6 ± 29.0 |
| Social Functioning (End of treatment) (n=449) | 2.7 ± 31.2 |
| Appetite loss (Cycle 2/Day 1) (n=936) | -2.1 ± 30.3 |
| Appetite loss (Cycle 3/Day 1) (n=877) | -6.3 ± 31.7 |
| Appetite loss (Cycle 4/Day 1) (n=833) | -9.1 ± 31.9 |
| Appetite loss (Cycle 5/Day 1) (n=810) | -10.4 ± 31.9 |
| Appetite loss (Cycle 6/Day 1) (n=778) | -11.4 ± 32.1 |
| Appetite loss (Cycle 7/Day 1) (n=738) | -11.4 ± 32.4 |
| Appetite loss (Cycle 8/Day 1) (n=704) | -11.5 ± 32.6 |
| Appetite loss (Cycle 9/Day 1) (n=673) | -11.7 ± 32.5 |
| Appetite loss (Cycle 10/Day 1) (n=637) | -11.9 ± 30.9 |
| Appetite loss (Cycle 11/Day 1) (n=577) | -11.2 ± 30.4 |
| Appetite loss (Cycle 12/Day 1) (n=413) | -9.1 ± 30.9 |
| Appetite loss (Cycle 13/Day 1) (n=517) | -11.3 ± 29.8 |
| Appetite loss (Cycle 14/Day 1) (n=358) | -9.9 ± 31.8 |
| Appetite loss (Cycle 15/Day 1) (n=466) | -10.5 ± 30.6 |
| Appetite loss (Cycle 16/Day 1) (n=296) | -10.4 ± 32.4 |
| Appetite loss (Cycle 17/Day 1) (n=424) | -8.6 ± 29.5 |
| Appetite loss (Cycle 18/Day 1) (n=250) | -10.1 ± 31.5 |
| Appetite loss (Cycle 19/Day 1) (n=380) | -8.9 ± 30.9 |
| Appetite loss (Cycle 20/Day 1) (n=224) | -12.8 ± 29.0 |
| Appetite loss (Cycle 21/Day 1) (n=346) | -7.5 ± 30.6 |
| Appetite loss (Cycle 22/Day 1) (n=181) | -9.2 ± 27.7 |
| Appetite loss (Cycle 23/Day 1) (n=310) | -4.9 ± 28.5 |
| Appetite loss (Cycle 24/Day 1) (n=157) | -10.9 ± 30.1 |
| Appetite loss (Cycle 25/Day 1) (n=297) | -4.6 ± 29.0 |
| Appetite loss (Cycle 26/Day 1) (n=129) | -12.1 ± 32.3 |
| Appetite loss (Cycle 27/Day 1) (n=275) | -4.2 ± 29.4 |
| Appetite loss (Cycle 28/Day 1) (n=121) | -6.6 ± 34.6 |
| Appetite loss (Cycle 29/Day 1) (n=251) | -3.2 ± 27.0 |
| Appetite loss (Cycle 30/Day 1) (n=109) | -7.6 ± 29.3 |
| Appetite loss (End of treatment) (n=451) | -0.0 ± 36.9 |
| Constipation (Cycle 2/Day 1) (n=929) | 15.4 ± 32.9 |
| Constipation (Cycle 3/Day 1) (n=870) | 10.9 ± 33.8 |
| Constipation (Cycle 4/Day 1) (n=827) | 7.0 ± 31.0 |
| Constipation (Cycle 5/Day 1) (n=804) | 5.5 ± 30.4 |
| Constipation (Cycle 6/Day 1) (n=771) | 5.4 ± 30.3 |
| Constipation (Cycle 7/Day 1) (n=732) | 4.7 ± 30.3 |
| Constipation (Cycle 8/Day 1) (n=698) | 4.5 ± 29.8 |
| Constipation (Cycle 9/Day 1) (n=665) | 5.0 ± 29.9 |
| Constipation (Cycle 10/Day 1) (n=631) | 3.8 ± 30.0 |
| Constipation (Cycle 11/Day 1) (n=571) | 5.2 ± 29.7 |
| Constipation (Cycle 12/Day 1) (n=410) | 6.4 ± 29.6 |
| Constipation (Cycle 13/Day 1) (n=513) | 5.2 ± 29.0 |
| Constipation (Cycle 14/Day 1) (n=349) | 5.0 ± 28.7 |
| Constipation (Cycle 15/Day 1) (n=464) | 6.0 ± 30.1 |
| Constipation (Cycle 16/Day 1) (n=291) | 4.4 ± 29.9 |
| Constipation (Cycle 17/Day 1) (n=420) | 8.3 ± 30.5 |
| Constipation (Cycle 18/Day 1) (n=246) | 6.0 ± 30.7 |
| Constipation (Cycle 19/Day 1) (n=376) | 7.4 ± 30.5 |
| Constipation (Cycle 20/Day 1) (n=221) | 5.9 ± 33.2 |
| Constipation (Cycle 21/Day 1) (n=340) | 7.7 ± 31.3 |
| Constipation (Cycle 22/Day 1) (n=178) | 6.2 ± 31.2 |
| Constipation (Cycle 23/Day 1) (n=306) | 9.7 ± 31.9 |
| Constipation (Cycle 24/Day 1) (n=154) | 9.0 ± 34.2 |
| Constipation (Cycle 25/Day 1) (n=293) | 10.9 ± 29.4 |
| Constipation (Cycle 26/Day 1) (n=126) | 5.6 ± 32.0 |
| Constipation (Cycle 27/Day 1) (n=269) | 8.3 ± 30.7 |
| Constipation (Cycle 28/Day 1) (n=119) | 9.8 ± 31.1 |
| Constipation (Cycle 29/Day 1) (n=247) | 7.8 ± 29.3 |
| Constipation (Cycle 30/Day 1) (n=105) | 11.7 ± 31.3 |
| Constipation (End of treatment) (n=444) | 8.9 ± 33.0 |
| Diarrhea (Cycle 2/Day 1) (n=927) | 11.4 ± 25.9 |
| Diarrhea (Cycle 3/Day 1) (n=872) | 12.8 ± 26.9 |
| Diarrhea (Cycle 4/Day 1) (n=826) | 11.7 ± 25.6 |
| Diarrhea (Cycle 5/Day 1) (n=805) | 12.6 ± 26.1 |
| Diarrhea (Cycle 6/Day 1) (n=772) | 11.6 ± 26.4 |
| Diarrhea (Cycle 7/Day 1) (n=732) | 10.9 ± 26.3 |
| Diarrhea (Cycle 8/Day 1) (n=698) | 9.8 ± 25.6 |
| Diarrhea (Cycle 9/Day 1) (n=665) | 10.5 ± 25.6 |
| Diarrhea (Cycle 10/Day 1) (n=632) | 11.1 ± 26.6 |
| Diarrhea (Cycle 11/Day 1) (n=570) | 10.1 ± 25.9 |
| Diarrhea (Cycle 12/Day 1) (n=411) | 8.1 ± 25.2 |
| Diarrhea (Cycle 13/Day 1) (n=512) | 8.8 ± 24.0 |
| Diarrhea (Cycle 14/Day 1) (n=352) | 10.1 ± 22.4 |
| Diarrhea (Cycle 15/Day 1) (n=461) | 8.5 ± 23.1 |
| Diarrhea (Cycle 16/Day 1) (n=293) | 10.0 ± 22.5 |
| Diarrhea (Cycle 17/Day 1) (n=419) | 8.6 ± 23.9 |
| Diarrhea (Cycle 18/Day 1) (n=247) | 7.4 ± 22.4 |
| Diarrhea (Cycle 19/Day 1) (n=376) | 7.8 ± 22.5 |
| Diarrhea (Cycle 20/Day 1) (n=222) | 6.8 ± 22.6 |
| Diarrhea (Cycle 21/Day 1) (n=340) | 6.6 ± 20.3 |
| Diarrhea (Cycle 22/Day 1) (n=179) | 6.8 ± 24.2 |
| Diarrhea (Cycle 23/Day 1) (n=305) | 8.7 ± 22.7 |
| Diarrhea (Cycle 24/Day 1) (n=154) | 6.4 ± 23.1 |
