Study of Oral cMET Inhibitor INC280 in Patients With EGFR... | NCT02414139 | Trialant
NCT02414139
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Mar 20, 2024Actual
Enrollment
373Actual
Phase
Phase 2
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
Capmatinib
Countries
United States
Argentina
Austria
Belgium
France
Germany
Israel
Italy
Japan
Lebanon
Mexico
Netherlands
Norway
Russia
Singapore
South Korea
Spain
Sweden
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02414139
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CINC280A2201
Secondary IDs
ID
Type
Description
Link
2014-003850-15
EudraCT Number
Brief Title
Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)
Official Title
A Phase II, Multicenter Study of Oral MET Inhibitor INC280 in Adult Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Feb 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 11, 2015Actual
Primary Completion Date
Apr 12, 2023Actual
Completion Date
May 16, 2023Actual
First Submitted Date
Mar 31, 2015
First Submission Date that Met QC Criteria
Apr 7, 2015
First Posted Date
Apr 10, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 19, 2023
Results First Submitted that Met QC Criteria
Feb 20, 2024
Results First Posted Date
Mar 20, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 20, 2024
Last Update Posted Date
Mar 20, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Study to evaluate the efficacy and safety of capmatinib as a single-agent treatment for subjects with advanced/metastatic (stage IIIB or IV) non-small cell lung cancer (NSCLC) who had wild-type epidermal growth factor receptor (EGFR wt) (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK)-negative rearrangement, and mesenchymal epithelial transition (MET) mutations leading to exon 14 deletion (referred to as MET mutation hereafter) and/or MET amplification.
Detailed Description
This was a Phase II, multicenter, open-label study. Patients were enrolled in different cohorts based on their MET status (amplification and/or mutation) and prior treatment status: Cohort 1a, Cohort 1b, Cohort 2, Cohort 3, Cohort 4, Cohort 5a, Cohort 5b, Cohort 6, and Cohort 7. MET mutation (by RT-PCR) and/or MET amplification status by gene copy number (GCN, by FISH) was determined by central laboratory.
Patients in Cohorts 1, 2, 3, and 4 had previously failed 1 or 2 prior lines of systemic therapy, while patients enrolled in Cohorts 5 and 7 were treatment-naïve for advanced disease/metastatic disease. Patients enrolled in Cohort 6 had failed 1 prior line of systemic therapy for advanced/ metastatic disease.
Patients with MET mutation were enrolled in Cohort 4 (pre-treated), Cohort 5b (treatment naïve) or Cohort 7 (treatment naïve expansion cohort of Cohort 5b), irrespective of their MET GCN. The enrollment in expansion Cohort 7 started after the completion of enrollment in Cohort 5b.
Patients without MET mutation, were enrolled in Cohorts 1a, 1b, 2, 3 (pre-treated) or 5a (treatment naïve), based on their MET GCN. Patients enrolled in Cohort 6 (expansion cohort of Cohort 1a and Cohort 4) had either MET GCN ≥10 without MET mutation (Cohort 6.1) or MET mutation, irrespective to their MET GCN (Cohort 6.2). The enrollment in Cohort 6 started upon enrollment completion of the respective Cohort 1a or Cohort 4.
All participants in the study received oral capmatinib 400 mg twice daily. A treatment cycle was defined as 21 days. Treatment with capmatinib continued until patient experienced any of the following: disease progression according to RECIST 1.1 as determined by investigator and confirmed by Blinded Independent Review Committee (BIRC), unacceptable toxicity that precluded further treatment, treatment discontinuation at the discretion of the Investigator or patient, lost to follow-up, or death. Treatment with capmatinib was allowed beyond RECIST 1.1-defined disease progression (as determined by investigator and confirmed by BIRC) if, in the judgment of the investigator, there was evidence of clinical benefit and the patient wished to continue on the study treatment. All patients continued to have safety evaluations for 30 days after the last dose of study treatment.
Patients who discontinued treatment with capmatinib for any reason other than disease progression, as determined by the investigator and confirmed by BIRC, death, withdrawal of consent for further assessments, or being lost to follow-up, continued to have tumor assessments (post-treatment efficacy follow-up) until disease progression confirmed by BIRC, death, withdrawal of consent for further assessments, or lost to follow-up.
All patients who discontinued treatment with capmatinib were followed for survival (post-treatment survival follow-up) until death, loss to follow-up, withdrawal of consent to survival follow-up, or the end of the study.
Conditions Module
Conditions
Carcinoma, Non-Small-Cell Lung
Keywords
Non Small Cell Lung
Non Small Cell Lung Cancer
Non-small cell lung cancer
NSCLC
INC280
EGFR wild-type (wt)
advanced non-small cell lung cancer
advanced/metastatic disease
Non-small cell lung carcinoma (NSCLC)
treatment of lung cancer after first metastasis
lung cancer
lung adenocarcinoma
Non small cell lung carcinoma
MET exon 14 deletion
METex14del
MET exon 14 skipping
MET exon 14 mutation
MET mutation
MET amplification
MET inhibitor
MET dysregulation
MET activation
MET signaling
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
373Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1a: Pre-treated patients with MET GCN ≥ 10 (2/3L)
Experimental
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
Drug: Capmatinib
Cohort 1b:Pre-treated patients with MET GCN ≥ 6 and < 10 (2/3L)
Experimental
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
Drug: Capmatinib
Cohort 2: Pre-treated patients with MET GCN ≥ 4 and < 6 (2/3L)
Experimental
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
Drug: Capmatinib
Cohort 3: Pre-treated patients with MET GCN < 4 (2/3L)
Experimental
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
Drug: Capmatinib
Cohort 4: Pre-treated patients with MET mutation regardless of MET GCN (2/3L)
Experimental
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Capmatinib
Drug
Capmatinib was administered orally, at a dose of 400 mg on a continuous twice daily dosing schedule.
Capmatinib was administered to participants in Cohorts 1a, 1b, 2, 3, 4, 5a and 5b in a fasted state. For Cohorts 6.1. 6.2 and 7, capmatinib was administered either with or without food.
Percentage of participants with a best overall response defined as confirmed complete response (CR) or partial response (PR) by BIRC assessment per RECIST 1.1.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 5 years
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DOR) by BIRC Assessment
Time from the date of the first documented CR or PR by BIRC per RECIST 1.1 to the first documented progression or date of death due to any cause for patients with confirmed PR or CR. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals was reported. If a subject did not have an event, DOR was censored at the date of last adequate tumor assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Subjects with Stage IIIB or IV NSCLC (any histology) at the time of study entry
Subjects with histologically or cytologically confirmed diagnosis of NSCLC that is:
EGFR wt status (for exon 19 deletions and exon 21 L858R substitution mutations)
and ALK rearrangement-negative
and MET-mutation and/or amplification status (as defined in the protocol).
For Cohorts 1a, 1b, 2, 3, 4 subjects must have failed one or two prior lines of systemic therapy for advanced disease (stage IIIB or IV NSCLC). For Cohort 6, subjects must have failed one prior line of systemic therapy for advanced disease (stage IIIB or IV NSCLC).
For Cohorts 5a, 5b, and 7, subjects must not have received any systemic therapy for advanced disease (stage IIIB or IV NSCLC).
