ALK Gene Rearrangement or ROS1 Gene Rearrangement, Crizotinib, NSCLC
Conditions
Keywords
Non-Small Cell Lung Cancer (NSCLC), crizotinib, ALK gene rearrangement or ROS1 gene rearrangement
Brief summary
Descriptive Observational Study. Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals
Detailed description
Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.
Interventions
None listed
Sponsors
French College of General Hospital Pneumologists (CPHG)
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Locally advanced or metastatic NSCLC * Patient ALK gene rearrangement or ROS1 gene rearrangement * Patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment * Patient followed up by a physician in a hospital pulmonary medicine department * Subject of reproductive age, using an effective method of contraception * Patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study. Non-inclusion criteria * Patient included within the scope of an interventional therapeutic trial * Patient not presenting with ALK gene rearrangement or ROS1 gene rearrangement * Patient not available for follow-up throughout the duration of the study * Patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement | Baseline | In this outcome measure, duration of previous brain irradiation therapy and radiotherapies was reported. |
| Age: Line of Treatment | Baseline | — |
| Body Weight: Line of Treatment and Gene Rearrangement | Baseline | Body weight in kilograms (kg) measured at baseline were reported. |
| Body Mass Index (BMI): Line of Treatment and Gene Rearrangement | Baseline | BMI was obtained by dividing body weight in kilograms (kg) by height in meters square (m\^2). |
| Gender: Line of Treatment | Baseline | — |
| Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Baseline | Number of participants were classified according to smoking status as non-smoker, ex-smoker (did not smoke in at least 1 year prior to baseline) and current-smoker. |
| Number of Pack Years: Line of Treatment and Gene Rearrangement | Baseline | The number of pack-years was calculated at baseline for ex-smokers and current smokers by multiplying the number of packs they consumed per day and the number of years that the participant had smoked this quantity of packs. Combined data is reported for ex-smokers and current smokers. |
| Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Baseline | Duration of smoking: a) for ex-smokers, duration of smoking (years) was calculated by subtracting start year with year of smoking stop, b) for current smokers, duration of smoking (years) was calculated by subtracting start year with year of Inclusion visit date. Combined data of duration of smoking is reported for ex-smokers and current smokers. Duration of quitting smoke (years) for ex-smokers was calculated by subtracting year of smoking stop with year of inclusion visit date. |
| Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | Baseline | Number of participants were categorized as yes or no, according to have undergone assessment with ECOG performance status. ECOG performance status was used to measure quality of life of oncology participants with scores running from 0 (no severity) to 5 (maximum severity); where 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (\>) 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. |
| Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | Baseline | ECOG performance status was used to measure quality of life of oncology patients with scores running from 0 (no severity) to 5 (maximum severity); where 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up \>50% of waking hours; 3= capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. Participants were categorized according to ECOG performance status scores of 0-1 and \>=2. |
| Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement | Baseline | Time since diagnosis of NSCLC (months) was calculated as: inclusion visit date minus date of the biopsy that enabled making the diagnosis divided by 365.35/12. If the day of the diagnosis was missing, it was replaced by the 15th of the month for calculation. |
| Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Baseline | Participants were categorized according to type of tumor's histology as adenocarcinoma, carcinoma indifferencier and other. |
| Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | Baseline | Participants were categorized according to tumor stage as IIIA/B or IVA/B classified as per Tumor Node Metastasis (TNM), 8th edition. TNM: based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant (other parts of body) metastasis. Stages included: stage 0 (no evidence of cancer cells), stage l (T1N0M0), stage IIA (T0N1M0, T1N1M0, T2N0M0), stage IIB (T2N1M0, T3N0M0), stage IIIA (T0N2M0, T1N2M0, T2N3M0, T3N1 or N2M0), stage IIIb (T4 any NM0, any TN3M0), stage IIIC (any TN3M0), stage IV (any T any NM1), where T0= early form of tumor, T1=\<2 centimeter (cm), T2 =2-5 cm, T3=\>2 cm, T4=large sized, N0= not spread to LN, N1= spread to 1 to 3, N2= spread to 4 to 9, N3= spread \>10 axillary LN, M0= no metastasis, M1= metastasis. Tumor stage categories with at least 1 participant in any reporting arm are reported. |
| Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Baseline | Participants were categorized according to location of tumor: upper right lobe, upper left lobe, middle right lobe, lower right lobe, and lower left lobe. |
| Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | Baseline | Participants were categorized according to presence of metastases as Yes or No. |
| Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | Baseline | Participants were categorized according to number of metastatic sites. |
| Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Baseline | Participants were categorized according to the location of metastases. Participant could have more than 1 location of metastases. |
| Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement | Baseline | Time since the first strategy start to crizotinib initiation (months) was calculated as: crizotinib initiation date minus start date of the first strategy divided by 365.35/12. If the start date was missing, it was replaced by the 15th of the month for calculation. |
| Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Baseline | Number of participants were categorized according to the different lines of chemotherapy. |
| Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Baseline | In this outcome measure, median of number of cycles for different lines of chemotherapy were reported. |
| Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Baseline | In this outcome measure, median duration of different lines of chemotherapy was reported. Duration of chemotherapy (months) was calculated as = End date of the last cycle minus start date of the first cycle plus 1 divided by 365.25/12. If the day of the date was missing, it was replaced by the 15th of the month. If the month of the date was missing, the duration was considered as missing. |
| Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Baseline | In this outcome measure, participants were categorized according to the previous treatments received. Participant could have received more than 1 type of previous therapies. |
| Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement | Baseline | In this outcome measure, median of dose of brain irradiation and radiotherapies were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Baseline | In this outcome measure, the number of participants were categorized according to diagnostic method used to detect ALK and ROS1 gene rearrangement. |
| Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Baseline | In this outcome measure, number of participants were categorized according to origin of specimen to detect ALK and ROS1 gene rearrangement. Origins of specimen included: primitive tumor, thoracic lymph node, extrathoracic lymph node, bone, adrenal glands and pleural. |
| Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Baseline | In this outcome measure, number of participants were categorized according to analysis platform to detect ALK and ROS1 gene rearrangement. Analysis platform included following sites: University hospital center (UHC) Alsace Cancer center of Strasbourg - Hospital Center of Mulhouse - Hospital Center of Colmar; UHC Aquitaine - Hospital Center de Bordeaux - La Réunion; UHC Bourgogne - Hospital Center of Dijon, UHC of Tours - Orléans; UHC Haute-Normandie - Hospital Center of Rouen, Ile-de-France AP - HP; UHC Languedoc Roussillon - Hospital Center of Montpellier - UHC of Nîmes; UHC Nord-Pas-de-Calais - Hospital Center of Lille; UHC Pays-de-la-Loire - Hospital Center of Nantes; UHC Pays-de-la-Loire - Hospital Center of Angers; UHC Picardie, Amiens; UHC Provence Alpes Côte d'Azur - Hospital Center of Nice; UHC Provence Alpes Côte d'Azur - Hospital Center of Marseille; UHC Rhône Alpes - Hospital Center of Lyon; UHC Rhône Alpes - Hospital Center of Grenoble; and other platform. |
| Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Baseline | In this outcome measure, number of participants were categorized according to the techniques used to detect ALK and ROS1 gene rearrangement. Techniques involved were: Immunohistochemistry (IHC); Fluorescence in situ hybridisation (FISH); Reverse transcriptase polymerase chain reaction (RT-PCR); Next-Generation Sequencing (NGS); Other; and Associations-FISH, IHC, IHC+FISH, IHC+FISH+NGS, NGS. |
| Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement | Baseline | Duration between sending and receipt of ALK for positive ALK was calculated in days by subtracting the date sent to the platform from date when positive ALK result was received. Duration between sending and receipt of ROS1 for positive ROS1 was calculated in days by subtracting the date sent to the platform from date when positive ROS1 result was received. |
| Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | Baseline | In this outcome measure, number of participants were categorized Yes or No for search of other biological markers. |
| Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3, 6, 9, 12, 15 and 18 | Number of participants were categorized according to clinical response as evaluated by physician. Clinical response was categorized into disease improvement, disease stabilization or disease degradation. |
| Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3, 6, 9, 12, 15 and 18 | Number of participants were categorized according to tumor response per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Tumor response included total (complete) response (CR), partial response (PR), stable disease (SD) or disease progression (PD) on imaging. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. Unequivocal progression of existing non-target lesions. 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. |
| Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3, 6, 9, 12, 15 and 18 | Time since diagnosis to progression (months) was calculated as: progression date minus date of biopsy that enabled making the diagnosis divided by 365.35/12. If the day of the diagnosis was missing, it was replaced by the 15th of the month for calculation. If the day of the progression was missing, it was replaced by the 1st of the month for calculation. |
| Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 3, 6, 9, 12, 15 and 18 | In this outcome measure, number of participants whose progression was noted at primary tumor site were reported. |
| Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 3, 6, 9, 12, 15 and 18 | In this outcome measure, number of participants whose progression was noted at already existing metastasis sites were reported. |
| Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 3, 6, 9, 12, 15 and 18 | In this outcome measure, participants were categorized according to location of progression in already existing metastasis which were located at adrenal glands, bone, brain, liver, lymph node, pleural, plueral liver, pleural lymph node, brain pleural, and kidney. Only those rows are reported with at least 1 participant as data for any reporting arm. |
| Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 3, 6, 9, 12, 15 and 18 | In this outcome measure, participants with new metastases as the site of progression were reported. |
| Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 3, 6, 9, 12, 15 and 18 | In this outcome measure, number of participants were categorized according to progression at location of new metastases. Location of new metastases included contralateral lung, extrathoracic lymph node, brain, liver, bone, adrenal glands, lymphangite carcinomateuse and pleural. Only those categories in which at least 1 participant had data were reported. |
| Treatment Duration Until Progression With Brain Metastases | Baseline | Treatment duration until progression with brain metastases (weeks) was calculated as: (\[date of progression - first treatment intake date\] + 1) divided by 7. If the day of the progression was missing, it was replaced by the 1st of the month for calculation. |
| Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3, 6, 9, 12, 15 and 18 | In this outcome measure, number of participants were categorized on the basis of conduction of biopsy on progression as Yes' or No. |
| Objective Response Rate (ORR) | Maximum up to 18 months | The objective response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) based on RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits. |
| Disease Control Rate (DCR) at Month 12 and 18 | Month 12, 18 | DCR at 12 and 18 months was defined as the percentage of participants with CR, PR or SD at 12 and at 18 months. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion 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 (at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions), taking as reference the smallest sum diameters while on study. |
| European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Baseline, Month 3, 6, 9, 12, 15, 18 | EORTC QLQ-LC13 consisted of following symptom scales/items: coughing, haemoptysis, dyspnoea, dyspnoea when resting, dyspnoea when walking, dyspnoea when stairs, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts and pain relief after medication. The dyspnoea scale was only calculated if all three items had been answered. Some respondents ignore question dyspnoea when stairs because they never climbed stairs. Hence if item dyspnoea when stairs was missing then items dyspnoea when resting and dyspnoea when walking was used as single-item measures under item dyspnoea. Transformed scores for each item ranged from 0 to 100, higher score is indicative of a higher response level (a high score for a symptom scale/item represents a high level of symptomatology/problems). |
| Time to Median Progression Free Survival (Months) With Its 95%CI | 18 months | PFS was defined as the time between the treatment start (date of the first Crizotinib intake) and the date of the first disease progression or the all-cause death. Participants who did not progress or were still alive at the end of the study or at the date of cut-off were censored at the last disease evaluation date. |
| 18-Month Overall Survival (OS) Rate (95%CI) | 18 months | OS was defined as the time from the date of first dose of study drug to the date of death due to any cause. Participants last known to be alive were censored at the date of last contact. 18-month OS rates was assessed by Kaplan-Meier method with right censoring. |
| Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3, 6, 9, 12, 15 and 18 | Compliance to study drug was evaluated using Morisky score. The questionnaire consisted of 4 questions in which the scale was 0 for yes (indicating poor compliance) and 1 for no (indicating good compliance). The items were summed to give a range of scores from 0 to 4. A score of 4 indicated high compliance, 2-3 indicated medium compliance and 0-1 indicated low compliance. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to maximum of 18 months | AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Serious AE: any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and all Non-SAEs. |
Countries
France
Participant flow
Recruitment details
Participants aged above or equal to (\>=) 18 years, treated with crizotinib for advanced (stage IIIB not suitable for radiotherapy) or metastatic (stage IV) non-small-cell lung cancer (NSCLC), with anaplastic lymphoma kinase-positive (ALK) gene rearrangement or proto-oncogene 1, receptor tyrosine kinase-positive (ROS1) gene rearrangement were observed.
Pre-assignment details
Participants received crizotinib 3 months before inclusion in the study or initiated crizotinib treatment (regardless of the line of treatment) in general hospitals as per normal routine healthcare practice in real world. Participants were followed up in this observational study for maximum of 18 months post inclusion in the study.
Participants by arm
| Arm | Count |
|---|---|
| Participants With ALK Gene Rearrangement Participants included in this arm were treated with crizotinib for advanced or metastatic NSCLC with ALK gene rearrangement, per normal routine medical care in real world practices. The participants were followed until the participant's death or early withdrawal from the study for another reason (up to maximum of 18 months). | 51 |
| Participants With ROS1 Gene Rearrangement Participants included in this arm were treated with crizotinib for advanced or metastatic NSCLC with ROS1 gene rearrangement, per normal routine medical care in real world practices. The participants were followed until the participant's death or early withdrawal from the study for another reason (up to maximum of 18 months). | 20 |
| Participants With Unknown Gene Rearrangement Participants included in this arm were treated with crizotinib for advanced or metastatic NSCLC with unknown gene rearrangement, per normal routine medical care in real world practices. The participants were followed from inclusion in the study until the participant's death or early withdrawal from the study for another reason (up to maximum of 18 months). | 2 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 12 | 11 | 0 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Participant not met eligibility criteria | 0 | 0 | 2 |
| Overall Study | Withdrawn due to adverse event (AE) | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Participants With ALK Gene Rearrangement | Participants With ROS1 Gene Rearrangement | Participants With Unknown Gene Rearrangement | Total |
|---|---|---|---|---|
| Age, Continuous | 60.4 Years STANDARD_DEVIATION 13.5 | 67.6 Years STANDARD_DEVIATION 14.4 | 64.0 Years | 62.4 Years STANDARD_DEVIATION 14 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 30 Participants | 15 Participants | 1 Participants | 46 Participants |
| Sex: Female, Male Male | 21 Participants | 5 Participants | 0 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 21 / 51 | 3 / 15 | 0 / 2 | 0 / 3 | 13 / 51 | 11 / 20 | 0 / 2 |
| other Total, other adverse events | 42 / 51 | 12 / 15 | 2 / 2 | 3 / 3 | 43 / 51 | 16 / 20 | 0 / 2 |
| serious Total, serious adverse events | 32 / 51 | 6 / 15 | 0 / 2 | 1 / 3 | 25 / 51 | 14 / 20 | 0 / 2 |
Outcome results
Primary
Age: Line of Treatment
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Age: Line of Treatment | 62.3 Years | Standard Deviation 15.1 |
| Crizotinib: Second Line of Treatment | Age: Line of Treatment | 63.1 Years | Standard Deviation 12.9 |
| Crizotinib: Third Line of Treatment | Age: Line of Treatment | 56.5 Years | Standard Deviation 3.5 |
| Crizotinib: Other Line of Treatment | Age: Line of Treatment | 64.3 Years | Standard Deviation 3.2 |
Primary
Body Mass Index (BMI): Line of Treatment and Gene Rearrangement
BMI was obtained by dividing body weight in kilograms (kg) by height in meters square (m\^2).