| Diarrhea (Cycle 25/Day 1) (n=293) | 10.1 ± 23.4 |
| Diarrhea (Cycle 26/Day 1) (n=127) | 5.0 ± 23.8 |
| Diarrhea (Cycle 27/Day 1) (n=269) | 8.3 ± 24.5 |
| Diarrhea (Cycle 28/Day 1) (n=119) | 5.6 ± 20.5 |
| Diarrhea (Cycle 29/Day 1) (n=247) | 9.7 ± 22.6 |
| Diarrhea (Cycle 30/Day 1) (n=106) | 10.1 ± 25.3 |
| Diarrhea (End of treatment) (n=449) | 5.9 ± 24.5 |
| Dyspnoea (Cycle 2/Day 1) (n=933) | -9.8 ± 26.2 |
| Dyspnoea (Cycle 3/Day 1) (n=876) | -11.4 ± 28.2 |
| Dyspnoea (Cycle 4/Day 1) (n=834) | -12.3 ± 28.6 |
| Dyspnoea (Cycle 5/Day 1) (n=808) | -12.2 ± 27.7 |
| Dyspnoea (Cycle 6/Day 1) (n=776) | -13.7 ± 27.6 |
| Dyspnoea (Cycle 7/Day 1) (n=737) | -13.8 ± 27.8 |
| Dyspnoea (Cycle 8/Day 1) (n=702) | -13.8 ± 28.2 |
| Dyspnoea (Cycle 9/Day 1) (n=671) | -13.3 ± 27.9 |
| Dyspnoea (Cycle 10/Day 1) (n=635) | -13.4 ± 27.6 |
| Dyspnoea (Cycle 11/Day 1) (n=575) | -15.0 ± 27.8 |
| Dyspnoea (Cycle 12/Day 1) (n=411) | -13.1 ± 26.8 |
| Dyspnoea (Cycle 13/Day 1) (n=515) | -13.1 ± 28.1 |
| Dyspnoea (Cycle 14/Day 1) (n=356) | -12.7 ± 27.5 |
| Dyspnoea (Cycle 15/Day 1) (n=463) | -12.6 ± 28.5 |
| Dyspnoea (Cycle 16/Day 1) (n=295) | -12.2 ± 27.6 |
| Dyspnoea (Cycle 17/Day 1) (n=421) | -11.8 ± 27.9 |
| Dyspnoea (Cycle 18/Day 1) (n=248) | -11.5 ± 27.4 |
| Dyspnoea (Cycle 19/Day 1) (n=377) | -14.2 ± 28.0 |
| Dyspnoea (Cycle 20/Day 1) (n=222) | -9.2 ± 26.4 |
| Dyspnoea (Cycle 21/Day 1) (n=344) | -13.4 ± 27.1 |
| Dyspnoea (Cycle 22/Day 1) (n=181) | -8.8 ± 26.4 |
| Dyspnoea (Cycle 23/Day 1) (n=309) | -10.9 ± 26.6 |
| Dyspnoea (Cycle 24/Day 1) (n=156) | -8.5 ± 27.3 |
| Dyspnoea (Cycle 25/Day 1) (n=295) | -10.5 ± 26.3 |
| Dyspnoea (Cycle 26/Day 1) (n=129) | -10.1 ± 27.2 |
| Dyspnoea (Cycle 27/Day 1) (n=273) | -9.3 ± 24.8 |
| Dyspnoea (Cycle 28/Day 1) (n=121) | -12.1 ± 28.9 |
| Dyspnoea (Cycle 29/Day 1) (n=249) | -8.8 ± 25.4 |
| Dyspnoea (Cycle 30/Day 1) (n=109) | -11.6 ± 27.7 |
| Dyspnoea (End of treatment) (n=450) | -4.2 ± 32.8 |
| Fatigue (Cycle 2/Day 1) (n=936) | -4.8 ± 21.8 |
| Fatigue (Cycle 3/Day 1) (n=879) | -8.9 ± 23.7 |
| Fatigue (Cycle 4/Day 1) (n=836) | -11.4 ± 24.1 |
| Fatigue (Cycle 5/Day 1) (n=810) | -12.0 ± 24.2 |
| Fatigue (Cycle 6/Day 1) (n=778) | -13.7 ± 24.3 |
| Fatigue (Cycle 7/Day 1) (n=739) | -14.0 ± 24.6 |
| Fatigue (Cycle 8/Day 1) (n=704) | -15.3 ± 23.7 |
| Fatigue (Cycle 9/Day 1) (n=671) | -14.9 ± 24.0 |
| Fatigue (Cycle 10/Day 1) (n=637) | -14.4 ± 24.2 |
| Fatigue (Cycle 11/Day 1) (n=577) | -13.7 ± 24.3 |
| Fatigue (Cycle 12/Day 1) (n=413) | -12.2 ± 23.4 |
| Fatigue (Cycle 13/Day 1) (n=517) | -13.4 ± 23.6 |
| Fatigue (Cycle 14/Day 1) (n=358) | -13.2 ± 22.3 |
| Fatigue (Cycle 15/Day 1) (n=466) | -13.1 ± 23.9 |
| Fatigue (Cycle 16/Day 1) (n=296) | -11.3 ± 24.1 |
| Fatigue (Cycle 17/Day 1) (n=424) | -11.3 ± 24.6 |
| Fatigue (Cycle 18/Day 1) (N=250) | -10.4 ± 25.2 |
| Fatigue (Cycle 19/Day 1) (n=380) | -11.9 ± 23.7 |
| Fatigue (Cycle 20/Day 1) (n=224) | -10.6 ± 23.2 |
| Fatigue (Cycle 21/Day 1) (n=346) | -11.0 ± 25.0 |
| Fatigue (Cycle 22/Day 1) (n=182) | -8.4 ± 23.0 |
| Fatigue (Cycle 23/Day 1) (n=311) | -8.7 ± 23.3 |
| Fatigue (Cycle 24/Day 1) (n=157) | -6.7 ± 24.1 |
| Fatigue (Cycle 25/Day 1) (n=297) | -7.9 ± 23.2 |
| Fatigue (Cycle 26/Day 1) (n=129) | -12.1 ± 24.8 |
| Fatigue (Cycle 27/Day 1) (n=275) | -7.0 ± 22.3 |
| Fatigue (Cycle 28/Day 1) (n=121) | -6.7 ± 25.2 |
| Fatigue (Cycle 29/Day 1) (n=251) | -7.1 ± 22.1 |
| Fatigue (Cycle 30/Day 1) (n=109) | -7.2 ± 27.0 |
| Fatigue (End of treatment) (n=451) | -5.3 ± 27.5 |
| Financial Difficulties (Cycle 2/Day 1) (n=928) | -4.6 ± 24.1 |
| Financial Difficulties (Cycle 3/Day 1) (n=871) | -4.2 ± 25.2 |
| Financial Difficulties (Cycle 4/Day 1) (n=827) | -5.9 ± 25.7 |
| Financial Difficulties (Cycle 5/Day 1) (n=803) | -5.1 ± 25.6 |
| Financial Difficulties (Cycle 6/Day 1) (n=772) | -5.5 ± 25.4 |
| Financial Difficulties (Cycle 7/Day 1) (n=732) | -6.2 ± 25.8 |
| Financial Difficulties (Cycle 8/Day 1) (n=697) | -6.4 ± 26.0 |
| Financial Difficulties (Cycle 9/Day 1) (n=663) | -5.8 ± 25.8 |
| Financial Difficulties (Cycle 10/Day 1) (n=631) | -7.4 ± 25.0 |
| Financial Difficulties (Cycle 11/Day 1) (n=569) | -6.6 ± 25.4 |
| Financial Difficulties (Cycle 12/Day 1) (n=410) | -4.8 ± 25.4 |
| Financial Difficulties (Cycle 13/Day 1) (n=512) | -6.3 ± 25.8 |
| Financial Difficulties (Cycle 14/Day 1) (n=352) | -5.8 ± 25.4 |
| Financial Difficulties (Cycle 15/Day 1) (n=461) | -6.1 ± 26.7 |
| Financial Difficulties (Cycle 16/Day 1) (n=294) | -4.0 ± 23.8 |
| Financial Difficulties (Cycle 17/Day 1) (n=418) | -5.5 ± 26.8 |
| Financial Difficulties (Cycle 18/Day 1) (n=247) | -3.8 ± 25.2 |
