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A single-Arm, open-label, multi-center, phase I/II study in which the pharmacokinetics, safety, tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with locally advanced or metastatic NSCLC harboring a confirmed ALK rearrangement. Patients must have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy. Approximately 100 patients will be enrolled. For the first 15 patients enrolled in this study, patients will have an additional 5-day PK run-in period before treatment period. The pharmacokinetics profile of LDK378 in Chinese adult patients with ALK-rearranged NSCLC will be evaluated.
This is a phase I/II, open-label, multi-center study in which the PK, safety, tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with locally advanced or metastatic NSCLC harboring a confirmed ALK rearrangement (positive) as assessed using the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) or positive as assessed by immunohistochemistry (IHC) test (Ventana Medical Systems, Inc) using rabbit monoclonal primary antibody assay (D5F3).
Patients must have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy.
Approximately 100 patients with locally advanced or metastatic NSCLC which carry ALK -rearrangement will be enrolled in the study. The first 15 patients to be enrolled in the study will have PK sampling over 120-hour during the 5-day PK run-in period following a single oral dose at 750 mg. After the PK run-in period, the treatment period will start in which LDK378 will be given starting on Cycle 1 Day 1 in a continuous daily oral dosing in 28-day cycles. Separated from these 15 patients, the rest of the enrolled patients will receive LDK378 treatment at 750 mg QD on Cycle 1 Day 1.
Tumor response will be evaluated every 8 weeks (i.e. every 2 cycles) starting from the first day of treatment with LDK378 until the time of RECIST-defined PD by investigator assessment, withdrawal of consent for further follow-up, loss to follow-up or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDK378 | Experimental | daily dosing, 28-day cycle patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDK378 | Drug | 750 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Pharmacokinetics (PK) Parameters of of LDK378 After Daily Oral Dose: AUClast, AUC0-24h, AUCinf | AUClast: The area under the concentration-time curve from time zero to the last measurable concentration time. AUC0-24h: The area under the plasma concentration-time curve calculated from time zero to 24 hours. AUCinf: Area under the plasma (serum, or blood) concentration versus time curve from time zero to infinity | PK run-in phase (0h, 1h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 96h after PK run-in dose and predose Cycle 1 day 1 (C1D1)(approximately 120h after PK run in dose)) |
| Primary Pharmacokinetics (PK) Parameter of of LDK378 After Daily Oral Dose: AUC0-24h | AUC0-24h: The area under the plasma concentration-time curve calculated from time zero to 24 hours. | Cycle 2 Day 1 (after one cycle (28 days) of continous dosing)(0h, 1h, 2h, 3h, 4h , 6h , 8h and 24h) |
| Primary Pharmacokinetics (PK) Parameter of LDK378 After Daily Oral Dose: Cmax | Cmax is the maximum (peak) concentration of drug in plasma | PK run-in phase (0h, 1h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 96h after PK run-in dose and predose Cycle 1 day 1 (C1D1)(approximately 120h after PK run in dose)) and C2D1(after one cycle (28 days) of continous dosing)(0h, 1h, 2h, 3h, 4h , 6h , 8h and 24h) |
| Primary Pharmacokinetics (PK) Parameter of LDK378 After Daily Oral Dose: Tmax | Tmax is the time to reach maximum plasma concentration. | PK run-in phase (0h, 1h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 96h after PK run-in dose and predose Cycle 1 day 1 (C1D1)(approximately 120h after PK run in dose)) and C2D1(after one cycle (28 days) of continous dosing)(0h, 1h, 2h, 3h, 4h , 6h , 8h and 24h) |
| Overall Summary of Adverse Events (AEs) - Per Occurence | Safety and tolerability of LDK378 at 750 mg once daily dose in Chinese adult patients with ALK-rearranged locally advanced or metastatic NSCLC |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Per RECIST 1.1 Per Investigator Assessment | ORR calculated as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR). CR is the 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. PR is 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 criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Beijing | Beijing Municipality | 100730 | China | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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Not Completed means that the participants discontinued from the treatment phase
Approximately 100 patients were planned to be enrolled, and 103 patients were actually enrolled and analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDK378 | daily dosing, 28-day cycle patients |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2017 | Jul 24, 2018 |
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| up to 41 months |
| 40 months |
| ORR Per RECIST 1.1 Per Blind Independent Review Committee (BIRC) Assessment | ORR per RECIST 1.1 calculated as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR). CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | 40 months |
| Duration of Response (DOR) Per Investigator Assessment | DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or all cause death. CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | 40 months |
| Disease Control Rate (DCR) Per Investigator Assessment | DCR, calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD). CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. SD is neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD 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. | 40 months |
| Time to Response (TTR) Per Investigator Assessment | TTR, calculated as the time from first dose of LDK378 to first documented response (CR+PR). CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | 40 months |
| Overall Intracranial Response Rate (OIRR) Per Investigator Assessment | OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline. CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | 40 months |
| Overall Intracranial Response Rate (OIRR) Per BIRC Assessment | OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline. CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | 40 months |
| Progression Free Survival (PFS) Per Investigator Assessment | PFS, defined as time from first dose of LDK378 to progression or death due to any cause. | 40 months |