Subjects with at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there was clear sign of progression since the irradiation.
Subjects who recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (Common Terminology Criteria for Adverse Events [CTCAE] v 4.03). Subjects with any grade of alopecia were allowed to enter the study.
Subjects with adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Key Exclusion Criteria:
Prior treatment with crizotinib, or any other MET or HGF inhibitor
Characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations.
Characterized ALK-positive rearrangement.
Symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting capmatinib or subjects who had not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy ≤ 2 weeks prior to starting capmatinib or subjects who had not recovered from radiotherapy-related toxicities.
Palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting capmatinib was allowed.
Receiving treatment with strong inducers of CYP3A4 and/or any enzyme-inducing anticonvulsant and could not be discontinued ≥ 1 week prior to the start of treatment with capmatinib and for the duration of the study.
Receiving treatment with unstable or increasing doses of corticosteroids.
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of capmatinib.
Applicable to Cohorts 1-4 and Cohort 6 only: previous anticancer and investigational agents within 4 weeks or ≤ 5 × half-life of the agent (whichever was longer) before first dose of- capmatinib. If previous treatment was a monoclonal antibody, then the treatment must have been discontinued ≥ 4 weeks before first dose of capmatinib. If previous treatment was an oral targeted agent, then the treatment must have been discontinued ≥ 5 × half-life of the agent before the first dose of capmatinib.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 7 days after stopping treatment
Sexually active males unless they used a condom during intercourse while taking drug and for 7 days after stopping treatment and should not father a child in this period.
Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
Wolf J, Hochmair M, Han JY, Reguart N, Souquet PJ, Smit EF, Orlov SV, Vansteenkiste J, Nishio M, de Jonge M, Akerley W, Garon EB, Groen HJM, Tan DSW, Seto T, Frampton GM, Robeva A, Carbini M, Le Mouhaer S, Yovine A, Boran A, Bossen C, Yang Y, Ji L, Fairchild L, Heist RS. Capmatinib in MET exon 14-mutated non-small-cell lung cancer: final results from the open-label, phase 2 GEOMETRY mono-1 trial. Lancet Oncol. 2024 Oct;25(10):1357-1370. doi: 10.1016/S1470-2045(24)00441-8.
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 review 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.
Screening assessments were conducted up to 28 days prior to the start of study treatment
Recruitment Details
Participants were enrolled in 95 centers across 20 countries
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
FG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Periods
Title
Milestones
Reasons Not Completed
Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 28, 2019
Apr 19, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Brazil
Canada
Poland
Switzerland
Turkey (Türkiye)
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
MET pathway
met
cMET
Geometry mono-1
Geometry
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Capmatinib
Cohort 5a: Treatment-naïve patients with MET GCN ≥10 (1L)
Experimental
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
Drug: Capmatinib
Cohort 5b: Treatment-naïve patients with MET mutation regardless of MET GCN (1L)
Experimental
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
Drug: Capmatinib
Cohort 6.1 (expansion of Cohort 1a): Pre-treated patients MET GCN ≥ 10 without MET mutation (2L)
Experimental
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
Drug: Capmatinib
Cohort 6.2 (expansion of Cohort 4): Pre-treated patients with MET mutation (2L)
Experimental
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
Drug: Capmatinib
Cohort 7 (expansion of Cohort 5b): Treatment-naïve with MET mutation regardless of MET GCN (1L)
Experimental
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
Drug: Capmatinib
Cohort 1a: Pre-treated patients with MET GCN ≥ 10 (2/3L)
Cohort 1b:Pre-treated patients with MET GCN ≥ 6 and < 10 (2/3L)
Cohort 2: Pre-treated patients with MET GCN ≥ 4 and < 6 (2/3L)
Cohort 3: Pre-treated patients with MET GCN < 4 (2/3L)
Cohort 4: Pre-treated patients with MET mutation regardless of MET GCN (2/3L)
Cohort 5a: Treatment-naïve patients with MET GCN ≥10 (1L)
Cohort 5b: Treatment-naïve patients with MET mutation regardless of MET GCN (1L)
Cohort 6.1 (expansion of Cohort 1a): Pre-treated patients MET GCN ≥ 10 without MET mutation (2L)
Cohort 6.2 (expansion of Cohort 4): Pre-treated patients with MET mutation (2L)
Cohort 7 (expansion of Cohort 5b): Treatment-naïve with MET mutation regardless of MET GCN (1L)
INC280
Up to approximately 5 years
ORR by Investigator Assessment
Percentage of patients with a best overall response defined as confirmed CR or PR per RECIST 1.1 by investigator assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 5 years
DOR by Investigator Assessment
Time from the date of the first documented CR or PR per RECIST 1.1 by investigator assessment to the first documented progression or death due to any cause for patients with confirmed PR or CR. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals was reported. If a subject did not have an event, DOR was censored at the date of last adequate tumor assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 5 years
Time to Response (TTR) by BIRC Assessment
Time between date of start of treatment until first documented response (confirmed CR or PR) per RECIST 1.1 by BIRC assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 5 years
TTR by Investigator Assessment
Time between date of start of treatment until first documented response (confirmed CR or PR) per RECIST 1.1 by investigator assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 5 years
Disease Control Rate (DCR)
Percentage of participants with a best overall response of confirmed CR, PR or stable disease (SD) per RECIST 1.1 by BIRC and investigator assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Up to approximately 5 years
Progression-Free Survival
Time from start of treatment to the date of the first documented progression or death due to any cause per RECIST 1.1 by BIRC and investigator assessment. Clinical deterioration was not considered as a qualifying event for progression. PFS was censored at the last adequate tumor assessment if one of the following occurred: absence of event or the event occurred after two or more missing tumor assessments.
The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported.
Progressive disease: For target lesions, 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 to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. For non-target lesions, unequivocal progression of existing non-target lesions
Up to approximately 5 years
Overall Survival (OS)
Time from start of treatment to the date of death due to any cause. If the patient was alive at the date of the analysis cut-off or lost to follow-up, then OS was censored at the last contact date prior to data cut-off date.
The Kaplan-Meier method was used to estimate OS, and the median OS, along with 95% confidence intervals, was reported.
Up to approximately 6 years
Pharmacokinetic (PK) Concentrations of Capmatinib
PK concentrations of capmatinib. Plasma concentrations of capmatinib were measured using validated liquid chromatography-tandem mass spectrometry (LCMS/MS) methods with a lower limit of quantification (LLOQ) of approximately 1.0 ng/mL.
Capmatinib concentration data was summarized for Cohorts 1a, 1b, 2, 3, 4, 5a and 5b when capmatinib was administered in fasted state; and for Cohorts 6 and 7 when capmatinib was administered with or without food.