| Financial Difficulties (Cycle 19/Day 1) (n=376) | -5.9 ± 26.8 |
| Financial Difficulties (Cycle 20/Day 1) (n=220) | -5.2 ± 25.4 |
| Financial Difficulties (Cycle 21/Day 1) (n=339) | -4.2 ± 25.9 |
| Financial Difficulties (Cycle 22/Day 1) (n=177) | -2.1 ± 23.1 |
| Financial Difficulties (Cycle 23/Day 1) (n=304) | -4.4 ± 24.9 |
| Financial Difficulties (Cycle 24/Day 1) (n=153) | -2.8 ± 27.3 |
| Financial Difficulties (Cycle 25/Day 1) (n=292) | -4.6 ± 24.8 |
| Financial Difficulties (Cycle 26/Day 1) (n=126) | -2.9 ± 26.0 |
| Financial Difficulties (Cycle 27/Day 1) (n=268) | -4.8 ± 25.5 |
| Financial Difficulties (Cycle 28/Day 1) (n=119) | -4.2 ± 29.9 |
| Financial Difficulties (Cycle 29/Day 1) (n=247) | -5.5 ± 25.2 |
| Financial Difficulties (Cycle 30/Day 1) (n=105) | -3.5 ± 26.5 |
| Financial Difficulties (End of treatment) (n=447) | -2.2 ± 27.5 |
| Insomnia (Cycle 2/Day 1) (n=934) | -7.6 ± 29.3 |
| Insomnia (Cycle 3/Day 1) (n=878) | -11.3 ± 30.1 |
| Insomnia (Cycle 4/Day 1) (n=833) | -13.0 ± 29.7 |
| Insomnia (Cycle 5/Day 1) (n=808) | -12.8 ± 29.8 |
| Insomnia (Cycle 6/Day 1) (n=778) | -13.3 ± 31.1 |
| Insomnia (Cycle 7/Day 1) (n=739) | -13.9 ± 29.7 |
| Insomnia (Cycle 8/Day 1) (n=703) | -12.6 ± 29.9 |
| Insomnia (Cycle 9/Day 1) (n=673) | -13.2 ± 28.8 |
| Insomnia (Cycle 10/Day 1) (n=637) | -13.2 ± 29.4 |
| Insomnia (Cycle 11/Day 1) (n=576) | -12.2 ± 30.0 |
| Insomnia (Cycle 12/Day 1) (n=413) | -11.3 ± 29.7 |
| Insomnia (Cycle 13/Day 1) (n=516) | -13.0 ± 29.5 |
| Insomnia (Cycle 14/Day 1) (n=358) | -11.7 ± 30.3 |
| Insomnia (Cycle 15/Day 1) (n=464) | -12.4 ± 30.0 |
| Insomnia (Cycle 16/Day 1) (n=296) | -10.9 ± 31.6 |
| Insomnia (Cycle 17/Day 1) (n=424) | -10.8 ± 29.2 |
| Insomnia (Cycle 18/Day 1) (n=250) | -10.4 ± 30.3 |
| Insomnia (Cycle 19/Day 1) (n=379) | -12.6 ± 28.9 |
| Insomnia (Cycle 20/Day 1) (n=224) | -11.5 ± 27.1 |
| Insomnia (Cycle 21/Day 1) (n=346) | -10.2 ± 27.6 |
| Insomnia (Cycle 22/Day 1) (n=182) | -7.9 ± 25.8 |
| Insomnia (Cycle 23/Day 1) (n=311) | -10.5 ± 27.2 |
| Insomnia (Cycle 24/Day 1) (n=157) | -5.7 ± 28.0 |
| Insomnia (Cycle 25/Day 1) (n=296) | -7.7 ± 28.8 |
| Insomnia (Cycle 26/Day 1) (n=129) | -10.9 ± 29.2 |
| Insomnia (Cycle 27/Day 1) (n=274) | -10.1 ± 27.4 |
| Insomnia (Cycle 28/Day 1) (n=121) | -6.9 ± 32.7 |
| Insomnia (Cycle 29/Day 1) (n=251) | -8.4 ± 28.5 |
| Insomnia (Cycle 30/Day 1) (n=109) | -11.3 ± 32.1 |
| Nausea and Vomiting (Cycle 2/Day 1) (n=936) | 6.2 ± 23.1 |
| Nausea and Vomiting (Cycle 3/Day 1) (n=879) | 2.4 ± 23.3 |
| Nausea and Vomiting (Cycle 4/Day 1) (n=836) | 0.3 ± 22.6 |
| Nausea and Vomiting (Cycle 5/Day 1) (n=810) | -0.4 ± 21.1 |
| Nausea and Vomiting (Cycle 6/Day 1) (n=779) | -1.6 ± 19.9 |
| Nausea and Vomiting (Cycle 7/Day 1) (n=739) | -2.3 ± 21.0 |
| Nausea and Vomiting (Cycle 8/Day 1) (n=704) | -1.9 ± 19.8 |
| Nausea and Vomiting (Cycle 9/Day 1) (n=673) | -1.8 ± 21.2 |
| Nausea and Vomiting (Cycle 10/Day 1) (n=637) | -1.4 ± 21.6 |
| Nausea and Vomiting (Cycle 11/Day 1) (n=577) | -1.7 ± 20.9 |
| Nausea and Vomiting (Cycle 12/Day 1) (n=413) | -1.5 ± 21.8 |
| Nausea and Vomiting (Cycle 13/Day 1) (n=517) | -0.7 ± 21.2 |
| Nausea and Vomiting (Cycle 14/Day 1) (n=358) | -0.4 ± 23.3 |
| Nausea and Vomiting (Cycle 15/Day 1) (n=466) | -0.7 ± 21.2 |
| Nausea and Vomiting (Cycle 16/Day 1) (n=296) | -0.8 ± 19.5 |
| Nausea and Vomiting (Cycle 17/Day 1) (n=424) | -0.3 ± 20.2 |
| Nausea and Vomiting (Cycle 18/Day 1) (n=250) | -0.9 ± 21.7 |
| Nausea and Vomiting (Cycle 19/Day 1) (n=380) | -0.3 ± 20.1 |
| Nausea and Vomiting (Cycle 20/Day 1) (n=224) | -2.3 ± 18.7 |
| Nausea and Vomiting (Cycle 21/Day 1) (n=346) | -1.1 ± 18.6 |
| Nausea and Vomiting (Cycle 22/Day 1) (n=182) | 0.2 ± 19.0 |
| Nausea and Vomiting (Cycle 23/Day 1) (n=311) | 0.8 ± 17.4 |
| Nausea and Vomiting (Cycle 24/Day 1) (n=157) | -1.3 ± 17.4 |
| Nausea and Vomiting (Cycle 25/Day 1) (n=297) | 0.6 ± 18.0 |
| Nausea and Vomiting (Cycle 26/Day 1) (n=129) | -2.3 ± 20.2 |
| Nausea and Vomiting (Cycle 27/Day 1) (n=275) | 1.9 ± 17.5 |
| Nausea and Vomiting (Cycle 28/Day 1) (n=121) | 1.8 ± 19.7 |
| Nausea and Vomiting (Cycle 29/Day 1) (n=251) | 2.5 ± 18.9 |
| Nausea and Vomiting (Cycle 30/Day 1) (n=109) | -0.5 ± 17.5 |
| Nausea and Vomiting (End of treatment) (n=451) | 4.0 ± 25.3 |
| Pain (Cycle 2/Day 1) (n=935) | -13.1 ± 26.6 |
| Pain (Cycle 3/Day 1) (n=880) | -16.0 ± 28.0 |
| Pain (Cycle 4/Day 1) (n=836) | -15.7 ± 27.8 |
| Pain (Cycle 5/Day 1) (n=810) | -15.5 ± 27.4 |
| Pain (Cycle 6/Day 1) (n=779) | -15.5 ± 27.8 |
| Pain (Cycle 7/Day 1) (n=739) | -16.0 ± 29.0 |
| Pain (Cycle 8/Day 1) (n=705) | -15.9 ± 28.5 |
| Pain (Cycle 9/Day 1) (n=673) | -15.5 ± 28.7 |