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Body Mass Index (BMI): Line of Treatment and Gene Rearrangement | 24.34 Kilogram per square meter | Standard Deviation 4.46 |
| Crizotinib: Second Line of Treatment | Body Mass Index (BMI): Line of Treatment and Gene Rearrangement | 24.73 Kilogram per square meter | Standard Deviation 4.84 |
| Crizotinib: Third Line of Treatment | Body Mass Index (BMI): Line of Treatment and Gene Rearrangement | 25.05 Kilogram per square meter | Standard Deviation 0.78 |
| Crizotinib: Other Line of Treatment | Body Mass Index (BMI): Line of Treatment and Gene Rearrangement | 23.50 Kilogram per square meter | Standard Deviation 4.95 |
| Participants With ALK Gene Rearrangement | Body Mass Index (BMI): Line of Treatment and Gene Rearrangement | 25.07 Kilogram per square meter | Standard Deviation 4.59 |
| Participants With ROS1 Gene Rearrangement | Body Mass Index (BMI): Line of Treatment and Gene Rearrangement | 22.81 Kilogram per square meter | Standard Deviation 3.57 |
Primary
Body Weight: Line of Treatment and Gene Rearrangement
Body weight in kilograms (kg) measured at baseline were reported.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Body Weight: Line of Treatment and Gene Rearrangement | 66.5 Kilogram | Standard Deviation 15.5 |
| Crizotinib: Second Line of Treatment | Body Weight: Line of Treatment and Gene Rearrangement | 69.3 Kilogram | Standard Deviation 13.8 |
| Crizotinib: Third Line of Treatment | Body Weight: Line of Treatment and Gene Rearrangement | 75.0 Kilogram | Standard Deviation 0 |
| Crizotinib: Other Line of Treatment | Body Weight: Line of Treatment and Gene Rearrangement | 58.5 Kilogram | Standard Deviation 14.8 |
| Participants With ALK Gene Rearrangement | Body Weight: Line of Treatment and Gene Rearrangement | 69.6 Kilogram | Standard Deviation 14.6 |
| Participants With ROS1 Gene Rearrangement | Body Weight: Line of Treatment and Gene Rearrangement | 61.1 Kilogram | Standard Deviation 14.1 |
Primary
Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement
In this outcome measure, median of dose of brain irradiation and radiotherapies were reported.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Overall Number of Participants Analyzed = 0, signifies there were no participants with brain irradiation therapy and radiotherapy in respective arms. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement | Radiotherapy dose | 20.0 Gray unit |
| Crizotinib: First Line of Treatment | Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement | Brain irradiation dose | 30.0 Gray unit |
| Crizotinib: Second Line of Treatment | Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement | Radiotherapy dose | 42.5 Gray unit |
| Crizotinib: Other Line of Treatment | Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement | Radiotherapy dose | 30.0 Gray unit |
| Participants With ALK Gene Rearrangement | Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement | Brain irradiation dose | 30.0 Gray unit |
| Participants With ALK Gene Rearrangement | Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement | Radiotherapy dose | 30.0 Gray unit |
| Participants With ROS1 Gene Rearrangement | Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement | Radiotherapy dose | 25.0 Gray unit |
Primary
Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement
In this outcome measure, median duration of different lines of chemotherapy was reported. Duration of chemotherapy (months) was calculated as = End date of the last cycle minus start date of the first cycle plus 1 divided by 365.25/12. If the day of the date was missing, it was replaced by the 15th of the month. If the month of the date was missing, the duration was considered as missing.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Overall Number of Participants Analyzed = 0, signifies there were no participants with previous chemotherapy in the respective arms. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Crizotinib: Second Line of Treatment | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line chemotherapy | 2.70 Months |
| Crizotinib: Third Line of Treatment | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line chemotherapy | 1.85 Months |
| Crizotinib: Third Line of Treatment | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line chemotherapy | 3.60 Months |
| Crizotinib: Other Line of Treatment | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line chemotherapy | 1.30 Months |
| Crizotinib: Other Line of Treatment | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line chemotherapy | 2.60 Months |
| Crizotinib: Other Line of Treatment | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line chemotherapy | 3.30 Months |
| Participants With ALK Gene Rearrangement | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line chemotherapy | 2.65 Months |
| Participants With ALK Gene Rearrangement | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line chemotherapy | 1.20 Months |
| Participants With ALK Gene Rearrangement | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line chemotherapy | 21.15 Months |
| Participants With ROS1 Gene Rearrangement | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line chemotherapy | 2.10 Months |
| Participants With ROS1 Gene Rearrangement | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line chemotherapy | 3.30 Months |
| Participants With ROS1 Gene Rearrangement | Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line chemotherapy | 11.30 Months |
Primary
Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement
In this outcome measure, duration of previous brain irradiation therapy and radiotherapies was reported.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Overall Number of Participants Analyzed = 0, signifies there were no participants with brain irradiation therapy and radiotherapy in respective arms. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement | Radiotherapies | 7.0 Months |
| Crizotinib: First Line of Treatment | Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement | Brain Irradiation therapy | 15.0 Months |
| Crizotinib: Second Line of Treatment | Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement | Radiotherapies | 30.5 Months |
| Crizotinib: Other Line of Treatment | Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement | Radiotherapies | 15.0 Months |
| Participants With ALK Gene Rearrangement | Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement | Brain Irradiation therapy | 15.0 Months |
| Participants With ALK Gene Rearrangement | Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement | Radiotherapies | 15.0 Months |
| Participants With ROS1 Gene Rearrangement | Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement | Radiotherapies | 11.5 Months |
Primary
Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement
Duration of smoking: a) for ex-smokers, duration of smoking (years) was calculated by subtracting start year with year of smoking stop, b) for current smokers, duration of smoking (years) was calculated by subtracting start year with year of Inclusion visit date. Combined data of duration of smoking is reported for ex-smokers and current smokers. Duration of quitting smoke (years) for ex-smokers was calculated by subtracting year of smoking stop with year of inclusion visit date.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows with non-missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crizotinib: First Line of Treatment | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of smoking for ex-smokers and current smokers | 22.6 Years | Standard Deviation 13.6 |
| Crizotinib: First Line of Treatment | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of quitting smoke for ex-smoker | 12.8 Years | Standard Deviation 14.3 |
| Crizotinib: Second Line of Treatment | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of smoking for ex-smokers and current smokers | 26.0 Years | Standard Deviation 13.5 |
| Crizotinib: Second Line of Treatment | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of quitting smoke for ex-smoker | 12.6 Years | Standard Deviation 15.4 |
| Crizotinib: Third Line of Treatment | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of quitting smoke for ex-smoker | 3.0 Years | — |
| Crizotinib: Third Line of Treatment | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of smoking for ex-smokers and current smokers | 36.0 Years | — |
| Crizotinib: Other Line of Treatment | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of quitting smoke for ex-smoker | 8.0 Years | Standard Deviation 2.8 |
| Participants With ALK Gene Rearrangement | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of smoking for ex-smokers and current smokers | 23.1 Years | Standard Deviation 12.8 |
| Participants With ALK Gene Rearrangement | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of quitting smoke for ex-smoker | 10.5 Years | Standard Deviation 14.4 |
| Participants With ROS1 Gene Rearrangement | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of smoking for ex-smokers and current smokers | 25.9 Years | Standard Deviation 14.9 |
| Participants With ROS1 Gene Rearrangement | Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement | Duration of quitting smoke for ex-smoker | 15.1 Years | Standard Deviation 11.6 |
Primary
Gender: Line of Treatment
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Gender: Line of Treatment | Female | 34 Participants |
| Crizotinib: First Line of Treatment | Gender: Line of Treatment | Male | 17 Participants |
| Crizotinib: Second Line of Treatment | Gender: Line of Treatment | Male | 7 Participants |
| Crizotinib: Second Line of Treatment | Gender: Line of Treatment | Female | 8 Participants |
| Crizotinib: Third Line of Treatment | Gender: Line of Treatment | Female | 0 Participants |
| Crizotinib: Third Line of Treatment | Gender: Line of Treatment | Male | 2 Participants |
| Crizotinib: Other Line of Treatment | Gender: Line of Treatment | Male | 0 Participants |
| Crizotinib: Other Line of Treatment | Gender: Line of Treatment | Female | 3 Participants |
Primary
Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement
In this outcome measure, median of number of cycles for different lines of chemotherapy were reported.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Overall Number of Participants Analyzed = 0, signifies there were no participants with previous chemotherapy in the respective arms. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Crizotinib: Second Line of Treatment | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line chemotherapy | 4.0 Cycles |
| Crizotinib: Third Line of Treatment | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line chemotherapy | 3.0 Cycles |
| Crizotinib: Third Line of Treatment | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line chemotherapy | 5.0 Cycles |
| Crizotinib: Other Line of Treatment | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line chemotherapy | 4.0 Cycles |
| Crizotinib: Other Line of Treatment | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line chemotherapy | 4.0 Cycles |
| Crizotinib: Other Line of Treatment | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line chemotherapy | 4.0 Cycles |
| Participants With ALK Gene Rearrangement | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line chemotherapy | 4.0 Cycles |
| Participants With ALK Gene Rearrangement | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line chemotherapy | 3.0 Cycles |
| Participants With ALK Gene Rearrangement | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line chemotherapy | 14.0 Cycles |
| Participants With ROS1 Gene Rearrangement | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line chemotherapy | 17.0 Cycles |
| Participants With ROS1 Gene Rearrangement | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line chemotherapy | 4.0 Cycles |
| Participants With ROS1 Gene Rearrangement | Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line chemotherapy | 13.5 Cycles |
Primary
Number of Pack Years: Line of Treatment and Gene Rearrangement
The number of pack-years was calculated at baseline for ex-smokers and current smokers by multiplying the number of packs they consumed per day and the number of years that the participant had smoked this quantity of packs. Combined data is reported for ex-smokers and current smokers.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Pack Years: Line of Treatment and Gene Rearrangement | 19.7 Pack-years | Standard Deviation 17.2 |
| Crizotinib: Second Line of Treatment | Number of Pack Years: Line of Treatment and Gene Rearrangement | 24.5 Pack-years | Standard Deviation 9.7 |
| Crizotinib: Third Line of Treatment | Number of Pack Years: Line of Treatment and Gene Rearrangement | 60.0 Pack-years | — |
| Crizotinib: Other Line of Treatment | Number of Pack Years: Line of Treatment and Gene Rearrangement | 10.0 Pack-years | Standard Deviation 0 |
| Participants With ALK Gene Rearrangement | Number of Pack Years: Line of Treatment and Gene Rearrangement | 21.7 Pack-years | Standard Deviation 16.1 |
| Participants With ROS1 Gene Rearrangement | Number of Pack Years: Line of Treatment and Gene Rearrangement | 20.5 Pack-years | Standard Deviation 19.9 |
Primary
Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement
ECOG performance status was used to measure quality of life of oncology patients with scores running from 0 (no severity) to 5 (maximum severity); where 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up \>50% of waking hours; 3= capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. Participants were categorized according to ECOG performance status scores of 0-1 and \>=2.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | 0-1 | 36 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | >= 2 | 10 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | 0-1 | 12 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | >= 2 | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | 0-1 | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | >= 2 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | 0-1 | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | >= 2 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | 0-1 | 38 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | >= 2 | 6 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | 0-1 | 14 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement | >= 2 | 5 Participants |
Primary
Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement
Participants were categorized according to the location of metastases. Participant could have more than 1 location of metastases.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Brain | 7 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 21 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Contralateral lung | 17 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Liver | 9 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Bone | 19 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Adrenal glands | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Pleural effusion | 16 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Other | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Liver | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Contralateral lung | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Pleural effusion | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Adrenal glands | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Brain | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Bone | 7 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Brain | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Liver | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Bone | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Adrenal glands | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Pleural effusion | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Contralateral lung | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Pleural effusion | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Adrenal glands | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Bone | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Contralateral lung | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Brain | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Liver | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Other | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Other | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Contralateral lung | 18 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Bone | 22 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Adrenal glands | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Pleural effusion | 12 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 19 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Brain | 7 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Liver | 9 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Other | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Bone | 7 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Brain | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Liver | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Adrenal glands | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 7 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Pleural effusion | 8 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement | Contralateral lung | 5 Participants |
Primary
Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement
Participants were categorized according to number of metastatic sites.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 2 | 8 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 1 | 20 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | >=3 | 17 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 2 | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 1 | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | >=3 | 4 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 2 | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 1 | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | >=3 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 2 | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 1 | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | >=3 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 2 | 11 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 1 | 19 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | >=3 | 15 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 1 | 9 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | >=3 | 6 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement | 2 | 3 Participants |
Primary
Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement
Participants were categorized according to presence of metastases as Yes or No.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | No | 6 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | Yes | 45 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | No | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | Yes | 13 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | No | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | Yes | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | No | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | Yes | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | No | 6 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | Yes | 45 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | No | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement | Yes | 18 Participants |
Primary
Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement
Participants were categorized according to location of tumor: upper right lobe, upper left lobe, middle right lobe, lower right lobe, and lower left lobe.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower right lobe | 9 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper left lobe | 10 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper right lobe | 15 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower left lobe | 9 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Middle right lobe | 8 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper left lobe | 6 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower right lobe | 3 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper right lobe | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower left lobe | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Middle right lobe | 4 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper left lobe | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower right lobe | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower left lobe | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Middle right lobe | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper right lobe | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Middle right lobe | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper right lobe | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper left lobe | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower right lobe | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower left lobe | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower right lobe | 10 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper right lobe | 11 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower left lobe | 7 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper left lobe | 12 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Middle right lobe | 11 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper right lobe | 8 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower right lobe | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Upper left lobe | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Lower left lobe | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement | Middle right lobe | 2 Participants |
Primary
Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement
Participants were categorized according to tumor stage as IIIA/B or IVA/B classified as per Tumor Node Metastasis (TNM), 8th edition. TNM: based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant (other parts of body) metastasis. Stages included: stage 0 (no evidence of cancer cells), stage l (T1N0M0), stage IIA (T0N1M0, T1N1M0, T2N0M0), stage IIB (T2N1M0, T3N0M0), stage IIIA (T0N2M0, T1N2M0, T2N3M0, T3N1 or N2M0), stage IIIb (T4 any NM0, any TN3M0), stage IIIC (any TN3M0), stage IV (any T any NM1), where T0= early form of tumor, T1=\<2 centimeter (cm), T2 =2-5 cm, T3=\>2 cm, T4=large sized, N0= not spread to LN, N1= spread to 1 to 3, N2= spread to 4 to 9, N3= spread \>10 axillary LN, M0= no metastasis, M1= metastasis. Tumor stage categories with at least 1 participant in any reporting arm are reported.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIA | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIB | 5 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVA | 18 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVB | 28 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVA | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIB | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIA | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVB | 6 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVB | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVA | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIB | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIA | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIA | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVB | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIB | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVA | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVA | 20 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVB | 24 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIB | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIA | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIB | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVA | 6 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IVB | 12 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement | IIIA | 0 Participants |
Primary
Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement
Participants were categorized according to type of tumor's histology as adenocarcinoma, carcinoma indifferencier and other.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Carcinom indifferencier | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Adenocarcinoma | 50 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Carcinom indifferencier | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Adenocarcinoma | 15 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Adenocarcinoma | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Carcinom indifferencier | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Carcinom indifferencier | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Adenocarcinoma | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Carcinom indifferencier | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Adenocarcinoma | 51 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Adenocarcinoma | 19 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Carcinom indifferencier | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement | Other | 1 Participants |
Primary
Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement
Number of participants were categorized according to the different lines of chemotherapy.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | No | 42 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Yes | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Yes | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Yes | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Missing | 9 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | No | 42 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | No | 42 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Missing | 9 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Missing | 9 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Yes | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Yes | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | No | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Yes | 15 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | No | 15 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | No | 15 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | No | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Yes | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | No | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Yes | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Yes | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | No | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Yes | 3 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | No | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Yes | 3 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | No | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | No | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Yes | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | No | 43 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Missing | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Missing | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Yes | 18 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Yes | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | No | 45 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | No | 29 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Missing | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Yes | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Missing | 5 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Missing | 5 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | Yes | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Yes | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | No | 14 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Third line | Missing | 5 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | Yes | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | Second line | No | 14 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement | First line | No | 13 Participants |
Primary
Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement
In this outcome measure, participants were categorized according to the previous treatments received. Participant could have received more than 1 type of previous therapies.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | No | 51 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Yes | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Yes | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Yes | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | No | 44 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | No | 44 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Missing | 6 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Missing | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Yes | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Yes | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | No | 15 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Yes | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | No | 15 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | No | 11 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | No | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Yes | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | No | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Yes | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Yes | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | No | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Yes | 3 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | No | 3 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Yes | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | No | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | No | 3 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Yes | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | No | 42 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Missing | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Yes | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Yes | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | No | 51 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | No | 48 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Missing | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Yes | 7 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Missing | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Missing | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | Yes | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Yes | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | No | 20 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Tyrosine Kinase inhibitor | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | Yes | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Radiotherapies | No | 15 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized as Yes or No for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement | Brain irradiation | No | 16 Participants |
Primary
Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement
Number of participants were classified according to smoking status as non-smoker, ex-smoker (did not smoke in at least 1 year prior to baseline) and current-smoker.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Ex-smoker | 19 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Current smoker | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Non-smoker | 31 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Current smoker | 3 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Ex-smoker | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Non-smoker | 7 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Non-smoker | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Ex-smoker | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Current smoker | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Ex-smoker | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Non-smoker | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Current smoker | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Ex-smoker | 19 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Non-smoker | 28 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Current smoker | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Non-smoker | 12 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Current smoker | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement | Ex-smoker | 8 Participants |
Primary
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement
Number of participants were categorized as yes or no, according to have undergone assessment with ECOG performance status. ECOG performance status was used to measure quality of life of oncology participants with scores running from 0 (no severity) to 5 (maximum severity); where 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (\>) 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | No | 5 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | Yes | 46 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | No | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | Yes | 13 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | No | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | Yes | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | No | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | Yes | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | No | 7 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | Yes | 44 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | No | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement | Yes | 19 Participants |
Primary
Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement
Time since diagnosis of NSCLC (months) was calculated as: inclusion visit date minus date of the biopsy that enabled making the diagnosis divided by 365.35/12. If the day of the diagnosis was missing, it was replaced by the 15th of the month for calculation.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizotinib: First Line of Treatment | Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement | 1.30 Months |
| Crizotinib: Second Line of Treatment | Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement | 8.00 Months |
| Crizotinib: Third Line of Treatment | Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement | 48.40 Months |
| Crizotinib: Other Line of Treatment | Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement | 61.70 Months |
| Participants With ALK Gene Rearrangement | Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement | 2.70 Months |
| Participants With ROS1 Gene Rearrangement | Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement | 1.25 Months |
Primary
Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement
Time since the first strategy start to crizotinib initiation (months) was calculated as: crizotinib initiation date minus start date of the first strategy divided by 365.35/12. If the start date was missing, it was replaced by the 15th of the month for calculation.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizotinib: First Line of Treatment | Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement | 1.00 Months |
| Crizotinib: Second Line of Treatment | Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement | 6.90 Months |
| Crizotinib: Third Line of Treatment | Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement | 44.45 Months |
| Crizotinib: Other Line of Treatment | Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement | 60.10 Months |
| Participants With ALK Gene Rearrangement | Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement | 6.90 Months |
| Participants With ROS1 Gene Rearrangement | Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement | 65.95 Months |
Secondary
18-Month Overall Survival (OS) Rate (95%CI)
OS was defined as the time from the date of first dose of study drug to the date of death due to any cause. Participants last known to be alive were censored at the date of last contact. 18-month OS rates was assessed by Kaplan-Meier method with right censoring.
Time frame: 18 months
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crizotinib: First Line of Treatment | 18-Month Overall Survival (OS) Rate (95%CI) | 61.5 Percentage of participants |
| Crizotinib: Second Line of Treatment | 18-Month Overall Survival (OS) Rate (95%CI) | 77.8 Percentage of participants |
| Crizotinib: Third Line of Treatment | 18-Month Overall Survival (OS) Rate (95%CI) | NA Percentage of participants |
| Crizotinib: Other Line of Treatment | 18-Month Overall Survival (OS) Rate (95%CI) | NA Percentage of participants |
| Participants With ALK Gene Rearrangement | 18-Month Overall Survival (OS) Rate (95%CI) | 77.5 Percentage of participants |
| Participants With ROS1 Gene Rearrangement | 18-Month Overall Survival (OS) Rate (95%CI) | 40.5 Percentage of participants |
Secondary
Disease Control Rate (DCR) at Month 12 and 18
DCR at 12 and 18 months was defined as the percentage of participants with CR, PR or SD at 12 and at 18 months. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion 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 (at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions), taking as reference the smallest sum diameters while on study.
