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| ID | Type | Description | Link |
|---|---|---|---|
| ALK-2016-CPHG | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| French College of General Hospital Pneumologists (CPHG) | OTHER |
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Descriptive Observational Study.
Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals
Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.
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| Measure | Description | Time Frame |
|---|---|---|
| Age: Line of Treatment | Baseline | |
| Body Weight: Line of Treatment and Gene Rearrangement | Body weight in kilograms (kg) measured at baseline were reported. | Baseline |
| 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). | Baseline |
| Gender: Line of Treatment | Baseline | |
| 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. | Baseline |
| 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. | Baseline |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
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Inclusion criteria
Non-inclusion criteria
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Participants with ALK positive or ROS1-positive Locally advanced or metastatic non-small cell lung cancer NSCLC, initiated in the previous 3 months or participants initiating crizotinib treatment regardless of the line of treatment
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie | Aix-en-Provence | 13616 | France | |||
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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). |
| FG001 | 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 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). |
| FG002 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number analyzed: signify number of participants with evaluable non-missing data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Age: Line of Treatment | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Mean | Standard Deviation | Years | Baseline |
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Up to maximum of 18 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all enrolled participants who received at least 1 dose of Crizotinib.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crizotinib: First Line of Treatment | Participants included in this arm were treated with crizotinib as first line of treatment for advanced or metastatic NSCLC with ALK or ROS 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA v19 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2018 | Jan 10, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2020 | Jan 10, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. |
| Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Month 3, 6, 9, 12, 15 and 18 |
| 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. | Month 3, 6, 9, 12, 15 and 18 |
| 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. | Month 3, 6, 9, 12, 15 and 18 |
| 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. | Month 3, 6, 9, 12, 15 and 18 |
| 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. | Month 3, 6, 9, 12, 15 and 18 |
| 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. | Month 3, 6, 9, 12, 15 and 18 |
| 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. | Month 3, 6, 9, 12, 15 and 18 |
| 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. | Month 3, 6, 9, 12, 15 and 18 |
| 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. | Baseline |
| 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". | Month 3, 6, 9, 12, 15 and 18 |
| 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. | Maximum up to 18 months |
| 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. | Month 12, 18 |
| European Organization for 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). | Baseline, Month 3, 6, 9, 12, 15, 18 |
| 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. | 18 months |
| 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. | 18 months |
| 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. | Month 3, 6, 9, 12, 15 and 18 |
| 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. | Up to maximum of 18 months |
| Clinique de l Europe |
| Amiens |
| 80000 |
| France |
| Hopital Robert Ballanger, Service de Pneumologie | Aulnay-sous-Bois | 93 602 | France |
| Centre Hospitalier d Avignon | Avignon | 84902 | France |
| Centre Hospitalier de Beauvais | Beauvais | 60021 | France |
| Centre Hospitalier General Beziers, Service De Pneumologie | Béziers | 34525 | France |
| Centre Hospitalier de Cannes | Cannes | 06414 | France |
| Centre Hospitalier Chalon sur Saone William Morey | Chalon-sur-Saône | 71321 | France |
| Centre Hospitalier Metropole de Savoie-Site de Chambery | Chambéry | 73000 | France |
| Hopitaux Civils de Colmar - Hopital Louis Pasteur | Colmar | 68024 | France |
| Centre Hospitalier ALPES LEMAN | Contamine-sur-Arve | 74130 | France |