| Overall Survival (OS) | OS, defined as time from first dose of LDK378 to death due to any cause. | 40 months |
| Duration of Response (DOR) Per BIRC Assessment | DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or all cause death. CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | 40 months |
| Disease Control Rate (DCR) Per BIRC Assessment | DCR, calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD). CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. SD is neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD 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. | 40 months |
| Time to Response (TTR) Per BIRC Assessment | TTR, calculated as the time from first dose of LDK378 to first documented response (CR+PR). CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | 40 months |
| Progression Free Survival (PFS) Per BIRC Assessment | PFS, defined as time from first dose of LDK378 to progression or death due to any cause. | 40 months |
| Chongqing |
| Chongqing Municipality |
| 400037 |
| China |
| Novartis Investigative Site | Guangzhou | Guangdong | 51000 | China |
| Novartis Investigative Site | Changchun | Jilin | 130012 | China |
| Novartis Investigative Site | Shanghai | Shanghai Municipality | 200032 | China |
| Novartis Investigative Site | Shanghai | Shanghai Municipality | 200433 | China |
| Novartis Investigative Site | Xi’an | Shanxi | 710038 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310003 | China |
| Novartis Investigative Site | Beijing | 100021 | China |
| Novartis Investigative Site | Beijing | 100036 | China |
| Novartis Investigative Site | Beijing | 100039 | China |
| Novartis Investigative Site | Chongqing | 400038 | China |
| Novartis Investigative Site | Guang Dong Province | 510120 | China |
| Novartis Investigative Site | Guangzhou | 510060 | China |
|
| Entered Post-treatment Follow-up |
|
| Entered Survival Follow-up |
|
| Discontinue From Study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | LDK378 | daily dosing, 28-day cycle patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib. | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex: Female, Male | The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib. | Count of Participants | Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib. | Number | 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 | Primary Pharmacokinetics (PK) Parameters of of LDK378 After Daily Oral Dose: AUClast, AUC0-24h, AUCinf | AUClast: The area under the concentration-time curve from time zero to the last measurable concentration time. AUC0-24h: The area under the plasma concentration-time curve calculated from time zero to 24 hours. AUCinf: Area under the plasma (serum, or blood) concentration versus time curve from time zero to infinity | The Pharmacokinetic Analysis Set (PAS) consists of all patients who receive at least one dose of LDK378 and provide at least one evaluable PK sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | PK run-in phase (0h, 1h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 96h after PK run-in dose and predose Cycle 1 day 1 (C1D1)(approximately 120h after PK run in dose)) |
|
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| |||||||||||||||||||||||||||
| Primary | Primary Pharmacokinetics (PK) Parameter of of LDK378 After Daily Oral Dose: AUC0-24h | AUC0-24h: The area under the plasma concentration-time curve calculated from time zero to 24 hours. | The Pharmacokinetic Analysis Set (PAS) consists of all patients who receive at least one dose of LDK378 and provide at least one evaluable PK sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Cycle 2 Day 1 (after one cycle (28 days) of continous dosing)(0h, 1h, 2h, 3h, 4h , 6h , 8h and 24h) |
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| Primary | Primary Pharmacokinetics (PK) Parameter of LDK378 After Daily Oral Dose: Cmax | Cmax is the maximum (peak) concentration of drug in plasma | The Pharmacokinetic Analysis Set (PAS) consists of all patients who receive at least one dose of LDK378 and provide at least one evaluable PK sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | PK run-in phase (0h, 1h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 96h after PK run-in dose and predose Cycle 1 day 1 (C1D1)(approximately 120h after PK run in dose)) and C2D1(after one cycle (28 days) of continous dosing)(0h, 1h, 2h, 3h, 4h , 6h , 8h and 24h) |
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| ||||||||||||||||||||||||||||
| Primary | Primary Pharmacokinetics (PK) Parameter of LDK378 After Daily Oral Dose: Tmax | Tmax is the time to reach maximum plasma concentration. | The Pharmacokinetic Analysis Set (PAS) consists of all patients who receive at least one dose of LDK378 and provide at least one evaluable PK sample. | Posted | Median | Full Range | hour | PK run-in phase (0h, 1h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 96h after PK run-in dose and predose Cycle 1 day 1 (C1D1)(approximately 120h after PK run in dose)) and C2D1(after one cycle (28 days) of continous dosing)(0h, 1h, 2h, 3h, 4h , 6h , 8h and 24h) |
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| Primary | Overall Summary of Adverse Events (AEs) - Per Occurence | Safety and tolerability of LDK378 at 750 mg once daily dose in Chinese adult patients with ALK-rearranged locally advanced or metastatic NSCLC | The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Number | occurrences | up to 41 months |
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| Secondary | Overall Response Rate (ORR) Per RECIST 1.1 Per Investigator Assessment | ORR calculated as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR). CR is the 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. PR is 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) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Number | Percentage of participants | 40 months |
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| Secondary | ORR Per RECIST 1.1 Per Blind Independent Review Committee (BIRC) Assessment | ORR per RECIST 1.1 calculated as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR). CR is the 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. PR is 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) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Number | 95% Confidence Interval | Percentage of participants | 40 months |