Cycle (C) 1 Day (D) 1 predose and 2 hours post-dose, C1D15 pre-dose and 2 hours post-dose, C3D1 pre-dose. Each Cycle is 21 days
Maximum Concentration (Cmax) of Capmatinib
Cmax of capmatinib was estimated by non-compartmental analysis. Cmax is the maximum plasma drug concentration after single dose administration. Plasma concentrations of capmatinib were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
Maximum Concentration (Cmax) of CMN288
Cmax of CMN288 (metabolite of capmatinib) was estimated by non-compartmental analysis. Cmax is the maximum plasma drug concentration after single dose administration. Plasma concentrations of metabolite CMN288 were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
Area Under the Plasma Concentration-time Curve From Zero to Time Infinity (AUCinf) of Capmatinib
AUCinf of capmatinib was estimated by non-compartmental analysis. AUCinf is the area under the plasma concentration-time curve extrapolated to infinity. Plasma concentrations of capmatinib were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Cycle 1 Day 1 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
Area Under the Plasma Concentration-time Curve From Zero to Time Infinity (AUCinf) of CMN288
AUCinf of CMN288 (metabolite of capmatinib) was estimated by non-compartmental analysis. AUCinf is the area under the plasma concentration-time curve extrapolated to infinity. Plasma concentrations of metabolite CMN288 were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Cycle 1 Day 1 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
Time to Reach Maximum Concentration (Tmax) of Capmatinib
Tmax of capmatinib was estimated by non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations. Plasma concentrations of capmatinib were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
Time to Reach Maximum Concentration (Tmax) of CMN288
Tmax of CMN288 (metabolite of capmatinib) was estimated by non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations. Plasma concentrations of metabolite CMN288 were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from cohorts 1-5, who had an extensive PK collection schedule, were included in this analysis
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
Elimination Half-life (T1/2) of Capmatinib
T1/2 of capmatinib was estimated by non-compartmental analysis. T1/2 is the time it takes for the concentration of capmatinib in the bloodstream to decrease by half. Plasma concentrations of capmatinib were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
Elimination Half-life (T1/2) of CMN288
T1/2 of CMN288 (metabolite of capmatinib) was estimated by non-compartmental analysis. T1/2 is the time it takes for the concentration of CMN288 in the bloodstream to decrease by half. Plasma concentrations of metabolite CMN288 were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
Los Angeles
California
90095
United States
University of California Irvine Medical Center Chao Family Chao Family Comp Cancer Center
Orange
California
92868
United States
H Lee Moffitt Cancer Center and Research Institute .
Tampa
Florida
33612
United States
University of Iowa Hospitals and Clinics SC-3
Iowa City
Iowa
52242
United States
Massachusetts General Hospital MGH Cancer Center
Boston
Massachusetts
02114
United States
VA Ann Arbor Health System VA Ann Arbor Health System
Ann Arbor
Michigan
48105
United States
Mayo Clinic Rochester .
Rochester
Minnesota
55905
United States
Oregon Health and Science University SC
Portland
Oregon
97239
United States
Lehigh Valley Health Network SC
Allentown
Pennsylvania
18103
United States
Andrew and Patel Associates
Camp Hill
Pennsylvania
17011
United States
Mays Cancer Ctr Uthsa Mdacc SC-5
San Antonio
Texas
78229
United States
University of Utah / Huntsman Cancer Institute Oncology
Salt Lake City
Utah
84103
United States
Novartis Investigative Site
CABA
Buenos Aires
C1426ANZ
Argentina
Novartis Investigative Site
Buenos Aires
Buenos Aires F.D.
C1431FWO
Argentina
Novartis Investigative Site
La Rioja
5300
Argentina
Novartis Investigative Site
Vienna
1210
Austria
Novartis Investigative Site
Leuven
3000
Belgium
Novartis Investigative Site
Marseille
Bouches Du Rhone
13915
France
Novartis Investigative Site
Dijon
Cote D Or
21034
France
Novartis Investigative Site
Clermont-Ferrand
63011
France
Novartis Investigative Site
La Tronche
38700
France
Novartis Investigative Site
Lille
59000
France
Novartis Investigative Site
Marseille
13273
France
Novartis Investigative Site
Paris
75970
France
Novartis Investigative Site
Pierre-Bénite
69495
France
Novartis Investigative Site
Rennes
35043
France
Novartis Investigative Site
Strasbourg
67091
France
Novartis Investigative Site
Heidelberg
Baden-Wurttemberg
69126
Germany
Novartis Investigative Site
Berlin
13125
Germany
Novartis Investigative Site
Cologne
50937
Germany
Novartis Investigative Site
Frankfurt
60590
Germany
Novartis Investigative Site
Göttingen
37075
Germany
Novartis Investigative Site
Halle
06120
Germany
Novartis Investigative Site
Hamburg
20251
Germany
Novartis Investigative Site
Hanover
30625
Germany
Novartis Investigative Site
Homburg
66421
Germany
Novartis Investigative Site
München
81925
Germany
Novartis Investigative Site
Nuremberg
90419
Germany
Novartis Investigative Site
Ravensburg
88214
Germany
Novartis Investigative Site
Tübingen
72076
Germany
Novartis Investigative Site
Ulm
89081
Germany
Novartis Investigative Site
Ramat Gan
52621
Israel
Novartis Investigative Site
Tel Aviv
6423906
Israel
Novartis Investigative Site
Bologna
BO
40138
Italy
Novartis Investigative Site
Brescia
BS
25123
Italy
Novartis Investigative Site
Catania
CT
95124
Italy
Novartis Investigative Site
Catanzaro
CZ
88100
Italy
Novartis Investigative Site
Meldola
FC
47014
Italy
Novartis Investigative Site
Florence
FI
50134
Italy
Novartis Investigative Site
Monza
MB
20900
Italy
Novartis Investigative Site
Milan
MI
20141
Italy
Novartis Investigative Site
Milan
MI
20162
Italy
Novartis Investigative Site
Modena
MO
41124
Italy
Novartis Investigative Site
Roma
RM
00155
Italy
Novartis Investigative Site
Verona
VR
37126
Italy
Novartis Investigative Site
Naples
80131
Italy
Novartis Investigative Site
Nagoya
Aichi-ken
464 8681
Japan
Novartis Investigative Site
Nagoya
Aichi-ken
466 8560
Japan
Novartis Investigative Site
Fukuoka
Fukuoka
811-1395
Japan
Novartis Investigative Site
Akashi
Hyōgo
673-8558
Japan
Novartis Investigative Site
Sendai
Miyagi
980 0873
Japan
Novartis Investigative Site
Okayama
Okayama-ken
700-8558
Japan
Novartis Investigative Site
Ōsaka-sayama
Osaka
589 8511
Japan
Novartis Investigative Site
Chuo Ku
Tokyo
104 0045
Japan
Novartis Investigative Site
Koto Ku
Tokyo
135 8550
Japan
Novartis Investigative Site
Ube
Yamaguchi
755-0241
Japan
Novartis Investigative Site
El Achrafiyé
166830
Lebanon
Novartis Investigative Site
Mexico City
Mexico City
14080
Mexico
Novartis Investigative Site
Amsterdam
1066 CX
Netherlands
Novartis Investigative Site
Groningen
9713 GZ
Netherlands
Novartis Investigative Site
Maastricht
6229 HX
Netherlands
Novartis Investigative Site
Rotterdam
3015 GD
Netherlands
Novartis Investigative Site
Oslo
NO 0424
Norway
Novartis Investigative Site
Moscow
109028
Russia
Novartis Investigative Site
Saint Petersburg
192148
Russia
Novartis Investigative Site
Tambov
392000
Russia
Novartis Investigative Site
Singapore
119228
Singapore
Novartis Investigative Site
Singapore
168583
Singapore
Novartis Investigative Site
Bundang Gu
Gyeonggi-do
13620
South Korea
Novartis Investigative Site
Gyeonggi-do
Korea
10408
South Korea
Novartis Investigative Site
Seoul
03080
South Korea
Novartis Investigative Site
Seville
Andalusia
41009
Spain
Novartis Investigative Site
Barcelona
Catalonia
08035
Spain
Novartis Investigative Site
Barcelona
Catalonia
08036
Spain
Novartis Investigative Site
A Coruña
Galicia
15006
Spain
Novartis Investigative Site
Oviedo
Principality of Asturias
33011
Spain
Novartis Investigative Site
Madrid
28034
Spain
Novartis Investigative Site
Madrid
28041
Spain
Novartis Investigative Site
Stockholm
SE-171 76
Sweden
Novartis Investigative Site
Kaohsiung City
82445
Taiwan
Novartis Investigative Site
Taipei
10002
Taiwan
Novartis Investigative Site
Taoyuan
33305
Taiwan
Novartis Investigative Site
Birmingham
B9 5SS
United Kingdom
Novartis Investigative Site
London
W6 8RF
United Kingdom
Derived
Wolf J, Garon EB, Groen HJM, Tan DSW, Gilloteau I, Le Mouhaer S, Hampe M, Cai C, Chassot-Agostinho A, Reynolds M, Sherif B, Heist RS. Patient-reported outcomes in capmatinib-treated patients with METex14-mutated advanced NSCLC: Results from the GEOMETRY mono-1 study. Eur J Cancer. 2023 Apr;183:98-108. doi: 10.1016/j.ejca.2022.10.030. Epub 2022 Dec 10.