| Centre Hospitalier Intercommunal Frejus | Fréjus | 83600 | France |
| Centre Hospitalier Départemental Les Oudairies | La Roche-sur-Yon | 85925 | France |
| CHD Vendee | La Roche-sur-Yon | 85925 | France |
| Le Mans Hospital Center | Le Mans | 72037 | France |
| Centre Hospitalier des Deux Vallees - Longjumeau BP 125 | Longjumeau | 91161 | France |
| Hopital Europeen - Service de Pneumologie | Marseille | 13003 | France |
| Centre Hospitalier de Macon | Mâcon | 71018 | France |
| GHR Mulhouse Sud Alsace | Mulhouse | 68051 | France |
| Centre Hospitalier de l'Agglomeration de Nevers | Nevers | 58033 | France |
| Centre Hospitalier Regional d Orleans | Orléans | 45000 | France |
| Centre Hospitalier Annecy Genevois | Pringy | 74374 | France |
| Groupe Hospitalier Sud Reunion | Saint Pierre La Réunion | 97448 | France |
| Hopitaux du Leman | Thonon-les-Bains | France |
| Centre Hospitalier de Troyes, Service de Pneumologie - Oncologie Thoracique | Troyes | 10003 | France |
| Centre Hospitalier de Villefranche sur Saone - BP80436 | Villefranche-sur-Saône | 69655 | France |
| Withdrawn due to adverse event (AE) |
|
| Participant not met eligibility criteria |
|
| BG001 |
| 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). |
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Number analyzed: signify number of participants with evaluable non-missing data. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 | Crizotinib: Third Line of Treatment | Participants included in this arm were treated with crizotinib as third line of treatment for advanced or metastatic NSCLC with ALK or ROS 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). |
| OG003 | Crizotinib: Other Line of Treatment | Participants included in this arm were treated with crizotinib as other line than first, second or third of treatment for advanced or metastatic NSCLC with ALK or ROS 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). |
|
|
| Primary | Body Weight: Line of Treatment and Gene Rearrangement | Body weight in kilograms (kg) measured at baseline were reported. | 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. | Posted | Mean | Standard Deviation | Kilogram | Baseline |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | Kilogram per square meter | Baseline |
|
|
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| Primary | Gender: Line of Treatment | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | 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. | Posted | Mean | Standard Deviation | Pack-years | Baseline |
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| 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. | 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. | Posted | Mean | Standard Deviation | Years | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Median | Inter-Quartile Range | Months | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Months | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Cycles | Baseline |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Months | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Gray unit | Baseline |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Months | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Days | Baseline |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Baseline |
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| 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. | 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. | Posted | Count of Participants | Participants | Month 3, 6, 9, 12, 15 and 18 |
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| 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. | 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. | Posted | Count of Participants | Participants | Month 3, 6, 9, 12, 15 and 18 |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Months | Month 3, 6, 9, 12, 15 and 18 |
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| 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. | 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. | Posted | Count of Participants | Participants | Month 3, 6, 9, 12, 15 and 18 |
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| 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. | 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. | Posted | Count of Participants | Participants | Month 3, 6, 9, 12, 15 and 18 |
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| 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. | 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. | Posted | Count of Participants | Participants | Month 3, 6, 9, 12, 15 and 18 |
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| 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. | 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. | Posted | Count of Participants | Participants | Month 3, 6, 9, 12, 15 and 18 |