| Pain (Cycle 10/Day 1) (n=637) | -15.1 ± 27.6 |
| Pain (Cycle 11/Day 1) (n=577) | -14.6 ± 27.6 |
| Pain (Cycle 12/Day 1) (n=414) | -13.6 ± 29.2 |
| Pain (Cycle 13/Day 1) (n=517) | -13.8 ± 28.0 |
| Pain (Cycle 14/Day 1) (n=357) | -13.9 ± 29.5 |
| Pain (Cycle 15/Day 1) (n=466) | -12.1 ± 27.0 |
| Pain (Cycle 16/Day 1) (n=296) | -12.5 ± 27.9 |
| Pain (Cycle 17/Day 1) (n=424) | -10.6 ± 25.6 |
| Pain (Cycle 18/Day 1) (n=250) | -11.1 ± 27.5 |
| Pain (Cycle 19/Day 1) (n=380) | -10.8 ± 24.1 |
| Pain (Cycle 20/Day 1) (n=224) | -11.0 ± 27.2 |
| Pain (Cycle 21/Day 1) (n=346) | -10.1 ± 25.2 |
| Pain (Cycle 22/Day 1) (n=182) | -7.7 ± 26.2 |
| Pain (Cycle 23/Day 1) (n=311) | -7.4 ± 26.0 |
| Pain (Cycle 24/Day 1) (n=157) | -8.8 ± 27.7 |
| Pain (Cycle 25/Day 1) (n=297) | -8.8 ± 24.6 |
| Pain (Cycle 26/Day 1) (n=129) | -12.5 ± 29.5 |
| Pain (Cycle 27/Day 1) (n=275) | -7.6 ± 25.3 |
| Pain (Cycle 28/Day 1) (n=121) | -7.9 ± 32.4 |
| Pain (Cycle 29/Day 1) (n=251) | -8.1 ± 24.6 |
| Pain (Cycle 30/Day 1) (n=109) | -7.5 ± 29.8 |
| Pain (End of treatment) (n=451) | -5.3 ± 31.2 |
| Insomnia (End of treatment) 9n=451) | -5.7 ± 33.6 |
The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
| Units on a scale | Crizotinib 250 mg BID |
|---|---|
| Alopecia (Cycle 2/Day 1) (n=920) | -9.1 ± 29.6 |
| Alopecia (Cycle 3/Day 1) (n=870) | -10.2 ± 31.6 |
| Alopecia (Cycle 4/Day 1) (n=829) | -11.6 ± 30.7 |
| Alopecia (Cycle 5/Day 1) (n=805) | -12.2 ± 32.3 |
| Alopecia (Cycle 6/Day 1) (n=770) | -10.5 ± 30.9 |
| Alopecia (Cycle 7/Day 1) (n=734) | -11.9 ± 32.3 |
| Alopecia (Cycle 8/Day 1) (n=700) | -11.9 ± 33.2 |
| Alopecia (Cycle 9/Day 1) (n=667) | -11.3 ± 34.7 |
| Alopecia (Cycle 10/Day 1) (n=633) | -10.8 ± 33.9 |
| Alopecia (Cycle 11/Day 1) (n=574) | -11.3 ± 34.8 |
| Alopecia (Cycle 12/Day 1) (n=409) | -7.8 ± 34.8 |
| Alopecia (Cycle 13/Day 1) (n=512) | -10.8 ± 35.0 |
| Alopecia (Cycle 14/Day 1) (n=353) | -8.2 ± 36.4 |
| Alopecia (Cycle 15/Day 1) (n=462) | -11.8 ± 34.3 |
| Alopecia (Cycle 16/Day 1) (n=293) | -7.7 ± 34.1 |
| Alopecia (Cycle 17/Day 1) (n=419) | -9.5 ± 32.9 |
| Alopecia (Cycle 18/Day 1) (n=247) | -6.4 ± 31.3 |
| Alopecia (Cycle 19/Day 1) (n=377) | -8.9 ± 34.1 |
| Alopecia (Cycle 20/Day 1) (n=222) | -9.0 ± 30.7 |
| Alopecia (Cycle 21/Day 1) (n=342) | -7.8 ± 32.9 |
| Alopecia (Cycle 22/Day 1) (n=180) | -7.6 ± 35.6 |
| Alopecia (Cycle 23/Day 1) (n=310) | -7.0 ± 33.2 |
| Alopecia (Cycle 24/Day 1) (n=156) | -4.1 ± 34.1 |
| Alopecia (Cycle 25/Day 1) (n=293) | -8.2 ± 31.8 |
| Alopecia (Cycle 26/Day 1) (n=126) | -4.5 ± 31.1 |
| Alopecia (Cycle 27/Day 1) (n=271) | -8.5 ± 31.5 |
| Alopecia (Cycle 28/Day 1) (n=119) | -3.9 ± 33.1 |
| Alopecia (Cycle 29/Day 1) (n=247) | -9.2 ± 28.3 |
| Alopecia (Cycle 30/Day 1) (n=107) | -5.0 ± 31.7 |
| Alopecia (End of treatment) (n=447) | -9.9 ± 35.3 |
| Coughing (Cycle 2/Day 1) (n=926) | -12.9 ± 28.8 |
| Coughing (Cycle 3/Day 1) (n=879) | -15.5 ± 31.8 |
| Coughing (Cycle 4/Day 1) (n=832) | -17.7 ± 31.1 |
| Coughing (Cycle 5/Day 1) (n=807) | -17.3 ± 31.8 |
| Coughing (Cycle 6/Day 1) (n=775) | -18.3 ± 32.1 |
| Coughing (Cycle 7/Day 1) (n=735) | -20.1 ± 32.2 |
| Coughing (Cycle 8/Day 1) (n=703) | -20.8 ± 31.8 |
| Coughing (Cycle 9/Day 1) (n=669) | -20.2 ± 30.9 |
| Coughing (Cycle 10/Day 1) (n=636) | -19.9 ± 32.0 |
| Coughing (Cycle 11/Day 1) (n=575) | -19.9 ± 31.6 |
| Coughing (Cycle 12/Day 1) (n=414) | -19.2 ± 29.5 |
| Coughing (Cycle 13/Day 1) (n=513) | -18.6 ± 32.6 |
| Coughing (Cycle 14/Day 1) (n=355) | -17.9 ± 32.1 |
| Coughing (Cycle 15/Day 1) (n=461) | -17.8 ± 31.7 |
| Coughing (Cycle 16/Day 1) (n=294) | -17.3 ± 29.5 |
| Coughing (Cycle 17/Day 1) (n=421) | -18.4 ± 32.5 |
| Coughing (Cycle 18/Day 1) (n=249) | -16.9 ± 33.1 |
| Coughing (Cycle 19/Day 1) (n=379) | -18.8 ± 30.3 |
| Coughing (Cycle 20/Day 1) (n=222) | -18.3 ± 32.7 |
| Coughing (Cycle 21/Day 1) (n=343) | -18.0 ± 31.0 |
| Coughing (Cycle 22/Day 1) (n=181) | -16.7 ± 33.1 |
| Coughing (Cycle 23/Day 1) (n=311) | -18.4 ± 32.1 |
| Coughing (Cycle 24/Day 1) (n=155) | -18.9 ± 31.3 |
| Coughing (Cycle 25/Day 1) (n=294) | -18.1 ± 31.3 |
| Coughing (Cycle 26/Day 1) (n=125) | -21.9 ± 30.8 |
| Coughing (Cycle 27/Day 1) (n=272) | -17.8 ± 32.2 |
| Coughing (Cycle 28/Day 1) (n=119) | -19.6 ± 30.8 |
| Coughing (Cycle 29/Day 1) (n=249) | -17.1 ± 31.3 |
| Coughing (Cycle 30/Day 1) (n=106) | -16.7 ± 29.5 |
| Coughing (End of treatment) (n=452) | -11.1 ± 33.5 |
| Dysphagia (Cycle 2/Day 1) (n=926) | 0.0 ± 19.6 |
| Dysphagia (Cycle 3/Day 1) (n=879) | -1.1 ± 20.1 |
| Dysphagia (Cycle 4/Day 1) (n=831) | -2.2 ± 20.8 |
| Dysphagia (Cycle 5/Day 1) (n=807) | -2.3 ± 20.0 |
