Phase I Study of LDK378 in Pediatric, Malignancies With a... | NCT01742286 | Trialant
NCT01742286
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jun 9, 2020Actual
Enrollment
83Actual
Phase
Phase 1
Conditions
ALK-activated Tumors
Interventions
Ceritinib
Countries
United States
Australia
Canada
France
Germany
Italy
Netherlands
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01742286
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLDK378X2103
Secondary IDs
ID
Type
Description
Link
2012-002074-31
EudraCT Number
Brief Title
Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)
Official Title
A Phase I, Open-label, Dose Escalation Study of LDK378 in Pediatric Patients With Malignancies That Have a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
May 2020
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
Aug 28, 2013Actual
Primary Completion Date
Apr 26, 2019Actual
Completion Date
Apr 26, 2019Actual
First Submitted Date
Nov 30, 2012
First Submission Date that Met QC Criteria
Dec 3, 2012
First Posted Date
Dec 5, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 24, 2019
Results First Submitted that Met QC Criteria
May 27, 2020
Results First Posted Date
Jun 9, 2020Actual
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
May 27, 2020
Last Update Posted Date
Jun 9, 2020Actual
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
The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors, with and without food.
Detailed Description
LDK378 is a novel inhibitor of ALK that is active in a broad range of ALK-activated tumor models, including models driven by mutated versions of ALK known to be resistant to crizotinib, and by ALK gene amplification.
The primary purpose of this study was to determine the maximum tolerated dose and/or recommended dose for expansion in pediatric patients, and to delineate a clinical dose to be used in any future pediatric studies, with and without food. This study also assessed the safety, tolerability, PK and preliminary evidence of antitumor activity of LDK378 in pediatric patients with neuroblastoma, and other ALK-activated tumors.
Fasted cohort: each daily dose of LDK378 (including days which involved PK blood sampling) was taken at least 2 hours after last meal & subjects did not eat until 1 hour after LDK378 was taken. Each daily dose of LDK378 was taken with 1-2 tablespoons (15-30 mL) of an appropriate food (such as applesauce or non-fat yogurt) & a glass of water
Fed cohort: each daily dose of LDK378 (including days which involved PK blood sampling) was taken with, or within 30 minutes after finishing a low-fat light snack containing 100-300 calories & 1.5-2 grams of fat.
Conditions Module
Conditions
ALK-activated Tumors
Keywords
LDK378
Ceritinib
pediatric
malignancies
anaplastic lymphoma kinase
ALK
ALK-activated tumors
neuroblastoma
rhabdomyosarcoma
anaplastic large-cell lymphoma
inflammatory myofibroblastic tumor
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
83Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LDK378
Experimental
All participants were administered a single-agent LDK378 (Ceritinib) orally, once daily, continuously in fasted or fed conditions.
Drug: Ceritinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ceritinib
Drug
LDK378 is a capsule taken by mouth, contents can be mixed with food for pediatric patients or mixed with water and given via nasogastric/gastric (NG/G) tube. For patients in fasted group: 1-2 tablespoons (15-30 mL) of an appropriate food such as apple sauce or non-fat yogurt and a glass of water were allowed.
For patients in the fed cohort: LDK378 was taken with, or within 30 minutes after finishing a low-fat light snack containing 100-300 calories and 1.5-2 grams of fat.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence Rate of Dose Limiting Toxicities (DLTs) Occurring During First Cycle of Treatment
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant therapies that occurs within the first 21 days of treatment with LDK378 and meets a specified defined criteria. A participant with multiple occurrences of DLTs under one treatment is counted only once in the Adverse Event category for that treatment. A participant with multiple DLTs within a primary system organ class is counted only once in the total row.
up to day 21 after the patient's first dose; cycle = within the first 21 days of patient's first dose
Secondary Outcomes
Measure
Description
Time Frame
Summary of Best Overall Response by Overall Response Rate (ORR) Per Investigator Assessment
ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR). ORR was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma & other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
Age ≥ 12 months and < 18 years
The tumor must carry a genetic alteration of ALK
Patients must have evaluable or measurable disease.
Karnofsky performance status score ≥ 60% for patients > 12 years of age; Lansky score ≥ 50% for patients ≤ 12 years of age.