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| 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. | 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. | Posted | Count of Participants | Participants | Month 3, 6, 9, 12, 15 and 18 |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Months | Baseline |
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| 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". | 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. | Posted | Count of Participants | Participants | Month 3, 6, 9, 12, 15 and 18 |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Number | Percentage of participants | Maximum up to 18 months |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Number | Percentage of participants | Month 12, 18 |
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| 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). | 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. | Posted | Median | Inter-Quartile Range | Units on a scale | Baseline, Month 3, 6, 9, 12, 15, 18 |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Median | 95% Confidence Interval | Months | 18 months |
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| 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. | FAS included all eligible participants (with known ALK or ROS1 gene rearrangement) who received at least 1 dose of Crizotinib. | Posted | Number | 95% Confidence Interval | Percentage of participants | 18 months |
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| 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. | 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. | Posted | Count of Participants | Participants | Month 3, 6, 9, 12, 15 and 18 |
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| 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. | Safety population included all enrolled participants who received at least 1 dose of Crizotinib. | Posted | Count of Participants | Participants | Up to maximum of 18 months |
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| 21 |
| 51 |
| 32 |
| 51 |
| 42 |
| 51 |
| EG001 | Crizotinib: Second Line of Treatment | Participants included in this arm were treated with crizotinib as second line of treatment for advanced or metastatic NSCLC with ALK or ROS 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). | 3 | 15 | 6 | 15 | 12 | 15 |
| EG002 | Crizotinib: Third Line of Treatment | Participants included in this arm were treated with crizotinib as third line of treatment for advanced or metastatic NSCLC with ALK or ROS 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). | 0 | 2 | 0 | 2 | 2 | 2 |
| EG003 | Crizotinib: Other Line of Treatment | Participants included in this arm were treated with crizotinib as other line than first, second or third of treatment for advanced or metastatic NSCLC with ALK or ROS 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). | 0 | 3 | 1 | 3 | 3 | 3 |
| EG004 | 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). | 13 | 51 | 25 | 51 | 43 | 51 |
| EG005 | 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). | 11 | 20 | 14 | 20 | 16 | 20 |
| EG006 | 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). | 0 | 2 | 0 | 2 | 0 | 2 |
| DEATH | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| COMPLICATION ASSOCIATED WITH DEVICE | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| CONDITION AGGRAVATED | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| PYREXIA | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| INTESTINAL INFARCTION | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19 | Non-systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| CANDIDA INFECTION | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| LYMPHANGITIS | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| PNEUMOCYSTIS JIROVECII | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| UROSEPSIS | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| BRADYCARDIA | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| CARDIOPULMONARY FAILURE | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| TACHYARRHYTHMIA | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| CEREBRAL VENOUS SINUS THROMBOSIS | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| CEREBRAL VENOUS THROMBOSIS | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| NEURALGIA | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| OSTEOPOROTIC FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA v19 | Non-systematic Assessment |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA v19 | Non-systematic Assessment |
|
| PRODUCT DISPENSING ERROR | Injury, poisoning and procedural complications | MedDRA v19 | Non-systematic Assessment |
|
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA v19 | Non-systematic Assessment |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA v19 | Non-systematic Assessment |