| Dysphagia (Cycle 6/Day 1) (n=776) | -3.0 ± 19.9 |
| Dysphagia (Cycle 7/Day 1) (n=737) | -3.1 ± 20.7 |
| Dysphagia (Cycle 8/Day 1) (n=702) | -3.1 ± 18.6 |
| Dysphagia (Cycle 9/Day 1) (n=670) | -2.7 ± 20.2 |
| Dysphagia (Cycle 10/Day 1) (n=637) | -2.9 ± 19.4 |
| Dysphagia (Cycle 11/Day 1) (n=577) | -3.0 ± 19.2 |
| Dysphagia (Cycle 12/Day 1) (n=414) | -2.7 ± 18.1 |
| Dysphagia (Cycle 13/Day 1) (n=513) | -3.1 ± 17.8 |
| Dysphagia (Cycle 14/Day 1) (n=355) | -1.7 ± 18.2 |
| Dysphagia (Cycle 15/Day 1) (n=463) | -2.8 ± 17.5 |
| Dysphagia (Cycle 16/Day 1) (n=294) | -1.3 ± 20.1 |
| Dysphagia (Cycle 17/Day 1) (n=422) | -2.2 ± 19.0 |
| Dysphagia (Cycle 18/Day 1) (n=249) | -2.5 ± 18.4 |
| Dysphagia (Cycle 19/Day 1) (n=378) | -2.0 ± 17.3 |
| Dysphagia (Cycle 20/Day 1) (n=223) | -3.4 ± 18.5 |
| Dysphagia (Cycle 21/Day 1) (n=344) | -2.5 ± 18.2 |
| Dysphagia (Cycle 22/Day 1) (n=182) | -1.8 ± 19.7 |
| Dysphagia (Cycle 23/Day 1) (n=311) | -3.4 ± 17.0 |
| Dysphagia (Cycle 24/Day 1) (n=156) | -1.4 ± 16.5 |
| Dysphagia (Cycle 25/Day 1) (n=295) | -2.8 ± 17.3 |
| Dysphagia (Cycle 26/Day 1) (n=126) | -1.1 ± 15.7 |
| Dysphagia (Cycle 27/Day 1) (n=274) | -1.6 ± 17.5 |
| Dysphagia (Cycle 28/Day 1) (n=120) | -1.4 ± 16.4 |
| Dysphagia (Cycle 29/Day 1) (n=248) | -1.5 ± 16.5 |
| Dysphagia (Cycle 30/Day 1) (n=107) | -0.9 ± 18.0 |
| Dysphagia (End of treatment) (n=449) | 1.9 ± 23.5 |
| Dyspnoea (Cycle 2/Day 1) (n=928) | -8.0 ± 19.0 |
| Dyspnoea (Cycle 3/Day 1) (n=878) | -9.7 ± 21.5 |
| Dyspnoea (Cycle 4/Day 1) (n=833) | -10.7 ± 21.7 |
| Dyspnoea (Cycle 5/Day 1) (n=809) | -10.6 ± 21.4 |
| Dyspnoea (Cycle 6/Day 1) (n=775) | -10.6 ± 21.7 |
| Dyspnoea (Cycle 7/Day 1) (n=737) | -11.1 ± 21.1 |
| Dyspnoea (Cycle 8/Day 1) (n=704) | -12.0 ± 20.7 |
| Dyspnoea (Cycle 9/Day 1) (n=669) | -11.0 ± 20.7 |
| Dyspnoea (Cycle 10/Day 1) (n=637) | -10.7 ± 21.1 |
| Dyspnoea (Cycle 12/Day 1) (n=414) | -9.0 ± 20.2 |
| Dyspnoea (Cycle 13/Day 1) (n=514) | -9.8 ± 21.1 |
| Dyspnoea (Cycle 14/Day 1) (n=354) | -9.2 ± 20.0 |
| Dyspnoea (Cycle 15/Day 1) (n=463) | -8.9 ± 21.6 |
| Dyspnoea (Cycle 16/Day 1) (n=293) | -7.7 ± 21.3 |
| Dyspnoea (Cycle 17/Day 1) (n=421) | -7.3 ± 20.5 |
| Dyspnoea (Cycle 18/Day 1) (n=249) | -6.9 ± 21.3 |
| Dyspnoea (Cycle 19/Day 1) (n=379) | -8.6 ± 19.7 |
| Dyspnoea (Cycle 20/Day 1) (n=223) | -5.8 ± 19.8 |
| Dyspnoea (Cycle 21/Day 1) (n=344) | -7.8 ± 19.5 |
| Dyspnoea (Cycle 22/Day 1) (n=182) | -5.6 ± 18.3 |
| Dyspnoea (Cycle 23/Day 1) (n=311) | -6.1 ± 19.3 |
| Dyspnoea (Cycle 24/Day 1) (n=156) | -6.2 ± 18.3 |
| Dyspnoea (Cycle 25/Day 1) (n=295) | -6.1 ± 19.7 |
| Dyspnoea (Cycle 26/Day 1) (n=126) | -6.6 ± 19.3 |
| Dyspnoea (Cycle 27/Day 1) (n=273) | -5.7 ± 19.0 |
| Dyspnoea (Cycle 28/Day 1) (n=120) | -5.8 ± 19.5 |
| Dyspnoea (Cycle 29/Day 1) (n=249) | -3.9 ± 19.2 |
| Dyspnoea (Cycle 30/Day 1) (n=107) | -4.6 ± 17.5 |
| Dyspnoea (End of treatment) (n=448) | -3.0 ± 25.7 |
| Haemoptysis (Cycle 2/Day 1) (n=925) | -2.6 ± 12.6 |
| Haemoptysis (Cycle 3/Day 1) (n=879) | -3.0 ± 12.6 |
| Haemoptysis (Cycle 4/Day 1) (n=833) | -2.9 ± 12.7 |
| Haemoptysis (Cycle 5/Day 1) (n=808) | -2.6 ± 12.9 |
| Haemoptysis (Cycle 6/Day 1) (n=774) | -2.8 ± 12.0 |
| Haemoptysis (Cycle 7/Day 1) (n=735) | -2.9 ± 12.7 |
| Haemoptysis (Cycle 8/Day 1) (n=703) | -3.1 ± 11.9 |
| Haemoptysis (Cycle 9/Day 1) (n=669) | -3.0 ± 11.7 |
| Haemoptysis (Cycle 10/Day 1) (n=635) | -2.6 ± 11.7 |
| Haemoptysis (Cycle 11/Day 1) (n=576) | -2.7 ± 11.6 |
| Haemoptysis (Cycle 12/Day 1) (n=413) | -2.6 ± 10.3 |
| Haemoptysis (Cycle 13/Day 1) (n=514) | -2.1 ± 12.0 |
| Haemoptysis (Cycle 14/Day 1) (n=354) | -2.7 ± 11.3 |
| Haemoptysis (Cycle 15/Day 1) (n=462) | -2.2 ± 10.8 |
| Haemoptysis (Cycle 16/Day 1) (n=294) | -2.5 ± 11.4 |
| Haemoptysis (Cycle 17/Day 1) (n=420) | -1.9 ± 11.4 |
| Haemoptysis (Cycle 18/Day 1) (n=249) | -2.4 ± 12.1 |
| Haemoptysis (Cycle 19/Day 1) (n=378) | -2.1 ± 11.5 |
| Haemoptysis (Cycle 20/Day 1) (n=223) | -2.4 ± 13.6 |
| Haemoptysis (Cycle 21/Day 1) (n=342) | -2.5 ± 11.5 |
| Haemoptysis (Cycle 22/Day 1) (n=182) | -2.9 ± 11.2 |
| Haemoptysis (Cycle 23/Day 1) (n=309) | -2.7 ± 12.5 |
| Haemoptysis (Cycle 24/Day 1) (n=156) | -2.4 ± 12.0 |
| Haemoptysis (Cycle 25/Day 1) (n=294) | -2.8 ± 12.4 |
| Haemoptysis (Cycle 26/Day 1) (n=126) | -3.2 ± 12.9 |
| Haemoptysis (Cycle 27/Day 1) (n=272) | -2.9 ± 11.4 |
| Haemoptysis (Cycle 28/Day 1) (n=119) | -3.1 ± 12.3 |
| Haemoptysis (Cycle 29/Day 1) (n=248) | -1.7 ± 12.1 |
| Haemoptysis (Cycle 30/Day 1) (n=107) | -2.8 ± 11.3 |
| Haemoptysis (End of treatment) (n=451) | -1.4 ± 15.9 |
| Pain in Arm or Shoulder (Cycle 2/Day 1) (n=926) | -9.6 ± 26.9 |
| Pain in Arm or Shoulder (Cycle 3/Day 1) (n=876) | -12.2 ± 27.0 |
