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An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

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ClinicalTrials.gov Identifier: NCT00932893
Recruitment Status : Completed
First Posted : July 3, 2009
Results First Posted : June 6, 2013
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: PF-02341066
Drug: Pemetrexed
Drug: Docetaxel
Enrollment 347
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Pemetrexed 500 mg per square meter (mg/m^2) intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Period Title: Overall Study
Started 173 174
Treated 172 171
Completed 40 4
Not Completed 133 170
Reason Not Completed
Death             115             24
Lost to Follow-up             8             0
Withdrawal by Subject             5             2
Other             5             144
Arm/Group Title Crizotinib Chemotherapy Total
Hide Arm/Group Description Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Total of all reporting groups
Overall Number of Baseline Participants 173 174 347
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who were randomized to study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 173 participants 174 participants 347 participants
50.3  (13.1) 49.8  (13.0) 50.0  (13.0)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 174 participants 347 participants
Female
98
  56.6%
95
  54.6%
193
  55.6%
Male
75
  43.4%
79
  45.4%
154
  44.4%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who were randomized to study treatment.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 173 174
Median (95% Confidence Interval)
Unit of Measure: months
7.7
(6.0 to 8.8)
3.0
(2.6 to 4.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crizotinib, Chemotherapy
Comments P-value was obtained from 1-sided log-rank test stratified by Eastern Cooperative Oncology Group performance status (ECOG PS) score, brain metastases, and prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment. The hazard ratio and corresponding 95% confidence interval (CI) from the stratified Cox Proportional Hazards model were also presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments To control family-wise Type 1 error, a step-down procedure was applied in following order: PFS, objective response rate (ORR), overall survival (OS), and disease control rate (DCR). Statistical significance: 1-sided at alpha=0.025.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.487
Confidence Interval 95%
0.371 to 0.638
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 173 174
Median (95% Confidence Interval)
Unit of Measure: months
21.7
(18.9 to 30.5)
21.9
(16.8 to 26.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crizotinib, Chemotherapy
Comments P-value was obtained from 1-sided log-rank test stratified by ECOG PS score, brain metastases, and prior EGFR TKI treatment. The hazard ratio and corresponding 95% CI from the stratified Cox proportional hazards model were also presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1145
Comments Statistical significance: 1-sided at alpha=0.025
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.854
Confidence Interval 95%
0.661 to 1.104
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival Probability at Months 6 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 173 174
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent chance of survival
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)
4.Secondary Outcome
Title Percentage of Participants With Objective Response (OR)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 173 174
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65.3
(57.7 to 72.4)
19.5
(13.9 to 26.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crizotinib, Chemotherapy
Comments P-value was obtained from Cochran-Mantel-Haenszel (CMH) test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical significance: 2-sided at alpha=0.025.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 3.394
Confidence Interval 95%
2.463 to 4.676
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Disease Control at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 173 174
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.5
(74.9 to 87.0)
55.2
(47.5 to 62.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crizotinib, Chemotherapy
Comments P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical significance: 2-sided at alpha=0.0004.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.502
Confidence Interval 95%
1.297 to 1.741
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Disease Control at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 173 174
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64.2
(56.5 to 71.3)
38.5
(31.2 to 46.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crizotinib, Chemotherapy
Comments P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical significance: 2-sided at alpha=0.0004.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.697
Confidence Interval (2-Sided) 95%
1.368 to 2.103
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Duration of Response (DR)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 113 34
Median (95% Confidence Interval)
Unit of Measure: weeks
32.1
(26.4 to 42.3)
24.4
(15 to 36)
8.Secondary Outcome
Title Time to Tumor Response (TTR)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 113 34
Median (Full Range)
Unit of Measure: weeks
6.3
(4.4 to 48.4)
12.6
(5 to 37.1)
9.Secondary Outcome
Title Plasma Concentration of Crizotinib
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants evaluable for this measure. n=participants evaluable at specific time points.
Arm/Group Title Crizotinib
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 152
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Cycle 1 Day 1 (n=15) NA [1]   (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)
[1]
Data was not summarized since none of the participants had Ctrough values above lower limit of quantification (LLOQ).
10.Secondary Outcome
Title Number of Participants With Categorical Maximum QTcF for Crizotinib
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ECG-evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline ECG measurement.
Arm/Group Title Crizotinib
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 155
Measure Type: Number
Unit of Measure: participants
<450 msec 137
450 msec to <480 msec 9
480 msec to <500 msec 1
>=500 msec 8
11.Secondary Outcome
Title Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The soluble biomarker-evaluable population includes patients from the SA population that received PF-02341066, who have an optional blood sample prior to dosing on Cycle 1 Day 1 and have at least 1 on-treatment soluble biomarker evaluation (Cycle 2 Day 1 and/or end of treatment).