|
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA v19 | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA v19 | Non-systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA v19 | Non-systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v19 | Non-systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA v19 | Non-systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA v19 | Non-systematic Assessment |
|
| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA v19 | Non-systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA v19 | Non-systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA v19 | Non-systematic Assessment |
|
| DISABILITY | Social circumstances | MedDRA v19 | Non-systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| APHTHOUS ULCER | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| FUNCTIONAL GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| GASTRIC DISORDER | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| GASTROINTESTINAL MOTILITY DISORDER | Gastrointestinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| FATIGUE | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| CREPITATIONS | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| FACE OEDEMA | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| PYREXIA | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| ADVERSE EVENT | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| CONDITION AGGRAVATED | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| DISCOMFORT | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| MALAISE | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| MASS | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| MUCOSAL DRYNESS | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| PAIN | General disorders | MedDRA v19 | Non-systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| TASTE DISORDER | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| COGNITIVE DISORDER | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| DYSAESTHESIA | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| HEAD DISCOMFORT | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| HYPERAESTHESIA | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| HYPERSOMNIA | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| MOTOR DYSFUNCTION | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| TENSION HEADACHE | Nervous system disorders | MedDRA v19 | Non-systematic Assessment |
|
| VISUAL IMPAIRMENT | Eye disorders | MedDRA v19 | Non-systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA v19 | Non-systematic Assessment |
|
| PHOTOPSIA | Eye disorders | MedDRA v19 | Non-systematic Assessment |
|
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA v19 | Non-systematic Assessment |
|
| CHALAZION | Eye disorders | MedDRA v19 | Non-systematic Assessment |
|
| CATARACT | Eye disorders | MedDRA v19 | Non-systematic Assessment |
|
| CHROMATOPSIA | Eye disorders | MedDRA v19 | Non-systematic Assessment |
|
| VITREOUS FLOATERS | Eye disorders | MedDRA v19 | Non-systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| TRANSAMINASES INCREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| BLOOD COUNT ABNORMAL | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| BREATH SOUNDS ABNORMAL | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| CREATININE RENAL CLEARANCE DECREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| GAMMAGLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| LIPASE INCREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| VITAMIN D DECREASED | Investigations | MedDRA v19 | Non-systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Non-systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA v19 | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA v19 | Non-systematic Assessment |
|
| FOOD AVERSION | Metabolism and nutrition disorders | MedDRA v19 | Non-systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA v19 | Non-systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA v19 | Non-systematic Assessment |
|
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA v19 | Non-systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v19 | Non-systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA v19 | Non-systematic Assessment |
|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA v19 | Non-systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA v19 | Non-systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| BONE LESION | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| TINEA VERSICOLOUR | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| SUPERINFECTION | Infections and infestations | MedDRA v19 | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA v19 | Non-systematic Assessment |
|
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA v19 | Non-systematic Assessment |
|
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA v19 | Non-systematic Assessment |
