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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003432-24 | EudraCT Number |
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A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDK378 | Experimental | Patients treated with ceritinib/LDK378 750 mg once-daily, fasted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDK378 | Drug | Ceritinib/LDK378 was supplied as 150 mg hard gelatin capsules and were administered orally, once-daily at a dose of 750 mg on a continuous dosing schedule (5 x 150 mg capsules). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) to LDK378 Per Investigator Assessment | ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | 6 cycles of 28 days up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR Per Blinded Independent Review Committee (BIRC) Assessment | ORR (CR+PR) by BIRC is calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by BIRC. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
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Inclusion critieria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville | Arkansas | 72703 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28369553 | Derived | Hida T, Satouchi M, Nakagawa K, Seto T, Matsumoto S, Kiura K, Nokihara H, Murakami H, Tokushige K, Hatano B, Nishio M. Ceritinib in patients with advanced, crizotinib-treated, anaplastic lymphoma kinase-rearranged NSCLC: Japanese subset. Jpn J Clin Oncol. 2017 Jul 1;47(7):618-624. doi: 10.1093/jjco/hyx045. | |
| 27432917 | Derived |
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Approximately 137 patients were planned to be enrolled. A total of 140 patients were enrolled and treated with ceritinib.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDK378 750mg | Patients treated with ceritinib/LDK378 750 mg once-daily, fasted. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 6 cycles of 28 days up to 24 weeks |
| Duration of Response (DOR) by Investigator | DOR, calculated as the time from the date of the first confirmed CR or PR to the first documented progression or death due to any cause, by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | 6 cycles of 28 days up to 24 weeks |
| Duration of Response (DOR) by BIRC | DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by BIRC (Blinded Imaging Review Committee). CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | 6 cycles of 28 days up to 24 weeks |
| Disease Control Rate (DCR) | DCR was calculated as the percentage of patients with best overall response of CR, PR, SD, or non-CR non-PD (NCRNPD), per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD (NCRNPD): refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline. | 6 cycles of 28 days up to 24 weeks |
| Time to Response (TTR) Per Investigator | TTR is the time from date of start of treatment to the first CR or PR observed which were confirmed afterwards. | 6 cycles of 28 days up to 24 weeks |
| Time to Response (TTR) Per BIRC | TTR is the time from date of start of treatment to the first CR or PR observed which are confirmed afterwards. | 6 cycles of 28 days up to 24 weeks |
| Progression-free Survival (PFS) Per Investigator | PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment. | 6 cycles of 28 days up to 24 weeks |
| Progression-free Survival (PFS) Per BIRC | PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment. | 6 cycles of 28 days up to 24 weeks |
| Overall Intracranial Response Rate (OIRR) Per Investigator | OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline. | 6 cycles of 28 days up to 24 weeks |
| Overall Intracranial Response Rate (OIRR) Per BIRC | OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline. | 6 cycles of 28 days up to 24 weeks |
| Overall Survival (OS) | OS, defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. | 6 cycles of 28 days up to 24 weeks |
| City of Hope National Medical Center Dept of Oncology 2 |
| Duarte |
| California |
| 91010-3000 |
| United States |
| University of California at Los Angeles Reg-5 | Los Angeles | California | 90095 | United States |
| University of California at San Diego, Moores Cancer Ctr SC | San Diego | California | 92103 | United States |
| Stanford University Medical Center Stanford Cancer Center(2) | Stanford | California | 94304 | United States |
| University of Colorado Hospital SC | Aurora | Colorado | 80045 | United States |
| Emory University School of Medicine/Winship Cancer Institute Dept of Oncology | Atlanta | Georgia | 30322 | United States |
| University of Chicago Medical Center SC | Chicago | Illinois | 60637 | United States |
| University of Kansas Cancer Center DeptofUofKansas CancerCenter-2 | Kansas City | Kansas | 66160 | United States |
| Cancer Center of Kansas Dept of CCK | Wichita | Kansas | 67214-3728 | United States |
| Maryland Oncology Hematology, P.A. SC | Rockville | Maryland | 20850 | United States |
| Massachusetts General Hospital Mass General | Boston | Massachusetts | 02114 | United States |
| Levine Cancer Institute SC 1 | Charlotte | North Carolina | 28203 | United States |
| Sarah Cannon Research Institute Drug Ship - 4 | Nashville | Tennessee | 37203 | United States |
| U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office | Dallas | Texas | 75390 | United States |
| Seattle Cancer Care Alliance SC-1 | Seattle | Washington | 98105 | United States |
| University of Wisconsin Univ Wisc 2 | Madison | Wisconsin | 53792 | United States |
| Novartis Investigative Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Novartis Investigative Site | Oshawa | Ontario | L1G 2B9 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Marseille | 13915 | France |
| Novartis Investigative Site | Paris | 75970 | France |
| Novartis Investigative Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Hong Kong | Hong Kong |
| Novartis Investigative Site | Avellino | AV | 83100 | Italy |
| Novartis Investigative Site | Livorno | LI | 57124 | Italy |
| Novartis Investigative Site | Monza | MB | 20900 | Italy |
| Novartis Investigative Site | Milan | MI | 20141 | Italy |
| Novartis Investigative Site | Perugia | PG | 06129 | Italy |
| Novartis Investigative Site | Parma | PR | 43100 | Italy |
| Novartis Investigative Site | Nagoya | Aichi-ken | 464-8681 | Japan |
| Novartis Investigative Site | Kashiwa | Chiba | 277-8577 | Japan |
| Novartis Investigative Site | Akashi | Hyōgo | 673-8558 | Japan |
| Novartis Investigative Site | Okayama | Okayama-ken | 700-8558 | Japan |
| Novartis Investigative Site | Sayama | Osaka | 589-8511 | Japan |
| Novartis Investigative Site | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | 104-0045 | Japan |
| Novartis Investigative Site | Koto | Tokyo | 135-8550 | Japan |
| Novartis Investigative Site | Fukuoka | 811-1395 | Japan |
| Novartis Investigative Site | Amsterdam | 1081 HV | Netherlands |
| Novartis Investigative Site | Groningen | 9713 GZ | Netherlands |
| Novartis Investigative Site | Maastricht | 5800 | Netherlands |