Arm/Group Title Overall Values
Hide Arm/Group Description:
Overall assessment for complete response, partial response, stable disease, progressive disease and early death
Overall Number of Participants Analyzed 172
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
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)
12.Secondary Outcome
Title Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Patient Reported Outcome (PRO) evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline PRO assessment.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 162 151
Median (95% Confidence Interval)
Unit of Measure: months
4.5
(3.0 to 6.9)
1.4
(1.0 to 1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crizotinib, Chemotherapy
Comments The p-value was obtained from 2-sided unstratified log-rank test. The hazard ratio and corresponding 95% CI from the Cox Proportional Hazards model were also presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.497
Confidence Interval 95%
0.373 to 0.661
Estimation Comments [Not Specified]
13.Secondary Outcome
Title European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 165 163
Mean (Standard Deviation)
Unit of Measure: units on a scale
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 [1]   (NA)
Global QoL: C31D1 (n=7, 0) 64.3  (17.2) NA [2]   (NA)
Global QoL: C32D1 (n=6, 0) 59.7  (17.0) NA [2]   (NA)
Global QoL: C33D1 (n=6, 0) 66.7  (18.3) NA [2]   (NA)
Global QoL: C34D1 (n=5, 0) 68.3  (14.9) NA [2]   (NA)
Global QoL: C35D1 (n=4, 0) 60.4  (22.9) NA [2]   (NA)
Global QoL: C36D1 (n=1, 0) 66.7 [1]   (NA) NA [2]   (NA)
Global QoL: C37D1 (n=1, 0) 66.7 [1]   (NA) NA [2]   (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 [1]   (NA)
Physical Functioning: C31D1 (n=7, 0) 83.8  (17.2) NA [2]   (NA)
Physical Functioning: C32D1 (n=6, 0) 88.9  (9.1) NA [2]   (NA)
Physical Functioning: C33D1 (n=6, 0) 90.0  (7.0) NA [2]   (NA)
Physical Functioning: C34D1 (n=5, 0) 85.3  (7.3) NA [2]   (NA)
Physical Functioning: C35D1 (n=4, 0) 91.7  (3.3) NA [2]   (NA)
Physical Functioning: C36D1 (n=1, 0) 86.7 [1]   (NA) NA [2]   (NA)
Physical Functioning: C37D1 (n=1, 0) 86.7 [1]   (NA) NA [2]   (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 [1]   (NA)
Role Functioning: C31D1 (n=7, 0) 71.4  (36.9) NA [2]   (NA)
Role Functioning: C32D1 (n=6, 0) 86.1  (12.5) NA [2]   (NA)
Role Functioning: C33D1 (n=6, 0) 88.9  (13.6) NA [2]   (NA)
Role Functioning: C34D1 (n=5, 0) 96.7  (7.5) NA [2]   (NA)
Role Functioning: C35D1 (n=4, 0) 91.7  (16.7) NA [2]   (NA)
Role Functioning: C36D1 (n=1, 0) 100.0 [1]   (NA) NA [2]   (NA)
Role Functioning: C37D1 (n=1, 0) 100.0 [1]   (NA) NA [2]   (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 [1]   (NA)
Emotional Functioning: C31D1 (n=7, 0) 76.2  (28.2) NA [2]   (NA)
Emotional Functioning: C32D1 (n=6, 0) 87.5  (17.3) NA [2]   (NA)
Emotional Functioning: C33D1 (n=6, 0) 90.3  (13.4) NA [2]   (NA)
Emotional Functioning: C34D1 (n=5, 0) 91.7  (14.4) NA [2]   (NA)
Emotional Functioning: C35D1 (n=4, 0) 83.3  (20.4) NA [2]   (NA)
Emotional Functioning: C36D1 (n=1, 0) 58.3 [1]   (NA) NA [2]   (NA)
Emotional Functioning: C37D1 (n=1, 0) 58.3 [1]   (NA) NA [2]   (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 [1]   (NA)
Cognitive Functioning: C31D1 (n=7, 0) 81.0  (20.2) NA [2]   (NA)
Cognitive Functioning: C32D1 (n=6, 0) 83.3  (18.3) NA [2]   (NA)
Cognitive Functioning: C33D1 (n=6, 0) 86.1  (16.4) NA [2]   (NA)
Cognitive Functioning: C34D1 (n=5, 0) 90.0  (9.1) NA [2]   (NA)
Cognitive Functioning: C35D1 (n=4, 0) 95.8  (8.3) NA [2]   (NA)
Cognitive Functioning: C36D1 (n=1, 0) 100.0 [1]   (NA) NA [2]   (NA)
Cognitive Functioning: C37D1 (n=1, 0) 83.3 [1]   (NA) NA [2]   (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 [1]   (NA)