|
| POLLAKIURIA | Renal and urinary disorders | MedDRA v19 | Non-systematic Assessment |
|
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA v19 | Non-systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| PRURIGO | Skin and subcutaneous tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| SKIN DISORDER | Skin and subcutaneous tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA v19 | Non-systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA v19 | Non-systematic Assessment |
|
| MENIERE'S DISEASE | Ear and labyrinth disorders | MedDRA v19 | Non-systematic Assessment |
|
| TINNITUS | Ear and labyrinth disorders | MedDRA v19 | Non-systematic Assessment |
|
| BRADYCARDIA | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| CARDIAC DISORDER | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| SINUS BRADYCARDIA | Cardiac disorders | MedDRA v19 | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA v19 | Non-systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA v19 | Non-systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA v19 | Non-systematic Assessment |
|
| LYMPHOEDEMA | Vascular disorders | MedDRA v19 | Non-systematic Assessment |
|
| THROMBOPHLEBITIS SUPERFICIAL | Vascular disorders | MedDRA v19 | Non-systematic Assessment |
|
| HEPATIC CYTOLYSIS | Hepatobiliary disorders | MedDRA v19 | Non-systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA v19 | Non-systematic Assessment |
|
| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA v19 | Non-systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA v19 | Non-systematic Assessment |
|
| MIXED ANXIETY AND DEPRESSIVE DISORDER | Psychiatric disorders | MedDRA v19 | Non-systematic Assessment |
|
| SLEEP DISORDER | Psychiatric disorders | MedDRA v19 | Non-systematic Assessment |
|
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19 | Non-systematic Assessment |
|
| LIPOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19 | Non-systematic Assessment |
|
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA v19 | Non-systematic Assessment |
|
| HIP ARTHROPLASTY | Surgical and medical procedures | MedDRA v19 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Male |
|
| Female |
|
| Ex-smoker |
|
| Current smoker |
|
|
| Duration of quitting smoke for ex-smoker |
|
|
| Yes |
|
| >= 2 |
|
| Carcinom indifferencier |
|
| Other |
|
| IIIB |
|
| IVA |
|
| IVB |
|
| Upper left lobe |
|
| Middle right lobe |
|
| Lower right lobe |
|
| Lower left lobe |
|
| Yes |
|
| 2 |
|
| >=3 |
|
| Extrathoracic lymph node |
|
| Brain |
|
| Liver |
|
| Bone |
|
| Adrenal glands |
|
| Pleural effusion |
|
| Other |
|
| No |
|
| Yes |
|
| Second line |
|
| Third line |
|
|
| Second line chemotherapy |
|
|
| Third line chemotherapy |
|
|
|
| Second line chemotherapy |
|
|
| Third line chemotherapy |
|
|
| No |
|
| Yes |
|
| Radiotherapies |
|
| Tyrosine Kinase inhibitor |
|
|
| Radiotherapy dose |
|
|
|
| Radiotherapies |
|
|
| Cytology |
|
| Thoracic lymph node |
|
| Extrathoracic lymph node |
|
| Bone |
|
| Adrenal glands |
|
| Pleural |
|
| 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 - University hospital center 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 |
|
| Other platform |
|
| FISH |
|
| RT-PCR |
|
| NGS |
|
| Other |
|
| Associations: FISH |
|
| Associations: IHC |
|
| Associations: IHC+FISH |
|
| Associations: IHC+FISH+NGS |
|
| Associations: IHC+NGS |
|
| Associations: NGS |
|
|
| ROS1+ |
|
|
| Yes |
|
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Month 15 |
|
|
| Month 18 |
|
|
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Month 15 |
|
|
| Month 18 |
|
|
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Month 15 |
|
|
| Month 18 |
|
|
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Month 15 |
|
|
| Month 18 |
|
|
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Month 15 |
|
|
| Month 18 |
|
|
|
| Bone: Month 3 |
|
|
| Brain: Month 3 |
|
|
| Liver: Month 3 |
|
|
| Lymph node: Month 3 |
|
|
| Pleural, liver: Month 3 |
|
|
| Adrenal glands: Month 6 |
|
|
| Bone: Month 6 |
|
|
| Brain: Month 6 |
|
|
| Lymph node: Month 6 |
|
|
| Pleural: Month 6 |
|
|
| Pleural, lymph node: Month 6 |
|
|
| Brain: Month 9 |
|
|
| Brain, pleural: Month 9 |
|
|
| Lymph node: Month 9 |
|
|
| Other: Month 9 |
|
|
| Brain: Month 12 |
|
|
| Brain, liver, bone: Month 12 |
|
|
| Kidney: Month 15 |
|
|
| Liver: Month 15 |
|
|
| Lymph node: Month 15 |
|
|
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Month 15 |
|
|
| Month 18 |
|
|
|
| Bone: Month 3 |
|
|
| Contralateral lung: Month 6 |
|
|
| Extrathoracic lymph node: Month 6 |
|
|
| Brain: Month 6 |
|
|
| Bone: Month 6 |
|
|
| Lymphangite carcinomateuse: Month 6 |
|
|
| Pleural: Month 6 |
|
|
| Extrathoracic lymph node: Month 9 |
|
|
| Brain: Month 9 |
|
|
| Other: Month 9 |
|
|
| Bone: Month 12 |
|
|
| Other: Month 12 |
|
|
| Contralateral lung: Month 15 |