Exclusion criteria:
Symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy (such as radiotherapy, surgery or intrathecal chemotherapy) to control their CNS disease
Inadequate end organ function as defined by specified laboratory values
Body surface area (BSA) < 0.35 m2
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LDK378 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
Use of medications that are known to be strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
Use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
History of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
History of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
Medications with a known risk of prolongation of QT interval
At least 15 patients for the fasted dose escalation & 12 patients for the fed dose escalation were expected to be treated. During the expansion part, approximately 45 patients were planned to be treated on the preferred regimen, approximately 25 patients in group 1 on the preferred regimen, and approximately 20 patients in group 2.
Recruitment Details
Eighty-three patients were treated at different dose levels in both fasted and fed states dose escalation and expansion groups.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
FG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
Periods
Title
Milestones
Reasons Not Completed
Escalation Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
May 18, 2018
Oct 24, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group 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
LDK378
LDK378
30 months
Duration of Response (DoR) Per Investigator Assessment
DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression (PD) or death due to any cause. DOR was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma & other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.
30 months
Progression Free Survival (PFS) Based on Investigator Assessment
PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma & other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.
30 months
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Only PK plasma concentrations with non-missing sampling date and time, and for which the last dose date and time prior to the PK sample draw are non-missing, were included in the PK analysis.
0hr pre-dose, 2hrs post-dose, 4hrs post-dose, 6hrs post-dose & 24hrs post-dose in Cycle1 Day1 & Cycle 2 day 1; 0hr pre-dose in Cycle 1 Day 15, Cycle 2 Day1, Cycle 2 Day 2, Cycle 3 day 1 & Cycle 4 Day 1
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Only PK plasma concentrations with non-missing sampling date and time, and for which the last dose date and time prior to the PK sample draw are non-missing, were included in the PK analysis.
0hr pre-dose Cycle 1 Day 1, cycle 1 Day 15; 0hr pre-dose, 2hrs post-dose, 4hrs post-dose, 6hrs post-dose & 24hrs post-dose in Cycle2 Day1; 0hr pre-dose in Cycle2 Day2, Cycle 3 Day 1 & Cycle 4 Day 1
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the concentration-time curve from time zero to the last measureable concentration time AUC0-24h: Area under the plasma concentration-time curve t=0-24 h
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the concentration-time curve from time zero to the last measureable concentration time; AUC0-24h: Area under the plasma concentration-time curve t=0-24 h
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1.
AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the plasma (serum, or blood) concentration versus time curverea under the concentration-time curve from time zero to the last measureable concentration time AUC0-24h: Area under the plasma concentration-time curve t=0-24 h
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
PK Parameter: Cmax in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Cmax: Maximum (peak) concentration of drug
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
PK Parameter: Cmax in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Cmax: Maximum (peak) concentration of drug.
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
PK Parameter: Cmax in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1.
Cmax: Maximum (peak) concentration of drug
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
PK Parameter: Tmax in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
PK Parameter: Tmax in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
PK Parameter: Tmax in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1.
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
PK Parameter: Racc in Dose Escalation Phase Cycle 2 Day 1
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Racc: Accumulation ratio
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
New York
New York
10017
United States
Cincinnati Children s Hospital Medical Center Dept of Oncology
Cincinnati
Ohio
45229-3039
United States
St Jude s Childrens Research Hospital Dept of Oncology
Memphis
Tennessee
38105-2794
United States
Texas Children's Hospital Dept of Oncology
Houston
Texas
77030
United States
Novartis Investigative Site
Randwick
New South Wales
2130
Australia
Novartis Investigative Site
Parkville
Victoria
3052
Australia
Novartis Investigative Site
Toronto
Ontario
M5G 1X8
Canada
Novartis Investigative Site
Paris
75231
France
Novartis Investigative Site
Villejuif
94805
France
Novartis Investigative Site
Cologne
North Rhine-Westphalia
50937
Germany
Novartis Investigative Site
Berlin
13353
Germany
Novartis Investigative Site
Essen
45147
Germany
Novartis Investigative Site
Milan
MI
20133
Italy
Novartis Investigative Site
Utrecht
CS
3584
Netherlands
Novartis Investigative Site
Amsterdam
1105 AZ
Netherlands
Novartis Investigative Site
Rotterdam
3015 CN
Netherlands
Novartis Investigative Site
Seoul
03080
South Korea
Novartis Investigative Site
Barcelona
Catalonia
08035
Spain
Novartis Investigative Site
Valencia
Valencia
46026
Spain
Novartis Investigative Site
Madrid
28009
Spain
Novartis Investigative Site
West Midlands
Birmingham
B4 6NH
United Kingdom
Novartis Investigative Site
Sutton
Surrey
SM2 5PT
United Kingdom
Derived
Brivio E, Zwaan CM. ALK inhibition in two emblematic cases of pediatric inflammatory myofibroblastic tumor: Efficacy and side effects. Pediatr Blood Cancer. 2019 May;66(5):e27645. doi: 10.1002/pbc.27645. Epub 2019 Jan 29.