Social Functioning: C31D1 (n=7, 0) 73.8  (38.3) NA [2]   (NA)
Social Functioning: C32D1 (n=6, 0) 83.3  (18.3) NA [2]   (NA)
Social Functioning: C33D1 (n=6, 0) 94.4  (13.6) NA [2]   (NA)
Social Functioning: C34D1 (n=5, 0) 96.7  (7.5) NA [2]   (NA)
Social Functioning: C35D1 (n=4, 0) 91.7  (16.7) NA [2]   (NA)
Social Functioning: C36D1 (n=1, 0) 66.7 [1]   (NA) NA [2]   (NA)
Social Functioning: C37D1 (n=1, 0) 66.7 [1]   (NA) NA [2]   (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 [1]   (NA)
Fatigue: C31D1 (n=7, 0) 28.6  (16.8) NA [2]   (NA)
Fatigue: C32D1 (n=6, 0) 25.9  (5.7) NA [1]   (NA)
Fatigue: C33D1 (n=6, 0) 18.5  (11.5) NA [2]   (NA)
Fatigue: C34D1 (n=5, 0) 15.6  (16.9) NA [2]   (NA)
Fatigue: C35D1 (n=4, 0) 27.8  (14.3) NA [2]   (NA)
Fatigue: C36D1 (n=1, 0) 33.3 [1]   (NA) NA [2]   (NA)
Fatigue: C37D1 (n=1, 0) 11.1 [1]   (NA) NA [2]   (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 [1]   (NA)
Nausea and Vomiting: C31D1 (n=7, 0) 14.3  (17.8) NA [2]   (NA)
Nausea and Vomiting: C32D1 (n=6, 0) 11.1  (17.2) NA [2]   (NA)
Nausea and Vomiting: C33D1 (n=6, 0) 11.1  (17.2) NA [2]   (NA)
Nausea and Vomiting: C34D1 (n=5, 0) 13.3  (18.3) NA [2]   (NA)
Nausea and Vomiting: C35D1 (n=4, 0) 12.5  (16.0) NA [2]   (NA)
Nausea and Vomiting: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (NA)
Nausea and Vomiting: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (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 [1]   (NA)
Pain: C31D1 (n=7, 0) 4.8  (8.1) NA [2]   (NA)
Pain: C32D1 (n=6, 0) 5.6  (8.6) NA [2]   (NA)
Pain: C33D1 (n=6, 0) 2.8  (6.8) NA [2]   (NA)
Pain: C34D1 (n=5, 0) 3.3  (7.5) NA [2]   (NA)
Pain: C35D1 (n=4, 0) 8.3  (16.7) NA [2]   (NA)
Pain: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (NA)
Pain: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (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 [1]   (NA)
Dyspnea: C31D1 (n=7, 0) 9.5  (16.3) NA [2]   (NA)
Dyspnea: C32D1 (n=6, 0) 16.7  (18.3) NA [2]   (NA)
Dyspnea: C33D1 (n=6, 0) 11.1  (17.2) NA [2]   (NA)
Dyspnea: C34D1 (n=5, 0) 13.3  (18.3) NA [2]   (NA)
Dyspnea: C35D1 (n=4, 0) 16.7  (19.2) NA [2]   (NA)
Dyspnea: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (NA)
Dyspnea: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (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 [1]   (NA)
Insomnia : C31D1 (n=7, 0) 0.0  (0.0) NA [2]   (NA)
Insomnia : C32D1 (n=6, 0) 5.6  (13.6) NA [2]   (NA)
Insomnia : C33D1 (n=6, 0) 5.6  (13.6) NA [2]   (NA)
Insomnia : C34D1 (n=5, 0) 13.3  (18.3) NA [2]   (NA)
Insomnia : C35D1 (n=4, 0) 16.7  (19.2) NA [2]   (NA)
Insomnia : C36D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (NA)
Insomnia : C37D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (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 [1]   (NA)
Appetite loss : C31/D1(n=7, 0) 14.3  (17.8) NA [2]   (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 [1]   (NA)
Constipation: C31D1 (n=7, 0) 33.3  (27.2) NA [2]   (NA)
Constipation: C32D1 (n=6, 0) 33.3  (42.2) NA [2]   (NA)
Constipation: C33D1 (n=6, 0) 38.9  (25.1) NA [2]   (NA)
Constipation: C34D1 (n=5, 0) 40.0  (43.5) NA [2]   (NA)
Constipation: C35D1 (n=4, 0) 33.3  (27.2) NA [2]   (NA)
Constipation: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (NA)
Constipation: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (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 [1]   (NA)
Diarrhea: C31D1 (n=7, 0) 14.3  (17.8) NA [2]   (NA)
Diarrhea: C32D1 (n=6, 0) 11.1  (17.2) NA [2]   (NA)
Diarrhea: C33D1 (n=6, 0) 11.1  (17.2) NA [2]   (NA)
Diarrhea: C34D1 (n=5, 0) 6.7  (14.9) NA [2]   (NA)
Diarrhea: C35D1 (n=4, 0) 16.7  (19.2) NA [2]   (NA)
Diarrhea: C36D1 (n=1, 0) 33.3 [1]   (NA) NA [2]   (NA)
Diarrhea: C37D1 (n=1, 0) 33.3 [1]   (NA) NA [2]   (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 [1]   (NA)