Wolf J, Seto T, Han JY, Reguart N, Garon EB, Groen HJM, Tan DSW, Hida T, de Jonge M, Orlov SV, Smit EF, Souquet PJ, Vansteenkiste J, Hochmair M, Felip E, Nishio M, Thomas M, Ohashi K, Toyozawa R, Overbeck TR, de Marinis F, Kim TM, Laack E, Robeva A, Le Mouhaer S, Waldron-Lynch M, Sankaran B, Balbin OA, Cui X, Giovannini M, Akimov M, Heist RS; GEOMETRY mono-1 Investigators. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Sep 3;383(10):944-957. doi: 10.1056/NEJMoa2002787.
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
FG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
FG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
FG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
FG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
FG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
FG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
FG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
FG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
FG00069 subjects
FG00142 subjects
FG00254 subjects
FG00330 subjects
FG00469 subjects
FG00515 subjects
FG00628 subjects
FG0073 subjects
FG00831 subjects
FG00932 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG00069 subjects
FG00142 subjects
FG00254 subjects
FG00330 subjects
FG00469 subjects
FG00515 subjects
FG00628 subjects
FG0073 subjects
FG00831 subjects
FG00932 subjects
Type
Comment
Reasons
Adverse Event
FG00011 subjects
FG0016 subjects
FG0028 subjects
FG0035 subjects
FG00414 subjects
FG0053 subjects
FG0066 subjects
FG0071 subjects
FG0086 subjects
FG0098 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Physician Decision
FG0005 subjects
FG0014 subjects
FG0026 subjects
FG0031 subjects
FG004
Progressive disease
FG00048 subjects
FG00131 subjects
FG00237 subjects
FG00321 subjects
FG004
Protocol deviation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Subject/Guardian decision
FG0005 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Study terminated (as per protocol) by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Post-treatment Efficacy Follow-up
Type
Comment
Milestone Data
STARTED
FG00016 subjects
FG00111 subjects
FG00216 subjects
FG0038 subjects
FG00423 subjects
FG0055 subjects
FG0066 subjects
FG0071 subjects
FG0083 subjects
FG0098 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG00016 subjects
FG00111 subjects
FG00216 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
BG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
BG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
BG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
BG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
BG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
BG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
BG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
BG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
BG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
Percentage of participants with a best overall response defined as confirmed complete response (CR) or partial response (PR) by BIRC assessment per RECIST 1.1.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm 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)-including all subjects who received at least one dose of capmatinib
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 5 years
ID
Title
Description
OG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
OG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
OG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
OG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
OG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
OG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
OG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
OG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
OG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
OG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
OG010
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
OG011
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
Units
Counts
Participants
OG00069
OG00142
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG00029.0(18.7 to 41.2)
OG00111.9(4.0 to 25.6)
OG0029.3(3.1 to 20.3)
OG003
Secondary
Duration of Response (DOR) by BIRC Assessment
Time from the date of the first documented CR or PR by BIRC per RECIST 1.1 to the first documented progression or date of death due to any cause for patients with confirmed PR or CR. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals was reported. If a subject did not have an event, DOR was censored at the date of last adequate tumor assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Participants with confirmed CR or PR by BIRC in FAS
Posted
Median
95% Confidence Interval
Months
Up to approximately 5 years
ID
Title
Description
OG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
OG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
OG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Secondary
ORR by Investigator Assessment
Percentage of patients with a best overall response defined as confirmed CR or PR per RECIST 1.1 by investigator assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
FAS, including all subjects who received at least one dose of capmatinib.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 5 years
ID
Title
Description
OG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
OG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
OG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
Secondary
DOR by Investigator Assessment
Time from the date of the first documented CR or PR per RECIST 1.1 by investigator assessment to the first documented progression or death due to any cause for patients with confirmed PR or CR. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals was reported. If a subject did not have an event, DOR was censored at the date of last adequate tumor assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Participants with confirmed CR or PR by investigator assessment in FAS.
Posted
Median
95% Confidence Interval
Months
Up to approximately 5 years
ID
Title
Description
OG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
OG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
OG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Secondary
Time to Response (TTR) by BIRC Assessment
Time between date of start of treatment until first documented response (confirmed CR or PR) per RECIST 1.1 by BIRC assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Participants with confirmed CR or PR by BIRC in FAS
Posted
Median
Full Range
Months
Up to approximately 5 years
ID
Title
Description
OG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
OG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
OG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
Secondary
TTR by Investigator Assessment
Time between date of start of treatment until first documented response (confirmed CR or PR) per RECIST 1.1 by investigator assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Participants with confirmed CR or PR by investigator assessment in FAS
Posted
Median
Full Range
Months
Up to approximately 5 years
ID
Title
Description
OG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
OG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
OG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
Secondary
Disease Control Rate (DCR)
Percentage of participants with a best overall response of confirmed CR, PR or stable disease (SD) per RECIST 1.1 by BIRC and investigator assessment.
CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
FAS, including all subjects who received at least one dose of capmatinib.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 5 years
ID
Title
Description
OG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
OG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
OG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Secondary
Progression-Free Survival
Time from start of treatment to the date of the first documented progression or death due to any cause per RECIST 1.1 by BIRC and investigator assessment. Clinical deterioration was not considered as a qualifying event for progression. PFS was censored at the last adequate tumor assessment if one of the following occurred: absence of event or the event occurred after two or more missing tumor assessments.
