A Phase 3 interventional study of PF-02341066 and Pemetrexed in Carcinoma, Non-Small-Cell Lung, sponsored by Pfizer. Completed at 264 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-02.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 347 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Drug: PF-02341066
Investigator selection of either pemetrexed or docetaxel as the active comparator
Drug: Pemetrexed · Drug: Docetaxel
PF-02341066, 250 mg BID will be administered orally on a continuous schedule
Pemetrexed, 500 mg/m\^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle
Docetaxel, 75 mg/m\^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle
Progression-Free Survival (PFS)
PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Time frame: Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Overall Survival (OS)
OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.
Time frame: Randomization until death (up to 4.5 years)
Overall Survival Probability at Months 6 and 12
Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.
Time frame: Month 6, 12
Percentage of Participants With Objective Response (OR)
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.
Time frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Percentage of Participants With Disease Control at Week 6
Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.
Time frame: Week 6
Percentage of Participants With Disease Control at Week 12
Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Time frame: Week 12
Duration of Response (DR)
Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Time to Tumor Response (TTR)
Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
Time frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Plasma Concentration of Crizotinib
Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.
Time frame: Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5
Number of Participants With Categorical Maximum QTcF for Crizotinib
QT interval corrected using Fridericia's formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (\<) 450 milliseconds (msec), 450 msec to \<480 msec, 480 msec to \<500 msec, and more than or equal to (\>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.
Time frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2
Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins
Descriptive statistics (absolute value and change from baseline as measured by ratio to baseline) for each best overall response category (CR, PR, SD, PD or combined) have been used to summarize the data from optional soluble c-Met ectodomain assays for crizotinib treated patients.
Time frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)
Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough
TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer \[EORTC QLQ-LC13\]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.
Time frame: Baseline up to end of treatment (up to 112 weeks)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, 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 averaged, transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.
Time frame: Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.
Time frame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)
European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)
| Milestone | Crizotinib | Chemotherapy |
|---|---|---|
| Started | 173 | 174 |
| Treated | 172 | 171 |
| Completed | 40 | 4 |
| Not completed | 133 | 170 |
| Withdrew: Death | 115 | 24 |
| Withdrew: Lost to follow-up | 8 | 0 |
| Withdrew: Withdrawal by subject | 5 | 2 |
| Withdrew: Other | 5 | 144 |
PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
| months | Crizotinib | Chemotherapy |
|---|---|---|
| Progression-Free Survival (PFS) | 7.7 (6.0 to 8.8) | 3.0 (2.6 to 4.3) |
OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.
| months | Crizotinib | Chemotherapy |
|---|---|---|
| Overall Survival (OS) | 21.7 (18.9 to 30.5) | 21.9 (16.8 to 26.0) |
Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.
| percent chance of survival | Crizotinib | Chemotherapy |
|---|---|---|
| Month 6 | 86.6 (80.5 to 90.9) | 83.8 (77.4 to 88.5) |
| Month 12 | 70.4 (62.9 to 76.7) | 66.7 (59.1 to 73.2) |
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.
| percentage of participants | Crizotinib | Chemotherapy |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | 65.3 (57.7 to 72.4) | 19.5 (13.9 to 26.2) |
Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.
| percentage of participants | Crizotinib | Chemotherapy |
|---|---|---|
| Percentage of Participants With Disease Control at Week 6 | 81.5 (74.9 to 87.0) | 55.2 (47.5 to 62.7) |
Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
| percentage of participants | Crizotinib | Chemotherapy |
|---|---|---|
| Percentage of Participants With Disease Control at Week 12 | 64.2 (56.5 to 71.3) | 38.5 (31.2 to 46.2) |
Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
| weeks | Crizotinib | Chemotherapy |
|---|---|---|
| Duration of Response (DR) | 32.1 (26.4 to 42.3) | 24.4 (15 to 36) |
Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
| weeks | Crizotinib | Chemotherapy |
|---|---|---|
| Time to Tumor Response (TTR) | 6.3 (4.4 to 48.4) | 12.6 (5 to 37.1) |
Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.
| nanogram per milliliter (ng/mL) | Crizotinib |
|---|---|
| Cycle 1 Day 1 (n=15) | NA ± NA |
| Cycle 1 Day 15 (n=92) | 298 ± 148 |
| Cycle 2 Day 1 (n=62) | 293 ± 154 |
| Cycle 3 Day 1 (n=61) | 306 ± 135 |
| Cycle 5 Day 1 (n=47) | 291 ± 156 |
QT interval corrected using Fridericia's formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (\<) 450 milliseconds (msec), 450 msec to \<480 msec, 480 msec to \<500 msec, and more than or equal to (\>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.
| participants | Crizotinib |
|---|---|
| <450 msec | 137 |
| 450 msec to <480 msec | 9 |
| 480 msec to <500 msec | 1 |
| >=500 msec | 8 |
Descriptive statistics (absolute value and change from baseline as measured by ratio to baseline) for each best overall response category (CR, PR, SD, PD or combined) have been used to summarize the data from optional soluble c-Met ectodomain assays for crizotinib treated patients.
| nanogram per milliliter (ng/mL) | Overall Values |
|---|---|
| Baseline (N = 81) | 1428.3 ± 363.9 |
| Cycle 2 Day 1 6-hour post dose (N = 69) | 1683.0 ± 325.6 |
| End of treatment (N = 40) | 1751.8 ± 327.9 |
TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer \[EORTC QLQ-LC13\]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.
| months | Crizotinib | Chemotherapy |
|---|---|---|
| Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough | 4.5 (3.0 to 6.9) | 1.4 (1.0 to 1.6) |
EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, 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 averaged, transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.
| units on a scale | Crizotinib | Chemotherapy |
|---|---|---|
| Global QoL: Baseline (n=165, 162) | 57.2 ± 21.5 | 58.1 ± 22.2 |
| Global QoL: C2D1 (n=154, 133) | 64.5 ± 21.8 | 58.1 ± 23.1 |
| Global QoL: C3D1 (n=154, 106) | 65.2 ± 22.1 | 59.4 ± 23.1 |
| Global QoL: C4D1 (n=135, 90) | 68.4 ± 19.6 | 61.1 ± 20.8 |
| Global QoL: C5D1 (n=123, 74) | 68.5 ± 20.2 | 64.1 ± 22.7 |
| Global QoL: C6D1 (n=120, 70) | 68.3 ± 19.8 | 67.5 ± 23.5 |
| Global QoL: C7D1 (n=114, 52) | 69.5 ± 19.3 | 66.5 ± 23.1 |
| Global QoL: C8D1 (n=110, 43) | 68.7 ± 20.1 | 66.9 ± 25.3 |
| Global QoL: C9D1 (n=101, 37) | 68.7 ± 21.0 | 66.4 ± 27.8 |
| Global QoL: C10D1 (n=94, 33) | 67.0 ± 21.6 | 67.4 ± 26.8 |
| Global QoL: C11D1 (n=83, 25) | 69.5 ± 20.2 | 71.0 ± 21.8 |
| Global QoL: C12D1 (n=76, 23) | 67.9 ± 22.0 | 65.6 ± 24.1 |
| Global QoL: C13D1 (n=74, 21) | 66.8 ± 23.6 | 66.7 ± 23.6 |
| Global QoL: C14D1 (n=66, 19) | 71.5 ± 20.0 | 65.8 ± 23.4 |
| Global QoL: C15D1 (n=62, 16) | 69.0 ± 22.2 | 66.1 ± 24.1 |
| Global QoL: C16D1 (n=53, 12) | 69.7 ± 18.1 | 63.2 ± 25.5 |
| Global QoL: C17D1 (n=47, 11) | 67.6 ± 20.5 | 69.7 ± 23.4 |
| Global QoL: C18D1 (n=44, 11) | 65.7 ± 19.9 | 70.5 ± 22.5 |
| Global QoL: C19D1 (n=40, 9) | 69.2 ± 19.2 | 72.2 ± 20.0 |
| Global QoL: C20D1 (n=35, 8) | 64.3 ± 20.6 | 60.4 ± 21.2 |
| Global QoL: C21D1 (n=30, 8) | 65.0 ± 18.4 | 63.5 ± 23.5 |
| Global QoL: C22D1 (n=24, 7) | 70.8 ± 19.3 | 64.3 ± 24.9 |
| Global QoL: C23D1 (n=23, 4) | 67.0 ± 22.5 | 50.0 ± 19.2 |
| Global QoL: C24D1 (n=20, 3) | 67.1 ± 18.8 | 55.6 ± 19.2 |
| Global QoL: C25D1 (n=18, 3) | 67.1 ± 17.7 | 61.1 ± 19.2 |
| Global QoL: C26D1 (n=14, 3) | 60.7 ± 22.0 | 55.6 ± 12.7 |
| Global QoL: C27D1 (n=14, 2) | 58.9 ± 20.3 | 41.7 ± 0.0 |