Financial Difficulties: C31D1 (n=7, 0) 9.5  (16.3) NA [2]   (NA)
Financial Difficulties: C32D1 (n=6, 0) 22.2  (27.2) NA [2]   (NA)
Financial Difficulties: C33D1 (n=6, 0) 16.7  (27.9) NA [2]   (NA)
Financial Difficulties: C34D1 (n=5, 0) 13.3  (18.3) NA [2]   (NA)
Financial Difficulties: C35D1 (n=4, 0) 8.3  (16.7) NA [2]   (NA)
Financial Difficulties: C36D1 (n=1, 0) 33.3 [1]   (NA) NA [2]   (NA)
Financial Difficulties: C37D1 (n=1, 0) 66.7 [1]   (NA) NA [2]   (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 [2]   (NA)
Appetite loss: C33D1 (n=6, 0) 11.1  (17.2) NA [2]   (NA)
Appetite loss: C34D1 (n=5, 0) 13.3  (18.3) NA [2]   (NA)
Appetite loss: C35D1 (n=4, 0) 16.7  (19.2) NA [2]   (NA)
Appetite loss: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (NA)
Appetite loss: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [2]   (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)
[1]
Standard deviation was not estimable since only one participant was evaluable.
[2]
Data was not analyzed as no participants were evaluable.
14.Secondary Outcome
Title European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 164 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
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 [1]   (NA)
Dyspnea: C31D1 (n=7, 0) 15.9  (8.7) NA [2]   (NA)
Dyspnea: C32D1 (n=6, 0) 18.5  (9.1) NA [2]   (NA)
Dyspnea: C33D1 (n=6, 0) 18.5  (9.1) NA [2]   (NA)
Dyspnea: C34D1 (n=5, 0) 20.0  (5.0) NA [2]   (NA)
Dyspnea: C35D1 (n=4, 0) 16.7  (6.4) NA [2]   (NA)
Dyspnea: C36D1 (n=1, 0) 22.2 [1]   (NA) NA [2]   (NA)
Dyspnea: C37D1 (n=1, 0) 11.1 [1]   (NA) NA [2]   (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 [1]   (NA)
Coughing: C31D1 (n=7, 0) 19.0  (17.8) NA [3]   (NA)
Coughing: C32D1 (n=6, 0) 16.7  (27.9) NA [3]   (NA)
Coughing: C33D1 (n=6, 0) 11.1  (17.2) NA [3]   (NA)
Coughing: C34D1 (n=5, 0) 20.0  (29.8) NA [3]   (NA)
Coughing: C35D1 (n=4, 0) 33.3  (47.1) NA [3]   (NA)
Coughing: C36D1 (n=1, 0) 33.3 [1]   (NA) NA [3]   (NA)
Coughing: C37D1 (n=1, 0) 33.3 [1]   (NA) NA [1]   (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 [1]   (NA)
Hemoptysis: C31D1 (n=7, 0) 0.0  (0.0) NA [3]   (NA)
Hemoptysis: C32D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Hemoptysis: C33D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Hemoptysis: C34D1 (n=5, 0) 0.0  (0.0) NA [3]   (NA)
Hemoptysis: C35D1 (n=4, 0) 0.0  (0.0) NA [3]   (NA)
Hemoptysis: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (NA)
Hemoptysis: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (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 [1]   (NA)
Sore Mouth: C31D1 (n=7, 0) 9.5  (25.2) NA [3]   (NA)
Sore Mouth: C32D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Sore Mouth: C33D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Sore Mouth: C34D1 (n=5, 0) 0.0  (0.0) NA [3]   (NA)
Sore Mouth: C35D1 (n=4, 0) 0.0  (0.0) NA [3]   (NA)
Sore Mouth: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (NA)
Sore Mouth: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (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 [1]   (NA)
Dysphagia: C31D1 (n=7, 0) 4.8  (12.6) NA [3]   (NA)
Dysphagia: C32D1 (n=6, 0) 5.6  (13.6) NA [3]   (NA)
Dysphagia: C33D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Dysphagia: C34D1 (n=5, 0) 6.7  (14.9) NA [3]   (NA)
Dysphagia: C35D1 (n=4, 0) 8.3  (16.7) NA [3]   (NA)
Dysphagia: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (NA)
Dysphagia: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (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 [1]   (NA)
Peripheral Neuropathy: C31D1 (n=7, 0) 19.0  (32.5) NA [3]   (NA)
Peripheral Neuropathy: C32D1 (n=6, 0) 11.1  (27.2) NA [3]   (NA)
Peripheral Neuropathy: C33D1 (n=6, 0) 11.1  (27.2) NA [3]   (NA)