The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported.
Progressive disease: For target lesions, 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 to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. For non-target lesions, unequivocal progression of existing non-target lesions
FAS, including all subjects who received at least one dose of capmatinib.
Posted
Median
95% Confidence Interval
Months
Up to approximately 5 years
ID
Title
Description
OG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
OG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
Secondary
Overall Survival (OS)
Time from start of treatment to the date of death due to any cause. If the patient was alive at the date of the analysis cut-off or lost to follow-up, then OS was censored at the last contact date prior to data cut-off date.
The Kaplan-Meier method was used to estimate OS, and the median OS, along with 95% confidence intervals, was reported.
FAS, including all subjects who received at least one dose of capmatinib.
Posted
Median
95% Confidence Interval
Months
Up to approximately 6 years
ID
Title
Description
OG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
OG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
OG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
OG003
Secondary
Pharmacokinetic (PK) Concentrations of Capmatinib
PK concentrations of capmatinib. Plasma concentrations of capmatinib were measured using validated liquid chromatography-tandem mass spectrometry (LCMS/MS) methods with a lower limit of quantification (LLOQ) of approximately 1.0 ng/mL.
Capmatinib concentration data was summarized for Cohorts 1a, 1b, 2, 3, 4, 5a and 5b when capmatinib was administered in fasted state; and for Cohorts 6 and 7 when capmatinib was administered with or without food.
Participants who received at least one dose of capmatinib and provided at least one evaluable pharmacokinetic concentration for capmatinib at the specified time points. Participants who received capmatinib under the same administration conditions (fasted state or with/without food) were pooled together.
Posted
Mean
Standard Deviation
nanogram/mililiter (ng/ml)
Cycle (C) 1 Day (D) 1 predose and 2 hours post-dose, C1D15 pre-dose and 2 hours post-dose, C3D1 pre-dose. Each Cycle is 21 days
ID
Title
Description
OG000
Cohorts 1-5: Capmatinib Administration in Fasted State
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
OG001
Cohorts 6-7: Capmatinib Administration With ot Without Food
Participants from Cohorts 6 and 7 who received capmatinib with or without food
Secondary
Maximum Concentration (Cmax) of Capmatinib
Cmax of capmatinib was estimated by non-compartmental analysis. Cmax is the maximum plasma drug concentration after single dose administration. Plasma concentrations of capmatinib were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (Cmax for capmatinib) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
Posted
Mean
Standard Deviation
ng/ml
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
ID
Title
Description
OG000
Cohorts 1-5: Capmatinib Administration in Fasted State
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
Units
Counts
Participants
OG000
Secondary
Maximum Concentration (Cmax) of CMN288
Cmax of CMN288 (metabolite of capmatinib) was estimated by non-compartmental analysis. Cmax is the maximum plasma drug concentration after single dose administration. Plasma concentrations of metabolite CMN288 were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (Cmax for CMN288) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
Posted
Mean
Standard Deviation
ng/ml
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
ID
Title
Description
OG000
Cohorts 1-5: Capmatinib Administration in Fasted State
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
Units
Counts
Participants
OG000
Secondary
Area Under the Plasma Concentration-time Curve From Zero to Time Infinity (AUCinf) of Capmatinib
AUCinf of capmatinib was estimated by non-compartmental analysis. AUCinf is the area under the plasma concentration-time curve extrapolated to infinity. Plasma concentrations of capmatinib were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (AUCinf for capmatinib) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
Posted
Mean
Standard Deviation
nanogram * hour / mililiter (ng*h/ml)
Cycle 1 Day 1 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
ID
Title
Description
OG000
Cohorts 1-5: Capmatinib Administration in Fasted State
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
Units
Counts
Participants
Secondary
Area Under the Plasma Concentration-time Curve From Zero to Time Infinity (AUCinf) of CMN288
AUCinf of CMN288 (metabolite of capmatinib) was estimated by non-compartmental analysis. AUCinf is the area under the plasma concentration-time curve extrapolated to infinity. Plasma concentrations of metabolite CMN288 were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (AUCinf for CMN288) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
Posted
Mean
Standard Deviation
ng*h/ml
Cycle 1 Day 1 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
ID
Title
Description
OG000
Cohorts 1-5: Capmatinib Administration in Fasted State
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
Units
Counts
Participants
Secondary
Time to Reach Maximum Concentration (Tmax) of Capmatinib
Tmax of capmatinib was estimated by non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations. Plasma concentrations of capmatinib were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (Tmax for capmatinib) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
Posted
Median
Full Range
hour
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
ID
Title
Description
OG000
Cohorts 1-5: Capmatinib Administration in Fasted State
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
Units
Counts
Participants
Secondary
Time to Reach Maximum Concentration (Tmax) of CMN288
Tmax of CMN288 (metabolite of capmatinib) was estimated by non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations. Plasma concentrations of metabolite CMN288 were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from cohorts 1-5, who had an extensive PK collection schedule, were included in this analysis
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (Tmax for CMN288) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
Posted
Median
Full Range
hour
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
ID
Title
Description
OG000
Cohorts 1-5: Capmatinib Administration in Fasted State
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
Units
Counts
Participants
Secondary
Elimination Half-life (T1/2) of Capmatinib
T1/2 of capmatinib was estimated by non-compartmental analysis. T1/2 is the time it takes for the concentration of capmatinib in the bloodstream to decrease by half. Plasma concentrations of capmatinib were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (T1/2 for capmatinib) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
Posted
Mean
Standard Deviation
hour
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
ID
Title
Description
OG000
Cohorts 1-5: Capmatinib Administration in Fasted State
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
Units
Counts
Participants
OG000
Secondary
Elimination Half-life (T1/2) of CMN288
T1/2 of CMN288 (metabolite of capmatinib) was estimated by non-compartmental analysis. T1/2 is the time it takes for the concentration of CMN288 in the bloodstream to decrease by half. Plasma concentrations of metabolite CMN288 were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL.
Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (T1/2 for CMN288) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
Posted
Mean
Standard Deviation
hour
Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
ID
Title
Description
OG000
Cohorts 1-5: Capmatinib Administration in Fasted State
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
Units
Counts
Participants
Post-Hoc
All Collected Deaths
On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment.
Post-treatment efficacy/survival follow-up deaths were collected from 31 days after last dose of treatment until the end of the study.
All deaths refer to the sum of on-treatment and post-treatment efficacy/survival follow-up deaths.