Time frame: Month 12, 18
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Disease Control Rate (DCR) at Month 12 and 18 | Month 12 | 76.5 Percentage of participants |
| Crizotinib: First Line of Treatment | Disease Control Rate (DCR) at Month 12 and 18 | Month 18 | 76.5 Percentage of participants |
| Crizotinib: Second Line of Treatment | Disease Control Rate (DCR) at Month 12 and 18 | Month 12 | 80 Percentage of participants |
| Crizotinib: Second Line of Treatment | Disease Control Rate (DCR) at Month 12 and 18 | Month 18 | 80 Percentage of participants |
| Crizotinib: Third Line of Treatment | Disease Control Rate (DCR) at Month 12 and 18 | Month 12 | 50 Percentage of participants |
| Crizotinib: Third Line of Treatment | Disease Control Rate (DCR) at Month 12 and 18 | Month 18 | 50 Percentage of participants |
| Crizotinib: Other Line of Treatment | Disease Control Rate (DCR) at Month 12 and 18 | Month 12 | 100 Percentage of participants |
| Crizotinib: Other Line of Treatment | Disease Control Rate (DCR) at Month 12 and 18 | Month 18 | 100 Percentage of participants |
| Participants With ALK Gene Rearrangement | Disease Control Rate (DCR) at Month 12 and 18 | Month 12 | 78.4 Percentage of participants |
| Participants With ALK Gene Rearrangement | Disease Control Rate (DCR) at Month 12 and 18 | Month 18 | 78.4 Percentage of participants |
| Participants With ROS1 Gene Rearrangement | Disease Control Rate (DCR) at Month 12 and 18 | Month 12 | 75 Percentage of participants |
| Participants With ROS1 Gene Rearrangement | Disease Control Rate (DCR) at Month 12 and 18 | Month 18 | 75 Percentage of participants |
Secondary
Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement
Duration between sending and receipt of ALK for positive ALK was calculated in days by subtracting the date sent to the platform from date when positive ALK result was received. Duration between sending and receipt of ROS1 for positive ROS1 was calculated in days by subtracting the date sent to the platform from date when positive ROS1 result was received.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement | ROS1+ | 8.0 Days |
| Crizotinib: First Line of Treatment | Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement | ALK+ | 8.0 Days |
| Crizotinib: Second Line of Treatment | Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement | ROS1+ | 5.0 Days |
| Crizotinib: Second Line of Treatment | Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement | ALK+ | 18.0 Days |
| Crizotinib: Third Line of Treatment | Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement | ALK+ | 19.5 Days |
| Crizotinib: Other Line of Treatment | Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement | ALK+ | 11.0 Days |
| Crizotinib: Other Line of Treatment | Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement | ROS1+ | 8.0 Days |
| Participants With ALK Gene Rearrangement | Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement | ALK+ | 10.0 Days |
| Participants With ROS1 Gene Rearrangement | Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement | ROS1+ | 8.0 Days |
Secondary
European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18
EORTC QLQ-LC13 consisted of following symptom scales/items: coughing, haemoptysis, dyspnoea, dyspnoea when resting, dyspnoea when walking, dyspnoea when stairs, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts and pain relief after medication. The dyspnoea scale was only calculated if all three items had been answered. Some respondents ignore question dyspnoea when stairs because they never climbed stairs. Hence if item dyspnoea when stairs was missing then items dyspnoea when resting and dyspnoea when walking was used as single-item measures under item dyspnoea. Transformed scores for each item ranged from 0 to 100, higher score is indicative of a higher response level (a high score for a symptom scale/item represents a high level of symptomatology/problems).
Time frame: Baseline, Month 3, 6, 9, 12, 15, 18
Population: FFAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 18 | 16.65 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 6 | 16.65 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 6 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 6 | 22.20 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 6: | 0.0 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 18 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 6 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 3 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Baseline | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 3 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 18 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 18 | 0.0 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 18 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 15 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 15 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Baseline | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 18 | 16.65 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 15 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 15 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 15 | 16.65 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 15 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Baseline | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Baseline | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 15 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 15 | 16.65 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 15 | 16.65 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 15 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Baseline | 0 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 18 | 50.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 15 | 16.65 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 15 | 0.0 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 15 | 16.65 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 12 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Baseline | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 18 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 12 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 12 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 12 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 12 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Baseline | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 18 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 12 | 0.0 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 12 | 0.0 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 12 | 0.0 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 12 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Baseline | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Baseline | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 12 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 12 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 12 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 12 | 0.0 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Baseline | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 18 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 12 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 9 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 9 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 9 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Baseline | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 18 | 0.0 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 9 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 9 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 9 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 9 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Baseline | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Baseline | 22.20 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 9 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 9 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 9 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 9 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Baseline | 66.70 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 18 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 9 | 22.20 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 9 | 0.0 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 9 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 6 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 18 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 6 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 6 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 6 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 6 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 3 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 18 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 6 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 6 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 6 | 0.00 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 6 | 33.30 Units on a scale |
| Crizotinib: First Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 3 | 11.10 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Baseline | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Baseline | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Baseline | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Baseline | 22.20 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Baseline | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Baseline | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Baseline | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Baseline | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Baseline | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Baseline | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Baseline | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Baseline | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Baseline | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Baseline | 50.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 3 | 16.65 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 3 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 3 | 22.20 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 3 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 3 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 3 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 3 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 3 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 3 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 3 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 3 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 3 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 3 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 3 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 6 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 6: | 0.0 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 6 | 22.20 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 6 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 6 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 6 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 6 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 6 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 6 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 6 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 6 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 6 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 6 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 6 | 50.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 9 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 9 | 0.0 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 9 | 38.85 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 9 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 9 | 50.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 9 | 66.70 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 9 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 9 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 9 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 9 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 9 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 9 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 9 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 9 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 12 | 16.65 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 12 | 0.0 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 12 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 12 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 12 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 12 | 50.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 12 | 0.0 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 12 | 0.0 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 12 | 0.0 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 12 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 12 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 12 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 12 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 12 | 100.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 15 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 15 | 0.0 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 15 | 66.70 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 15 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 15 | 66.70 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 15 | 100.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 15 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 15 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 15 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 15 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 15 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 15 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 15 | 66.70 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 15 | 33.30 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 18 | 50.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 18 | 0.0 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 18 | 55.60 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 18 | 33.35 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 18 | 66.70 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 18 | 66.65 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 18 | 0.0 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 18 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 18 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 18 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 18 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 18 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 18 | 0.00 Units on a scale |
| Crizotinib: Second Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 18 | 33.30 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Baseline | 16.65 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 3 | 0.00 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Baseline | 0.00 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 3 | 66.70 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 3 | 66.70 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 3 | 66.70 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Baseline | 16.65 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 3 | 66.70 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Baseline | 16.65 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 3 | 66.70 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Baseline | 0.00 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Baseline | 0.00 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Baseline | 33.35 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 3 | 66.70 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 3 | 66.70 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Baseline | 11.10 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Baseline | 0.00 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Baseline | 33.30 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Baseline | 16.65 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 3 | 0.00 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Baseline | 0.00 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 3 | 66.70 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 3 | 66.70 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Baseline | 0.00 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 3 | 66.70 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Baseline | 0.00 Units on a scale |
| Crizotinib: Third Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 3 | 33.30 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 3 | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 3 | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 3 | 16.65 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 3 | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 3 | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Baseline | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 3 | 16.65 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 3 | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 3 | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Baseline | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Baseline | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 3 | 16.65 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Baseline | 33.30 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 3 | 16.65 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Baseline | 50.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Baseline | 50.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 3 | 16.65 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Baseline | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 3 | 16.65 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Baseline | 33.30 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Baseline | 22.20 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Baseline | 100.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Baseline | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Baseline | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Baseline | 0.00 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Baseline | 16.65 Units on a scale |
| Crizotinib: Other Line of Treatment | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 3 | 16.65 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 12 | 27.75 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 6 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Baseline | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 6 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 6 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 15 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 6 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 6 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 6 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 15 | 66.65 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 6 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Baseline | 66.70 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 9 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 9 | 0.0 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 9 | 22.20 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 18 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 9 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Baseline | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 9 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 9 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 18 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 9 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 18 | 0.0 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 9 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Baseline | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 9 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 9 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 9 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 18 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 9 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Baseline | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 9 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Baseline | 22.20 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 9 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Baseline | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 12 | 16.65 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 18 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 12 | 0.0 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Baseline | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 12 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 12 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 18 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 12 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Baseline | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 12 | 0.0 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 12 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 18 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 12 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 18 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 12 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Baseline | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 12 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 12 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 12 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 18 | 0.0 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 12 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Baseline | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 15 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Baseline | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 15 | 0.0 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 15 | 22.20 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 18 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 15 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Baseline | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 15 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 15 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 18 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 15 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 18 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 15 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 3 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Baseline | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 15 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 15 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 3 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 6 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 18 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 6: | 0.0 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 3 | 11.10 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 15 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 6 | 22.20 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 6 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 6 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 18 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 6 | 33.30 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 3 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 15 | 0.00 Units on a scale |