| Global QoL: C28D1 (n=11, 2) | 66.7 ± 18.3 | 54.2 ± 17.7 |
| Global QoL: C29D1 (n=8, 2) | 59.4 ± 18.6 | 41.7 ± 11.8 |
| Global QoL: C30D1 (n=8, 1) | 64.6 ± 19.3 | 33.3 ± NA |
| Global QoL: C31D1 (n=7, 0) | 64.3 ± 17.2 | NA ± NA |
| Global QoL: C32D1 (n=6, 0) | 59.7 ± 17.0 | NA ± NA |
| Global QoL: C33D1 (n=6, 0) | 66.7 ± 18.3 | NA ± NA |
| Global QoL: C34D1 (n=5, 0) | 68.3 ± 14.9 | NA ± NA |
| Global QoL: C35D1 (n=4, 0) | 60.4 ± 22.9 | NA ± NA |
| Global QoL: C36D1 (n=1, 0) | 66.7 ± NA | NA ± NA |
| Global QoL: C37D1 (n=1, 0) | 66.7 ± NA | NA ± NA |
| Physical Functioning: Baseline (n=165, 163) | 76.3 ± 20.7 | 75.8 ± 21.9 |
| Physical Functioning: C2D1 (n=155, 133) | 79.2 ± 20.9 | 73.5 ± 22.3 |
| Physical Functioning: C3D1 (n=154, 106) | 82.3 ± 18.1 | 75.5 ± 20.2 |
| Physical Functioning: C4D1 (n=135, 91) | 83.8 ± 16.2 | 76.6 ± 20.2 |
| Physical Functioning: C5D1 (n=123, 74) | 84.5 ± 16.2 | 78.6 ± 23.0 |
| Physical Functioning: C6D1 (n=120, 70) | 86.2 ± 16.7 | 80.7 ± 19.7 |
| Physical Functioning: C7D1 (n=115, 52) | 86.7 ± 15.0 | 80.3 ± 19.7 |
| Physical Functioning: C8D1 (n=111, 43) | 86.5 ± 16.3 | 81.6 ± 18.5 |
| Physical Functioning: C9D1 (n=101, 37) | 87.7 ± 14.2 | 82.3 ± 19.1 |
| Physical Functioning: C10D1 (n=94, 33) | 87.9 ± 14.8 | 81.8 ± 20.7 |
| Physical Functioning: C11D1 (n=84, 25) | 87.2 ± 16.7 | 83.2 ± 19.0 |
| Physical Functioning: C12D1 (n=76, 23) | 88.1 ± 15.3 | 79.7 ± 22.8 |
| Physical Functioning: C13D1 (n=74, 21) | 89.3 ± 13.9 | 78.4 ± 23.6 |
| Physical Functioning: C14D1 (n=66, 19) | 89.0 ± 14.3 | 80.0 ± 21.4 |
| Physical Functioning: C15D1 (n=62, 16) | 87.8 ± 15.3 | 82.9 ± 15.4 |
| Physical Functioning: C16D1 (n=53, 12) | 89.3 ± 11.5 | 81.1 ± 19.5 |
| Physical Functioning: C17D1 (n=47, 11) | 86.6 ± 16.8 | 81.8 ± 15.8 |
| Physical Functioning: C18D1 (n=45, 11) | 88.4 ± 13.3 | 82.4 ± 16.1 |
| Physical Functioning: C19D1 (n=40, 9) | 88.3 ± 12.4 | 81.5 ± 12.8 |
| Physical Functioning: C20D1 (n=35, 8) | 87.6 ± 12.7 | 79.2 ± 17.3 |
| Physical Functioning: C21D1 (n=30, 8) | 88.4 ± 10.9 | 77.5 ± 22.5 |
| Physical Functioning: C22D1 (n=24, 7) | 90.6 ± 8.3 | 78.1 ± 24.3 |
| Physical Functioning: C23D1 (n=23, 4) | 88.0 ± 13.1 | 60.0 ± 27.2 |
| Physical Functioning: C24D1 (n=20, 3) | 85.0 ± 14.0 | 64.4 ± 32.9 |
| Physical Functioning: C25D1 (n=18, 3) | 87.4 ± 11.6 | 60.0 ± 29.1 |
| Physical Functioning: C26D1 (n=14, 3) | 80.5 ± 25.3 | 62.2 ± 30.8 |
| Physical Functioning: C27D1 (n=14, 2) | 78.6 ± 27.8 | 50.0 ± 23.6 |
| Physical Functioning: C28D1 (n=11, 2) | 81.8 ± 24.1 | 60.0 ± 18.9 |
| Physical Functioning: C29D1 (n=8, 2) | 85.0 ± 15.0 | 46.7 ± 28.3 |
| Physical Functioning: C30D1 (n=8, 1) | 82.5 ± 21.4 | 26.7 ± NA |
| Physical Functioning: C31D1 (n=7, 0) | 83.8 ± 17.2 | NA ± NA |
| Physical Functioning: C32D1 (n=6, 0) | 88.9 ± 9.1 | NA ± NA |
| Physical Functioning: C33D1 (n=6, 0) | 90.0 ± 7.0 | NA ± NA |
| Physical Functioning: C34D1 (n=5, 0) | 85.3 ± 7.3 | NA ± NA |
| Physical Functioning: C35D1 (n=4, 0) | 91.7 ± 3.3 | NA ± NA |
| Physical Functioning: C36D1 (n=1, 0) | 86.7 ± NA | NA ± NA |
| Physical Functioning: C37D1 (n=1, 0) | 86.7 ± NA | NA ± NA |
| Role Functioning: Baseline (n=165, 163) | 69.3 ± 28.7 | 66.6 ± 30.2 |
| Role Functioning: C2D1 (n=155, 133) | 73.8 ± 28.9 | 64.7 ± 29.7 |
| Role Functioning: C3D1 (n=154, 106) | 74.4 ± 28.6 | 65.3 ± 27.7 |
| Role Functioning: C4D1 (n=134, 91) | 77.9 ± 25.7 | 67.2 ± 27.3 |
| Role Functioning: C5D1 (n=123, 74) | 78.2 ± 24.3 | 69.6 ± 27.4 |
| Role Functioning: C6D1 (n=120, 70) | 80.0 ± 24.1 | 69.5 ± 26.2 |
| Role Functioning: C7D1 (n=115, 52) | 81.7 ± 22.6 | 72.1 ± 25.9 |
| Role Functioning: C8D1 (n=111, 43) | 80.4 ± 23.9 | 75.2 ± 28.3 |
| Role Functioning: C9D1 (n=101, 37) | 80.9 ± 25.8 | 76.6 ± 27.6 |
| Role Functioning: C10D1 (n=94, 33) | 81.6 ± 23.1 | 75.3 ± 28.3 |
| Role Functioning: C11D1 (n=84, 25) | 81.3 ± 23.8 | 75.3 ± 25.5 |
| Role Functioning: C12D1 (n=76, 23) | 81.6 ± 23.2 | 72.5 ± 29.6 |
| Role Functioning: C13D1 (n=74, 21) | 80.2 ± 25.5 | 68.3 ± 32.0 |
| Role Functioning: C14D1 (n=66, 19) | 83.8 ± 21.3 | 68.4 ± 30.4 |
| Role Functioning: C15D1 (n=62, 16) | 80.6 ± 24.0 | 77.1 ± 27.8 |
| Role Functioning: C16D1 (n=53, 12) | 84.0 ± 19.0 | 69.4 ± 34.0 |
| Role Functioning: C17D1 (n=47, 11) | 77.7 ± 25.4 | 71.2 ± 38.1 |
| Role Functioning: C18D1 (n=45, 11) | 80.0 ± 22.4 | 71.2 ± 31.7 |
| Role Functioning: C19D1 (n=40, 9) | 82.1 ± 19.4 | 74.1 ± 29.0 |
| Role Functioning: C20D1 (n=35, 8) | 81.9 ± 17.8 | 70.8 ± 36.5 |
| Role Functioning: C21D1 (n=30, 8) | 80.0 ± 24.1 | 66.7 ± 32.1 |
| Role Functioning: C22D1 (n=24, 7) | 84.7 ± 19.0 | 67.9 ± 33.5 |
| Role Functioning: C23D1 (n=23, 4) | 76.8 ± 26.9 | 37.5 ± 25.0 |
| Role Functioning: C24D1 (n=20, 3) | 80.8 ± 24.3 | 44.4 ± 38.5 |
| Role Functioning: C25D1 (n=18, 3) | 87.0 ± 19.4 | 44.4 ± 25.5 |
| Role Functioning: C26D1 (n=14, 3) | 75.0 ± 29.1 | 33.3 ± 33.3 |
| Role Functioning: C27D1 (n=14, 2) | 69.0 ± 35.1 | 25.0 ± 11.8 |
| Role Functioning: C28D1 (n=11, 2) | 77.3 ± 33.6 | 25.0 ± 35.4 |
| Role Functioning: C29D1 (n=8, 2) | 77.1 ± 34.4 | 25.0 ± 11.8 |
| Role Functioning: C30D1 (n=8, 1) | 77.1 ± 34.4 | 0.0 ± NA |
| Role Functioning: C31D1 (n=7, 0) | 71.4 ± 36.9 | NA ± NA |
| Role Functioning: C32D1 (n=6, 0) | 86.1 ± 12.5 | NA ± NA |
| Role Functioning: C33D1 (n=6, 0) | 88.9 ± 13.6 | NA ± NA |
| Role Functioning: C34D1 (n=5, 0) | 96.7 ± 7.5 | NA ± NA |
| Role Functioning: C35D1 (n=4, 0) | 91.7 ± 16.7 | NA ± NA |
| Role Functioning: C36D1 (n=1, 0) | 100.0 ± NA | NA ± NA |
| Role Functioning: C37D1 (n=1, 0) | 100.0 ± NA | NA ± NA |
| Emotional Functioning: Baseline (n=165, 162) | 74.5 ± 21.3 | 73.7 ± 20.7 |
| Emotional Functioning: C2D1 (n=155, 133) | 83.1 ± 18.7 | 77.7 ± 19.3 |
| Emotional Functioning: C3D1 (n=154, 106) | 83.3 ± 16.7 | 77.9 ± 21.5 |
| Emotional Functioning: C4D1 (n=135, 90) | 84.1 ± 17.3 | 80.5 ± 18.9 |
| Emotional Functioning: C5D1 (n=123, 74) | 83.0 ± 19.1 | 79.8 ± 19.9 |
| Emotional Functioning: C6D1 (n=120, 70) | 85.3 ± 17.8 | 81.2 ± 19.4 |
| Emotional Functioning: C7D1 (n=115, 52) | 86.4 ± 16.5 | 81.9 ± 17.6 |
| Emotional Functioning: C8D1 (n=111, 43) | 83.9 ± 19.8 | 81.6 ± 20.7 |
| Emotional Functioning: C9D1 (n=101, 37) | 84.4 ± 19.0 | 82.4 ± 19.6 |
| Emotional Functioning: C10D1 (n=94, 33) | 87.2 ± 16.8 | 81.8 ± 21.2 |
| Emotional Functioning: C11D1 (n=84,25) | 86.1 ± 16.7 | 85.0 ± 17.8 |
| Emotional Functioning: C12D1 (n=76, 23) | 85.3 ± 18.6 | 84.8 ± 18.6 |
| Emotional Functioning: C13D1 (n=74, 21) | 84.9 ± 19.0 | 80.6 ± 19.1 |
| Emotional Functioning: C14D1 (n=66, 19) | 84.5 ± 19.9 | 81.6 ± 21.1 |
| Emotional Functioning: C15D1 (n=62, 16) | 86.3 ± 18.0 | 82.3 ± 18.2 |
| Emotional Functioning: C16D1 (n=53, 12) | 85.8 ± 17.6 | 77.8 ± 27.8 |
| Emotional Functioning: C17D1 (n=47, 11) | 85.6 ± 22.0 | 79.5 ± 23.4 |
| Emotional Functioning: C18D1 (n=44, 11) | 86.4 ± 17.2 | 75.8 ± 27.8 |
| Emotional Functioning: C19D1 (n=40, 9) | 87.3 ± 16.0 | 81.5 ± 20.7 |
| Emotional Functioning: C20D1 (n=35, 8) | 83.8 ± 17.5 | 82.3 ± 25.0 |
| Emotional Functioning: C21D1 (n=30, 8) | 84.5 ± 17.1 | 80.2 ± 29.5 |
| Emotional Functioning: C22D1 (n=24, 7) | 83.7 ± 21.6 | 78.6 ± 24.9 |
| Emotional Functioning: C23D1 (n=23, 4) | 84.1 ± 19.8 | 70.8 ± 21.0 |
| Emotional Functioning: C24D1 (n=20, 3) | 87.9 ± 16.1 | 66.7 ± 30.0 |
| Emotional Functioning: C25D1 (n=18, 3) | 81.5 ± 19.5 | 72.2 ± 24.1 |
| Emotional Functioning: C26D1 (n=14, 3) | 73.2 ± 28.3 | 72.2 ± 24.1 |
| Emotional Functioning: C27D1 (n=14, 2) | 70.8 ± 27.3 | 58.3 ± 0.0 |
| Emotional Functioning: C28D1 (n=11, 2) | 81.1 ± 27.2 | 58.3 ± 0.0 |
| Emotional Functioning: C29D1 (n=8, 2) | 86.5 ± 15.4 | 54.2 ± 5.9 |
| Emotional Functioning: C30D1 (n=8, 1) | 84.4 ± 25.0 | 58.3 ± NA |
| Emotional Functioning: C31D1 (n=7, 0) | 76.2 ± 28.2 | NA ± NA |
| Emotional Functioning: C32D1 (n=6, 0) | 87.5 ± 17.3 | NA ± NA |
| Emotional Functioning: C33D1 (n=6, 0) | 90.3 ± 13.4 | NA ± NA |
| Emotional Functioning: C34D1 (n=5, 0) | 91.7 ± 14.4 | NA ± NA |
| Emotional Functioning: C35D1 (n=4, 0) | 83.3 ± 20.4 | NA ± NA |
| Emotional Functioning: C36D1 (n=1, 0) | 58.3 ± NA | NA ± NA |
| Emotional Functioning: C37D1 (n=1, 0) | 58.3 ± NA | NA ± NA |
| Cognitive Functioning: Baseline (n=165, 162) | 85.6 ± 18.3 | 83.6 ± 22.3 |
| Cognitive Functioning: C2D1 (n=155, 133) | 85.5 ± 18.9 | 84.5 ± 20.6 |
| Cognitive Functioning: C3D1 (n=154, 106) | 87.0 ± 15.7 | 83.8 ± 20.4 |
| Cognitive Functioning: C4D1 (n=135, 90) | 88.1 ± 15.6 | 82.6 ± 20.4 |
| Cognitive Functioning: C5D1 (n=123, 74) | 88.9 ± 14.4 | 82.7 ± 22.0 |
| Cognitive Functioning: C6D1 (n=120, 70) | 87.5 ± 15.3 | 83.8 ± 19.2 |