FAS, including all subjects who received at least one dose of capmatinib
Posted
Number
Participants
On-treatment: Up to approximately 5.5 years. Post-treatment efficacy/survival follow-up: Up to approximately 6 years
ID
Title
Description
OG000
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
OG001
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
OG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
Time Frame
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
Description
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1a: On-treatment
AEs collected during the on-treatment period (up to 30 days post-treatment)
10
69
42
69
66
69
EG001
Cohort 1b: On-treatment
AEs collected during the on-treatment period (up to 30 days post-treatment)
7
42
21
42
41
42
EG002
Cohort 2: On-treatment
AEs collected during on-treatment period (up to 30 days post-treatment)
12
54
30
54
53
54
EG003
Cohort 3: On-treatment
AEs collected during on-treatment period (up to 30 days post-treatment)
4
30
15
30
28
30
EG004
Cohort 4: On-treatment
AEs collected during on-treatment period (up to 30 days post-treatment)
14
69
38
69
66
69
EG005
Cohort 5a: On-treatment
AEs collected during on-treatment period (up to 30 days post-treatment)
0
15
9
15
15
15
EG006
Cohort 5b: On-treatment
AEs collected during on-treatment period (up to 30 days post-treatment)
5
28
14
28
28
28
EG007
Cohort 6.1 (Expansion of Cohort 1a): On-treatment
AEs collected during on-treatment period (up to 30 days post-treatment)
1
3
2
3
3
3
EG008
Cohort 6.2 (Expansion of Cohort 4): On-treatment
AEs collected during on-treatment period (up to 30 days post-treatment)
5
31
14
31
29
31
EG009
Cohort 7 (Expansion of Cohort 5b): On-treatment
AEs collected during on-treatment period (up to 30 days post-treatment)
5
32
17
32
31
32
EG010
Cohort 4 + Cohort 6.2: On-treatment
AEs collected during on-treatment period (up to 30 days post-treatment)
19
100
52
100
95
100
EG011
Cohort 5b + Cohort 7: On-treatment
AEs collected during on-treatment period (up to 30 days post-treatment)
10
60
31
60
59
60
EG012
All Patients: On-treatment
AEs collected during the on-treatment period (up to 30 days post-treatment)
Deaths collected in the post- treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
44
59
0
0
0
0
EG014
Cohort 1b: Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post- treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
26
35
0
0
0
0
EG015
Cohort 2: Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
34
42
0
0
0
0
EG016
Cohort 3: Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
22
25
0
0
0
0
EG017
Cohort 4: Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
44
55
0
0
0
0
EG018
Cohort 5a: Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
13
15
0
0
0
0
EG019
Cohort 5b: Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
13
20
0
0
0
0
EG020
Cohort 6.1 (Expansion of Cohort 1a): Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
2
2
0
0
0
0
EG021
Cohort 6.2 (Expansion of Cohort 4): Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
17
20
0
0
0
0
EG022
Cohort 7 (Expansion of Cohort 5b): Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
16
23
0
0
0
0
EG023
Cohort 4 + Cohort 6.2: Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
61
75
0
0
0
0
EG024
Cohort 5b + Cohort 7: Post-treatment Efficacy/Survival Follow-up Period
Deaths collected in the post-treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
29
43
0
0
0
0
EG025
All Patients: Post-treatment Efficacy/Survival Follow-up
Deaths collected in the post- treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
231
296
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG0030 affected30 at risk
EG0040 affected69 at risk
EG0050 affected15 at risk
EG0060 affected28 at risk
EG0070 affected3 at risk
EG0080 affected31 at risk
EG0090 affected32 at risk
EG0100 affected100 at risk
EG0110 affected60 at risk
EG0121 affected373 at risk
EG0130 at risk
EG0140 at risk
EG0150 at risk
EG0160 at risk
EG0170 at risk
EG0180 at risk
EG0190 at risk
EG0200 at risk
EG0210 at risk
EG0220 at risk
EG0230 at risk
EG0240 at risk
EG0250 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Spinal muscular atrophy
Congenital, familial and genetic disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Primary adrenal insufficiency
Endocrine disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0012 affected42 at risk
EG0022 affected54 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Anal prolapse
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Duodenal stenosis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0022 affected54 at risk
EG003
Intestinal polyp
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0013 affected42 at risk
EG0020 affected54 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected69 at risk
EG0012 affected42 at risk
EG0020 affected54 at risk
EG003
Asthenia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Fatigue
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
General physical health deterioration
General disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0013 affected42 at risk
EG0022 affected54 at risk
EG003
Generalised oedema
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Malaise
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Peripheral swelling
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Pyrexia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Stenosis
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Vascular device occlusion
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Device related infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Haemophilus infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Influenza
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Lung abscess
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Medical device site infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pleural infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0007 affected69 at risk
EG0014 affected42 at risk
EG0023 affected54 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0022 affected54 at risk
EG003
Sepsis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Septic shock
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Accidental exposure to product
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Fracture displacement
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Radiation necrosis
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Amylase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Eastern Cooperative Oncology Group performance status worsened
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
General physical condition abnormal
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Liver function test abnormal
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Platelet count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Troponin increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Osteolysis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Sacroiliitis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Cerebral mass effect
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Neurological symptom
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Paraplegia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Seizure
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Organic brain syndrome
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Renal infarct
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Genital prolapse
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0006 affected69 at risk
EG0014 affected42 at risk
EG0023 affected54 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0006 affected69 at risk
EG0011 affected42 at risk
EG0023 affected54 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0013 affected42 at risk
EG0021 affected54 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pulmonary venous thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Embolism
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hypotension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0005 affected69 at risk
EG0012 affected42 at risk
EG0025 affected54 at risk
EG0036 affected30 at risk
EG0048 affected69 at risk
EG0051 affected15 at risk
EG0062 affected28 at risk
EG0070 affected3 at risk
EG0084 affected31 at risk
EG0092 affected32 at risk
EG01012 affected100 at risk
EG0114 affected60 at risk
EG01235 affected373 at risk
EG0130 at risk
EG0140 at risk
EG0150 at risk
EG0160 at risk
EG0170 at risk
EG0180 at risk
EG0190 at risk
EG0200 at risk
EG0210 at risk
EG0220 at risk
EG0230 at risk
EG0240 at risk
EG0250 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0022 affected54 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0022 affected54 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0013 affected42 at risk
EG0020 affected54 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0012 affected42 at risk
EG0022 affected54 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0013 affected42 at risk
EG0020 affected54 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0013 affected42 at risk
EG0027 affected54 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected69 at risk
EG0014 affected42 at risk
EG0022 affected54 at risk
EG003
Abnormal faeces
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG00016 affected69 at risk
EG0019 affected42 at risk
EG00210 affected54 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG00018 affected69 at risk
EG0016 affected42 at risk
EG0027 affected54 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected69 at risk
EG0013 affected42 at risk
EG0024 affected54 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0014 affected42 at risk
EG0026 affected54 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0011 affected42 at risk