| Participants With ALK Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 6 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 6 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 3 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 15 | 16.65 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 15 | 33.35 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 18 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 15 | 16.65 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 15 | 33.35 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 9 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Baseline | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 6 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 15 | 50.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 9 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 6 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 3 | 66.70 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 15 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Baseline | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 6 | 16.65 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 18 | 66.70 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 15 | 16.65 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 18 | 0.0 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 6 | 16.65 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 3 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 9 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 6 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Baseline | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 9 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 3 | 22.20 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 3 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 3 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 18 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 9 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 9 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Baseline | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 3 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 6 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 6: | 0.0 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 18 | 100.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 9 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 6 | 16.65 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 12 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 15 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 18 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 3 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 12 | 16.65 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 12 | 0.0 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Baseline | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Baseline | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 12 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Baseline | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 15 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 9 | 27.75 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 12 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 18 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when walking: Month 18 | 66.70 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 3 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 12 | 0.0 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 12 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 9 | 100.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 3 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 12 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 9 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 9 | 0.0 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 9 | 16.65 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Peripheral neuropathy: Month 12 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Baseline | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 15 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 6 | 100.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Alopecia: Month 12 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dysphagia: Month 6 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Month 18 | 100.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 3 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 12 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 18 | 66.70 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Baseline | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when resting: Month 3 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 12 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 9 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Arm/Shoulders: Month 18 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Baseline | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Other Parts: Month 12 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Baseline | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain other parts: Month 6 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Baseline | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain relief after medication: Month 12 | 100.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 6 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Sore mouth: Month 18 | 0.0 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 3 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 15 | 50.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Baseline | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Coughing: Month 3 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 15 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Haemoptysis: Month 15 | 0.0 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain chest: Month 9 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain Chest: Month 18 | 33.30 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Pain arm/shoulders: Month 6 | 0.00 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea: Month 15 | 33.35 Units on a scale |
| Participants With ROS1 Gene Rearrangement | European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 | Dyspnoea when stairs: Baseline | 33.30 Units on a scale |
Secondary
Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement
In this outcome measure, number of participants were categorized Yes or No for search of other biological markers.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | No | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | Yes | 49 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | No | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | Yes | 11 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | No | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | Yes | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | No | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | Yes | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | No | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | Yes | 47 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | No | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement | Yes | 18 Participants |
Secondary
Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement
In this outcome measure, number of participants were categorized according to analysis platform to detect ALK and ROS1 gene rearrangement. Analysis platform included following sites: University hospital center (UHC) Alsace Cancer center of Strasbourg - Hospital Center of Mulhouse - Hospital Center of Colmar; UHC Aquitaine - Hospital Center de Bordeaux - La Réunion; UHC Bourgogne - Hospital Center of Dijon, UHC of Tours - Orléans; UHC Haute-Normandie - Hospital Center of Rouen, Ile-de-France AP - HP; UHC Languedoc Roussillon - Hospital Center of Montpellier - UHC of Nîmes; UHC Nord-Pas-de-Calais - Hospital Center of Lille; UHC Pays-de-la-Loire - Hospital Center of Nantes; UHC Pays-de-la-Loire - Hospital Center of Angers; UHC Picardie, Amiens; UHC Provence Alpes Côte d'Azur - Hospital Center of Nice; UHC Provence Alpes Côte d'Azur - Hospital Center of Marseille; UHC Rhône Alpes - Hospital Center of Lyon; UHC Rhône Alpes - Hospital Center of Grenoble; and other platform.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Haute-Normandie - Hospital Center of Rouen | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Aquitaine - Hospital Center de Bordeaux - La Réunion | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Bourgogne - Hospital Center of Dijon | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC of Tours - Orléans | 6 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Alsace Cancer center of Strasbourg - Hospital Center of Mulhouse - Hospital Center of Colmar | 10 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Ile-de-France AP - HP | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Languedoc Roussillon - Hospital Center of Montpellier - University hospital center of Nîmes | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Nord-Pas-de-Calais - Hospital Center of Lille | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Nantes | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Angers | 3 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Picardie, Amiens | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Nice | 3 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Marseille | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Lyon | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Grenoble | 8 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other platform | 8 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC of Tours - Orléans | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Nantes | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Nord-Pas-de-Calais - Hospital Center of Lille | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Languedoc Roussillon - Hospital Center of Montpellier - University hospital center of Nîmes | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Bourgogne - Hospital Center of Dijon | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Alsace Cancer center of Strasbourg - Hospital Center of Mulhouse - Hospital Center of Colmar | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Lyon | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Marseille | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Nice | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Haute-Normandie - Hospital Center of Rouen | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Aquitaine - Hospital Center de Bordeaux - La Réunion | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other platform | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Picardie, Amiens | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Angers | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Grenoble | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Ile-de-France AP - HP | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Grenoble | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC of Tours - Orléans | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Haute-Normandie - Hospital Center of Rouen | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Ile-de-France AP - HP | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Languedoc Roussillon - Hospital Center of Montpellier - University hospital center of Nîmes | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Nord-Pas-de-Calais - Hospital Center of Lille | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Nantes | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Angers | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Picardie, Amiens | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Nice | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other platform | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Marseille | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Lyon | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Alsace Cancer center of Strasbourg - Hospital Center of Mulhouse - Hospital Center of Colmar | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Aquitaine - Hospital Center de Bordeaux - La Réunion | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Bourgogne - Hospital Center of Dijon | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC of Tours - Orléans | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Nantes | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Haute-Normandie - Hospital Center of Rouen | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Bourgogne - Hospital Center of Dijon | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Aquitaine - Hospital Center de Bordeaux - La Réunion | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Nice | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Grenoble | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Lyon | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Picardie, Amiens | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Angers | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Nord-Pas-de-Calais - Hospital Center of Lille | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Marseille | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Alsace Cancer center of Strasbourg - Hospital Center of Mulhouse - Hospital Center of Colmar | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Ile-de-France AP - HP | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other platform | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Languedoc Roussillon - Hospital Center of Montpellier - University hospital center of Nîmes | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC of Tours - Orléans | 6 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Bourgogne - Hospital Center of Dijon | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Haute-Normandie - Hospital Center of Rouen | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Alsace Cancer center of Strasbourg - Hospital Center of Mulhouse - Hospital Center of Colmar | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Languedoc Roussillon - Hospital Center of Montpellier - University hospital center of Nîmes | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Ile-de-France AP - HP | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Nord-Pas-de-Calais - Hospital Center of Lille | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Grenoble | 9 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Picardie, Amiens | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other platform | 5 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Nice | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Nantes | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Aquitaine - Hospital Center de Bordeaux - La Réunion | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Angers | 5 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Marseille | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Lyon | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Nord-Pas-de-Calais - Hospital Center of Lille | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Nantes | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Grenoble | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Haute-Normandie - Hospital Center of Rouen | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Rhône Alpes - Hospital Center of Lyon | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Pays-de-la-Loire - Hospital Center of Angers | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other platform | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Picardie, Amiens | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Nice | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC of Tours - Orléans | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Aquitaine - Hospital Center de Bordeaux - La Réunion | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Provence Alpes Côte d'Azur - Hospital Center of Marseille | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Bourgogne - Hospital Center of Dijon | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Ile-de-France AP - HP | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Languedoc Roussillon - Hospital Center of Montpellier - University hospital center of Nîmes | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | UHC Alsace Cancer center of Strasbourg - Hospital Center of Mulhouse - Hospital Center of Colmar | 7 Participants |
Secondary
Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18
Number of participants were categorized according to clinical response as evaluated by physician. Clinical response was categorized into disease improvement, disease stabilization or disease degradation.
Time frame: Month 3, 6, 9, 12, 15 and 18
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease stabilization | 12 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stabilization | 20 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease degradation | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Improvement | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease degradation | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Improvement | 14 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stabilization | 18 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease degradation | 3 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease degradation | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease degradation | 7 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stabilization | 17 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Improvement | 9 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease stabilization | 14 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stabilization | 17 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Improvement | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Improvement | 6 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease degradation | 7 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Improvement | 21 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease degradation | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Improvement | 6 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Improvement | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stabilization | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Improvement | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stabilization | 8 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease degradation | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease degradation | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease degradation | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease stabilization | 6 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Improvement | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Improvement | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease stabilization | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease degradation | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stabilization | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stabilization | 7 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Improvement | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease degradation | 3 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Improvement | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stabilization | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease degradation | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Improvement | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stabilization | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease degradation | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Improvement | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stabilization | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease degradation | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Improvement | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stabilization | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease degradation | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Improvement | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease stabilization | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease degradation | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Improvement | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease stabilization | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease degradation | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stabilization | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Improvement | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease degradation | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease degradation | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Improvement | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease degradation | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Improvement | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Improvement | 3 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stabilization | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stabilization | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease degradation | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stabilization | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stabilization | 18 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Improvement | 5 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stabilization | 20 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Improvement | 13 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease degradation | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease degradation | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease stabilization | 18 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Improvement | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease degradation | 5 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease stabilization | 18 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stabilization | 22 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease degradation | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease degradation | 9 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Improvement | 21 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Improvement | 8 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stabilization | 17 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Improvement | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease degradation | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stabilization | 7 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Improvement | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease degradation | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Improvement | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Improvement | 10 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stabilization | 7 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease degradation | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Improvement | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Improvement | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease degradation | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease stabilization | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease degradation | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Improvement | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease degradation | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stabilization | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease degradation | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease stabilization | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stabilization | 6 Participants |
Secondary
Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement
In this outcome measure, the number of participants were categorized according to diagnostic method used to detect ALK and ROS1 gene rearrangement.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Cytology | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Histology | 47 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Cytology | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Histology | 13 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Cytology | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Histology | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Cytology | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Histology | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Histology | 44 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Cytology | 7 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Cytology | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Histology | 20 Participants |
Secondary
Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18
In this outcome measure, participants were categorized according to location of progression in already existing metastasis which were located at adrenal glands, bone, brain, liver, lymph node, pleural, plueral liver, pleural lymph node, brain pleural, and kidney. Only those rows are reported with at least 1 participant as data for any reporting arm.