| Cognitive Functioning: C7D1 (n=115, 52) | 86.7 ± 15.6 | 85.3 ± 18.3 |
| Cognitive Functioning: C8D1 (n=111, 43) | 87.8 ± 14.7 | 82.2 ± 23.4 |
| Cognitive Functioning: C9D1 (n=101, 37) | 88.3 ± 16.6 | 84.7 ± 21.7 |
| Cognitive Functioning: C10D1 (n=94, 33) | 89.2 ± 16.0 | 80.8 ± 22.1 |
| Cognitive Functioning: C11D1 (n=84, 25) | 87.9 ± 14.9 | 85.3 ± 19.4 |
| Cognitive Functioning: C12D1 (n=76, 23) | 89.5 ± 14.4 | 80.4 ± 22.8 |
| Cognitive Functioning: C13D1 (n=74, 21) | 88.5 ± 15.6 | 79.4 ± 27.8 |
| Cognitive Functioning: C14D1 (n=66, 19) | 88.9 ± 14.7 | 81.6 ± 24.1 |
| Cognitive Functioning: C15D1 (n=62, 16) | 87.6 ± 15.4 | 84.4 ± 18.7 |
| Cognitive Functioning: C16D1 (n=53, 12) | 87.4 ± 14.2 | 72.2 ± 25.9 |
| Cognitive Functioning: C17D1 (n=47, 11) | 85.1 ± 15.2 | 75.8 ± 21.6 |
| Cognitive Functioning: C18D1 (n=44, 11) | 88.3 ± 14.6 | 75.8 ± 25.1 |
| Cognitive Functioning: C19D1 (n=40, 9) | 87.5 ± 14.5 | 70.4 ± 23.2 |
| Cognitive Functioning: C20D1 (n=35, 8) | 85.7 ± 15.2 | 72.9 ± 23.5 |
| Cognitive Functioning: C21D1 (n=30, 8) | 85.6 ± 15.0 | 72.9 ± 23.5 |
| Cognitive Functioning: C22D1 (n=24, 7) | 86.1 ± 15.3 | 69.0 ± 24.4 |
| Cognitive Functioning: C23D1 (n=23, 4) | 85.5 ± 14.5 | 58.3 ± 21.5 |
| Cognitive Functioning: C24D1 (n=20, 3) | 85.8 ± 19.7 | 61.1 ± 34.7 |
| Cognitive Functioning: C25D1 (n=18, 3) | 86.1 ± 15.4 | 55.6 ± 25.5 |
| Cognitive Functioning: C26D1 (n=14, 3) | 81.0 ± 26.0 | 61.1 ± 34.7 |
| Cognitive Functioning: C27D1 (n=14, 2) | 76.2 ± 25.9 | 41.7 ± 11.8 |
| Cognitive Functioning: C28D1 (n=11, 2) | 78.8 ± 21.2 | 41.7 ± 11.8 |
| Cognitive Functioning: C29D1 (n=8, 2) | 87.5 ± 11.8 | 33.3 ± 0.0 |
| Cognitive Functioning: C30D1 (n=8, 1) | 83.3 ± 23.6 | 16.7 ± NA |
| Cognitive Functioning: C31D1 (n=7, 0) | 81.0 ± 20.2 | NA ± NA |
| Cognitive Functioning: C32D1 (n=6, 0) | 83.3 ± 18.3 | NA ± NA |
| Cognitive Functioning: C33D1 (n=6, 0) | 86.1 ± 16.4 | NA ± NA |
| Cognitive Functioning: C34D1 (n=5, 0) | 90.0 ± 9.1 | NA ± NA |
| Cognitive Functioning: C35D1 (n=4, 0) | 95.8 ± 8.3 | NA ± NA |
| Cognitive Functioning: C36D1 (n=1, 0) | 100.0 ± NA | NA ± NA |
| Cognitive Functioning: C37D1 (n=1, 0) | 83.3 ± NA | NA ± NA |
| Social Functioning: Baseline (n=165, 162) | 68.0 ± 27.7 | 67.1 ± 29.0 |
| Social Functioning: C2D1 (n=155, 133) | 75.9 ± 25.1 | 69.5 ± 28.1 |
| Social Functioning: C3D1 (n=154, 106) | 78.5 ± 24.0 | 72.5 ± 26.7 |
| Social Functioning: C4D1 (n=135, 90) | 79.4 ± 23.9 | 71.7 ± 26.3 |
| Social Functioning: C5D1 (n=123, 74) | 79.4 ± 23.8 | 74.5 ± 27.1 |
| Social Functioning: C6D1 (n=120, 70) | 81.8 ± 22.1 | 76.4 ± 27.3 |
| Social Functioning: C7D1 (n=115, 52) | 82.3 ± 21.8 | 77.9 ± 24.6 |
| Social Functioning: C8D1 (n=111, 43) | 82.0 ± 21.3 | 77.5 ± 24.4 |
| Social Functioning: C9D1 (n=101, 37) | 80.4 ± 24.7 | 80.2 ± 21.8 |
| Social Functioning: C10D1 (n=94, 33) | 81.9 ± 25.1 | 76.3 ± 27.0 |
| Social Functioning: C11D1 (n=84, 25) | 81.9 ± 23.0 | 78.7 ± 24.8 |
| Social Functioning: C12D1 (n=76, 23) | 82.0 ± 23.5 | 71.0 ± 31.9 |
| Social Functioning: C13D1 (n=74, 21) | 81.8 ± 24.7 | 71.4 ± 28.9 |
| Social Functioning: C14D1 (n=66, 19) | 81.3 ± 23.8 | 69.3 ± 34.8 |
| Social Functioning: C15D1 (n=62, 16) | 81.5 ± 25.6 | 74.0 ± 28.5 |
| Social Functioning: C16D1 (n=53, 12) | 82.7 ± 21.9 | 65.3 ± 35.9 |
| Social Functioning: C17D1 (n=47, 11) | 81.9 ± 24.8 | 69.7 ± 33.2 |
| Social Functioning: C18D1 (n=44, 11) | 82.6 ± 22.7 | 65.2 ± 35.3 |
| Social Functioning: C19D1 (n=40, 9) | 84.6 ± 22.8 | 64.8 ± 31.7 |
| Social Functioning: C20D1 (n=35, 8) | 82.9 ± 23.7 | 70.8 ± 33.0 |
| Social Functioning: C21D1 (n=30, 8) | 82.8 ± 24.2 | 64.6 ± 36.1 |
| Social Functioning: C22D1 (n=24, 7) | 82.6 ± 23.8 | 65.5 ± 39.8 |
| Social Functioning: C23D1 (n=23, 4) | 84.4 ± 23.9 | 41.7 ± 50.0 |
| Social Functioning: C24D1 (n=20, 3) | 84.2 ± 27.3 | 61.1 ± 53.6 |
| Social Functioning: C25D1 (n=18, 3) | 89.8 ± 19.1 | 50.0 ± 50.0 |
| Social Functioning: C26D1 (n=14, 3) | 78.6 ± 28.8 | 50.0 ± 50.0 |
| Social Functioning: C27D1 (n=14, 2) | 85.7 ± 15.8 | 33.3 ± 47.1 |
| Social Functioning: C28D1 (n=11, 2) | 83.3 ± 26.9 | 33.3 ± 47.1 |
| Social Functioning: C29D1 (n=8, 2) | 83.3 ± 25.2 | 33.3 ± 47.1 |
| Social Functioning: C30D1 (n=8, 1) | 85.4 ± 24.3 | 0.0 ± NA |
| Social Functioning: C31D1 (n=7, 0) | 73.8 ± 38.3 | NA ± NA |
| Social Functioning: C32D1 (n=6, 0) | 83.3 ± 18.3 | NA ± NA |
| Social Functioning: C33D1 (n=6, 0) | 94.4 ± 13.6 | NA ± NA |
| Social Functioning: C34D1 (n=5, 0) | 96.7 ± 7.5 | NA ± NA |
| Social Functioning: C35D1 (n=4, 0) | 91.7 ± 16.7 | NA ± NA |
| Social Functioning: C36D1 (n=1, 0) | 66.7 ± NA | NA ± NA |
| Social Functioning: C37D1 (n=1, 0) | 66.7 ± NA | NA ± NA |
| Fatigue: Baseline (n=165, 163) | 38.3 ± 24.4 | 36.1 ± 25.3 |
| Fatigue: C2D1 (n=155, 133) | 31.4 ± 23.4 | 39.5 ± 24.8 |
| Fatigue: C3D1 (n=154, 106) | 30.8 ± 24.1 | 39.4 ± 24.5 |
| Fatigue: C4D1 (n=135, 91) | 27.1 ± 22.3 | 34.1 ± 22.1 |
| Fatigue: C5D1 (n=123, 74) | 24.7 ± 19.8 | 31.5 ± 25.2 |
| Fatigue: C6D1 (n=120, 70) | 24.6 ± 19.3 | 31.0 ± 22.8 |
| Fatigue: C7D1 (n=115, 52) | 23.9 ± 19.8 | 27.6 ± 23.1 |
| Fatigue: C8D1 (n=111, 43) | 23.2 ± 18.9 | 26.6 ± 23.6 |
| Fatigue: C9D1 (n=101, 37) | 22.9 ± 21.7 | 28.5 ± 26.6 |
| Fatigue: C10D1 (n=94, 33) | 21.4 ± 20.0 | 28.6 ± 27.9 |
| Fatigue: C11D1 (n=84, 25) | 22.1 ± 19.6 | 22.2 ± 22.9 |
| Fatigue: C12D1 (n=76, 23) | 21.9 ± 22.9 | 26.1 ± 24.1 |
| Fatigue: C13D1 (n=74, 21) | 23.3 ± 21.3 | 27.5 ± 25.2 |
| Fatigue: C14D1 (n=66, 19) | 21.7 ± 21.7 | 28.1 ± 26.8 |
| Fatigue: C15D1 (n=62, 16) | 20.8 ± 22.5 | 24.3 ± 24.8 |
| Fatigue: C16D1 (n=53, 12) | 22.2 ± 18.0 | 24.1 ± 21.6 |
| Fatigue: C17D1 (n=47, 11) | 23.4 ± 20.0 | 23.2 ± 23.0 |
| Fatigue: C18D1 (n=45, 11) | 21.5 ± 18.3 | 27.3 ± 22.4 |
| Fatigue: C19D1 (n=40, 9) | 20.8 ± 18.7 | 24.7 ± 20.6 |
| Fatigue: C20D1 (n=35, 8) | 24.4 ± 19.2 | 27.8 ± 26.6 |
| Fatigue: C21D1 (n=30, 8) | 23.9 ± 17.8 | 25.7 ± 27.7 |
| Fatigue: C22D1 (n=24, 7) | 23.6 ± 16.2 | 27.0 ± 23.9 |
| Fatigue: C23D1 (n=23, 4) | 25.1 ± 19.3 | 47.2 ± 14.0 |
| Fatigue: C24D1 (n=20, 3) | 24.4 ± 18.9 | 40.7 ± 23.1 |
| Fatigue: C25D1 (n=18, 3) | 24.7 ± 16.0 | 44.4 ± 19.2 |
| Fatigue: C26D1 (n=14, 3) | 30.2 ± 25.6 | 44.4 ± 19.2 |
| Fatigue: C27D1 (n=14, 2) | 35.7 ± 25.1 | 55.6 ± 15.7 |
| Fatigue: C28D1 (n=11, 2) | 28.3 ± 22.4 | 38.9 ± 7.9 |
| Fatigue: C29D1 (n=8, 2) | 30.6 ± 22.8 | 50.0 ± 23.6 |
| Fatigue: C30D1 (n=8, 1) | 26.4 ± 24.4 | 55.6 ± NA |
| Fatigue: C31D1 (n=7, 0) | 28.6 ± 16.8 | NA ± NA |
| Fatigue: C32D1 (n=6, 0) | 25.9 ± 5.7 | NA ± NA |
| Fatigue: C33D1 (n=6, 0) | 18.5 ± 11.5 | NA ± NA |
| Fatigue: C34D1 (n=5, 0) | 15.6 ± 16.9 | NA ± NA |
| Fatigue: C35D1 (n=4, 0) | 27.8 ± 14.3 | NA ± NA |
| Fatigue: C36D1 (n=1, 0) | 33.3 ± NA | NA ± NA |
| Fatigue: C37D1 (n=1, 0) | 11.1 ± NA | NA ± NA |
| Nausea and Vomiting: Baseline (n=165, 163) | 8.4 ± 14.4 | 11.7 ± 18.0 |
| Nausea and Vomiting: C2D1 (n=155, 133) | 15.2 ± 20.9 | 12.7 ± 19.0 |
| Nausea and Vomiting: C3D1 (n=154, 106) | 13.9 ± 21.2 | 9.9 ± 16.6 |
| Nausea and Vomiting: C4D1 (n=135, 91) | 9.9 ± 18.1 | 8.1 ± 14.1 |
| Nausea and Vomiting: C5D1 (n=123, 74) | 9.2 ± 14.7 | 9.0 ± 16.8 |
| Nausea and Vomiting: C6D1 (n=120, 70) | 10.1 ± 15.2 | 6.9 ± 13.2 |
| Nausea and Vomiting: C7D1 (n=115, 52) | 7.1 ± 11.9 | 7.7 ± 11.7 |
| Nausea and Vomiting: C8D1 (n=111, 43) | 8.8 ± 13.7 | 8.9 ± 14.7 |
| Nausea and Vomiting: C9D1 (n=101, 37) | 6.9 ± 13.0 | 9.5 ± 19.9 |
| Nausea and Vomiting: C10D1 (n=94, 33) | 8.5 ± 14.6 | 8.1 ± 15.7 |
| Nausea and Vomiting: C11D1 (n=84, 25) | 8.3 ± 12.8 | 8.0 ± 16.0 |
| Nausea and Vomiting: C12D1 (n=76, 23) | 6.4 ± 12.8 | 7.2 ± 15.8 |
| Nausea and Vomiting: C13D1 (n=74, 21) | 8.6 ± 14.1 | 7.1 ± 16.3 |
| Nausea and Vomiting: C14D1 (n=66, 19) | 5.8 ± 13.9 | 7.0 ± 14.0 |
| Nausea and Vomiting: C15D1 (n=62, 16) | 5.9 ± 11.3 | 6.2 ± 13.4 |
| Nausea and Vomiting: C16D1 (n=53, 12) | 5.3 ± 9.7 | 6.9 ± 11.1 |
| Nausea and Vomiting: C17D1 (n=47, 11) | 7.8 ± 12.5 | 10.6 ± 11.2 |
| Nausea and Vomiting: C18D1 (n=45, 11) | 7.0 ± 13.5 | 3.0 ± 6.7 |
| Nausea and Vomiting: C19D1 (n=40, 9) | 8.8 ± 14.6 | 9.3 ± 12.1 |
| Nausea and Vomiting: C20D1 (n=35, 8) | 7.4 ± 13.5 | 10.4 ± 15.3 |
| Nausea and Vomiting: C21D1 (n=30, 8) | 7.8 ± 12.9 | 8.3 ± 12.6 |
| Nausea and Vomiting: C22D1 (n=24, 7) | 2.8 ± 6.3 | 14.3 ± 17.8 |
| Nausea and Vomiting: C23D1 (n=23, 4) | 5.4 ± 10.5 | 45.8 ± 21.0 |
| Nausea and Vomiting: C24D1 (n=20, 3) | 7.5 ± 14.8 | 33.3 ± 28.9 |
| Nausea and Vomiting: C25D1 (n=18, 3) | 3.7 ± 9.1 | 27.8 ± 25.5 |
| Nausea and Vomiting: C26D1 (n=14, 3) | 10.7 ± 27.4 | 33.3 ± 16.7 |
| Nausea and Vomiting: C27D1 (n=14, 2) | 11.9 ± 27.3 | 33.3 ± 23.6 |
| Nausea and Vomiting: C28D1 (n=11, 2) | 3.0 ± 6.7 | 25.0 ± 11.8 |