Peripheral Neuropathy: C34D1 (n=5, 0) 20.0  (44.7) NA [3]   (NA)
Peripheral Neuropathy: C35D1 (n=4, 0) 25.0  (50.0) NA [3]   (NA)
Peripheral Neuropathy: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (NA)
Peripheral Neuropathy: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (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 [1]   (NA)
Alopecia: C31D1 (n=7, 0) 9.5  (25.2) NA [3]   (NA)
Alopecia: C32D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Alopecia: C33D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Alopecia: C34D1 (n=5, 0) 0.0  (0.0) NA [3]   (NA)
Alopecia: C35D1 (n=4, 0) 0.0  (0.0) NA [3]   (NA)
Alopecia: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (NA)
Alopecia: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (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 [1]   (NA)
Pain in Chest: C31D1 (n=7, 0) 9.5  (16.3) NA [3]   (NA)
Pain in Chest: C32D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Pain in Chest: C33D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Pain in Chest: C34D1 (n=5, 0) 6.7  (14.9) NA [3]   (NA)
Pain in Chest: C35D1 (n=4, 0) 8.3  (16.7) NA [3]   (NA)
Pain in Chest: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (NA)
Pain in Chest: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (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 [1]   (NA)
Pain in Arm or Shoulder: C31D1 (n=7, 0) 0.0  (0.0) NA [3]   (NA)
Pain in Arm or Shoulder: C32D1 (n=6, 0) 11.1  (17.2) NA [3]   (NA)
Pain in Arm or Shoulder: C33D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Pain in Arm or Shoulder: C34D1 (n=5, 0) 0.0  (0.0) NA [3]   (NA)
Pain in Arm or Shoulder: C35D1 (n=4, 0) 0.0  (0.0) NA [3]   (NA)
Pain in Arm or Shoulder: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (NA)
Pain in Arm or Shoulder: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (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 [1]   (NA)
Pain in Other Parts: C31D1 (n=7, 0) 9.5  (16.3) NA [3]   (NA)
Pain in Other Parts: C32D1 (n=6, 0) 5.6  (13.6) NA [3]   (NA)
Pain in Other Parts: C33D1 (n=6, 0) 0.0  (0.0) NA [3]   (NA)
Pain in Other Parts: C34D1 (n=5, 0) 6.7  (14.9) NA [3]   (NA)
Pain in Other Parts: C35D1 (n=4, 0) 0.0  (0.0) NA [3]   (NA)
Pain in Other Parts: C36D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (NA)
Pain in Other Parts: C37D1 (n=1, 0) 0.0 [1]   (NA) NA [3]   (NA)
Pain in Other Parts: EOT (n=49, 90) 18.4  (29.7) 29.6  (34.8)
[1]
Standard deviation was not estimable since only one participant was evaluable.
[2]
Data was not analyzed as no participants were evaluable
[3]
Data was not analyzed as no participants were evaluable.
15.Secondary Outcome
Title European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description:
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Number of Participants Analyzed 164 161
Mean (Standard Deviation)
Unit of Measure: units on a scale
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 [1]   (NA)
C31D1 (n=7, 0) 68.57  (16.76) NA [2]   (NA)
C32D1 (n=6, 0) 65.83  (19.41) NA [2]   (NA)
C33D1 (n=6, 0) 67.50  (20.34) NA [2]   (NA)
C34D1 (n=5, 0) 68.00  (20.80) NA [2]   (NA)
C35D1 (n=4, 0) 72.25  (14.84) NA [2]   (NA)
C36D1 (n=1, 0) 90.00 [1]   (NA) NA [2]   (NA)
C37D1 (n=1, 0) 85.00 [1]   (NA) NA [2]   (NA)
EOT (n=49, 90) 68.33  (21.25) 58.34  (23.71)
[1]
Standard deviation was not estimable since only one participant was evaluable
[2]
Data was not analyzed as no participants were evaluable
Time Frame Active reporting period is from the time of informed consent until at least 28 days after the last dose of study treatment.
Adverse Event Reporting Description All causality (serious and non-serious) adverse events have been reported. Non-serious adverse events above the 5% threshold are reported herein.