| Pain in Arm or Shoulder (Cycle 4/Day 1) (n=832) | -12.5 ± 28.2 |
| Pain in Arm or Shoulder (Cycle 5/Day 1) (n=807) | -11.7 ± 27.1 |
| Pain in Arm or Shoulder (Cycle 6/Day 1) (n=773) | -11.6 ± 26.3 |
| Pain in Arm or Shoulder (Cycle 7/Day 1) (n=738) | -11.3 ± 28.1 |
| Pain in Arm or Shoulder (Cycle 8/Day 1) (n=702) | -11.7 ± 28.5 |
| Pain in Arm or Shoulder (Cycle 9/Day 1) (n=669) | -11.9 ± 28.5 |
| Pain in Arm or Shoulder (Cycle 10/Day 1) (n=635) | -11.3 ± 28.0 |
| Pain in Arm or Shoulder (Cycle 11/Day 1) (n=576) | -12.1 ± 27.3 |
| Pain in Arm or Shoulder (Cycle 12/Day 1) (n=414) | -11.0 ± 27.7 |
| Pain in Arm or Shoulder (Cycle 13/Day 1) (n=513) | -10.9 ± 27.2 |
| Pain in Arm or Shoulder (Cycle 14/Day 1) (n=355) | -11.3 ± 27.3 |
| Pain in Arm or Shoulder (Cycle 15/Day 1) (n=461) | -10.3 ± 25.6 |
| Pain in Arm or Shoulder (Cycle 16/Day 1) (n=293) | -9.9 ± 28.0 |
| Pain in Arm or Shoulder (Cycle 17/Day 1) (n=421) | -8.2 ± 26.5 |
| Pain in Arm or Shoulder (Cycle 18/Day 1) (n=249) | -9.4 ± 27.6 |
| Pain in Arm or Shoulder (Cycle 19/Day 1) (n=379) | -9.1 ± 26.5 |
| Pain in Arm or Shoulder (Cycle 20/Day 1) (n=222) | -7.4 ± 27.3 |
| Pain in Arm or Shoulder (Cycle 21/Day 1) (n=344) | -9.0 ± 27.0 |
| Pain in Arm or Shoulder (Cycle 22/Day 1) (n=182) | -9.0 ± 29.1 |
| Pain in Arm or Shoulder (Cycle 23/Day 1) (n=311) | -8.9 ± 25.5 |
| Pain in Arm or Shoulder (Cycle 24/Day 1) (n=155) | -9.7 ± 30.6 |
| Pain in Arm or Shoulder (Cycle 25/Day 1) (n=295) | -9.2 ± 26.0 |
| Pain in Arm or Shoulder (Cycle 26/Day 1) (n=126) | -10.8 ± 33.7 |
| Pain in Arm or Shoulder (Cycle 27/Day 1) (n=274) | -8.6 ± 26.5 |
| Pain in Arm or Shoulder (Cycle 28/Day 1) (n=119) | -8.7 ± 29.6 |
| Pain in Arm or Shoulder (Cycle 29/Day 1) (n=248) | -7.9 ± 27.2 |
| Pain in Arm or Shoulder (Cycle 30/Day 1) (n=107) | -8.1 ± 30.3 |
| Pain in Arm or Shoulder (End of treatment) (n=445) | -5.8 ± 30.7 |
| Pain in Chest (Cycle 2/Day 1) (n=928) | -9.5 ± 23.4 |
| Pain in Chest (Cycle 3/Day 1) (n=875) | -11.9 ± 25.1 |
| Pain in Chest (Cycle 4/Day 1) (n=833) | -12.1 ± 26.1 |
| Pain in Chest (Cycle 5/Day 1) (n=808) | -11.8 ± 25.8 |
| Pain in Chest (Cycle 6/Day 1) (n=774) | -12.1 ± 25.3 |
| Pain in Chest (Cycle 7/Day 1) (n=735) | -12.6 ± 25.4 |
| Pain in Chest (Cycle 8/Day 1) (n=703) | -13.2 ± 25.0 |
| Pain in Chest (Cycle 9/Day 1) (n=665) | -13.1 ± 25.8 |
| Pain in Chest (Cycle 10/Day 1) (n=633) | -12.9 ± 26.0 |
| Pain in Chest (Cycle 11/Day 1) (n=574) | -12.0 ± 25.5 |
| Pain in Chest (Cycle 12/Day 1) (n=414) | -10.7 ± 25.5 |
| Pain in Chest (Cycle 13/Day 1) (n=513) | -12.6 ± 24.5 |
| Pain in Chest (Cycle 14/Day 1) (n=355) | -11.5 ± 24.4 |
| Pain in Chest (Cycle 15/Day 1) (n=462) | -11.9 ± 24.7 |
| Pain in Chest (Cycle 16/Day 1) (n=294) | -11.0 ± 23.4 |
| Pain in Chest (Cycle 17/Day 1) (n=421) | -11.6 ± 23.8 |
| Pain in Chest (Cycle 18/Day 1) (n=249) | -8.0 ± 23.1 |
| Pain in Chest (Cycle 19/Day 1) (n=378) | -11.2 ± 23.8 |
| Pain in Chest (Cycle 20/Day 1) (n=222) | -9.4 ± 24.3 |
| Pain in Chest (Cycle 21/Day 1) (n=343) | -11.9 ± 23.5 |
| Pain in Chest (Cycle 22/Day 1) (n=182) | -10.1 ± 21.9 |
| Pain in Chest (Cycle 23/Day 1) (n=308) | -10.8 ± 24.0 |
| Pain in Chest (Cycle 24/Day 1) (n=156) | -7.1 ± 26.8 |
| Pain in Chest (Cycle 25/Day 1) (n=293) | -10.2 ± 22.3 |
| Pain in Chest (Cycle 26/Day 1) (n=126) | -10.6 ± 25.2 |
| Pain in Chest (Cycle 27/Day 1) (n=272) | -9.2 ± 22.0 |
| Pain in Chest (Cycle 28/Day 1) (n=120) | -9.4 ± 26.7 |
| Pain in Chest (Cycle 29/Day 1) (n=248) | -9.5 ± 24.4 |
| Pain in Chest (Cycle 30/Day 1) (n=107) | -5.3 ± 26.8 |
| Pain in Chest (End of treatment) (n=451) | -6.7 ± 28.0 |
| Pain in Other Parts (Cycle 2/Day 1) (n=893) | -10.0 ± 31.3 |
| Pain in Other Parts (Cycle 3/Day 1) (n=854) | -12.0 ± 31.9 |
| Pain in Other Parts (Cycle 4/Day 1) (n=806) | -13.5 ± 31.0 |
| Pain in Other Parts (Cycle 5/Day 1) (n=793) | -12.2 ± 30.2 |
| Pain in Other Parts (Cycle 6/Day 1) (n=752) | -12.5 ± 30.9 |
| Pain in Other Parts (Cycle 7/Day 1) (n=715) | -11.8 ± 30.3 |
| Pain in Other Parts (Cycle 8/Day 1) (n=680) | -11.7 ± 30.5 |
| Pain in Other Parts (Cycle 9/Day 1) (n=650) | -13.1 ± 29.9 |
| Pain in Other Parts (Cycle 10/Day 1) (n=616) | -12.1 ± 30.4 |
| Pain in Other Parts (Cycle 11/Day 1) (n=562) | -10.8 ± 29.3 |
| Pain in Other Parts (Cycle 12/Day 1) (n=399) | -11.6 ± 30.9 |
| Pain in Other Parts (Cycle 13/Day 1) (n=499) | -9.9 ± 30.0 |
| Pain in Other Parts (Cycle 14/Day 1) (n=342) | -11.5 ± 31.3 |
| Pain in Other Parts (Cycle 15/Day 1) (n=451) | -10.1 ± 28.9 |
| Pain in Other Parts (Cycle 16/Day 1) (n=282) | -9.6 ± 30.3 |
| Pain in Other Parts (Cycle 17/Day 1) (n=411) | -8.8 ± 28.1 |