EG0023 affected54 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG00032 affected69 at risk
EG00116 affected42 at risk
EG00224 affected54 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0023 affected54 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG00022 affected69 at risk
EG00114 affected42 at risk
EG00212 affected54 at risk
EG003
Asthenia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0006 affected69 at risk
EG0018 affected42 at risk
EG00211 affected54 at risk
EG003
Chest discomfort
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Face oedema
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Fatigue
General disorders
MedDRA (26.0)
Systematic Assessment
EG00011 affected69 at risk
EG00110 affected42 at risk
EG00216 affected54 at risk
EG003
Generalised oedema
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Malaise
General disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0008 affected69 at risk
EG0015 affected42 at risk
EG0027 affected54 at risk
EG003
Oedema
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.0)
Systematic Assessment
EG00034 affected69 at risk
EG00118 affected42 at risk
EG00224 affected54 at risk
EG003
Pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Peripheral swelling
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Pyrexia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0008 affected69 at risk
EG0017 affected42 at risk
EG0028 affected54 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0023 affected54 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Epididymitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Influenza
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0013 affected42 at risk
EG0021 affected54 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0007 affected69 at risk
EG0014 affected42 at risk
EG0021 affected54 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0023 affected54 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0006 affected69 at risk
EG0015 affected42 at risk
EG0021 affected54 at risk
EG003
Pyuria
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Sepsis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Anastomotic ulcer
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG00013 affected69 at risk
EG0014 affected42 at risk
EG0025 affected54 at risk
EG003
Amylase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0009 affected69 at risk
EG0013 affected42 at risk
EG0022 affected54 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG00011 affected69 at risk
EG0012 affected42 at risk
EG0024 affected54 at risk
EG003
Blood albumin decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0008 affected69 at risk
EG0011 affected42 at risk
EG0023 affected54 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0012 affected42 at risk
EG0021 affected54 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG00016 affected69 at risk
EG0018 affected42 at risk
EG00214 affected54 at risk
EG003
Blood urine present
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0012 affected42 at risk
EG0020 affected54 at risk
EG003
Eastern Cooperative Oncology Group performance status worsened
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0009 affected69 at risk
EG0012 affected42 at risk
EG0025 affected54 at risk
EG003
Lipase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0005 affected69 at risk
EG0014 affected42 at risk
EG0021 affected54 at risk
EG003
Liver function test abnormal
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Liver function test increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0010 affected42 at risk
EG0022 affected54 at risk
EG003
Platelet count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0010 affected42 at risk
EG0023 affected54 at risk
EG003
Procalcitonin increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Protein total decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Weight decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0007 affected69 at risk
EG0014 affected42 at risk
EG0022 affected54 at risk
EG003
Weight increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0007 affected69 at risk
EG0010 affected42 at risk
EG0022 affected54 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG00015 affected69 at risk
EG0016 affected42 at risk
EG00212 affected54 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0023 affected54 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0024 affected54 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0009 affected69 at risk
EG0014 affected42 at risk
EG0025 affected54 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0005 affected69 at risk
EG0012 affected42 at risk
EG0022 affected54 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0012 affected42 at risk
EG0023 affected54 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0009 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0006 affected69 at risk
EG0013 affected42 at risk
EG0027 affected54 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0008 affected69 at risk
EG0017 affected42 at risk
EG00210 affected54 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected69 at risk
EG0016 affected42 at risk
EG0023 affected54 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0011 affected42 at risk
EG0023 affected54 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected69 at risk
EG0013 affected42 at risk
EG0021 affected54 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0006 affected69 at risk
EG0012 affected42 at risk
EG0023 affected54 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected69 at risk
EG0015 affected42 at risk
EG0021 affected54 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0006 affected69 at risk
EG0014 affected42 at risk
EG0023 affected54 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0013 affected42 at risk
EG0022 affected54 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Syncope
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Tremor
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0012 affected42 at risk
EG0022 affected54 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0013 affected42 at risk
EG0024 affected54 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Depression
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0022 affected54 at risk
EG003
Dysphoria
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0007 affected69 at risk
EG0013 affected42 at risk
EG0023 affected54 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Breast swelling
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Oedema genital
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0009 affected69 at risk
EG0019 affected42 at risk
EG0029 affected54 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG00011 affected69 at risk
EG00115 affected42 at risk
EG00211 affected54 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0013 affected42 at risk
EG0023 affected54 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0021 affected54 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0014 affected42 at risk
EG0023 affected54 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0010 affected42 at risk
EG0022 affected54 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0014 affected42 at risk
EG0022 affected54 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0013 affected42 at risk
EG0020 affected54 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0009 affected69 at risk
EG0011 affected42 at risk
EG0022 affected54 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0007 affected69 at risk
EG0016 affected42 at risk
EG0023 affected54 at risk
EG003
Pruritus allergic
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected69 at risk
EG0011 affected42 at risk
EG0024 affected54 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected69 at risk
EG0010 affected42 at risk
EG0022 affected54 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected42 at risk
EG0020 affected54 at risk
EG003
Stasis dermatitis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0012 affected42 at risk
EG0022 affected54 at risk
EG003
Embolism
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected69 at risk
EG0010 affected42 at risk
EG0021 affected54 at risk
EG003
Hypotension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected69 at risk
EG0011 affected42 at risk
EG0022 affected54 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected42 at risk
EG0020 affected54 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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 the pooled data (ie, data from all sites) in the clinical trial.
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
OG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
OG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
OG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
OG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
OG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
OG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
OG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
OG010
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
OG011
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
Units
Counts
Participants
OG00020
OG0015
OG0025
OG0032
OG00428
OG0056
OG00619
OG0070
OG00816
OG00922
OG01044
OG01141
Title
Denominators
Categories
Title
Measurements
OG0008.31(4.17 to 15.44)
OG00124.94(2.69 to 24.94)
OG0029.66(4.17 to NA)NA: not estimable due to the insufficient number of participants with events
OG0034.19(4.17 to 4.21)
OG0049.72(5.55 to 12.98)
OG0057.54(2.56 to 14.26)
OG00612.58(5.55 to 38.67)
OG0089.05(4.17 to 27.60)
OG00916.59(8.34 to NA)NA: not estimable due to the insufficient number of participants with events
OG0109.72(5.62 to 12.98)
OG01116.59(8.41 to 22.11)