| Nausea and Vomiting: C29D1 (n=8, 2) | 10.4 ± 15.3 | 25.0 ± 11.8 |
| Nausea and Vomiting: C30D1 (n=8, 1) | 6.3 ± 12.4 | 33.3 ± NA |
| Nausea and Vomiting: C31D1 (n=7, 0) | 14.3 ± 17.8 | NA ± NA |
| Nausea and Vomiting: C32D1 (n=6, 0) | 11.1 ± 17.2 | NA ± NA |
| Nausea and Vomiting: C33D1 (n=6, 0) | 11.1 ± 17.2 | NA ± NA |
| Nausea and Vomiting: C34D1 (n=5, 0) | 13.3 ± 18.3 | NA ± NA |
| Nausea and Vomiting: C35D1 (n=4, 0) | 12.5 ± 16.0 | NA ± NA |
| Nausea and Vomiting: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Nausea and Vomiting: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Pain: Baseline (n=165, 163) | 23.9 ± 24.7 | 28.0 ± 27.3 |
| Pain: C2D1 (n=155, 133) | 13.9 ± 19.8 | 25.7 ± 25.3 |
| Pain: C3D1 (n=154, 106) | 13.7 ± 20.4 | 23.3 ± 26.6 |
| Pain: C4D1 (n=135, 91) | 13.0 ± 19.5 | 19.0 ± 21.5 |
| Pain: C5D1 (n=123, 74) | 11.5 ± 16.7 | 20.5 ± 23.0 |
| Pain: C6D1 (n=120, 70) | 10.6 ± 15.0 | 19.5 ± 23.0 |
| Pain: C7D1 (n=115, 52) | 9.6 ± 14.3 | 21.5 ± 24.3 |
| Pain: C8D1 (n=111, 43) | 11.3 ± 18.0 | 17.4 ± 23.6 |
| Pain: C9D1 (n=101, 37) | 11.8 ± 18.8 | 23.0 ± 27.6 |
| Pain: C10D1 (n=94, 33) | 8.7 ± 14.0 | 24.2 ± 28.6 |
| Pain: C11D1 (n=84, 25) | 10.5 ± 16.3 | 22.0 ± 27.9 |
| Pain: C12D1 (n=76, 23) | 8.6 ± 14.3 | 25.4 ± 29.7 |
| Pain: C13D1 (n=74, 21) | 10.1 ± 15.3 | 27.8 ± 30.4 |
| Pain: C14D1 (n=66, 19) | 8.1 ± 12.8 | 23.7 ± 26.2 |
| Pain: C15D1 (n=62, 16) | 9.4 ± 15.6 | 22.9 ± 25.7 |
| Pain: C16D1 (n=53, 12) | 9.4 ± 14.4 | 31.9 ± 28.8 |
| Pain: C17D1 (n=47, 11) | 10.6 ± 16.1 | 24.2 ± 27.2 |
| Pain: C18D1 (n=45, 11) | 11.1 ± 18.1 | 24.2 ± 29.2 |
| Pain: C19D1 (n=40, 9) | 11.3 ± 17.0 | 24.1 ± 20.6 |
| Pain: C20D1 (n=35, 8) | 11.9 ± 18.8 | 22.9 ± 28.1 |
| Pain: C21D1 (n=30, 8) | 11.7 ± 15.3 | 29.2 ± 30.5 |
| Pain: C22D1 (n=24, 7) | 6.9 ± 12.9 | 33.3 ± 28.9 |
| Pain: C23D1 (n=23, 4) | 9.1 ± 16.1 | 33.3 ± 36.0 |
| Pain: C24D1 (n=20, 3) | 4.2 ± 11.9 | 27.8 ± 48.1 |
| Pain: C25D1 (n=18, 3) | 4.6 ± 7.7 | 38.9 ± 41.9 |
| Pain: C26D1 (n=14, 3) | 17.9 ± 27.3 | 38.9 ± 41.9 |
| Pain: C27D1 (n=14, 2) | 13.1 ± 25.5 | 58.3 ± 35.4 |
| Pain: C28D1 (n=11, 2) | 4.5 ± 7.8 | 50.0 ± 47.1 |
| Pain: C29D1 (n=8, 2) | 2.1 ± 5.9 | 41.7 ± 35.4 |
| Pain: C30D1 (n=8, 1) | 4.2 ± 7.7 | 83.3 ± NA |
| Pain: C31D1 (n=7, 0) | 4.8 ± 8.1 | NA ± NA |
| Pain: C32D1 (n=6, 0) | 5.6 ± 8.6 | NA ± NA |
| Pain: C33D1 (n=6, 0) | 2.8 ± 6.8 | NA ± NA |
| Pain: C34D1 (n=5, 0) | 3.3 ± 7.5 | NA ± NA |
| Pain: C35D1 (n=4, 0) | 8.3 ± 16.7 | NA ± NA |
| Pain: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Pain: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Dyspnea: Baseline (n=165, 163) | 31.1 ± 28.3 | 32.5 ± 28.2 |
| Dyspnea: C2D1 (n=155, 133) | 21.5 ± 21.4 | 33.6 ± 27.7 |
| Dyspnea: C3D1 (n=154, 106) | 21.6 ± 23.0 | 33.3 ± 28.4 |
| Dyspnea: C4D1 (n=135, 91) | 17.3 ± 20.7 | 29.3 ± 26.2 |
| Dyspnea: C5D1 (n=123, 74) | 16.0 ± 20.6 | 29.3 ± 24.0 |
| Dyspnea: C6D1 (n=120, 70) | 15.8 ± 22.0 | 26.2 ± 24.7 |
| Dyspnea: C7D1 (n=115, 52) | 17.4 ± 20.9 | 28.2 ± 22.3 |
| Dyspnea: C8D1 (n=111, 43) | 15.8 ± 19.7 | 22.5 ± 28.8 |
| Dyspnea: C9D1 (n=101, 37) | 13.9 ± 19.0 | 23.4 ± 24.7 |
| Dyspnea: C10D1 (n=94, 33) | 17.7 ± 20.6 | 24.2 ± 22.5 |
| Dyspnea: C11D1 (n=84, 25) | 17.5 ± 22.8 | 25.3 ± 22.1 |
| Dyspnea: C12D1 (n=76, 23) | 14.5 ± 19.9 | 30.4 ± 28.3 |
| Dyspnea: C13D1 (n=74, 21) | 14.0 ± 20.6 | 23.8 ± 23.9 |
| Dyspnea: C14D1 (n=66, 19) | 15.2 ± 21.2 | 29.8 ± 24.6 |
| Dyspnea: C15D1 (n=62, 16) | 15.6 ± 21.5 | 20.8 ± 20.6 |
| Dyspnea: C16D1 (n=53, 12) | 13.8 ± 17.8 | 19.4 ± 22.3 |
| Dyspnea: C17D1 (n=46, 11) | 14.5 ± 20.7 | 24.2 ± 21.6 |
| Dyspnea: C18D1 (n=45, 11) | 14.1 ± 16.6 | 24.2 ± 26.2 |
| Dyspnea: C19D1 (n=40, 9) | 14.2 ± 18.3 | 25.9 ± 22.2 |
| Dyspnea: C20D1 (n=35, 8) | 10.5 ± 17.7 | 33.3 ± 25.2 |
| Dyspnea: C21D1 (n=30, 8) | 13.3 ± 16.6 | 33.3 ± 17.8 |
| Dyspnea: C22D1 (n=24, 7) | 13.9 ± 19.5 | 28.6 ± 23.0 |
| Dyspnea: C23D1 (n=23, 4) | 9.4 ± 14.9 | 41.7 ± 16.7 |
| Dyspnea: C24D1 (n=20, 3) | 18.3 ± 20.2 | 44.4 ± 19.2 |
| Dyspnea: C25D1 (n=18, 3) | 11.1 ± 16.2 | 33.3 ± 33.3 |
| Dyspnea: C26D1 (n=14, 3) | 14.3 ± 28.4 | 33.3 ± 33.3 |
| Dyspnea: C27D1 (n=14, 2) | 11.9 ± 16.6 | 50.0 ± 23.6 |
| Dyspnea: C28D1 (n=11, 2) | 12.1 ± 16.8 | 50.0 ± 23.6 |
| Dyspnea: C29D1 (n=8, 2) | 4.2 ± 11.8 | 50.0 ± 23.6 |
| Dyspnea: C30D1 (n=8, 1) | 8.3 ± 15.4 | 66.7 ± NA |
| Dyspnea: C31D1 (n=7, 0) | 9.5 ± 16.3 | NA ± NA |
| Dyspnea: C32D1 (n=6, 0) | 16.7 ± 18.3 | NA ± NA |
| Dyspnea: C33D1 (n=6, 0) | 11.1 ± 17.2 | NA ± NA |
| Dyspnea: C34D1 (n=5, 0) | 13.3 ± 18.3 | NA ± NA |
| Dyspnea: C35D1 (n=4, 0) | 16.7 ± 19.2 | NA ± NA |
| Dyspnea: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Dyspnea: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Insomnia : Baseline (n=164, 163) | 22.6 ± 26.4 | 27.8 ± 27.3 |
| Insomnia : C2D1 (n=155, 133) | 15.3 ± 23.5 | 27.1 ± 25.3 |
| Insomnia : C3D1 (n=154, 106) | 16.2 ± 26.2 | 23.6 ± 26.0 |
| Insomnia : C4D1 (n=135, 91) | 13.3 ± 21.2 | 23.8 ± 26.9 |
| Insomnia : C5D1 (n=123, 74) | 13.6 ± 21.3 | 25.7 ± 26.8 |
| Insomnia : C6D1 (n=120, 70) | 14.2 ± 21.9 | 23.3 ± 25.0 |
| Insomnia : C7D1 (n=114, 52) | 9.4 ± 17.5 | 21.8 ± 25.5 |
| Insomnia : C8D1 (n=111, 43) | 12.5 ± 21.5 | 21.7 ± 22.9 |
| Insomnia : C9D1 (n=100, 37) | 12.3 ± 21.5 | 22.5 ± 24.9 |
| Insomnia : C10D1 (n=94, 33) | 13.5 ± 23.6 | 24.2 ± 25.4 |
| Insomnia : C11D1 (n=84, 25) | 13.9 ± 22.1 | 22.7 ± 24.9 |
| Insomnia : C12D1 (n=76, 23) | 13.6 ± 21.9 | 23.2 ± 25.5 |
| Insomnia : C13D1 (n=74, 21) | 10.8 ± 19.2 | 25.4 ± 25.6 |
| Insomnia : C14D1 (n=66, 19) | 11.1 ± 18.8 | 24.6 ± 29.1 |
| Insomnia : C15D1 (n=62, 16) | 11.3 ± 20.0 | 29.2 ± 26.9 |
| Insomnia : C16D1 (n=53, 11) | 13.8 ± 20.1 | 21.2 ± 22.5 |
| Insomnia : C17D1 (n=47, 11) | 13.5 ± 21.6 | 15.2 ± 22.9 |
| Insomnia : C18D1 (n=45, 11) | 12.6 ± 17.8 | 21.2 ± 27.0 |
| Insomnia : C19D1 (n=40, 9) | 13.3 ± 19.7 | 22.2 ± 28.9 |
| Insomnia : C20D1 (n=35, 8) | 15.2 ± 20.4 | 20.8 ± 24.8 |
| Insomnia : C21D1 (n=30, 8) | 12.2 ± 18.5 | 29.2 ± 27.8 |
| Insomnia : C22D1 (n=24, 7) | 12.5 ± 19.2 | 31.0 ± 24.4 |
| Insomnia : C23D1 (n=23, 4) | 17.4 ± 26.3 | 50.0 ± 19.2 |
| Insomnia : C24D1 (n=20, 3) | 11.7 ± 22.4 | 22.2 ± 38.5 |
| Insomnia : C25D1 (n=18, 3) | 20.4 ± 30.5 | 44.4 ± 19.2 |
| Insomnia : C26D1 (n=14, 3) | 21.4 ± 33.6 | 22.2 ± 38.5 |
| Insomnia : C27D1 (n=14, 2) | 16.7 ± 21.7 | 50.0 ± 23.6 |
| Insomnia : C28D1 (n=11, 2) | 9.1 ± 15.6 | 50.0 ± 23.6 |
| Insomnia : C29D1 (n=8, 2) | 8.3 ± 15.4 | 33.0 ± 0.0 |
| Insomnia : C30D1 (n=8, 1) | 12.5 ± 24.8 | 33.3 ± NA |
| Insomnia : C31D1 (n=7, 0) | 0.0 ± 0.0 | NA ± NA |
| Insomnia : C32D1 (n=6, 0) | 5.6 ± 13.6 | NA ± NA |
| Insomnia : C33D1 (n=6, 0) | 5.6 ± 13.6 | NA ± NA |
| Insomnia : C34D1 (n=5, 0) | 13.3 ± 18.3 | NA ± NA |
| Insomnia : C35D1 (n=4, 0) | 16.7 ± 19.2 | NA ± NA |
| Insomnia : C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Insomnia : C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Appetite loss : Baseline(n=165, 163) | 24.4 ± 28.8 | 23.3 ± 28.2 |
| Appetite loss : C2/D1(n=155, 133) | 21.1 ± 30.2 | 24.3 ± 28.5 |
| Appetite loss : C3/D1(n=154, 106) | 18.4 ± 29.0 | 21.7 ± 27.2 |
| Appetite loss : C4/D1(n=135, 91) | 14.6 ± 24.3 | 19.4 ± 23.3 |
| Appetite loss : C5/D1(n=123, 74) | 12.7 ± 22.4 | 19.4 ± 28.1 |
| Appetite loss : C6/D1(n=120, 70) | 13.6 ± 21.8 | 12.9 ± 23.6 |
| Appetite loss : C7/D1(n=115, 52) | 10.4 ± 19.4 | 12.8 ± 22.0 |
| Appetite loss : C8/D1(n=111, 43) | 12.8 ± 20.8 | 10.9 ± 22.7 |
| Appetite loss : C9/D1(n=101, 37) | 12.2 ± 239 | 14.4 ± 27.8 |
| Appetite loss : C10/D1(n=94, 33) | 12.4 ± 22.9 | 14.1 ± 25.0 |
| Appetite loss : C11/D1(n=84, 25) | 13.5 ± 19.4 | 14.7 ± 25.6 |
| Appetite loss : C12/D1(n=76, 23) | 11.0 ± 21.4 | 14.5 ± 24.3 |
| Appetite loss : C13/D1(n=74, 21) | 9.5 ± 20.3 | 17.5 ± 27.1 |
| Appetite loss : C15/D1(n=62, 16) | 8.6 ± 20.9 | 12.5 ± 26.9 |
| Appetite loss : C16/D1(n=53, 12) | 8.8 ± 18.7 | 16.7 ± 30.2 |
| Appetite loss : C17/D1(n=47, 11) | 8.5 ± 16.3 | 15.2 ± 31.1 |
| Appetite loss : C18/D1(n=45, 11) | 11.1 ± 17.4 | 12.1 ± 22.5 |
| Appetite loss : C19/D1(n=40, 9) | 8.3 ± 16.5 | 18.5 ± 33.8 |
| Appetite loss : C20/D1(n=35, 8) | 7.6 ± 16.3 | 20.8 ± 35.4 |
| Appetite loss : C21/D1(n=30, 8) | 11.1 ± 16.0 | 25.0 ± 34.5 |
| Appetite loss : C22/D1(n=24, 7) | 6.9 ± 13.8 | 14.3 ± 37.8 |
| Appetite loss : C23/D1(n=23, 4) | 9.4 ± 14.9 | 50.0 ± 43.0 |
| Appetite loss : C24/D1(n=20, 3) | 5.0 ± 12.2 | 33.3 ± 33.3 |
| Appetite loss : C25/D1(n=18, 3) | 1.9 ± 7.9 | 44.4 ± 50.9 |
| Appetite loss : C26/D1(n=14, 3) | 11.9 ± 21.1 | 33.3 ± 33.3 |
| Appetite loss : C27/D1(n=14, 2) | 7.1 ± 19.3 | 33.3 ± 47.1 |
| Appetite loss : C28/D1(n=11, 2) | 15.2 ± 17.4 | 33.3 ± 47.1 |