 
Arm/Group Title Crizotinib Chemotherapy
Hide Arm/Group Description Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
All-Cause Mortality
Crizotinib Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Crizotinib Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   80/172 (46.51%)   42/171 (24.56%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/172 (1.16%)  2/171 (1.17%) 
Febrile neutropenia * 1  1/172 (0.58%)  12/171 (7.02%) 
Neutropenia * 1  2/172 (1.16%)  2/171 (1.17%) 
Thrombocytopenia * 1  0/172 (0.00%)  1/171 (0.58%) 
Lymphadenopathy * 1  1/172 (0.58%)  0/171 (0.00%) 
Cardiac disorders     
Arrhythmia * 1  1/172 (0.58%)  0/171 (0.00%) 
Cardiac arrest * 1  1/172 (0.58%)  0/171 (0.00%) 
Cardiac tamponade * 1  1/172 (0.58%)  1/171 (0.58%) 
Pericardial effusion * 1  1/172 (0.58%)  2/171 (1.17%) 
Supraventricular tachycardia * 1  0/172 (0.00%)  1/171 (0.58%) 
Coronary artery disease * 1  1/172 (0.58%)  0/171 (0.00%) 
Myocardial ischaemia * 1  1/172 (0.58%)  0/171 (0.00%) 
Syncope * 1  1/172 (0.58%)  0/171 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  1/172 (0.58%)  0/171 (0.00%) 
Diarrhoea * 1  1/172 (0.58%)  0/171 (0.00%) 
Ileus paralytic * 1  1/172 (0.58%)  0/171 (0.00%) 
Intestinal perforation * 1  1/172 (0.58%)  0/171 (0.00%) 
Nausea * 1  1/172 (0.58%)  2/171 (1.17%) 
Oesophageal stenosis * 1  1/172 (0.58%)  0/171 (0.00%) 
Stomatitis * 1  0/172 (0.00%)  1/171 (0.58%) 
Vomiting * 1  3/172 (1.74%)  0/171 (0.00%) 
Food poisoning * 1  1/172 (0.58%)  0/171 (0.00%) 
Haematemesis * 1  1/172 (0.58%)  0/171 (0.00%) 
Melaena * 1  0/172 (0.00%)  1/171 (0.58%) 
General disorders     
Product contamination microbial * 1  0/172 (0.00%)  1/171 (0.58%) 
Chest pain * 1  0/172 (0.00%)  2/171 (1.17%) 
Death * 1  2/172 (1.16%)  0/171 (0.00%) 
Disease progression * 1  18/172 (10.47%)  3/171 (1.75%) 
Fatigue * 1  1/172 (0.58%)  1/171 (0.58%) 
Mucosal inflammation * 1  0/172 (0.00%)  2/171 (1.17%) 
Pyrexia * 1  1/172 (0.58%)  1/171 (0.58%) 
Sudden death * 1  1/172 (0.58%)  0/171 (0.00%) 
General physical health deterioration * 1  1/172 (0.58%)  0/171 (0.00%) 
Malaise * 1  1/172 (0.58%)  0/171 (0.00%) 
Hepatobiliary disorders     
Hepatic failure * 1  1/172 (0.58%)  0/171 (0.00%) 
Hepatitis * 1  1/172 (0.58%)  0/171 (0.00%) 
Infections and infestations     
Empyema * 1  1/172 (0.58%)  0/171 (0.00%) 
Extradural abscess * 1  1/172 (0.58%)  0/171 (0.00%) 
Lower respiratory tract infection * 1  2/172 (1.16%)  2/171 (1.17%) 
Lung abscess * 1  2/172 (1.16%)  0/171 (0.00%) 
Lung infection * 1  2/172 (1.16%)  1/171 (0.58%) 
Pneumonia * 1  8/172 (4.65%)  3/171 (1.75%) 
Pneumonia bacterial * 1  1/172 (0.58%)  0/171 (0.00%) 
Sepsis * 1  1/172 (0.58%)  1/171 (0.58%) 
Urinary tract infection * 1  0/172 (0.00%)  1/171 (0.58%) 
Cellulitis * 1  2/172 (1.16%)  0/171 (0.00%) 
Gastroenteritis * 1  1/172 (0.58%)  0/171 (0.00%) 
Pneumonia influenzal * 1  1/172 (0.58%)  0/171 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture * 1  1/172 (0.58%)  1/171 (0.58%) 
Spinal fracture * 1  1/172 (0.58%)  0/171 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  3/172 (1.74%)  0/171 (0.00%) 
Aspartate aminotransferase increased * 1  2/172 (1.16%)  0/171 (0.00%) 
Blood glucose increased * 1  1/172 (0.58%)  0/171 (0.00%) 
Electrocardiogram QT prolonged * 1  1/172 (0.58%)  0/171 (0.00%) 
Haemoglobin * 1  0/172 (0.00%)  1/171 (0.58%) 
Neutrophil count decreased * 1  0/172 (0.00%)  1/171 (0.58%) 
White blood cell count decreased * 1  0/172 (0.00%)  2/171 (1.17%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  2/172 (1.16%)  1/171 (0.58%) 