| Pain in Other Parts (Cycle 18/Day 1) (n=239) | -8.6 ± 31.0 |
| Pain in Other Parts (Cycle 19/Day 1) (n=370) | -8.8 ± 29.0 |
| Pain in Other Parts (Cycle 20/Day 1) (n=210) | -9.4 ± 31.3 |
| Pain in Other Parts (Cycle 21/Day 1) (n=337) | -8.2 ± 28.6 |
| Pain in Other Parts (Cycle 22/Day 1) (n=176) | -10.4 ± 30.2 |
| Pain in Other Parts (Cycle 23/Day 1) (n=300) | -6.6 ± 29.2 |
| Pain in Other Parts (Cycle 24/Day 1) (n=149) | -7.8 ± 35.2 |
| Pain in Other Parts (Cycle 25/Day 1) (n=286) | -7.2 ± 30.2 |
| Pain in Other Parts (Cycle 26/Day 1) (n=121) | -8.8 ± 34.6 |
| Pain in Other Parts (Cycle 27/Day 1) (n=267) | -5.9 ± 29.5 |
| Pain in Other Parts (Cycle 28/Day 1) (n=116) | -3.2 ± 34.6 |
| Pain in Other Parts (Cycle 29/Day 1) (n=242) | -6.3 ± 27.1 |
| Pain in Other Parts (Cycle 30/Day 1) (n=102) | -6.5 ± 34.8 |
| Pain in Other Parts (End of treatment) (n=427) | -4.6 ± 34.8 |
| Peripheral Neuropathy (Cycle 2/Day 1) (n=925) | 0.6 ± 25.3 |
| Peripheral Neuropathy (Cycle 3/Day 1) (n=876) | -0.4 ± 25.6 |
| Peripheral Neuropathy (Cycle 4/Day 1) (n=833) | -1.7 ± 26.5 |
| Peripheral Neuropathy (Cycle 5/Day 1) (n=807) | -1.2 ± 26.3 |
| Peripheral Neuropathy (Cycle 6/Day 1) (n=775) | -1.4 ± 26.5 |
| Peripheral Neuropathy (Cycle 7/Day 1) (n=737) | -2.6 ± 27.2 |
| Peripheral Neuropathy (Cycle 8/Day 1) (n=703) | -2.1 ± 25.6 |
| Peripheral Neuropathy (Cycle 9/Day 1) (n=668) | -1.8 ± 27.2 |
| Peripheral Neuropathy (Cycle 10/Day 1) (n=635) | -1.0 ± 26.4 |
| Peripheral Neuropathy (Cycle 11/Day 1) (n=575) | -1.6 ± 27.5 |
| Peripheral Neuropathy (Cycle 12/Day 1) (n=413) | -0.8 ± 27.3 |
| Peripheral Neuropathy (Cycle 13/Day 1) (n=512) | -1.5 ± 27.0 |
| Peripheral Neuropathy (Cycle 14/Day 1) (n=354) | -2.1 ± 28.6 |
| Peripheral Neuropathy (Cycle 15/Day 1) (n=462) | -0.7 ± 27.5 |
| Peripheral Neuropathy (Cycle 16/Day 1) (n=294) | -1.5 ± 29.9 |
| Peripheral Neuropathy (Cycle 17/Day 1) (n=418) | -0.3 ± 28.3 |
| Peripheral Neuropathy (Cycle 18/Day 1) (n=249) | -0.7 ± 28.3 |
| Peripheral Neuropathy (Cycle 19/Day 1) (n=378) | -1.5 ± 23.9 |
| Peripheral Neuropathy (Cycle 20/Day 1) (n=221) | -0.0 ± 28.1 |
| Peripheral Neuropathy (Cycle 21/Day 1) (n=342) | 0.2 ± 27.6 |
| Peripheral Neuropathy (Cycle 22/Day 1) (n=182) | -3.7 ± 27.6 |
| Peripheral Neuropathy (Cycle 23/Day 1) (n=310) | -1.0 ± 26.2 |
| Peripheral Neuropathy (Cycle 24/Day 1) (n=156) | -1.7 ± 26.4 |
| Peripheral Neuropathy (Cycle 25/Day 1) (n=295) | 2.3 ± 25.5 |
| Peripheral Neuropathy (Cycle 26/Day 1) (n=126) | -1.6 ± 24.9 |
| Peripheral Neuropathy (Cycle 27/Day 1) (n=274) | 2.1 ± 27.1 |
| Peripheral Neuropathy (Cycle 28/Day 1) (n=119) | -0.6 ± 27.1 |
| Peripheral Neuropathy (Cycle 29/Day 1) (n=249) | 1.5 ± 26.3 |
| Peripheral Neuropathy (Cycle 30/Day 1) (n=107) | -0.6 ± 28.2 |
| Peripheral Neuropathy (End of treatment) (n=451) | -0.6 ± 26.6 |
| Sore Mouth (Cycle 2/Day 1) (n=928) | 1.0 ± 20.0 |
| Sore Mouth (Cycle 3/Day 1) (n=879) | -0.2 ± 19.8 |
| Sore Mouth (Cycle 4/Day 1) (n=834) | -0.6 ± 19.1 |
| Sore Mouth (Cycle 5/Day 1) (n=808) | -1.3 ± 17.9 |
| Sore Mouth (Cycle 6/Day 1) (n=776) | -1.8 ± 17.1 |
| Sore Mouth (Cycle 7/Day 1) (n=738) | -1.2 ± 18.3 |
| Sore Mouth (Cycle 8/Day 1) (n=704) | -2.2 ± 17.0 |
| Sore Mouth (Cycle 9/Day 1) (n=669) | -2.1 ± 18.3 |
| Sore Mouth (Cycle 10/Day 1) (n=636) | -1.7 ± 19.1 |
| Sore Mouth (Cycle 11/Day 1) (n=577) | -1.8 ± 17.2 |
| Sore Mouth (Cycle 12/Day 1) (n=414) | -1.9 ± 17.1 |
| Sore Mouth (Cycle 13/Day 1) (n=514) | -1.5 ± 18.0 |
| Sore Mouth (Cycle 14/Day 1) (n=354) | -1.3 ± 14.8 |
| Sore Mouth (Cycle 15/Day 1) (n=463) | -0.9 ± 16.1 |
| Sore Mouth (Cycle 16/Day 1) (n=294) | 0.1 ± 16.6 |
| Sore Mouth (Cycle 17/Day 1) (n=422) | -1.4 ± 17.6 |
| Sore Mouth (Cycle 18/Day 1) (n=249) | -0.9 ± 18.0 |
| Sore Mouth (Cycle 19/Day 1) (n=379) | -0.9 ± 17.3 |
| Sore Mouth (Cycle 20/Day 1) (n=223) | -1.3 ± 17.7 |
| Sore Mouth (Cycle 21/Day 1) (n=344) | -0.6 ± 18.0 |
| Sore Mouth (Cycle 22/Day 1) (n=182) | -1.1 ± 14.8 |
| Sore Mouth (Cycle 23/Day 1) (n=311) | 0.3 ± 17.7 |
| Sore Mouth (Cycle 24/Day 1) (n=156) | 2.6 ± 17.2 |
| Sore Mouth (Cycle 25/Day 1) (n=294) | -1.6 ± 17.6 |
| Sore Mouth (Cycle 26/Day 1) (n=126) | -2.4 ± 14.7 |
| Sore Mouth (Cycle 27/Day 1) (n=274) | -0.6 ± 18.4 |
| Sore Mouth (Cycle 28/Day 1) (n=120) | -0.3 ± 15.3 |
| Sore Mouth (Cycle 29/Day 1) (n=249) | -1.7 ± 16.4 |
| Sore Mouth (Cycle 30/Day 1) (n=107) | -1.2 ± 12.9 |
| Sore Mouth (End of treatment) (n=451) | -0.4 ± 20.0 |
The participants who responded to the question: "Have you experienced any visual disturbances?" Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question.