| Appetite loss : C29/D1(n=8, 2) | 12.5 ± 17.3 | 33.3 ± 47.1 |
| Appetite loss : C30/D1(n=8, 1) | 8.3 ± 15.4 | 100.0 ± NA |
| Appetite loss : C31/D1(n=7, 0) | 14.3 ± 17.8 | NA ± NA |
| Constipation: Baseline (n=164, 162) | 14.8 ± 25.1 | 16.9 ± 25.0 |
| Constipation: C2D1 (n=155, 133) | 28.6 ± 30.5 | 14.0 ± 24.3 |
| Constipation: C3D1 (n=154, 106) | 27.1 ± 30.0 | 16.0 ± 22.2 |
| Constipation: C4D1 (n=134, 90) | 22.9 ± 26.6 | 14.8 ± 25.5 |
| Constipation: C5D1 (n=123, 74) | 21.4 ± 25.7 | 20.3 ± 29.6 |
| Constipation: C6D1 (n=120, 70) | 21.7 ± 23.9 | 15.7 ± 23.2 |
| Constipation: C7D1 (n=115, 52) | 21.7 ± 26.1 | 19.9 ± 26.6 |
| Constipation: C8D1 (n=111, 43) | 18.6 ± 24.1 | 16.3 ± 24.5 |
| Constipation: C9D1 (n=101, 37) | 18.8 ± 22.3 | 16.2 ± 21.7 |
| Constipation: C10D1 (n=94, 33) | 16.0 ± 22.8 | 19.2 ± 25.0 |
| Constipation: C11D1 (n=84, 25) | 21.0 ± 25.8 | 21.3 ± 19.0 |
| Constipation: C12D1 (n=76, 23) | 19.7 ± 24.5 | 21.7 ± 23.8 |
| Constipation: C13D1 (n=74, 21) | 21.2 ± 26.2 | 22.2 ± 26.5 |
| Constipation: C14D1 (n=66, 19) | 21.7 ± 27.1 | 24.6 ± 31.1 |
| Constipation: C15D1 (n=62, 16) | 22.6 ± 27.5 | 18.7 ± 21.0 |
| Constipation: C16D1 (n=53, 12) | 19.5 ± 26.5 | 22.2 ± 25.9 |
| Constipation: C17D1 (n=47, 11) | 22.0 ± 27.2 | 24.2 ± 30.2 |
| Constipation: C18D1 (n=44, 11) | 22.7 ± 25.7 | 15.2 ± 22.9 |
| Constipation: C19D1 (n=40, 9) | 25.0 ± 25.9 | 22.2 ± 23.6 |
| Constipation: C20D1 (n=35, 8) | 22.9 ± 26.5 | 20.8 ± 24.8 |
| Constipation: C21D1 (n=30, 8) | 24.4 ± 28.9 | 16.7 ± 25.2 |
| Constipation: C22D1 (n=24, 7) | 18.1 ± 24.0 | 19.0 ± 26.2 |
| Constipation: C23D1 (n=23, 4) | 11.6 ± 19.1 | 25.0 ± 31.9 |
| Constipation: C24D1 (n=20, 3) | 21.7 ± 24.8 | 22.2 ± 19.2 |
| Constipation: C25D1 (n=18, 3) | 22.2 ± 32.3 | 33.3 ± 33.3 |
| Constipation: C26D1 (n=14, 3) | 26.2 ± 32.5 | 44.4 ± 50.9 |
| Constipation: C27D1 (n=14, 2) | 35.7 ± 40.2 | 50.0 ± 23.6 |
| Constipation: C28D1 (n=11, 2) | 21.2 ± 16.8 | 50.0 ± 23.6 |
| Constipation: C29D1 (n=8, 2) | 29.2 ± 21.4 | 50.0 ± 23.6 |
| Constipation: C30D1 (n=8, 1) | 29.2 ± 27.8 | 33.3 ± NA |
| Constipation: C31D1 (n=7, 0) | 33.3 ± 27.2 | NA ± NA |
| Constipation: C32D1 (n=6, 0) | 33.3 ± 42.2 | NA ± NA |
| Constipation: C33D1 (n=6, 0) | 38.9 ± 25.1 | NA ± NA |
| Constipation: C34D1 (n=5, 0) | 40.0 ± 43.5 | NA ± NA |
| Constipation: C35D1 (n=4, 0) | 33.3 ± 27.2 | NA ± NA |
| Constipation: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Constipation: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Constipation: EOT (n=49, 90) | 28.6 ± 27.2 | 18.1 ± 25.6 |
| Diarrhea: Baseline (n=165, 162) | 9.7 ± 19.1 | 7.8 ± 16.0 |
| Diarrhea: C2D1 (n=155, 132) | 18.1 ± 26.7 | 11.1 ± 20.5 |
| Diarrhea: C3D1 (n=153, 106) | 21.6 ± 28.7 | 7.9 ± 18.1 |
| Diarrhea: C4D1 (n=134, 90) | 23.1 ± 26.9 | 8.5 ± 18.4 |
| Diarrhea: C5D1 (n=123, 74) | 24.4 ± 25.6 | 5.9 ± 15.0 |
| Diarrhea: C6D1 (n=120, 70) | 22.2 ± 26.4 | 7.1 ± 16.9 |
| Diarrhea: C7D1 (n=115, 52) | 20.6 ± 24.8 | 9.6 ± 16.6 |
| Diarrhea: C8D1 (n=111, 43) | 18.6 ± 24.1 | 9.3 ± 19.7 |
| Diarrhea: C9D1 (n=101, 37) | 17.3 ± 22.8 | 7.2 ± 16.0 |
| Diarrhea: C10D1 (n=94, 33) | 17.7 ± 22.3 | 7.1 ± 16.2 |
| Diarrhea: C11D1 (n=84, 25) | 21.0 ± 22.4 | 8.0 ± 17.4 |
| Diarrhea: C12D1 (n=76, 23) | 17.5 ± 25.2 | 8.7 ± 15.0 |
| Diarrhea: C13D1 (n=74, 21) | 17.6 ± 23.6 | 12.7 ± 19.7 |
| Diarrhea: C14D1 (n=66, 19) | 17.7 ± 22.8 | 8.8 ± 18.7 |
| Diarrhea: C15D1 (n=62, 16) | 16.1 ± 21.5 | 4.2 ± 11.4 |
| Diarrhea: C16D1 (n=52, 12) | 16.0 ± 20.3 | 5.6 ± 13.0 |
| Diarrhea: C17D1 (n=47, 11) | 19.9 ± 22.7 | 12.1 ± 22.5 |
| Diarrhea: C18D1 (n=44, 11) | 22.7 ± 25.7 | 12.1 ± 22.5 |
| Diarrhea: C19D1 (n=40, 9) | 21.7 ± 25.7 | 7.4 ± 14.7 |
| Diarrhea: C20D1 (n=35, 8) | 21.0 ± 24.4 | 4.2 ± 11.8 |
| Diarrhea: C21D1 (n=30, 8) | 22.2 ± 22.0 | 8.3 ± 15.4 |
| Diarrhea: C22D1 (n=24, 7) | 23.6 ± 25.0 | 11.9 ± 15.9 |
| Diarrhea: C23D1 (n=23, 4) | 15.9 ± 19.8 | 25.0 ± 16.7 |
| Diarrhea: C24D1 (n=20, 3) | 21.7 ± 22.4 | 11.1 ± 19.2 |
| Diarrhea: C25D1 (n=18, 3) | 20.4 ± 25.9 | 22.2 ± 19.2 |
| Diarrhea: C26D1 (n=14, 3) | 19.0 ± 25.2 | 11.1 ± 19.2 |
| Diarrhea: C27D1 (n=14, 2) | 23.8 ± 30.5 | 16.7 ± 23.6 |
| Diarrhea: C28D1 (n=11, 2) | 15.2 ± 17.4 | 16.7 ± 23.6 |
| Diarrhea: C29D1 (n=8, 2) | 20.8 ± 24.8 | 16.7 ± 23.6 |
| Diarrhea: C30D1 (n=8, 1) | 12.5 ± 17.3 | 0.0 ± NA |
| Diarrhea: C31D1 (n=7, 0) | 14.3 ± 17.8 | NA ± NA |
| Diarrhea: C32D1 (n=6, 0) | 11.1 ± 17.2 | NA ± NA |
| Diarrhea: C33D1 (n=6, 0) | 11.1 ± 17.2 | NA ± NA |
| Diarrhea: C34D1 (n=5, 0) | 6.7 ± 14.9 | NA ± NA |
| Diarrhea: C35D1 (n=4, 0) | 16.7 ± 19.2 | NA ± NA |
| Diarrhea: C36D1 (n=1, 0) | 33.3 ± NA | NA ± NA |
| Diarrhea: C37D1 (n=1, 0) | 33.3 ± NA | NA ± NA |
| Diarrhea: EOT (n=49, 90) | 18.4 ± 23.6 | 10.0 ± 21.5 |
| Financial Difficulties: Baseline (n=165, 161) | 28.5 ± 33.0 | 27.3 ± 30.7 |
| Financial Difficulties: C2D1 (n=155, 133) | 21.9 ± 27.2 | 22.3 ± 28.9 |
| Financial Difficulties: C3D1 (n=154, 105) | 19.0 ± 26.6 | 20.3 ± 27.9 |
| Financial Difficulties: C4D1 (n=135, 90) | 17.5 ± 26.0 | 21.9 ± 26.0 |
| Financial Difficulties: C5D1 (n=123, 74) | 16.8 ± 25.0 | 19.4 ± 23.4 |
| Financial Difficulties: C6D1 (n=120, 70) | 15.6 ± 24.0 | 18.6 ± 25.1 |
| Financial Difficulties: C7D1 (n=115, 52) | 14.8 ± 21.3 | 18.6 ± 25.9 |
| Financial Difficulties: C8D1 (n=111, 43) | 16.8 ± 25.0 | 15.5 ± 23.4 |
| Financial Difficulties: C9D1 (n=101, 36) | 17.8 ± 26.1 | 16.7 ± 23.2 |
| Financial Difficulties: C10D1 (n=94, 33) | 16.3 ± 26.2 | 15.2 ± 23.7 |
| Financial Difficulties: C11D1 (n=84, 25) | 17.5 ± 25.1 | 17.3 ± 21.8 |
| Financial Difficulties: C12D1 (n=76, 23) | 17.1 ± 24.6 | 18.8 ± 28.1 |
| Financial Difficulties: C13D1 (n=74, 21) | 16.2 ± 24.2 | 17.5 ± 27.1 |
| Financial Difficulties: C14D1 (n=66, 19) | 14.1 ± 20.3 | 17.5 ± 32.1 |
| Financial Difficulties: C15D1 (n=62, 16) | 14.0 ± 23.0 | 16.7 ± 27.2 |
| Financial Difficulties: C16D1 (n=53, 12) | 15.7 ± 25.0 | 30.6 ± 36.1 |
| Financial Difficulties: C17D1 (n=47, 11) | 17.7 ± 29.4 | 33.3 ± 36.5 |
| Financial Difficulties: C18D1 (n=44, 11) | 18.9 ± 30.0 | 15.2 ± 31.1 |
| Financial Difficulties: C19D1 (n=40, 9) | 17.5 ± 31.1 | 25.9 ± 32.4 |
| Financial Difficulties: C20D1 (n=35, 8) | 16.2 ± 27.3 | 25.0 ± 34.5 |
| Financial Difficulties: C21D1 (n=30, 8) | 13.3 ± 27.1 | 29.2 ± 33.0 |
| Financial Difficulties: C22D1 (n=24, 7) | 18.1 ± 31.1 | 28.6 ± 35.6 |
| Financial Difficulties: C23D1 (n=23, 4) | 17.4 ± 31.6 | 33.3 ± 47.1 |
| Financial Difficulties: C24D1 (n=20, 3) | 20.0 ± 33.2 | 33.3 ± 57.7 |
| Financial Difficulties: C25D1 (n=18, 3) | 11.1 ± 16.2 | 44.4 ± 50.9 |
| Financial Difficulties: C26D1 (n=14, 3) | 14.3 ± 17.1 | 44.4 ± 50.9 |
| Financial Difficulties: C27D1 (n=14, 2) | 14.3 ± 17.1 | 66.7 ± 47.1 |
| Financial Difficulties: C28D1 (n=11, 2) | 15.2 ± 22.9 | 66.7 ± 47.1 |
| Financial Difficulties: C29D1 (n=8, 2) | 8.3 ± 15.4 | 66.7 ± 47.1 |
| Financial Difficulties: C30D1 (n=8, 1) | 4.2 ± 11.8 | 100.0 ± NA |
| Financial Difficulties: C31D1 (n=7, 0) | 9.5 ± 16.3 | NA ± NA |
| Financial Difficulties: C32D1 (n=6, 0) | 22.2 ± 27.2 | NA ± NA |
| Financial Difficulties: C33D1 (n=6, 0) | 16.7 ± 27.9 | NA ± NA |
| Financial Difficulties: C34D1 (n=5, 0) | 13.3 ± 18.3 | NA ± NA |
| Financial Difficulties: C35D1 (n=4, 0) | 8.3 ± 16.7 | NA ± NA |
| Financial Difficulties: C36D1 (n=1, 0) | 33.3 ± NA | NA ± NA |
| Financial Difficulties: C37D1 (n=1, 0) | 66.7 ± NA | NA ± NA |
| Financial Difficulties: EOT (n=49, 90) | 17.0 ± 27.3 | 24.1 ± 30.0 |
| Appetite loss: C32D1 (n=6, 0) | 11.1 ± 17.2 | NA ± NA |
| Appetite loss: C33D1 (n=6, 0) | 11.1 ± 17.2 | NA ± NA |
| Appetite loss: C34D1 (n=5, 0) | 13.3 ± 18.3 | NA ± NA |
| Appetite loss: C35D1 (n=4, 0) | 16.7 ± 19.2 | NA ± NA |
| Appetite loss: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Appetite loss: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Appetite loss: EOT (n=49, 90) | 21.8 ± 26.0 | 28.1 ± 30.4 |
| Global Qol: EOT (n=49, 90) | 56.1 ± 24.5 | 46.4 ± 25.4 |
| Physical Functioning: EOT (n=49, 90) | 80.7 ± 23.0 | 66.2 ± 27.7 |
| Role Functioning: EOT (n=49, 90) | 71.8 ± 27.7 | 54.1 ± 34.7 |
| Emotional Functioning: EOT (n=49, 90) | 75.2 ± 25.1 | 74.5 ± 25.2 |
| Cognitive Functioning: EOT (n=49, 90) | 83.7 ± 20.3 | 80.0 ± 24.0 |
| Social Function: EOT (n=49, 90) | 78.2 ± 27.9 | 59.4 ± 33.5 |
| Fatigue: EOT (n=49, 90) | 32.0 ± 28.2 | 46.9 ± 26.9 |
| Nausea and Vomiting: EOT (n=49, 90) | 16.3 ± 22.9 | 15.7 ± 20.4 |
| Pain: EOT (n=49, 90) | 23.8 ± 30.4 | 33.7 ± 31.3 |
| Dyspnea: EOT (n=49, 90) | 23.8 ± 28.1 | 40.0 ± 30.1 |
| Insomnia: EOT (n=49, 90) | 18.4 ± 24.6 | 30.4 ± 27.7 |
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.