Hyperglycaemia * 1  1/172 (0.58%)  0/171 (0.00%) 
Hyperkalaemia * 1  1/172 (0.58%)  0/171 (0.00%) 
Hypoglycaemia * 1  2/172 (1.16%)  1/171 (0.58%) 
Hypokalaemia * 1  1/172 (0.58%)  0/171 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/172 (1.16%)  2/171 (1.17%) 
Muscular weakness * 1  1/172 (0.58%)  0/171 (0.00%) 
Musculoskeletal pain * 1  0/172 (0.00%)  1/171 (0.58%) 
Spinal column stenosis * 1  1/172 (0.58%)  0/171 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour haemorrhage * 1  0/172 (0.00%)  1/171 (0.58%) 
Colon cancer * 1  0/172 (0.00%)  1/171 (0.58%) 
Colon cancer recurrent * 1  0/172 (0.00%)  1/171 (0.58%) 
Nervous system disorders     
Brain oedema * 1  1/172 (0.58%)  0/171 (0.00%) 
Headache * 1  1/172 (0.58%)  2/171 (1.17%) 
Intracranial pressure increased * 1  2/172 (1.16%)  0/171 (0.00%) 
Lethargy * 1  1/172 (0.58%)  0/171 (0.00%) 
Paraesthesia * 1  1/172 (0.58%)  0/171 (0.00%) 
Presyncope * 1  1/172 (0.58%)  0/171 (0.00%) 
Cerebral cyst * 1  1/172 (0.58%)  0/171 (0.00%) 
Dizziness * 1  1/172 (0.58%)  0/171 (0.00%) 
Seizure * 1  2/172 (1.16%)  1/171 (0.58%) 
Psychiatric disorders     
Confusional state * 1  0/172 (0.00%)  1/171 (0.58%) 
Mental status changes * 1  1/172 (0.58%)  0/171 (0.00%) 
Delirium * 1  1/172 (0.58%)  0/171 (0.00%) 
Renal and urinary disorders     
Renal cyst * 1  1/172 (0.58%)  0/171 (0.00%) 
Ureteric stenosis * 1  1/172 (0.58%)  0/171 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  1/172 (0.58%)  0/171 (0.00%) 
Acute respiratory failure * 1  1/172 (0.58%)  0/171 (0.00%) 
Cough * 1  1/172 (0.58%)  0/171 (0.00%) 
Dyspnoea * 1  6/172 (3.49%)  2/171 (1.17%) 
Interstitial lung disease * 1  3/172 (1.74%)  0/171 (0.00%) 
Organising pneumonia * 1  0/172 (0.00%)  1/171 (0.58%) 
Pleural effusion * 1  2/172 (1.16%)  3/171 (1.75%) 
Pneumonitis * 1  1/172 (0.58%)  0/171 (0.00%) 
Pulmonary artery thrombosis * 1  1/172 (0.58%)  0/171 (0.00%) 
Pulmonary embolism * 1  7/172 (4.07%)  3/171 (1.75%) 
Pulmonary oedema * 1  0/172 (0.00%)  1/171 (0.58%) 
Respiratory failure * 1  1/172 (0.58%)  0/171 (0.00%) 
Skin and subcutaneous tissue disorders     
Drug eruption * 1  1/172 (0.58%)  0/171 (0.00%) 
Surgical and medical procedures     
Cancer surgery * 1  1/172 (0.58%)  0/171 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  1/172 (0.58%)  2/171 (1.17%) 
Pelvic venous thrombosis * 1  1/172 (0.58%)  0/171 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Crizotinib Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   172/172 (100.00%)   169/171 (98.83%) 
Blood and lymphatic system disorders     
Anaemia * 1  36/172 (20.93%)  27/171 (15.79%) 
Leukopenia * 1  24/172 (13.95%)  9/171 (5.26%) 
Neutropenia * 1  41/172 (23.84%)  18/171 (10.53%) 
Cardiac disorders     
Bradycardia * 1  9/172 (5.23%)  0/171 (0.00%) 
Eye disorders     
Photopsia * 1  21/172 (12.21%)  1/171 (0.58%) 
Vision blurred * 1  13/172 (7.56%)  5/171 (2.92%) 
Visual impairment * 1  74/172 (43.02%)  8/171 (4.68%) 
Lacrimation increased * 1  1/172 (0.58%)  9/171 (5.26%) 
Gastrointestinal disorders     
Abdominal pain * 1  18/172 (10.47%)  8/171 (4.68%) 
Abdominal pain upper * 1  17/172 (9.88%)  13/171 (7.60%) 
Constipation * 1  83/172 (48.26%)  39/171 (22.81%) 
Diarrhoea * 1  106/172 (61.63%)  34/171 (19.88%) 
Dyspepsia * 1  18/172 (10.47%)  6/171 (3.51%) 
Nausea * 1  104/172 (60.47%)  60/171 (35.09%) 
Stomatitis * 1  9/172 (5.23%)  13/171 (7.60%) 
Vomiting * 1  88/172 (51.16%)  32/171 (18.71%) 
Dysphagia * 1  9/172 (5.23%)  2/171 (1.17%) 
Gastrooesophageal reflux disease * 1  12/172 (6.98%)  0/171 (0.00%) 