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| Secondary | Duration of Response (DOR) Per Investigator Assessment | DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or all cause death. CR is the 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. PR is 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) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Median | 95% Confidence Interval | months | 40 months |
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| Secondary | Disease Control Rate (DCR) Per Investigator Assessment | DCR, calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD). CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. SD is neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD 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. | The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Number | 95% Confidence Interval | Percentage of participants | 40 months |
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| Secondary | Time to Response (TTR) Per Investigator Assessment | TTR, calculated as the time from first dose of LDK378 to first documented response (CR+PR). CR is the 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. PR is 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) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Median | Full Range | Months | 40 months |
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| Secondary | Overall Intracranial Response Rate (OIRR) Per Investigator Assessment | OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline. CR is the 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. PR is 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) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Number | 95% Confidence Interval | Percentage of participants | 40 months |
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| Secondary | Overall Intracranial Response Rate (OIRR) Per BIRC Assessment | OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline. CR is the 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. PR is 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) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Number | 95% Confidence Interval | Percentage of participants | 40 months |
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| Secondary | Progression Free Survival (PFS) Per Investigator Assessment | PFS, defined as time from first dose of LDK378 to progression or death due to any cause. | The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Median | 95% Confidence Interval | Months | 40 months |
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| Secondary | Overall Survival (OS) | OS, defined as time from first dose of LDK378 to death due to any cause. | The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Median | 95% Confidence Interval | Months | 40 months |
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| Secondary | Duration of Response (DOR) Per BIRC Assessment | DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or all cause death. CR is the 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. PR is 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) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Median | 95% Confidence Interval | months | 40 months |
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| Secondary | Disease Control Rate (DCR) Per BIRC Assessment | DCR, calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD). CR is the 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. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. SD is neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD 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. | The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Number | 95% Confidence Interval | Percentage of participants | 40 months |
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| Secondary | Time to Response (TTR) Per BIRC Assessment | TTR, calculated as the time from first dose of LDK378 to first documented response (CR+PR). CR is the 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. PR is 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) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Median | Full Range | Months | 40 months |
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| Secondary | Progression Free Survival (PFS) Per BIRC Assessment | PFS, defined as time from first dose of LDK378 to progression or death due to any cause. | The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib. | Posted | Median | 95% Confidence Interval | Months | 40 months |
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Adverse Events are collected and reported from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to 41 months.
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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 | LDK378 | daily dosing, 28-day cycle patients | 23 | 103 | 36 | 103 | 101 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Ureteric cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gallbladder enlargement | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Apolipoprotein A-I decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Creatinine renal clearance increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Electrocardiogram QT interval | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphocyte percentage decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Neutrophil percentage increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Ureteric cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthma exercise induced | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Choking sensation | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (20.1) | 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 | novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 7, 2015 | Jul 24, 2018 | Prot_001.pdf |
| 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
|
| AUCinf |
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| All deaths |
| |||||
| On-treatment deaths |
| |||||
| Adverse Events (AEs) |
| |||||
| AEs suspected to be drug related |
| |||||
| Serious Adverse Events (SAEs) |
| |||||
| SAEs suspected to be drug related |
| |||||
| AEs leading to discontinuation |
| |||||
| AEs requiring dose interruption |
| |||||
| AEs requiring dose adjustment |
| |||||
| AEs requiring dose adjustment or interruption |
| |||||
| AEs requiring additional therapy |
|
|
|
|
|
|
|
|
|
| Title | Denominators | Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
|
|
|
| Title | Denominators | Categories |
|---|
|