| Novartis Investigative Site | Singapore | 169610 | Singapore |
| Novartis Investigative Site | Seoul | Korea | 03080 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 03722 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 06351 | South Korea |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | A Coruña | Galicia | 15006 | Spain |
| Novartis Investigative Site | Madrid | 28046 | Spain |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Crino L, Ahn MJ, De Marinis F, Groen HJ, Wakelee H, Hida T, Mok T, Spigel D, Felip E, Nishio M, Scagliotti G, Branle F, Emeremni C, Quadrigli M, Zhang J, Shaw AT. Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2. J Clin Oncol. 2016 Aug 20;34(24):2866-73. doi: 10.1200/JCO.2015.65.5936. Epub 2016 Jul 18. |
| Entered Post-treatment Efficacy f/u |
|
| Entered Survival Follow up |
|
| Discontinued From Study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LDK378 750mg | Patients treated with ceritinib/LDK378 750 mg once-daily, fasted. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Overall Response Rate (ORR) to LDK378 Per Investigator Assessment | ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 cycles of 28 days up to 24 weeks |
|
|
| |||||||||||||||||||||||||
| Secondary | ORR Per Blinded Independent Review Committee (BIRC) Assessment | ORR (CR+PR) by BIRC is calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by BIRC. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 cycles of 28 days up to 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) by Investigator | DOR, calculated as the time from the date of the first confirmed CR or PR to the first documented progression or death due to any cause, by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per Investigator were included in this analysis. | Posted | Median | 95% Confidence Interval | Months | 6 cycles of 28 days up to 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) by BIRC | DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by BIRC (Blinded Imaging Review Committee). CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per BIRC were included in this analysis. | Posted | Median | 95% Confidence Interval | Months | 6 cycles of 28 days up to 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR was calculated as the percentage of patients with best overall response of CR, PR, SD, or non-CR non-PD (NCRNPD), per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD (NCRNPD): refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline. | Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 cycles of 28 days up to 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) Per Investigator | TTR is the time from date of start of treatment to the first CR or PR observed which were confirmed afterwards. | The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis. | Posted | Mean | Standard Deviation | Months | 6 cycles of 28 days up to 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) Per BIRC | TTR is the time from date of start of treatment to the first CR or PR observed which are confirmed afterwards. | The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis. | Posted | Mean | Standard Deviation | Months | 6 cycles of 28 days up to 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Per Investigator | PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment. | The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. | Posted | Median | 95% Confidence Interval | months | 6 cycles of 28 days up to 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Per BIRC | PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment. | The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. | Posted | Median | 95% Confidence Interval | months | 6 cycles of 28 days up to 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Intracranial Response Rate (OIRR) Per Investigator | OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline. | The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by Investigator were included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 cycles of 28 days up to 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Intracranial Response Rate (OIRR) Per BIRC | OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline. | The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by BIRC were included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 cycles of 28 days up to 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS, defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. | Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. | Posted | Median | 95% Confidence Interval | Months | 6 cycles of 28 days up to 24 weeks |
|
|
Timeframe for AE
AE additional description
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LDK378 750 mg | Patients treated with ceritinib/LDK378 750 mg once-daily, fasted. | 67 | 140 | 139 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| FAECALOMA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| GASTROINTESTINAL TOXICITY | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| RETROPERITONEAL FIBROSIS | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HEPATOCELLULAR INJURY | Hepatobiliary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| EMPYEMA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| ENTERITIS INFECTIOUS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| PLEURAL INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| VIRAL PERICARDITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| PUBIS FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| BLOOD CALCIUM INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| METASTASES TO LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| METASTASES TO MENINGES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| ALTERED STATE OF CONSCIOUSNESS | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HYPERAESTHESIA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| LETHARGY | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| MOTOR DYSFUNCTION | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| PARAESTHESIA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| PARAPARESIS | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| SEIZURE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| SENSORY LOSS | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
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| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
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| POLLAKIURIA | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
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| RENAL FAILURE | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
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| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA (18.1) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (18.1) | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C586847 | ceritinib |
Not provided
Not provided
Not provided
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