General disorders     
Asthenia * 1  31/172 (18.02%)  32/171 (18.71%) 
Chest pain * 1  15/172 (8.72%)  13/171 (7.60%) 
Fatigue * 1  51/172 (29.65%)  60/171 (35.09%) 
Oedema * 1  15/172 (8.72%)  6/171 (3.51%) 
Oedema peripheral * 1  59/172 (34.30%)  15/171 (8.77%) 
Pyrexia * 1  41/172 (23.84%)  33/171 (19.30%) 
Pain * 1  10/172 (5.81%)  9/171 (5.26%) 
Infections and infestations     
Nasopharyngitis * 1  32/172 (18.60%)  7/171 (4.09%) 
Upper respiratory tract infection * 1  24/172 (13.95%)  14/171 (8.19%) 
Injury, poisoning and procedural complications     
Fall * 1  11/172 (6.40%)  3/171 (1.75%) 
Investigations     
Alanine aminotransferase increased * 1  72/172 (41.86%)  21/171 (12.28%) 
Aspartate aminotransferase increased * 1  55/172 (31.98%)  17/171 (9.94%) 
Blood alkaline phosphatase increased * 1  18/172 (10.47%)  6/171 (3.51%) 
Blood creatinine increased * 1  13/172 (7.56%)  3/171 (1.75%) 
Neutrophil count decreased * 1  15/172 (8.72%)  9/171 (5.26%) 
Weight decreased * 1  21/172 (12.21%)  8/171 (4.68%) 
White blood cell count decreased * 1  16/172 (9.30%)  13/171 (7.60%) 
Electrocardiogram QT prolonged * 1  9/172 (5.23%)  0/171 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  56/172 (32.56%)  46/171 (26.90%) 
Hyperglycaemia * 1  12/172 (6.98%)  9/171 (5.26%) 
Hypoalbuminaemia * 1  16/172 (9.30%)  1/171 (0.58%) 
Hypokalaemia * 1  15/172 (8.72%)  5/171 (2.92%) 
Hypocalcaemia * 1  13/172 (7.56%)  0/171 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  15/172 (8.72%)  20/171 (11.70%) 
Back pain * 1  30/172 (17.44%)  11/171 (6.43%) 
Musculoskeletal pain * 1  14/172 (8.14%)  6/171 (3.51%) 
Myalgia * 1  5/172 (2.91%)  19/171 (11.11%) 
Pain in extremity * 1  20/172 (11.63%)  10/171 (5.85%) 
Muscle spasms * 1  9/172 (5.23%)  4/171 (2.34%) 
Neck pain * 1  11/172 (6.40%)  5/171 (2.92%) 
Nervous system disorders     
Dizziness * 1  34/172 (19.77%)  13/171 (7.60%) 
Dysgeusia * 1  45/172 (26.16%)  17/171 (9.94%) 
Headache * 1  46/172 (26.74%)  26/171 (15.20%) 
Neuropathy peripheral * 1  5/172 (2.91%)  10/171 (5.85%) 
Paraesthesia * 1  13/172 (7.56%)  7/171 (4.09%) 
Peripheral sensory neuropathy * 1  9/172 (5.23%)  6/171 (3.51%) 
Visual perseveration * 1  12/172 (6.98%)  0/171 (0.00%) 
Psychiatric disorders     
Insomnia * 1  19/172 (11.05%)  13/171 (7.60%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  37/172 (21.51%)  35/171 (20.47%) 
Dyspnoea * 1  27/172 (15.70%)  29/171 (16.96%) 
Epistaxis * 1  3/172 (1.74%)  10/171 (5.85%) 
Haemoptysis * 1  9/172 (5.23%)  11/171 (6.43%) 
Oropharyngeal pain * 1  20/172 (11.63%)  7/171 (4.09%) 
Rhinorrhoea * 1  4/172 (2.33%)  9/171 (5.26%) 
Productive cough * 1  12/172 (6.98%)  8/171 (4.68%) 
Pulmonary embolism * 1  9/172 (5.23%)  2/171 (1.17%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  21/172 (12.21%)  35/171 (20.47%) 
Dry skin * 1  10/172 (5.81%)  2/171 (1.17%) 
Pruritus * 1  12/172 (6.98%)  7/171 (4.09%) 
Rash * 1  23/172 (13.37%)  30/171 (17.54%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
No analyses of ALK fusion variants or protein expression were done due to limited slide stability of unstained tissue sections required for immunohistochemistry and no nucleic acid based assay was available to identify specific ALK gene fusion.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00932893     History of Changes
Other Study ID Numbers: A8081007
2009-012595-27 ( EudraCT Number )
First Submitted: June 30, 2009
First Posted: July 3, 2009
Results First Submitted: March 13, 2013
Results First Posted: June 6, 2013
Last Update Posted: January 2, 2017