Time frame: Month 3, 6, 9, 12, 15 and 18
Population: FAS analyzed. Overall Number of Participants Analyzed = 0, signifies there was no participant with progression at already existing metastasis sites in respective arm. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. At Month 18 no participant had progression at already existing metastasis sites for any reporting arm, hence no rows for Month 18 are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 3 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 3 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 3 | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Liver: Month 3 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Adrenal glands: Month 3 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural, liver: Month 3 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Adrenal glands: Month 6 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 6 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 6 | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 6 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural: Month 6 | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural, lymph node: Month 6 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 9 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain, pleural: Month 9 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 9 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Other: Month 9 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 12 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain, liver, bone: Month 12 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Kidney: Month 15 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Liver: Month 15 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 15 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 6 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural: Month 6 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Adrenal glands: Month 6 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural, lymph node: Month 6 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural, liver: Month 3 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 6 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 3 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 3 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 6 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Liver: Month 3 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Adrenal glands: Month 3 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 3 | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Liver: Month 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Adrenal glands: Month 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural, liver: Month 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 3 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Other: Month 9 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 3 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural, liver: Month 3 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Liver: Month 15 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Adrenal glands: Month 6 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 12 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 6 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 6 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 6 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain, liver, bone: Month 12 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural: Month 6 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural, lymph node: Month 6 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 9 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Kidney: Month 15 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain, pleural: Month 9 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Adrenal glands: Month 3 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 9 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 3 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 3 | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 15 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Liver: Month 3 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Kidney: Month 15 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 6 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Liver: Month 15 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Liver: Month 3 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Adrenal glands: Month 3 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural, liver: Month 3 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 6 | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 12 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Other: Month 9 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 3 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 9 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain, liver, bone: Month 12 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural: Month 6 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 6 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Pleural, lymph node: Month 6 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 15 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Adrenal glands: Month 6 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 9 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Lymph node: Month 3 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 3 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Brain, pleural: Month 9 | 0 Participants |
Secondary
Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18
In this outcome measure, number of participants were categorized according to progression at location of new metastases. Location of new metastases included contralateral lung, extrathoracic lymph node, brain, liver, bone, adrenal glands, lymphangite carcinomateuse and pleural. Only those categories in which at least 1 participant had data were reported.
Time frame: Month 3, 6, 9, 12, 15 and 18
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Overall Number of Participants Analyzed = 0, signifies there was no participant with new metastases as site of progression in the respective arm. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 9 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 15 | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Other: Month 9 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 3 | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 15 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 12 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 6 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Other: Month 12 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Contralateral lung: Month 15 | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 3 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 6 | 3 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 6 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Lymphangite carcinomateuse: Month 6 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Pleural: Month 6 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Contralateral lung: Month 6 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 9 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Other: Month 15 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Pleural: Month 6 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 12 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Lymphangite carcinomateuse: Month 6 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 6 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 18 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Contralateral lung: Month 6 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 6 | 3 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 3 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 9 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 6 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Other: Month 9 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 3 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 9 | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 6 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 6 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 6 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Contralateral lung: Month 6 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Pleural: Month 6 | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Lymphangite carcinomateuse: Month 6 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 18 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 3 | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 3 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Contralateral lung: Month 6 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 6 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 6 | 6 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 6 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Lymphangite carcinomateuse: Month 6 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Pleural: Month 6 | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 9 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 9 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Other: Month 9 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 12 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Other: Month 12 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Contralateral lung: Month 15 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 15 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 15 | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Other: Month 15 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 15 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 9 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Bone: Month 3 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 15 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Extrathoracic lymph node: Month 9 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Brain: Month 3 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Contralateral lung: Month 15 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Other: Month 9 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Other: Month 15 | 0 Participants |
Secondary
Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement
In this outcome measure, number of participants were categorized according to origin of specimen to detect ALK and ROS1 gene rearrangement. Origins of specimen included: primitive tumor, thoracic lymph node, extrathoracic lymph node, bone, adrenal glands and pleural.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Thoracic lymph node | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Adrenal glands | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Pleural | 6 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Bone | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Primitive tumor | 37 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 3 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Bone | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Thoracic lymph node | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Primitive tumor | 10 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Adrenal glands | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Pleural | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Adrenal glands | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Primitive tumor | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Thoracic lymph node | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Bone | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Pleural | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Bone | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Thoracic lymph node | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Primitive tumor | 3 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Pleural | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Adrenal glands | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Thoracic lymph node | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Bone | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Adrenal glands | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Pleural | 6 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Primitive tumor | 36 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Thoracic lymph node | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Primitive tumor | 16 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Adrenal glands | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Bone | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Extrathoracic lymph node | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Pleural | 2 Participants |
Secondary
Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement
In this outcome measure, number of participants were categorized according to the techniques used to detect ALK and ROS1 gene rearrangement. Techniques involved were: Immunohistochemistry (IHC); Fluorescence in situ hybridisation (FISH); Reverse transcriptase polymerase chain reaction (RT-PCR); Next-Generation Sequencing (NGS); Other; and Associations-FISH, IHC, IHC+FISH, IHC+FISH+NGS, NGS.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC | 14 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: NGS | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH+NGS | 13 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: FISH | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | FISH | 34 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | IHC | 46 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | RT-PCR | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | NGS | 16 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH | 17 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+NGS | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+NGS | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | NGS | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | RT-PCR | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: NGS | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH+NGS | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH | 10 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | IHC | 14 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: FISH | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | FISH | 12 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: FISH | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | FISH | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | IHC | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | RT-PCR | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+NGS | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | NGS | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: NGS | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH+NGS | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+NGS | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | IHC | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | FISH | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | RT-PCR | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | NGS | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: FISH | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH+NGS | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: NGS | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH | 21 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | RT-PCR | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: NGS | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+NGS | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH+NGS | 8 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | FISH | 32 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | IHC | 47 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | NGS | 12 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC | 15 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: FISH | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: FISH | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: NGS | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH | 7 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Other | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | NGS | 7 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+FISH+NGS | 7 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | RT-PCR | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | FISH | 17 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC+NGS | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | IHC | 17 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement | Associations: IHC | 3 Participants |
Secondary
Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18
Number of participants were categorized according to tumor response per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Tumor response included total (complete) response (CR), partial response (PR), stable disease (SD) or disease progression (PD) on imaging. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. Unequivocal progression of existing non-target lesions. 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.
Time frame: Month 3, 6, 9, 12, 15 and 18
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Total response | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Total response | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Progression | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Partial response | 19 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Progression | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Total response | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Partial response | 14 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Partial response | 9 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Progression | 5 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stable | 13 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Partial response | 16 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stable | 5 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stable | 6 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease stable | 3 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Total response | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Progression | 11 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease stable | 5 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Partial response | 8 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Partial response | 25 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Total response | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Total response | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stable | 7 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Progression | 5 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Progression | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Partial response | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease stable | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Progression | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stable | 3 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Progression | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Progression | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Total response | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stable | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Partial response | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Partial response | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stable | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Partial response | 3 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Progression | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Total response | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Partial response | 6 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Total response | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Partial response | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Total response | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease stable | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Total response | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Progression | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stable | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Progression | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Total response | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Progression | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Partial response | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Total response | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Progression | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Progression | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease stable | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Partial response | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Total response | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Total response | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease stable | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Total response | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stable | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stable | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Partial response | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Partial response | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Progression | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Total response | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stable | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Progression | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Progression | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Partial response | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Partial response | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stable | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Total response | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Progression | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Total response | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Partial response | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stable | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Progression | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Total response | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Partial response | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stable | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Progression | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Partial response | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Progression | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stable | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Total response | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Partial response | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stable | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Progression | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Total response | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Progression | 5 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease stable | 5 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Partial response | 9 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Total response | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Partial response | 18 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Total response | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Progression | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stable | 7 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Partial response | 27 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stable | 5 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Partial response | 14 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Total response | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Total response | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Partial response | 22 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stable | 12 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Progression | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Progression | 11 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Total response | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Progression | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease stable | 5 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stable | 6 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Partial response | 10 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Total response | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Progression | 7 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Total response | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Partial response | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Disease stable | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Progression | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Total response | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Partial response | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Disease stable | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Progression | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Total response | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Partial response | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Disease stable | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Progression | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Total response | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Partial response | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Disease stable | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Progression | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Total response | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Partial response | 7 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Disease stable | 6 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Progression | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Total response | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Partial response | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Disease stable | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Progression | 5 Participants |
Secondary
Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18
Compliance to study drug was evaluated using Morisky score. The questionnaire consisted of 4 questions in which the scale was 0 for yes (indicating poor compliance) and 1 for no (indicating good compliance). The items were summed to give a range of scores from 0 to 4. A score of 4 indicated high compliance, 2-3 indicated medium compliance and 0-1 indicated low compliance.