|
|
| Extrathoracic lymph node: Month 15 |
|
|
| Brain: Month 15 |
|
|
| Other: Month 15 |
|
|
| Extrathoracic lymph node: Month 18 |
|
|
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Month 15 |
|
|
| Month 18 |
|
|
| Month 18 |
|
|
| Haemoptysis: Baseline |
|
|
| Dyspnoea: Baseline |
|
|
| Dyspnoea when resting: Baseline |
|
|
| Dyspnoea when walking: Baseline |
|
|
| Dyspnoea when stairs: Baseline |
|
|
| Sore mouth: Baseline |
|
|
| Dysphagia: Baseline |
|
|
| Peripheral neuropathy: Baseline |
|
|
| Alopecia: Baseline |
|
|
| Pain Chest: Baseline |
|
|
| Pain Arm/Shoulders: Baseline |
|
|
| Pain Other Parts: Baseline |
|
|
| Pain relief after medication: Baseline |
|
|
| Coughing: Month 3 |
|
|
| Haemoptysis: Month 3 |
|
|
| Dyspnoea: Month 3 |
|
|
| Dyspnoea when resting: Month 3 |
|
|
| Dyspnoea when walking: Month 3 |
|
|
| Dyspnoea when stairs: Month 3 |
|
|
| Sore mouth: Month 3 |
|
|
| Dysphagia: Month 3 |
|
|
| Peripheral neuropathy: Month 3 |
|
|
| Alopecia: Month 3 |
|
|
| Pain chest: Month 3 |
|
|
| Pain arm/shoulders: Month 3 |
|
|
| Pain other parts: Month 3 |
|
|
| Pain relief after medication: Month 3 |
|
|
| Coughing: Month 6 |
|
|
| Haemoptysis: Month 6: |
|
|
| Dyspnoea: Month 6 |
|
|
| Dyspnoea when resting: Month 6 |
|
|
| Dyspnoea when walking: Month 6 |
|
|
| Dyspnoea when stairs: Month 6 |
|
|
| Sore mouth: Month 6 |
|
|
| Dysphagia: Month 6 |
|
|
| Peripheral neuropathy: Month 6 |
|
|
| Alopecia: Month 6 |
|
|
| Pain chest: Month 6 |
|
|
| Pain arm/shoulders: Month 6 |
|
|
| Pain other parts: Month 6 |
|
|
| Pain relief after medication: Month 6 |
|
|
| Coughing: Month 9 |
|
|
| Haemoptysis: Month 9 |
|
|
| Dyspnoea: Month 9 |
|
|
| Dyspnoea when resting: Month 9 |
|
|
| Dyspnoea when walking: Month 9 |
|
|
| Dyspnoea when stairs: Month 9 |
|
|
| Sore mouth: Month 9 |
|
|
| Dysphagia: Month 9 |
|
|
| Peripheral neuropathy: Month 9 |
|
|
| Alopecia: Month 9 |
|
|
| Pain chest: Month 9 |
|
|
| Pain arm/shoulders: Month 9 |
|
|
| Pain other parts: Month 9 |
|
|
| Pain relief after medication: Month 9 |
|
|
| Coughing: Month 12 |
|
|
| Haemoptysis: Month 12 |
|
|
| Dyspnoea: Month 12 |
|
|
| Dyspnoea when resting: Month 12 |
|
|
| Dyspnoea when walking: Month 12 |
|
|
| Dyspnoea when stairs: Month 12 |
|
|
| Sore mouth: Month 12 |
|
|
| Dysphagia: Month 12 |
|
|
| Peripheral neuropathy: Month 12 |
|
|
| Alopecia: Month 12 |
|
|
| Pain Chest: Month 12 |
|
|
| Pain Arm/Shoulders: Month 12 |
|
|
| Pain Other Parts: Month 12 |
|
|
| Pain relief after medication: Month 12 |
|
|
| Coughing: Month 15 |
|
|
| Haemoptysis: Month 15 |
|
|
| Dyspnoea: Month 15 |
|
|
| Dyspnoea when resting: Month 15 |
|
|
| Dyspnoea when walking: Month 15 |
|
|
| Dyspnoea when stairs: Month 15 |
|
|
| Sore mouth: Month 15 |
|
|
| Dysphagia: Month 15 |
|
|
| Peripheral neuropathy: Month 15 |
|
|
| Alopecia: Month 15 |
|
|
| Pain Chest: Month 15 |
|
|
| Pain Arm/Shoulders: Month 15 |
|
|
| Pain Other Parts: Month 15 |
|
|
| Pain relief after medication: Month 15 |
|
|
| Coughing: Month 18 |
|
|
| Haemoptysis: Month 18 |
|
|
| Dyspnoea: Month 18 |
|
|
| Dyspnoea when resting: Month 18 |
|
|
| Dyspnoea when walking: Month 18 |
|
|
| Dyspnoea when stairs: Month 18 |
|
|
| Sore mouth: Month 18 |
|
|
| Dysphagia: Month 18 |
|
|
| Peripheral neuropathy: Month 18 |
|
|
| Alopecia: Month 18 |
|
|
| Pain Chest: Month 18 |
|
|
| Pain Arm/Shoulders: Month 18 |
|
|
| Pain Other Parts: Month 18 |
|
|
| Pain relief after medication: Month 18 |
|
|
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Month 15 |
|
|
| Month 18 |
|
|
| SAE |
|
| Improvement |
|
| Disease stabilization |
|
| Disease degradation |
|
| Improvement |
|
| Disease stabilization |
|
| Disease degradation |
|
| Improvement |
|
| Disease stabilization |
|
| Disease degradation |
|
| Improvement |
|
| Disease stabilization |
|
| Disease degradation |
|
| Improvement |
|
| Disease stabilization |
|
| Disease degradation |
|
| Total response |
|
| Partial response |
|
| Disease stable |
|
| Progression |
|
| Total response |
|
| Partial response |
|
| Disease stable |
|
| Progression |
|
| Total response |
|
| Partial response |
|
| Disease stable |
|
| Progression |
|
| Total response |
|
| Partial response |
|
| Disease stable |
|
| Progression |
|
| Total response |
|
| Partial response |
|
| Disease stable |
|
| Progression |
|
| Yes |
|
| Missing |
|
| Yes |
|
| Missing |
|
| Yes |
|
| Missing |
|
| Yes |
|
| Missing |
|
| Missing |
|
| Morisky score 1 |
|
| Morisky score 2 |
|
| Morisky score 3 |
|
| Morisky score 4 |
|
| Morisky score 1 |
|
| Morisky score 2 |
|
| Morisky score 3 |
|
| Morisky score 4 |
|
| Morisky score 1 |
|
| Morisky score 2 |
|
| Morisky score 3 |
|
| Morisky score 4 |
|
| Morisky score 1 |
|
| Morisky score 2 |
|
| Morisky score 3 |
|
| Morisky score 4 |
|
| Morisky score 1 |
|
| Morisky score 2 |
|
| Morisky score 3 |
|
| Morisky score 4 |
|