| units on a scale | Crizotinib | Chemotherapy |
|---|---|---|
| Dyspnea: Baseline (n=164, 162) | 27.2 ± 21.7 | 26.9 ± 23.4 |
| Dyspnea: C2D1 (n=155, 132) | 17.6 ± 18.1 | 28.6 ± 22.3 |
| Dyspnea: C3D1 (n=153, 106) | 17.9 ± 17.8 | 28.0 ± 25.4 |
| Dyspnea: C4D1 (n=135, 91) | 16.2 ± 17.5 | 27.5 ± 22.8 |
| Dyspnea: C5D1 (n=123, 74) | 16.9 ± 16.7 | 24.8 ± 22.9 |
| Dyspnea: C6D1 (n=119, 70) | 15.2 ± 15.8 | 25.2 ± 23.0 |
| Dyspnea: C7D1 (n=115, 52) | 15.6 ± 16.5 | 24.4 ± 20.3 |
| Dyspnea: C8D1 (n=111, 43) | 14.7 ± 16.0 | 22.0 ± 22.8 |
| Dyspnea: C9D1 (n=101, 37) | 13.9 ± 15.8 | 19.5 ± 19.0 |
| Dyspnea: C10D1 (n=94, 33) | 15.4 ± 17.0 | 21.5 ± 21.0 |
| Dyspnea: C11D1 (n=84, 25) | 15.1 ± 17.5 | 20.4 ± 24.1 |
| Dyspnea: C12D1 (n=76, 23) | 13.7 ± 15.5 | 22.7 ± 22.1 |
| Dyspnea: C13D1 (n=74, 21) | 12.8 ± 14.0 | 26.5 ± 25.9 |
| Dyspnea: C14D1 (n=66, 19) | 14.8 ± 16.9 | 26.3 ± 26.8 |
| Dyspnea: C15D1 (n=62, 16) | 13.2 ± 15.4 | 22.9 ± 18.4 |
| Dyspnea: C16D1 (n=53, 12) | 12.6 ± 11.7 | 22.2 ± 18.3 |
| Dyspnea: C17D1 (n=46, 11) | 12.3 ± 11.5 | 30.3 ± 23.9 |
| Dyspnea: C18D1 (n=45, 11) | 14.1 ± 13.5 | 26.3 ± 20.7 |
| Dyspnea: C19D1 (n=40, 9) | 14.4 ± 13.8 | 23.5 ± 15.2 |
| Dyspnea: C20D1 (n=35, 8) | 13.7 ± 12.9 | 34.7 ± 24.1 |
| Dyspnea: C21D1 (n=30, 8) | 12.6 ± 13.0 | 25.0 ± 14.2 |
| Dyspnea: C22D1 (n=24, 7) | 10.6 ± 11.1 | 27.0 ± 21.1 |
| Dyspnea: C23D1 (n=23, 4) | 13.8 ± 14.2 | 52.8 ± 19.0 |
| Dyspnea: C24D1 (n=20, 3) | 14.4 ± 14.9 | 48.1 ± 23.1 |
| Dyspnea: C25D1 (n=18, 3) | 15.4 ± 12.1 | 40.7 ± 23.1 |
| Dyspnea: C26D1 (n=14, 3) | 14.3 ± 10.2 | 44.4 ± 22.2 |
| Dyspnea: C27D1 (n=14, 2) | 15.1 ± 11.2 | 55.6 ± 0.0 |
| Dyspnea: C28D1 (n=11, 2) | 11.1 ± 8.6 | 61.1 ± 7.9 |
| Dyspnea: C29D1 (n=8, 2) | 12.5 ± 11.0 | 50.0 ± 7.9 |
| Dyspnea: C30D1 (n=8, 1) | 9.7 ± 7.1 | 77.8 ± NA |
| Dyspnea: C31D1 (n=7, 0) | 15.9 ± 8.7 | NA ± NA |
| Dyspnea: C32D1 (n=6, 0) | 18.5 ± 9.1 | NA ± NA |
| Dyspnea: C33D1 (n=6, 0) | 18.5 ± 9.1 | NA ± NA |
| Dyspnea: C34D1 (n=5, 0) | 20.0 ± 5.0 | NA ± NA |
| Dyspnea: C35D1 (n=4, 0) | 16.7 ± 6.4 | NA ± NA |
| Dyspnea: C36D1 (n=1, 0) | 22.2 ± NA | NA ± NA |
| Dyspnea: C37D1 (n=1, 0) | 11.1 ± NA | NA ± NA |
| Dyspnea: EOT (n=49, 90) | 21.8 ± 19.0 | 35.6 ± 26.7 |
| Coughing: Baseline (n=164, 162) | 38.2 ± 27.4 | 42.2 ± 31.3 |
| Coughing: C2D1 (n=155, 132) | 23.0 ± 19.6 | 34.8 ± 26.3 |
| Coughing: C3D1 (n=153, 106) | 23.5 ± 21.6 | 32.4 ± 27.4 |
| Coughing: C4D1 (n=135, 91) | 19.8 ± 22.4 | 27.1 ± 24.8 |
| Coughing: C5D1 (n=123, 74) | 18.4 ± 21.0 | 25.7 ± 25.0 |
| Coughing: C6D1 (n=119, 70) | 14.6 ± 18.2 | 30.0 ± 25.5 |
| Coughing: C7D1 (n=115, 52) | 15.9 ± 18.4 | 26.3 ± 23.2 |
| Coughing: C8D1 (n=111, 43) | 13.2 ± 18.7 | 22.5 ± 23.8 |
| Coughing: C9D1 (n=101, 37) | 13.5 ± 18.4 | 25.2 ± 28.8 |
| Coughing: C10D1 (n=94, 33) | 14.2 ± 19.2 | 20.2 ± 26.3 |
| Coughing: C11D1 (n=83, 25) | 12.9 ± 20.7 | 18.7 ± 25.6 |
| Coughing: C12D1 (n=76, 23) | 14.5 ± 20.6 | 23.2 ± 25.5 |
| Coughing: C13D1 (n=74, 21) | 14.0 ± 21.4 | 27.0 ± 27.1 |
| Coughing: C14D1 (n=66, 19) | 13.1 ± 19.3 | 24.6 ± 31.1 |
| Coughing: C15D1 (n=62, 16) | 11.8 ± 21.0 | 20.8 ± 20.6 |
| Coughing: C16D1 (n=53, 12) | 13.8 ± 19.0 | 22.2 ± 21.7 |
| Coughing: C17D1 (n=47, 11) | 6.4 ± 15.0 | 27.3 ± 25.0 |
| Coughing: C18D1 (n=45, 11) | 13.3 ± 18.0 | 18.2 ± 17.4 |
| Coughing: C19D1 (n=40, 9) | 12.5 ± 18.0 | 14.8 ± 17.6 |
| Coughing: C20D1 (n=35, 8) | 10.5 ± 15.7 | 29.2 ± 21.4 |
| Coughing: C21D1 (n=30, 8) | 13.3 ± 24.1 | 33.3 ± 25.2 |
| Coughing: C22D1 (n=24, 7) | 8.3 ± 14.7 | 28.6 ± 23.0 |
| Coughing: C23D1 (n=23, 4) | 11.6 ± 19.1 | 33.3 ± 0.0 |
| Coughing: C24D1 (n=20, 3) | 8.3 ± 14.8 | 44.4 ± 19.2 |
| Coughing: C25D1 (n=18, 3) | 5.6 ± 12.8 | 44.4 ± 19.2 |
| Coughing: C26D1 (n=14, 3) | 2.4 ± 8.9 | 33.3 ± 0.0 |
| Coughing: C27D1 (n=14, 2) | 7.1 ± 14.2 | 50.0 ± 23.6 |
| Coughing: C28D1 (n=11, 2) | 18.2 ± 31.1 | 50.0 ± 23.6 |
| Coughing: C29D1 (n=8, 2) | 8.3 ± 15.4 | 33.3 ± 0.0 |
| Coughing: C30D1 (n=8, 1) | 20.8 ± 24.8 | 33.3 ± NA |
| Coughing: C31D1 (n=7, 0) | 19.0 ± 17.8 | NA ± NA |
| Coughing: C32D1 (n=6, 0) | 16.7 ± 27.9 | NA ± NA |
| Coughing: C33D1 (n=6, 0) | 11.1 ± 17.2 | NA ± NA |
| Coughing: C34D1 (n=5, 0) | 20.0 ± 29.8 | NA ± NA |
| Coughing: C35D1 (n=4, 0) | 33.3 ± 47.1 | NA ± NA |
| Coughing: C36D1 (n=1, 0) | 33.3 ± NA | NA ± NA |
| Coughing: C37D1 (n=1, 0) | 33.3 ± NA | NA ± NA |
| Coughing: EOT (n=49, 90) | 25.9 ± 23.8 | 37.4 ± 29.1 |
| Hemoptysis: Baseline (n=164, 162) | 2.4 ± 9.5 | 3.7 ± 12.3 |
| Hemoptysis: C2D1 (n=155, 132) | 1.7 ± 7.4 | 3.5 ± 12.5 |
| Hemoptysis: C3D1 (n=153, 106) | 0.9 ± 5.3 | 2.2 ± 8.3 |
| Hemoptysis: C4D1 (n=135, 91) | 1.0 ± 5.7 | 1.5 ± 6.9 |
| Hemoptysis: C5D1 (n=123, 74) | 0.3 ± 3.0 | 0.9 ± 5.4 |
| Hemoptysis: C6D1 (n=119, 70) | 0.6 ± 4.3 | 3.8 ± 14.5 |
| Hemoptysis: C7D1 (n=115, 52) | 0.0 ± 0.0 | 1.3 ± 9.2 |
| Hemoptysis: C8D1 (n=111, 43) | 0.9 ± 7.0 | 2.3 ± 11.3 |
| Hemoptysis: C9D1 (n=101, 37) | 0.3 ± 3.3 | 2.7 ± 12.1 |
| Hemoptysis: C10D1 (n=94, 33) | 0.4 ± 3.4 | 3.0 ± 17.4 |
| Hemoptysis: C11D1 (n=83, 25) | 2.4 ± 11.4 | 4.0 ± 14.7 |
| Hemoptysis: C12D1 (n=76, 23) | 0.9 ± 5.4 | 5.8 ± 21.7 |
| Hemoptysis: C13D1 (n=74, 21) | 2.3 ± 10.1 | 4.8 ± 15.9 |
| Hemoptysis: C14D1 (n=66, 19) | 0.5 ± 4.1 | 0.0 ± 0.0 |
| Hemoptysis: C15D1 (n=62, 16) | 1.1 ± 5.9 | 0.0 ± 0.0 |
| Hemoptysis: C16D1 (n=53, 12) | 0.6 ± 4.6 | 5.6 ± 13.0 |
| Hemoptysis: C17D1 (n=47, 11) | 0.0 ± 0.0 | 9.1 ± 21.6 |
| Hemoptysis: C18D1 (n=45, 11) | 1.5 ± 6.9 | 3.0 ± 10.1 |
| Hemoptysis: C19D1 (n=40, 9) | 0.0 ± 0.0 | 3.7 ± 11.1 |
| Hemoptysis: C20D1 (n=35, 8) | 1.0 ± 5.6 | 8.3 ± 15.4 |
| Hemoptysis: C21D1 (n=30, 8) | 0.0 ± 0.0 | 4.2 ± 11.8 |
| Hemoptysis: C22D1 (n=24, 7) | 0.0 ± 0.0 | 9.5 ± 16.3 |
| Hemoptysis: C23D1 (n=23, 4) | 1.4 ± 7.0 | 0.0 ± 0.0 |
| Hemoptysis: C24D1 (n=20, 3) | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Hemoptysis: C25D1 (n=18, 3) | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Hemoptysis: C26D1 (n=14, 3) | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Hemoptysis: C27D1 (n=14, 2) | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Hemoptysis: C28D1 (n=11, 2) | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Hemoptysis: C29D1 (n=8, 2) | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Hemoptysis: C30D1 (n=8, 1) | 0.0 ± 0.0 | 0.0 ± NA |
| Hemoptysis: C31D1 (n=7, 0) | 0.0 ± 0.0 | NA ± NA |
| Hemoptysis: C32D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Hemoptysis: C33D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Hemoptysis: C34D1 (n=5, 0) | 0.0 ± 0.0 | NA ± NA |
| Hemoptysis: C35D1 (n=4, 0) | 0.0 ± 0.0 | NA ± NA |
| Hemoptysis: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Hemoptysis: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Hemoptysis: EOT (n=49, 90) | 0.7 ± 4.8 | 4.8 ± 13.7 |
| Sore Mouth: Baseline (n=164, 162) | 5.5 ± 15.3 | 6.4 ± 18.4 |
| Sore Mouth: C2D1 (n=155, 132) | 8.0 ± 17.9 | 9.1 ± 18.5 |
| Sore Mouth: C3D1 (n=153, 106) | 7.0 ± 14.6 | 9.4 ± 21.0 |
| Sore Mouth: C4D1 (n=135, 91) | 8.1 ± 16.5 | 10.3 ± 21.5 |
| Sore Mouth: C5D1 (n=123, 73) | 5.1 ± 12.1 | 9.6 ± 20.4 |
| Sore Mouth: C6D1 (n=119, 70) | 4.8 ± 13.9 | 10.5 ± 19.3 |
| Sore Mouth: C7D1 (n=115, 52) | 5.2 ± 15.0 | 7.7 ± 15.6 |
| Sore Mouth: C8D1 (n=111, 43) | 3.0 ± 9.6 | 10.9 ± 18.9 |
| Sore Mouth: C9D1 (n=101, 37) | 4.8 ± 12.5 | 10.8 ± 22.3 |
| Sore Mouth: C10D1 (n=94, 33) | 6.4 ± 14.9 | 12.1 ± 23.3 |
| Sore Mouth: C11D1 (n=84, 25) | 4.8 ± 14.8 | 9.3 ± 18.1 |
| Sore Mouth: C12D1 (n=76, 23) | 3.9 ± 12.1 | 8.7 ± 18.0 |
| Sore Mouth: C13D1 (n=74, 21) | 4.5 ± 12.7 | 9.5 ± 15.4 |
| Sore Mouth: C14D1 (n=66, 19) | 4.5 ± 12.9 | 7.0 ± 14.0 |
| Sore Mouth: C15D1 (n=62, 16) | 5.4 ± 12.4 | 14.6 ± 29.7 |
| Sore Mouth: C16D1 (n=53, 12) | 6.3 ± 14.7 | 8.3 ± 15.1 |
| Sore Mouth: C17D1 (n=47, 11) | 3.5 ± 10.4 | 6.1 ± 13.5 |
| Sore Mouth: C18D1 (n=45, 11) | 5.2 ± 12.2 | 12.1 ± 16.8 |
| Sore Mouth: C19D1 (n=40, 9) | 4.2 ± 11.2 | 7.4 ± 14.7 |
| Sore Mouth: C20D1 (n=35, 8) | 7.6 ± 16.3 | 12.5 ± 24.8 |
| Sore Mouth: C21D1 (n=30, 8) | 4.4 ± 11.5 | 4.2 ± 11.8 |
| Sore Mouth: C22D1 (n=24, 7) | 5.6 ± 12.7 | 7.1 ± 13.1 |
| Sore Mouth: C23D1 (n=23, 4) | 5.1 ± 11.7 | 16.7 ± 19.2 |
| Sore Mouth: C24D1 (n=20, 3) | 6.7 ± 17.4 | 0.0 ± 0.0 |
| Sore Mouth: C25D1 (n=18, 3) | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Sore Mouth: C26D1 (n=14, 3) | 4.8 ± 17.8 | 11.1 ± 19.2 |
| Sore Mouth: C27D1 (n=14, 2) | 7.1 ± 19.3 | 16.7 ± 23.6 |
| Sore Mouth: C28D1 (n=11, 2) | 6.1 ± 20.1 | 0.0 ± 0.0 |
| Sore Mouth: C29D1 (n=8, 2) | 8.3 ± 15.4 | 16.7 ± 23.6 |
| Sore Mouth: C30D1 (n=8, 1) | 8.3 ± 23.6 | 0.0 ± NA |
| Sore Mouth: C31D1 (n=7, 0) | 9.5 ± 25.2 | NA ± NA |
| Sore Mouth: C32D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Sore Mouth: C33D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Sore Mouth: C34D1 (n=5, 0) | 0.0 ± 0.0 | NA ± NA |
| Sore Mouth: C35D1 (n=4, 0) | 0.0 ± 0.0 | NA ± NA |
| Sore Mouth: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Sore Mouth: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Sore Mouth: EOT (n=49, 90) | 3.4 ± 10.2 | 8.1 ± 18.2 |
| Dysphagia: Baseline (n=164, 162) | 7.1 ± 16.4 | 8.6 ± 20.9 |
| Dysphagia: C2D1 (n=155, 132) | 8.2 ± 15.4 | 9.8 ± 19.2 |
| Dysphagia: C3D1 (n=153, 106) | 7.6 ± 16.4 | 9.7 ± 20.6 |
| Dysphagia: C4D1 (n=135, 91) | 6.2 ± 15.3 | 8.1 ± 19.5 |
| Dysphagia: C5D1 (n=123, 74) | 6.0 ± 14.8 | 7.7 ± 17.0 |