Time frame: Month 3, 6, 9, 12, 15 and 18
Population: Safety population included all enrolled participants who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 14 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 1 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 10 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 4 | 19 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 2 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 3 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 1 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 5 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 3 | 5 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 2 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 1 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 4 | 10 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 8 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 8 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 4 | 12 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 1 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 3 | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 4 | 17 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 3 | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 3 | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 2 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 4 | 7 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 2 | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 2 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 4 | 28 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 2 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 1 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 1 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 13 Participants |
| Crizotinib: First Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 3 | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 3 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 4 | 3 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 3 | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 3 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 1 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 2 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 4 | 10 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 3 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 1 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 2 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 1 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 2 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 3 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 4 | 6 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 1 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 1 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 4 | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 2 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 3 | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 2 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 4 | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 3 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 3 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 1 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 2 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 4 | 3 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 1 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 2 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 2 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 1 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 2 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 4 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 2 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 2 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 4 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 2 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 1 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 1 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 4 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 4 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 1 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 1 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 4 | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 3 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 4 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 3 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 3 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 4 | 2 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 1 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 2 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 1 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 4 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 4 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 2 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 1 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 2 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 2 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 3 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 4 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 1 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 3 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 3 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 9 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 11 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 1 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 2 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 3 | 6 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 4 | 30 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 14 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 1 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 2 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 3 | 5 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 4 | 20 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 7 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 1 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 2 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 3 | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 4 | 18 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 10 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 1 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 2 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 3 | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 4 | 12 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 9 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 1 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 2 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 3 | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 4 | 11 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 1 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 2 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 3 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 4 | 8 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 3 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 2 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 1 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 2 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 4 | 2 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 4 | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 3 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 2 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Morisky score 1 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 6 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 4 | 5 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 1 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 1 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 3 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 2 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Morisky score 1 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 6 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 2 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 8 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 4 | 11 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Morisky score 3 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 4 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 2 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 1 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Morisky score 4 | 3 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Morisky score 3 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Morisky score 3 | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Serious AE: any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and all Non-SAEs.
Time frame: Up to maximum of 18 months
Population: Safety population included all enrolled participants who received at least 1 dose of Crizotinib.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 49 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 32 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 13 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 6 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 2 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 3 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 47 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 25 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 20 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 14 Participants |
| Participants With Unknown Gene Rearrangement | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 0 Participants |
| Participants With Unknown Gene Rearrangement | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 Participants |
Secondary
Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18
In this outcome measure, number of participants were categorized on the basis of conduction of biopsy on progression as Yes' or No.
Time frame: Month 3, 6, 9, 12, 15 and 18
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | No | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | No | 10 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Yes | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Yes | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | No | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Yes | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | No | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Yes | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | No | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Yes | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | No | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | No | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Yes | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | No | 4 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Yes | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | No | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Yes | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | No | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Yes | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Yes | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 18 | No | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Yes | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | No | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Yes | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Yes | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | No | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | No | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | No | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Yes | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Yes | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Yes | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 18 | Yes | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | No | 5 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | No | 4 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | No | 10 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 18 | No | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Yes | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Yes | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | No | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | No | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | No | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | No | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Yes | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | Missing | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Yes | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | Yes | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | Yes | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | Missing | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | No | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | Yes | 1 Participants |
Secondary
Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18
In this outcome measure, number of participants whose progression was noted at already existing metastasis sites were reported.
Time frame: Month 3, 6, 9, 12, 15 and 18
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 6 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 4 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 3 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 2 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 18 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 6 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 18 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 2 Participants |
Secondary
Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18
In this outcome measure, participants with new metastases as the site of progression were reported.
Time frame: Month 3, 6, 9, 12, 15 and 18
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 3 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 3 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 5 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 3 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 18 | 1 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 0 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 18 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 3 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 7 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 4 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 0 Participants |
Secondary
Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18
In this outcome measure, number of participants whose progression was noted at primary tumor site were reported.
Time frame: Month 3, 6, 9, 12, 15 and 18
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 2 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 0 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 1 Participants |
| Crizotinib: First Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 0 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 1 Participants |
| Crizotinib: Second Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 18 | 0 Participants |
| Crizotinib: Third Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 1 Participants |
| Crizotinib: Other Line of Treatment | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 18 | 0 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 2 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 1 Participants |
| Participants With ALK Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 1 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 0 Participants |
| Participants With ROS1 Gene Rearrangement | Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 0 Participants |
Secondary
Objective Response Rate (ORR)
The objective response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) based on RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits.
Time frame: Maximum up to 18 months
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crizotinib: First Line of Treatment | Objective Response Rate (ORR) | 56.9 Percentage of participants |
| Crizotinib: Second Line of Treatment | Objective Response Rate (ORR) | 66.7 Percentage of participants |
| Crizotinib: Third Line of Treatment | Objective Response Rate (ORR) | 50 Percentage of participants |
| Crizotinib: Other Line of Treatment | Objective Response Rate (ORR) | 100 Percentage of participants |
| Participants With ALK Gene Rearrangement | Objective Response Rate (ORR) | 62.7 Percentage of participants |
| Participants With ROS1 Gene Rearrangement | Objective Response Rate (ORR) | 55 Percentage of participants |
Secondary
Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18
Time since diagnosis to progression (months) was calculated as: progression date minus date of biopsy that enabled making the diagnosis divided by 365.35/12. If the day of the diagnosis was missing, it was replaced by the 15th of the month for calculation. If the day of the progression was missing, it was replaced by the 1st of the month for calculation.
Time frame: Month 3, 6, 9, 12, 15 and 18
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Crizotinib: First Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 7.10 Months |
| Crizotinib: First Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 11.35 Months |
| Crizotinib: First Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 9.30 Months |
| Crizotinib: First Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 4.30 Months |
| Crizotinib: First Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 17.00 Months |
| Crizotinib: Second Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 35.45 Months |
| Crizotinib: Second Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 50.60 Months |
| Crizotinib: Second Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 16.85 Months |
| Crizotinib: Second Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 62.90 Months |
| Crizotinib: Second Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 17.80 Months |
| Crizotinib: Second Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 18 | 57.50 Months |
| Crizotinib: Third Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 35.90 Months |
| Crizotinib: Other Line of Treatment | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 140.60 Months |
| Participants With ALK Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 18 | 57.50 Months |
| Participants With ALK Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 6.70 Months |
| Participants With ALK Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 10.40 Months |
| Participants With ALK Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 10.50 Months |
| Participants With ALK Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 11.35 Months |
| Participants With ALK Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 17.50 Months |
| Participants With ROS1 Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 9 | 10.30 Months |
| Participants With ROS1 Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 3 | 2.90 Months |
| Participants With ROS1 Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 15 | 15.10 Months |
| Participants With ROS1 Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 6 | 7.30 Months |
| Participants With ROS1 Gene Rearrangement | Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 | Month 12 | 12.80 Months |
Secondary
Time to Median Progression Free Survival (Months) With Its 95%CI
PFS was defined as the time between the treatment start (date of the first Crizotinib intake) and the date of the first disease progression or the all-cause death. Participants who did not progress or were still alive at the end of the study or at the date of cut-off were censored at the last disease evaluation date.
Time frame: 18 months
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizotinib: First Line of Treatment | Time to Median Progression Free Survival (Months) With Its 95%CI | 9.2 Months |
| Crizotinib: Second Line of Treatment | Time to Median Progression Free Survival (Months) With Its 95%CI | 9.2 Months |
| Crizotinib: Third Line of Treatment | Time to Median Progression Free Survival (Months) With Its 95%CI | NA Months |
| Crizotinib: Other Line of Treatment | Time to Median Progression Free Survival (Months) With Its 95%CI | NA Months |
| Participants With ALK Gene Rearrangement | Time to Median Progression Free Survival (Months) With Its 95%CI | 9.4 Months |
| Participants With ROS1 Gene Rearrangement | Time to Median Progression Free Survival (Months) With Its 95%CI | 6.6 Months |
Secondary
Treatment Duration Until Progression With Brain Metastases
Treatment duration until progression with brain metastases (weeks) was calculated as: (\[date of progression - first treatment intake date\] + 1) divided by 7. If the day of the progression was missing, it was replaced by the 1st of the month for calculation.
Time frame: Baseline
Population: FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizotinib: First Line of Treatment | Treatment Duration Until Progression With Brain Metastases | 35.55 Months |
| Crizotinib: Second Line of Treatment | Treatment Duration Until Progression With Brain Metastases | 29.70 Months |
| Participants With ALK Gene Rearrangement | Treatment Duration Until Progression With Brain Metastases | 29.40 Months |
| Participants With ROS1 Gene Rearrangement | Treatment Duration Until Progression With Brain Metastases | 62.00 Months |