| Percentage of participants | Crizotinib 250 mg BID |
|---|---|
| Cycle 2/Day 1 (Yes) (N=798) | 64.5 |
| Cycle 2/Day 1 (No) (N=798) | 35.5 |
| Cycle 3/Day 1 (Yes) (N=768) | 56.5 |
| Cycle 3/Day 1 (No) (N=768) | 43.5 |
| Cycle 4/Day 1 (Yes) (N=754) | 52.3 |
| Cycle 4/Day 1 (No) (N=754) | 47.7 |
| Cycle 5/Day 1 (Yes) (N=743) | 49.1 |
| Cycle 5/Day 1 (No) (N=743) | 50.9 |
| Cycle 6/Day 1 (Yes) (N=731) | 48.8 |
| Cycle 6/Day 1 (No) (N=731) | 51.2 |
| Cycle 7/Day 1 (Yes) (N=699) | 45.8 |
| Cycle 7/Day 1 (No) (N=699) | 54.2 |
| Cycle 8/Day 1 (Yes) (N=670) | 43.7 |
| Cycle 8/Day 1 (No) (N=670) | 56.3 |
| Cycle 9/Day 1 (Yes) (N=653) | 43.5 |
| Cycle 9/Day 1 (No) (N=653) | 56.5 |
| Cycle 10/Day 1 (Yes) (N=621) | 42.7 |
| Cycle 10/Day 1 (No) (N=621) | 57.3 |
| Cycle 11/Day 1 (Yes) (N=565) | 40.2 |
| Cycle 11/Day 1 (No) (N=565) | 59.8 |
| Cycle 12/Day 1 (Yes) (N=403) | 42.9 |
| Cycle 12/Day 1 (No) (N=403) | 57.1 |
| Cycle 13/Day 1 (Yes) (N=507) | 41.2 |
| Cycle 13/Day 1 (No) (N=507) | 58.8 |
| Cycle 14/Day 1 (Yes) (N=354) | 41.5 |
| Cycle 14/Day 1 (No) (N=354) | 58.5 |
| Cycle 15/Day 1 (Yes) (N=468) | 39.1 |
| Cycle 15/Day 1 (No) (N=468) | 60.9 |
| Cycle 16/Day 1 (Yes) (N=296) | 43.6 |
| Cycle 16/Day 1 (No) (N=296) | 56.4 |
| Cycle 17/Day 1 (Yes) (N=418) | 37.3 |
| Cycle 17/Day 1 (No) (N=418) | 62.7 |
| Cycle 18/Day 1 (Yes) (N=249) | 40.2 |
| Cycle 18/Day 1 (No) (N=249) | 59.8 |
| Cycle 19/Day 1 (Yes) (N=378) | 36.8 |
| Cycle 19/Day 1 (No) (N=378) | 63.2 |
| Cycle 20/Day 1 (Yes) (N=221) | 38.9 |
| Cycle 20/Day 1 (No) (N=221) | 61.1 |
| Cycle 21/Day 1 (Yes) (N=344) | 39.0 |
| Cycle 21/Day 1 (No) (N=344) | 61.0 |
| Cycle 22/Day 1 (Yes) (N=181) | 39.2 |
| Cycle 22/Day 1 (No) (N=181) | 60.8 |
| Cycle 23/Day 1 (Yes) (N=312) | 34.9 |
| Cycle 23/Day 1 (No) (N=312) | 65.1 |
| Cycle 24/Day 1 (Yes) (N=155) | 34.8 |
| Cycle 24/Day 1 (No) (N=155) | 65.2 |
| Cycle 25/Day 1 (Yes) (N=302) | 35.8 |
| Cycle 25/Day 1 (No) (N=302) | 64.2 |
| Cycle 26/Day 1 (Yes) (N=130) | 30.8 |
| Cycle 26/Day 1 (No) (N=130) | 69.2 |
| Cycle 27/Day 1 (Yes) (N=276) | 32.6 |
| Cycle 27/Day 1 (No) (N=276) | 67.4 |
| Cycle 28/Day 1 (Yes) (N=118) | 31.4 |
| Cycle 28/Day 1 (No) (N=118) | 68.6 |
| Cycle 29/Day 1 (Yes) (N=249) | 30.5 |
| Cycle 29/Day 1 (No) (N=249) | 69.5 |
| Cycle 30/Day 1 (Yes) (N=106) | 27.4 |
| Cycle 30/Day 1 (No) (N=106) | 72.6 |
| End of Treatment (Yes) (N=428) | 39.3 |
| End of Treatment (No) (N=428) | 60.7 |
The EQ-5D descriptive system measured a patient's health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.
| Units on a scale | Crizotinib 250 mg BID |
|---|---|
| CYCLE 2/DAY 1 (n=926) | 5.72 ± 17.51 |
| CYCLE 3/DAY 1 (n=875) | 8.57 ± 18.82 |
| CYCLE 4/DAY 1 (n=836) | 10.01 ± 19.73 |
| CYCLE 5/DAY 1 (n=804) | 10.38 ± 19.85 |
| CYCLE 6/DAY 1 (n=771) | 10.17 ± 20.38 |
| CYCLE 7/DAY 1 (n=728) | 10.17 ± 20.38 |
| CYCLE 8/DAY 1 (n=693) | 10.35 ± 19.22 |
| CYCLE 9/DAY 1 (n=667) | 10.69 ± 19.82 |
| CYCLE 10/DAY 1 (n=633) | 10.34 ± 19.15 |
| CYCLE 11/DAY 1 (n=573) | 10.09 ± 19.72 |
| CYCLE 12/DAY 1 (n=409) | 9.69 ± 18.81 |
| CYCLE 13/DAY 1 (n=512) | 9.74 ± 19.64 |
| CYCLE 14/DAY 1 (n=351) | 10.93 ± 18.67 |
| CYCLE 15/DAY 1 (n=461) | 8.71 ± 20.53 |
| CYCLE 16/DAY 1 (n=289) | 8.47 ± 20.66 |
| CYCLE 17/DAY 1 (n=417) | 7.99 ± 20.80 |
| CYCLE 18/DAY 1 (n=244) | 7.62 ± 19.86 |
| CYCLE 19/DAY 1 (n=372) | 8.17 ± 18.92 |
| CYCLE 20/DAY 1 (n=219) | 8.03 ± 18.45 |
| CYCLE 21/DAY 1 (n=339) | 6.96 ± 18.71 |
| CYCLE 22/DAY 1 (n=179) | 6.59 ± 18.97 |
| CYCLE 23/DAY 1 (n=310) | 5.53 ± 19.50 |
| CYCLE 24/DAY 1 (n=154) | 7.61 ± 19.58 |
| CYCLE 25/DAY 1 (n=299) | 4.97 ± 17.98 |
| CYCLE 26/DAY 1 (n=128) | 8.54 ± 18.97 |
| CYCLE 27/DAY 1 (n=272) | 5.24 ± 17.61 |
| CYCLE 28/DAY 1 (n=120) | 7.93 ± 19.53 |
| CYCLE 29/DAY 1 (n=249) | 5.05 ± 17.07 |
| CYCLE 30/DAY 1 (n=108) | 8.07 ± 19.95 |
| End of Treatment (n=450) | 0.09 ± 23.92 |
The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.
| Percentage of participants | Crizotinib 250 mg BID |
|---|---|
| ALK Positive by IUO; N=908 | 54.1 (50.8 to 57.4) |
| ALK Positive by non-IUO only, N= 158 | 40.5 (32.8 to 48.6) |
Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 4.0).
| Percentage of Participants | Crizotinib 250 mg BID |
|---|---|
| Serious AEs (all causalities) | 50.6 |
| Grade 3/4 AEs (all causalities) | 65.6 |
| Grade 5 AEs (all causalities) | 22.7 |
| Serious AEs (treatment related) | 11.5 |
| Grade 3/4 AEs (treatment related) | 40.2 |
| Grade 5 AEs (treatment related) | 1.6 |
Collected over Active reporting period is from the time of informed consent until at least 28 days after study treatment last dose. For serious adverse events: those with the possibility of being related to study drug must be reported as minimum thereafter.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Crizotinib 250 mg BID | — | 539/1,066 (50.6%) | 1,038/1,066 (97.4%) |
| Event | Crizotinib 250 mg BID |
|---|---|
| Disease progressionGeneral disorders | 135/1066 |
| PneumoniaInfections and infestations | 74/1066 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 39/1066 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 26/1066 |
| PyrexiaGeneral disorders | 18/1066 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 17/1066 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 17/1066 |
| Lung infectionInfections and infestations | 14/1066 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 14/1066 |
| Deep vein thrombosisVascular disorders | 14/1066 |
| Event | Crizotinib 250 mg BID |
|---|---|
| NauseaGastrointestinal disorders | 603/1066 |
| VomitingGastrointestinal disorders | 565/1066 |
| DiarrhoeaGastrointestinal disorders | 548/1066 |
| ConstipationGastrointestinal disorders | 475/1066 |
| Visual impairmentEye disorders | 460/1066 |
| Oedema peripheralGeneral disorders | 450/1066 |
| FatigueGeneral disorders | 326/1066 |
| Decreased appetiteMetabolism and nutrition disorders | 326/1066 |
| Alanine aminotransferase increasedInvestigations | 302/1006 |
| DizzinessNervous system disorders | 265/1066 |
An Investigational Use Only (IUO) population (N=908) was all participants whose non-small cell lung cancer (NSCLC) was Fluorescent In-Situ Hybridization (FISH) ALK (Anaplastic Lymphoma Receptor Tyrosine Kinase) (+) by the central laboratory. A non-IUO population (N=158) was all partcipants whose NSCLC was ALK (+) by local assay testing.
| Age, Continuous(Years) | Crizotinib 250 mg BID |
|---|---|
| Mean | 52.2 ± 12.33 |
| Age, Customized(Participants) | Crizotinib 250 mg BID |
|---|---|
| < 65 years | 894 |
| >=65 years | 172 |
| Gender(Participants) | Crizotinib 250 mg BID |
|---|---|
| Female | 601 |
| Male | 465 |
| Race/Ethnicity, Customized(participants) | Crizotinib 250 mg BID |
|---|---|
| Chinese | 252 |
| Japanese | 81 |
| Korean | 144 |
| White | 532 |
| Black | 20 |
| Other | 19 |
| Other-Asian | 18 |
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Carcinoma, Non-Small-Cell Lung→
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