| Dysphagia: C6D1 (n=119, 70) | 7.0 ± 15.0 | 10.0 ± 16.4 |
| Dysphagia: C7D1 (n=115, 52) | 4.1 ± 11.8 | 5.1 ± 13.8 |
| Dysphagia: C8D1 (n=111, 43) | 3.2 ± 11.1 | 6.2 ± 15.0 |
| Dysphagia: C9D1 (n=101, 37) | 5.0 ± 11.9 | 7.2 ± 16.0 |
| Dysphagia: C10D1 (n=94, 33) | 4.3 ± 12.2 | 6.1 ± 13.1 |
| Dysphagia: C11D1 (n=84, 25) | 3.2 ± 9.8 | 4.0 ± 11.1 |
| Dysphagia: C12D1 (n=76, 23) | 3.5 ± 10.3 | 7.2 ± 17.3 |
| Dysphagia: C13D1 (n=74, 21) | 4.1 ± 11.0 | 6.3 ± 13.4 |
| Dysphagia: C14D1 (n=66, 19) | 3.0 ± 11.3 | 7.0 ± 14.0 |
| Dysphagia: C15D1 (n=62, 16) | 3.8 ± 13.6 | 4.2 ± 16.7 |
| Dysphagia: C16D1 (n=53, 12) | 4.4 ± 11.4 | 2.8 ± 9.6 |
| Dysphagia: C17D1 (n=47, 11) | 2.8 ± 9.4 | 6.1 ± 13.5 |
| Dysphagia: C18D1 (n=45, 11) | 3.7 ± 10.6 | 3.0 ± 10.1 |
| Dysphagia: C19D1 (n=40, 9) | 4.2 ± 11.2 | 0.0 ± 0.0 |
| Dysphagia: C20D1 (n=35, 8) | 4.8 ± 14.3 | 8.3 ± 15.4 |
| Dysphagia: C21D1 (n=30, 8) | 3.3 ± 10.2 | 8.3 ± 15.4 |
| Dysphagia: C22D1 (n=24, 7) | 2.8 ± 9.4 | 0.0 ± 0.0 |
| Dysphagia: C23D1 (n=23, 4) | 2.9 ± 9.6 | 8.3 ± 16.7 |
| Dysphagia: C24D1 (n=20, 3) | 5.0 ± 22.4 | 0.0 ± 0.0 |
| Dysphagia: C25D1 (n=18, 3) | 0.0 ± 0.0 | 11.1 ± 19.2 |
| Dysphagia: C26D1 (n=14, 3) | 9.5 ± 27.5 | 11.1 ± 19.2 |
| Dysphagia: C27D1 (n=14, 2) | 2.4 ± 8.9 | 16.7 ± 23.6 |
| Dysphagia: C28D1 (n=11, 2) | 6.1 ± 13.5 | 16.7 ± 23.6 |
| Dysphagia: C29D1 (n=8, 2) | 8.3 ± 15.4 | 16.7 ± 23.6 |
| Dysphagia: C30D1 (n=8, 1) | 0.0 ± 0.0 | 33.3 ± NA |
| Dysphagia: C31D1 (n=7, 0) | 4.8 ± 12.6 | NA ± NA |
| Dysphagia: C32D1 (n=6, 0) | 5.6 ± 13.6 | NA ± NA |
| Dysphagia: C33D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Dysphagia: C34D1 (n=5, 0) | 6.7 ± 14.9 | NA ± NA |
| Dysphagia: C35D1 (n=4, 0) | 8.3 ± 16.7 | NA ± NA |
| Dysphagia: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Dysphagia: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Dysphagia: EOT (n=49, 90) | 4.8 ± 13.6 | 8.5 ± 19.7 |
| Peripheral Neuropathy: Baseline (n=164, 162) | 14.0 ± 22.1 | 17.7 ± 27.3 |
| Peripheral Neuropathy: C2D1 (n=155, 132) | 18.1 ± 24.1 | 21.5 ± 29.2 |
| Peripheral Neuropathy: C3D1 (n=153, 106) | 17.6 ± 26.2 | 18.2 ± 29.1 |
| Peripheral Neuropathy: C4D1 (n=134, 91) | 15.9 ± 23.0 | 21.6 ± 27.8 |
| Peripheral Neuropathy: C5D1 (n=123, 74) | 15.2 ± 21.0 | 21.2 ± 28.4 |
| Peripheral Neuropathy: C6D1 (n=119, 70) | 13.7 ± 21.9 | 18.1 ± 27.0 |
| Peripheral Neuropathy: C7D1 (n=115, 52) | 13.0 ± 21.0 | 21.8 ± 28.7 |
| Peripheral Neuropathy: C8D1 (n=111, 43) | 10.8 ± 20.2 | 24.0 ± 32.8 |
| Peripheral Neuropathy: C9D1 (n=101, 37) | 11.2 ± 19.6 | 29.7 ± 34.1 |
| Peripheral Neuropathy: C10D1 (n=94, 33) | 11.3 ± 21.1 | 27.3 ± 29.4 |
| Peripheral Neuropathy: C11D1 (n=84, 25) | 11.1 ± 21.5 | 24.0 ± 31.2 |
| Peripheral Neuropathy: C12D1 (n=76, 23) | 11.4 ± 22.1 | 33.3 ± 36.2 |
| Peripheral Neuropathy: C13D1 (n=74, 21) | 10.4 ± 19.1 | 33.3 ± 35.0 |
| Peripheral Neuropathy: C14D1 (n=66, 19) | 10.6 ± 21.2 | 29.8 ± 35.0 |
| Peripheral Neuropathy: C15D1 (n=62, 16) | 8.6 ± 18.0 | 25.0 ± 31.0 |
| Peripheral Neuropathy: C16D1 (n=52, 12) | 10.3 ± 19.3 | 25.0 ± 20.7 |
| Peripheral Neuropathy: C17D1 (n=47, 11) | 12.1 ± 23.5 | 27.3 ± 29.1 |
| Peripheral Neuropathy: C18D1 (n=45, 11) | 11.9 ± 22.6 | 30.3 ± 31.5 |
| Peripheral Neuropathy: C19D1 (n=40, 9) | 9.2 ± 20.0 | 22.2 ± 16.7 |
| Peripheral Neuropathy: C20D1 (n=35, 8) | 12.4 ± 25.7 | 33.3 ± 30.9 |
| Peripheral Neuropathy: C21D1 (n=30, 8) | 11.1 ± 18.2 | 29.2 ± 21.4 |
| Peripheral Neuropathy: C22D1 (n=24, 7) | 8.3 ± 20.3 | 28.6 ± 23.0 |
| Peripheral Neuropathy: C23D1 (n=23, 4) | 8.7 ± 20.6 | 41.7 ± 31.9 |
| Peripheral Neuropathy: C24D1 (n=20, 3) | 3.3 ± 14.9 | 44.4 ± 38.5 |
| Peripheral Neuropathy: C25D1 (n=18, 3) | 9.3 ± 19.2 | 44.4 ± 38.5 |
| Peripheral Neuropathy: C26D1 (n=14, 3) | 16.7 ± 36.4 | 22.2 ± 19.2 |
| Peripheral Neuropathy: C27D1 (n=14, 2) | 9.5 ± 20.4 | 66.7 ± 0.0 |
| Peripheral Neuropathy: C28D1 (n=11, 2) | 15.2 ± 22.9 | 33.3 ± 0.0 |
| Peripheral Neuropathy: C29D1 (n=8, 2) | 12.5 ± 24.8 | 50.0 ± 23.6 |
| Peripheral Neuropathy: C30D1 (n=8, 1) | 16.7 ± 30.9 | 33.3 ± NA |
| Peripheral Neuropathy: C31D1 (n=7, 0) | 19.0 ± 32.5 | NA ± NA |
| Peripheral Neuropathy: C32D1 (n=6, 0) | 11.1 ± 27.2 | NA ± NA |
| Peripheral Neuropathy: C33D1 (n=6, 0) | 11.1 ± 27.2 | NA ± NA |
| Peripheral Neuropathy: C34D1 (n=5, 0) | 20.0 ± 44.7 | NA ± NA |
| Peripheral Neuropathy: C35D1 (n=4, 0) | 25.0 ± 50.0 | NA ± NA |
| Peripheral Neuropathy: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Peripheral Neuropathy: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Peripheral Neuropathy: EOT (n=49, 90) | 10.2 ± 16.9 | 21.9 ± 29.6 |
| Alopecia: Baseline (n=163, 162) | 17.4 ± 30.6 | 16.9 ± 29.8 |
| Alopecia: C2D1 (n=155, 132) | 9.5 ± 21.4 | 36.6 ± 39.7 |
| Alopecia: C3D1 (n=153, 106) | 7.6 ± 18.1 | 30.5 ± 36.5 |
| Alopecia: C4D1 (n=135, 91) | 8.9 ± 22.0 | 24.9 ± 32.0 |
| Alopecia: C5D1 (n=123, 74) | 6.0 ± 17.1 | 23.9 ± 31.0 |
| Alopecia: C6D1 (n=118, 70) | 4.2 ± 14.8 | 23.3 ± 32.8 |
| Alopecia: C7D1 (n=115, 52) | 4.9 ± 14.1 | 19.9 ± 30.4 |
| Alopecia: C8D1 (n=111, 43) | 3.9 ± 11.7 | 18.6 ± 28.5 |
| Alopecia: C9D1 (n=101, 37) | 4.0 ± 11.8 | 16.2 ± 23.1 |
| Alopecia: C10D1 (n=94, 33) | 4.6 ± 14.3 | 14.1 ± 22.1 |
| Alopecia: C11D1 (n=84, 25) | 4.0 ± 15.0 | 16.0 ± 21.8 |
| Alopecia: C12D1 (n=76, 23) | 4.4 ± 14.7 | 20.3 ± 26.1 |
| Alopecia: C13D1 (n=74, 21) | 6.3 ± 18.0 | 12.7 ± 19.7 |
| Alopecia: C14D1 (n=65, 19) | 3.6 ± 14.6 | 15.8 ± 23.2 |
| Alopecia: C15D1 (n=62, 16) | 4.8 ± 16.9 | 8.3 ± 19.2 |
| Alopecia: C16D1 (n=53, 12) | 6.3 ± 18.6 | 13.9 ± 22.3 |
| Alopecia: C17D1 (n=46, 11) | 5.1 ± 17.2 | 18.2 ± 22.9 |
| Alopecia: C18D1 (n=45, 11) | 3.7 ± 12.8 | 18.2 ± 22.9 |
| Alopecia: C19D1 (n=40, 9) | 5.8 ± 19.8 | 18.5 ± 24.2 |
| Alopecia: C20D1 (n=35, 8) | 3.8 ± 13.5 | 25.0 ± 23.6 |
| Alopecia: C21D1 (n=30, 8) | 7.8 ± 22.6 | 16.7 ± 25.2 |
| Alopecia: C22D1 (n=24, 7) | 2.8 ± 9.4 | 14.3 ± 17.8 |
| Alopecia: C23D1 (n=23, 3) | 1.4 ± 7.0 | 22.2 ± 19.2 |
| Alopecia: C24D1 (n=20, 3) | 6.7 ± 23.2 | 33.3 ± 33.3 |
| Alopecia: C25D1 (n=18, 3) | 9.3 ± 27.5 | 33.3 ± 33.3 |
| Alopecia: C26D1 (n=14, 3) | 7.1 ± 26.7 | 44.4 ± 38.5 |
| Alopecia: C27D1 (n=14, 2) | 16.7 ± 36.4 | 33.3 ± 0.0 |
| Alopecia: C28D1 (n=11, 2) | 6.1 ± 20.1 | 50.0 ± 23.6 |
| Alopecia: C29D1 (n=8, 2) | 16.7 ± 35.6 | 33.3 ± 0.0 |
| Alopecia: C30D1 (n=8, 1) | 12.5 ± 35.4 | 33.3 ± NA |
| Alopecia: C31D1 (n=7, 0) | 9.5 ± 25.2 | NA ± NA |
| Alopecia: C32D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Alopecia: C33D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Alopecia: C34D1 (n=5, 0) | 0.0 ± 0.0 | NA ± NA |
| Alopecia: C35D1 (n=4, 0) | 0.0 ± 0.0 | NA ± NA |
| Alopecia: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Alopecia: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Alopecia: EOT (n=49, 90) | 6.8 ± 18.0 | 33.3 ± 37.7 |
| Pain in Chest: Baseline (n=163, 160) | 18.8 ± 22.8 | 24.0 ± 27.5 |
| Pain in Chest: C2D1 (n=155, 132) | 9.5 ± 17.7 | 23.7 ± 25.9 |
| Pain in Chest: C3D1 (n=153, 106) | 7.0 ± 13.6 | 23.3 ± 26.5 |
| Pain in Chest: C4D1 (n=135, 91) | 7.4 ± 13.9 | 19.8 ± 22.8 |
| Pain in Chest: C5D1 (n=123, 74) | 6.8 ± 14.1 | 17.1 ± 21.5 |
| Pain in Chest: C6D1 (n=119, 70) | 6.2 ± 13.0 | 16.2 ± 22.5 |
| Pain in Chest: C7D1 (n=115, 52) | 7.5 ± 14.7 | 16.7 ± 22.4 |
| Pain in Chest: C8D1 (n=111, 43) | 5.1 ± 14.4 | 14.0 ± 20.9 |
| Pain in Chest: C9D1 (n=101, 37) | 5.9 ± 12.8 | 17.1 ± 23.1 |
| Pain in Chest: C10D1 (n=94, 33) | 6.7 ± 14.3 | 18.2 ± 31.3 |
| Pain in Chest: C11D1 (n=84, 25) | 6.3 ± 13.2 | 20.0 ± 25.5 |
| Pain in Chest: C12D1 (n=76, 23) | 5.3 ± 12.2 | 23.2 ± 30.9 |
| Pain in Chest: C13D1 (n=74, 21) | 6.3 ± 13.1 | 23.8 ± 30.1 |
| Pain in Chest: C14D1 (n=66, 19) | 7.6 ± 16.3 | 22.8 ± 22.4 |
| Pain in Chest: C15D1 (n=62, 16) | 5.9 ± 14.2 | 18.7 ± 24.2 |
| Pain in Chest: C16D1 (n=53, 12) | 3.8 ± 10.7 | 16.7 ± 17.4 |
| Pain in Chest: C17D1 (n=46, 11) | 7.2 ± 15.6 | 21.2 ± 22.5 |
| Pain in Chest: C18D1 (n=45, 11) | 5.9 ± 16.3 | 24.2 ± 33.6 |
| Pain in Chest: C19D1 (n=40, 9) | 5.0 ± 14.2 | 18.5 ± 24.2 |
| Pain in Chest: C20D1 (n=35, 8) | 5.7 ± 15.1 | 29.2 ± 21.4 |
| Pain in Chest: C21D1 (n=30, 8) | 5.6 ± 15.4 | 25.0 ± 23.6 |
| Pain in Chest: C22D1 (n=24, 7) | 4.2 ± 11.3 | 26.2 ± 30.2 |
| Pain in Chest: C23D1 (n=23, 4) | 3.6 ± 10.0 | 41.7 ± 31.9 |
| Pain in Chest: C24D1 (n=20, 3) | 1.7 ± 7.5 | 33.3 ± 33.3 |
| Pain in Chest: C25D1 (n=18, 3) | 5.6 ± 12.8 | 33.3 ± 33.3 |
| Pain in Chest: C26D1 (n=14, 3) | 7.1 ± 19.3 | 33.3 ± 33.3 |
| Pain in Chest: C27D1 (n=14, 2) | 4.8 ± 12.1 | 50.0 ± 23.6 |
| Pain in Chest: C28D1 (n=11, 2) | 9.1 ± 15.6 | 50.0 ± 23.6 |
| Pain in Chest: C29D1 (n=8, 2) | 0.0 ± 0.0 | 50.0 ± 23.6 |
| Pain in Chest: C30D1 (n=8, 1) | 4.2 ± 11.8 | 66.7 ± NA |
| Pain in Chest: C31D1 (n=7, 0) | 9.5 ± 16.3 | NA ± NA |
| Pain in Chest: C32D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Pain in Chest: C33D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Pain in Chest: C34D1 (n=5, 0) | 6.7 ± 14.9 | NA ± NA |
| Pain in Chest: C35D1 (n=4, 0) | 8.3 ± 16.7 | NA ± NA |
| Pain in Chest: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Pain in Chest: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Pain in Chest: EOT (n=49, 90) | 17.0 ± 24.6 | 28.5 ± 29.4 |
| Pain in Arm or Shoulder: Baseline (n=164, 161) | 16.3 ± 24.1 | 19.5 ± 28.0 |
| Pain in Arm or Shoulder: C2D1 (n=155, 132) | 9.0 ± 18.3 | 19.9 ± 27.0 |