OG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
OG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
OG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
OG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
OG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
OG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
OG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
OG010
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
OG011
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
Units
Counts
Participants
OG00069
OG00142
OG00254
OG00330
OG00469
OG00515
OG00628
OG0073
OG00831
OG00932
OG010100
OG01160
Title
Denominators
Categories
Title
Measurements
OG00027.5(17.5 to 39.6)
OG0017.1(1.5 to 19.5)
OG0029.3(3.1 to 20.3)
OG0033.3(0.1 to 17.2)
OG00443.5(31.6 to 56.0)
OG00540.0(16.3 to 67.7)
OG00660.7(40.6 to 78.5)
OG0070.0(0.0 to 70.8)
OG00845.2(27.3 to 64.0)
OG00956.3(37.7 to 73.6)
OG01044.0(34.1 to 54.3)
OG01158.3(44.9 to 70.9)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
OG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
OG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
OG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
OG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
OG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
OG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
OG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
OG010
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
OG011
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
Units
Counts
Participants
OG00019
OG0013
OG0025
OG0031
OG00430
OG0056
OG00617
OG0070
OG00814
OG00918
OG01044
OG01135
Title
Denominators
Categories
Title
Measurements
OG0006.80(4.21 to 20.73)
OG0016.93(5.75 to 8.34)
OG00219.48(2.83 to NA)NA: not estimable due to the insufficient number of participants with events
OG0036.93(NA to NA)NA: not estimable due to the insufficient number of participants with events
OG0048.31(4.34 to 12.06)
OG0059.66(4.01 to 17.08)
OG00613.83(4.27 to 25.33)
OG00814.57(4.17 to 27.60)
OG00915.21(6.77 to 31.77)
OG0108.38(5.55 to 13.80)
OG01113.96(9.33 to 22.18)
OG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
OG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
OG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
OG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
OG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
OG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
OG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
OG010
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
OG011
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
Units
Counts
Participants
OG00020
OG0015
OG0025
OG0032
OG00428
OG0056
OG00619
OG0070
OG00816
OG00922
OG01044
OG01141
Title
Denominators
Categories
Title
Measurements
OG0001.4(0.5 to 6.8)
OG0012.8(1.4 to 16.6)
OG0021.4(1.2 to 6.2)
OG0033.4(1.3 to 5.5)
OG0041.4(1.2 to 5.6)
OG0051.4(1.2 to 2.9)
OG0061.4(1.3 to 6.9)
OG0081.4(1.1 to 9.8)
OG0091.4(1.2 to 7.2)
OG0101.4(1.1 to 9.8)
OG0111.4(1.2 to 7.2)
OG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
OG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
OG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
OG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
OG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
OG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
OG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
OG010
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
OG011
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
Units
Counts
Participants
OG00019
OG0013
OG0025
OG0031
OG00430
OG0056
OG00617
OG0070
OG00814
OG00918
OG01044
OG01135
Title
Denominators
Categories
Title
Measurements
OG0001.4(1.2 to 5.4)
OG0011.4(1.3 to 1.4)
OG0021.3(1.2 to 1.7)
OG0031.3(1.3 to 1.3)
OG0041.4(1.2 to 11.1)
OG0051.4(1.3 to 2.5)
OG0061.4(1.2 to 4.0)
OG0081.4(1.1 to 12.3)
OG0091.4(1.2 to 5.6)
OG0101.4(1.1 to 12.3)
OG0111.4(1.2 to 5.6)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
OG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
OG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
OG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
OG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
OG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
OG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
OG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
OG010
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
OG011
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
Units
Counts
Participants
OG00069
OG00142
OG00254
OG00330
OG00469
OG00515
OG00628
OG0073
OG00831
OG00932
OG010100
OG01160
Title
Denominators
Categories
By BIRC assessment
Title
Measurements
OG00071.0(58.8 to 81.3)
OG00154.8(38.7 to 70.2)
OG00246.3(32.6 to 60.4)
OG00353.3(34.3 to 71.7)
OG00478.3(66.7 to 87.3)
OG00566.7(38.4 to 88.2)
OG00696.4(81.7 to 99.9)
OG007100.0(29.2 to 100.0)
OG00890.3(74.2 to 98.0)
OG009100.0(89.1 to 100.0)
OG01082.0(73.1 to 89.0)
OG01198.3(91.1 to 100.0)
By investigator assessment
Title
Measurements
OG00060.9(48.4 to 72.4)
OG00145.2(29.8 to 61.3)
OG00244.4(30.9 to 58.6)
OG003
OG002
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
OG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
OG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
OG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
OG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
OG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
OG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
OG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
OG010
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
OG011
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
Units
Counts
Participants
OG00069
OG00142
OG00254
OG00330
OG00469
OG00515
OG00628
OG0073
OG00831
OG00932
OG010100
OG01160
Title
Denominators
Categories
By BIRC assessment
Title
Measurements
OG0004.07(2.86 to 4.83)
OG0012.66(1.41 to 3.09)
OG0022.66(1.41 to 4.14)
OG0033.55(2.20 to 4.21)
OG0045.42(4.17 to 6.97)
OG0054.17(1.45 to 6.87)
OG00612.42(8.21 to 23.39)
OG0072.79(2.07 to 4.24)
OG0086.93(4.17 to 13.34)
OG00912.45(6.87 to 22.05)
OG0105.49(4.17 to 8.11)
OG01112.45(8.31 to 17.97)
By investigator assessment
Title
Measurements
OG0004.14(2.79 to 5.52)
OG0012.40(1.45 to 2.83)
OG0022.60(1.48 to 3.09)
OG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
OG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
OG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
OG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
OG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
OG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
OG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
OG010
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
OG011
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
Units
Counts
Participants
OG00069
OG00142
OG00254
OG00330
OG00469
OG00515
OG00628
OG0073
OG00831
OG00932
OG010100
OG01160
Title
Denominators
Categories
Title
Measurements
OG00010.61(6.28 to 17.22)
OG0017.46(5.59 to 10.18)
OG00210.15(5.52 to 15.74)
OG0039.46(4.11 to 12.32)
OG00413.57(8.61 to 22.24)
OG0059.56(4.80 to NA)NA: not estimable due to the insufficient number of participants with events
OG00620.76(12.42 to 43.93)
OG0074.14(2.07 to NA)NA: not estimable due to the insufficient number of participants with events
OG00825.95(13.54 to 43.40)
OG00921.36(12.85 to 34.76)
OG01016.79(11.63 to 23.82)
OG01121.36(15.24 to 30.52)
Units
Counts
Participants
OG000275
OG00154
Title
Denominators
Categories
Cycle 1 Day 1- pre-dose
ParticipantsOG000275
ParticipantsOG00154
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
Cycle 1 Day 1- 2 hours post-dose
ParticipantsOG000275
ParticipantsOG00153
Title
Measurements
OG0003360± 1920
OG001
Cycle 1 Day 15 - pre-dose
ParticipantsOG000176
ParticipantsOG00129
Title
Measurements
OG000727± 781
OG001
Cycle 1 Day 15- 2 hours post-dose
ParticipantsOG000209
ParticipantsOG00147
Title
Measurements
OG0004100± 2100
OG001
Cycle 3 Day 1 - pre-dose
ParticipantsOG00096
ParticipantsOG00118
Title
Measurements
OG000687± 1000
OG001
55
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00055
Title
Measurements
OG0004230± 2290
Cycle 1 Day 15
ParticipantsOG00044
Title
Measurements
OG0005450± 2560
51
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00051
Title
Measurements
OG0001910± 1420
Cycle 1 Day 15
ParticipantsOG00042
Title
Measurements
OG0001420± 725
OG00044
Title
Denominators
Categories
Title
Measurements
OG00017000± 7770
OG00027
Title
Denominators
Categories
Title
Measurements
OG0009020± 5060
OG000
55
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00055
Title
Measurements
OG0001.87(0.583 to 4.03)
Cycle 1 Day 15
ParticipantsOG00044
Title
Measurements
OG0001.09(0.5 to 6.07)
OG000
51
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00051
Title
Measurements
OG0001.93(0.950 to 4.03)
Cycle 1 Day 15
ParticipantsOG00042
Title
Measurements
OG0001.91(0.883 to 7.98)
47
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00047
Title
Measurements
OG0001.87± 0.947
Cycle 1 Day 15
ParticipantsOG00037
Title
Measurements
OG0002.40± 0.652
OG000
40
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00040
Title
Measurements
OG0003.14± 1.42
Cycle 1 Day 15
ParticipantsOG00034
Title
Measurements
OG0003.06± 0.949
OG003
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
OG004
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
OG005
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
OG006
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
OG007
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
OG008
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
OG009
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
OG010
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
OG011
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)