| Pain in Arm or Shoulder: C3D1 (n=153, 105) | 8.1 ± 14.8 | 17.5 ± 24.5 |
| Pain in Arm or Shoulder: C4D1 (n=135, 91) | 6.9 ± 15.3 | 14.3 ± 22.3 |
| Pain in Arm or Shoulder: C5D1 (n=123, 74) | 6.2 ± 15.0 | 13.1 ± 21.9 |
| Pain in Arm or Shoulder: C6D1 (n=119, 70) | 6.7 ± 14.1 | 17.1 ± 25.8 |
| Pain in Arm or Shoulder: C7D1 (n=115, 52) | 6.4 ± 13.2 | 17.3 ± 23.3 |
| Pain in Arm or Shoulder: C8D1 (n=111, 43) | 6.9 ± 14.3 | 20.2 ± 28.3 |
| Pain in Arm or Shoulder: C9D1 (n=101, 37) | 5.6 ± 12.5 | 23.4 ± 28.2 |
| Pain in Arm or Shoulder: C10D1 (n=94, 33) | 7.4 ± 17.0 | 25.3 ± 32.3 |
| Pain in Arm or Shoulder: C11D1 (n=84, 25) | 6.0 ± 14.8 | 24.0 ± 26.4 |
| Pain in Arm or Shoulder: C12D1 (n=76, 23) | 6.6 ± 15.4 | 29.0 ± 35.3 |
| Pain in Arm or Shoulder: C13D1 (n=74, 21) | 5.9 ± 12.8 | 25.4 ± 34.8 |
| Pain in Arm or Shoulder: C14D1 (n=66, 19) | 7.6 ± 18.3 | 29.8 ± 31.2 |
| Pain in Arm or Shoulder: C15D1 (n=62, 16) | 5.4 ± 13.8 | 25.0 ± 25.8 |
| Pain in Arm or Shoulder: C16D1 (n=53, 12) | 5.0 ± 12.0 | 16.7 ± 22.5 |
| Pain in Arm or Shoulder: C17D1 (n=47, 11) | 3.5 ± 10.4 | 21.2 ± 22.5 |
| Pain in Arm or Shoulder: C18D1 (n=45, 11) | 8.1 ± 20.3 | 30.3 ± 34.8 |
| Pain in Arm or Shoulder: C19D1 (n=40, 9) | 6.7 ± 15.5 | 18.5 ± 24.2 |
| Pain in Arm or Shoulder: C20D1 (n=35, 8) | 9.5 ± 22.2 | 25.0 ± 23.6 |
| Pain in Arm or Shoulder: C21D1 (n=30, 8) | 7.8 ± 16.8 | 29.2 ± 27.8 |
| Pain in Arm or Shoulder: C22D1 (n=24, 7) | 2.8 ± 9.4 | 21.4 ± 24.9 |
| Pain in Arm or Shoulder: C23D1 (n=23, 4) | 0.7 ± 3.5 | 33.3 ± 38.5 |
| Pain in Arm or Shoulder: C24D1 (n=20, 3) | 3.3 ± 10.3 | 44.4 ± 38.5 |
| Pain in Arm or Shoulder: C25D1 (n=18, 3) | 1.9 ± 7.9 | 33.3 ± 33.3 |
| Pain in Arm or Shoulder: C26D1 (n=14, 3) | 7.1 ± 19.3 | 22.2 ± 19.2 |
| Pain in Arm or Shoulder: C27D1 (n=14, 2) | 4.8 ± 12.1 | 50.0 ± 23.6 |
| Pain in Arm or Shoulder: C28D1 (n=11, 2) | 0.0 ± 0.0 | 33.3 ± 0.0 |
| Pain in Arm or Shoulder: C29D1 (n=8, 2) | 0.0 ± 0.0 | 66.7 ± 0.0 |
| Pain in Arm or Shoulder: C30D1 (n=8, 1) | 0.0 ± 0.0 | 33.3 ± NA |
| Pain in Arm or Shoulder: C31D1 (n=7, 0) | 0.0 ± 0.0 | NA ± NA |
| Pain in Arm or Shoulder: C32D1 (n=6, 0) | 11.1 ± 17.2 | NA ± NA |
| Pain in Arm or Shoulder: C33D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Pain in Arm or Shoulder: C34D1 (n=5, 0) | 0.0 ± 0.0 | NA ± NA |
| Pain in Arm or Shoulder: C35D1 (n=4, 0) | 0.0 ± 0.0 | NA ± NA |
| Pain in Arm or Shoulder: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Pain in Arm or Shoulder: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Pain in Arm or Shoulder: EOT (n=48, 90) | 11.1 ± 21.0 | 21.9 ± 28.8 |
| Pain in Other Parts: Baseline (n=163, 158) | 23.1 ± 27.3 | 31.4 ± 30.4 |
| Pain in Other Parts: C2D1 (n=153, 125) | 15.0 ± 23.2 | 25.9 ± 28.0 |
| Pain in Other Parts: C3D1 (n=152, 104) | 11.4 ± 20.7 | 21.2 ± 27.1 |
| Pain in Other Parts: C4D1 (n=134, 90) | 12.7 ± 22.7 | 21.5 ± 24.6 |
| Pain in Other Parts: C5D1 (n=123, 73) | 14.4 ± 23.0 | 20.5 ± 27.6 |
| Pain in Other Parts: C6D1 (n=118, 68) | 10.7 ± 18.9 | 18.1 ± 26.0 |
| Pain in Other Parts: C7D1 (n=115, 51) | 11.3 ± 20.7 | 16.3 ± 26.1 |
| Pain in Other Parts: C8D1 (n=111, 42) | 10.5 ± 20.6 | 22.2 ± 30.9 |
| Pain in Other Parts: C9D1 (n=100, 37) | 10.7 ± 21.1 | 24.3 ± 31.1 |
| Pain in Other Parts: C10D1 (n=92, 33) | 9.8 ± 18.8 | 28.3 ± 35.5 |
| Pain in Other Parts: C11D1 (n=83, 25) | 12.4 ± 21.3 | 24.0 ± 29.7 |
| Pain in Other Parts: C12D1 (n=74, 23) | 12.2 ± 20.3 | 24.6 ± 30.5 |
| Pain in Other Parts: C13D1 (n=74, 21) | 10.8 ± 19.2 | 31.7 ± 34.1 |
| Pain in Other Parts: C14D1 (n=66, 19) | 11.6 ± 18.0 | 24.6 ± 29.1 |
| Pain in Other Parts: C15D1 (n=61, 16) | 9.8 ± 15.3 | 25.0 ± 22.8 |
| Pain in Other Parts: C16D1 (n=53, 12) | 10.7 ± 19.4 | 38.9 ± 34.3 |
| Pain in Other Parts: C17D1 (n=46, 11) | 13.8 ± 19.3 | 24.2 ± 21.6 |
| Pain in Other Parts: C18D1 (n=45, 11) | 10.4 ± 19.9 | 33.3 ± 39.4 |
| Pain in Other Parts: C19D1 (n=40, 9) | 14.2 ± 22.5 | 25.9 ± 14.7 |
| Pain in Other Parts: C20D1 (n=35, 8) | 13.3 ± 20.1 | 29.2 ± 21.4 |
| Pain in Other Parts: C21D1 (n=30, 8) | 21.1 ± 27.0 | 29.2 ± 37.5 |
| Pain in Other Parts: C22D1 (n=24, 7) | 12.5 ± 21.6 | 40.5 ± 30.2 |
| Pain in Other Parts: C23D1 (n=23, 4) | 5.1 ± 11.7 | 41.7 ± 31.9 |
| Pain in Other Parts: C24D1 (n=20, 3) | 6.7 ± 17.4 | 11.1 ± 19.2 |
| Pain in Other Parts: C25D1 (n=18, 3) | 9.3 ± 15.4 | 44.4 ± 38.5 |
| Pain in Other Parts: C26D1 (n=14, 3) | 23.8 ± 30.5 | 33.3 ± 33.3 |
| Pain in Other Parts: C27D1 (n=14, 2) | 16.7 ± 31.4 | 50.0 ± 23.6 |
| Pain in Other Parts: C28D1 (n=11, 2) | 6.1 ± 13.5 | 33.3 ± 0.0 |
| Pain in Other Parts: C29D1 (n=8, 2) | 4.2 ± 11.8 | 16.7 ± 23.6 |
| Pain in Other Parts: C30D1 (n=8, 1) | 12.5 ± 17.3 | 33.3 ± NA |
| Pain in Other Parts: C31D1 (n=7, 0) | 9.5 ± 16.3 | NA ± NA |
| Pain in Other Parts: C32D1 (n=6, 0) | 5.6 ± 13.6 | NA ± NA |
| Pain in Other Parts: C33D1 (n=6, 0) | 0.0 ± 0.0 | NA ± NA |
| Pain in Other Parts: C34D1 (n=5, 0) | 6.7 ± 14.9 | NA ± NA |
| Pain in Other Parts: C35D1 (n=4, 0) | 0.0 ± 0.0 | NA ± NA |
| Pain in Other Parts: C36D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Pain in Other Parts: C37D1 (n=1, 0) | 0.0 ± NA | NA ± NA |
| Pain in Other Parts: EOT (n=49, 90) | 18.4 ± 29.7 | 29.6 ± 34.8 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
| units on a scale | Crizotinib | Chemotherapy |
|---|---|---|
| Baseline (n=164, 161) | 64.09 ± 21.04 | 66.76 ± 20.74 |
| C2D1 (n=153, 131) | 69.19 ± 19.42 | 66.33 ± 20.30 |
| C3D1 (n=153, 105) | 73.13 ± 18.97 | 65.84 ± 20.80 |
| C4D1 (n=135, 90) | 73.78 ± 18.25 | 69.13 ± 18.14 |
| C5D1 (n=122, 74) | 75.27 ± 17.99 | 68.12 ± 23.19 |
| C6D1 (n=120, 70) | 75.79 ± 18.67 | 69.71 ± 22.46 |
| C7D1 (n=115, 52) | 77.02 ± 17.34 | 70.63 ± 24.31 |
| C8D1 (n=110, 43) | 74.72 ± 18.09 | 72.30 ± 23.54 |
| C9D1 (n=101, 37) | 74.45 ± 18.32 | 72.27 ± 25.85 |
| C10D1 (n=94, 33) | 75.49 ± 18.18 | 74.27 ± 24.88 |
| C11D1 (n=84, 25) | 76.32 ± 17.00 | 77.24 ± 20.31 |
| C12D1 (n=77, 23) | 76.95 ± 17.63 | 74.83 ± 22.60 |
| C13D1 (n=73, 21) | 76.38 ± 17.50 | 73.00 ± 23.54 |
| C14D1 (n=66, 19) | 78.77 ± 15.54 | 74.11 ± 22.56 |
| C15D1 (n=62, 16) | 77.71 ± 16.78 | 77.44 ± 19.52 |
| C16D1 (n=53, 12) | 75.32 ± 16.21 | 79.00 ± 13.28 |
| C17D1 (n=47, 11) | 75.09 ± 17.68 | 81.73 ± 15.98 |
| C18D1 (n=45, 11) | 75.87 ± 16.63 | 78.91 ± 16.25 |
| C19D1 (n=40, 9) | 76.85 ± 16.39 | 78.00 ± 14.04 |
| C20D1 (n=35, 8) | 72.66 ± 19.81 | 76.75 ± 17.65 |
| C21D1 (n=30, 8) | 74.13 ± 16.19 | 73.63 ± 19.41 |
| C22D1 (n=24, 7) | 77.54 ± 17.54 | 72.21 ± 19.79 |
| C23D1 (n=23, 4) | 75.48 ± 17.75 | 54.00 ± 16.35 |
| C24D1 (n=20, 3) | 71.40 ± 23.15 | 62.00 ± 20.30 |
| C25D1 (n=18, 3) | 75.61 ± 15.97 | 63.67 ± 22.59 |
| C26D1 (n=14, 3) | 72.14 ± 20.71 | 63.00 ± 17.52 |
| C27D1 (n=14, 2) | 66.57 ± 16.96 | 50.00 ± 14.14 |
| C28D1 (n=11, 2) | 72.36 ± 12.72 | 55.00 ± 21.21 |
| C29D1 (n=8, 2) | 71.38 ± 12.28 | 45.00 ± 14.14 |
| C30D1 (n=8, 1) | 69.50 ± 17.00 | 40.00 ± NA |
| C31D1 (n=7, 0) | 68.57 ± 16.76 | NA ± NA |
| C32D1 (n=6, 0) | 65.83 ± 19.41 | NA ± NA |
| C33D1 (n=6, 0) | 67.50 ± 20.34 | NA ± NA |
| C34D1 (n=5, 0) | 68.00 ± 20.80 | NA ± NA |
| C35D1 (n=4, 0) | 72.25 ± 14.84 | NA ± NA |
| C36D1 (n=1, 0) | 90.00 ± NA | NA ± NA |
| C37D1 (n=1, 0) | 85.00 ± NA | NA ± NA |
| EOT (n=49, 90) | 68.33 ± 21.25 | 58.34 ± 23.71 |
Collected over Active reporting period is from the time of informed consent until at least 28 days after the last dose of study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Crizotinib | — | 80/172 (46.5%) | 172/172 (100%) |
| Chemotherapy | — | 42/171 (24.6%) | 169/171 (98.8%) |
| Event | Crizotinib | Chemotherapy |
|---|---|---|
| Disease progressionGeneral disorders | 18/172 | 3/171 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/172 | 12/171 |
| PneumoniaInfections and infestations | 8/172 | 3/171 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 7/172 | 3/171 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 6/172 | 2/171 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/172 | 3/171 |
| VomitingGastrointestinal disorders | 3/172 | 0/171 |
| Alanine aminotransferase increasedInvestigations | 3/172 | 0/171 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 3/172 | 0/171 |
| AnaemiaBlood and lymphatic system disorders | 2/172 | 2/171 |
| Event | Crizotinib | Chemotherapy |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 106/172 | 34/171 |
| NauseaGastrointestinal disorders | 104/172 | 60/171 |
| VomitingGastrointestinal disorders | 88/172 | 32/171 |
| ConstipationGastrointestinal disorders | 83/172 | 39/171 |
| Visual impairmentEye disorders | 74/172 | 8/171 |
| Alanine aminotransferase increasedInvestigations | 72/172 | 21/171 |
| FatigueGeneral disorders | 51/172 | 60/171 |
| Oedema peripheralGeneral disorders | 59/172 | 15/171 |
| Decreased appetiteMetabolism and nutrition disorders | 56/172 | 46/171 |
| Aspartate aminotransferase increasedInvestigations | 55/172 | 17/171 |
Full analysis set (FAS) included all participants who were randomized to study treatment.
| Age, Continuous(years) | Crizotinib | Chemotherapy | Total |
|---|---|---|---|
| Mean | 50.3 ± 13.1 | 49.8 ± 13.0 | 50.0 ± 13.0 |
| Gender(Participants) | Crizotinib | Chemotherapy | Total |
|---|---|---|---|
| Female | 98 | 95 | 193 |
| Male | 75 | 79 | 154 |
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Carcinoma, Non-Small-Cell Lung→
Pfizer