FG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
FG003
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
FG004
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
FG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
FG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
FG0005 subjects
FG00112 subjects
FG0026 subjects
FG0032 subjects
FG0044 subjects
FG0055 subjects
FG0066 subjects
Ended Treatment = Not Completed)
FG0005 subjects
FG00112 subjects
FG0026 subjects
FG0032 subjects
FG0044 subjects
FG0055 subjects
FG0066 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0005 subjects
FG00112 subjects
FG0026 subjects
FG0032 subjects
FG0044 subjects
FG0055 subjects
FG0066 subjects
Type
Comment
Reasons
Administrative problems
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Disease progression
FG0003 subjects
FG0017 subjects
FG0024 subjects
FG0031 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
FG004
Subject/guardian decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Expansion Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0027 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00636 subjects
End of Treatment = Not Ccompleted
FG0000 subjects
FG0010 subjects
FG0027 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0027 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Administrative problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Full analysis set (FAS) included all patients who received at least one dose of ceritinib.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
BG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
BG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
BG003
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
BG004
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
BG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
BG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG00112
BG00213
BG0032
BG0044
BG0055
BG00642
BG00783
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00011.6± 5.27
BG00110.0± 4.94
BG0029.2± 5.34
BG003
Age, Customized
Number
Participants
Title
Denominators
Categories
1 - < 7 yrs
Title
Measurements
BG0001
BG0014
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Incidence Rate of Dose Limiting Toxicities (DLTs) Occurring During First Cycle of Treatment
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant therapies that occurs within the first 21 days of treatment with LDK378 and meets a specified defined criteria. A participant with multiple occurrences of DLTs under one treatment is counted only once in the Adverse Event category for that treatment. A participant with multiple DLTs within a primary system organ class is counted only once in the total row.
The dose determining analysis set (DDS) consisted of all patients from the Safety set who either met the minimum exposure criterion and had sufficient safety evaluations or discontinued earlier due to DLT in the escalation phase.
Posted
Number
Participants
up to day 21 after the patient's first dose; cycle = within the first 21 days of patient's first dose
ID
Title
Description
OG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
OG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
OG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG003
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
OG004
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
OG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
OG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG0004
OG00112
OG0026
OG003
Title
Denominators
Categories
Investigations: Alanine aminotransferase incr.
Title
Measurements
OG0000
OG0010
OG0020
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
MTD/RDE
510
Other
OG004
OG005
OG006
Secondary
Summary of Best Overall Response by Overall Response Rate (ORR) Per Investigator Assessment
ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR). ORR was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma & other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.
Full Analysis Set (FAS)/Maximum Tolerated Dose MTD)/Recommended dose for expansion (RDE): Results are presented only for patients who received at least 1 dose of ceritinib in either of the 2 MTD/RDE groups and were based on combining data from across the dose-escalation & dose-expansion phases, & summarized according to primary diagnosis of tumor.
Posted
Number
95% Confidence Interval
percentage of participants
30 months
ID
Title
Description
OG000
ALK-activated Neuroblastoma
Participants with ALK-activated neuroblastoma enrolled in the expansion part of the study and were given ceritinib once daily, continuously
OG001
Secondary
Duration of Response (DoR) Per Investigator Assessment
DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression (PD) or death due to any cause. DOR was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma & other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.
Full Analysis Set/MTD/RDE patients with confirmed CR or PR): Efficacy results are presented only for patients with confirmed CR or PR who received at least 1 dose of ceritinib in either of the 2 MTD/RDE groups & were based on combining data from across the dose-escalation & dose-expansion phases, & summarized according to primary tumor diagnosis.
Posted
Median
95% Confidence Interval
months
30 months
ID
Title
Description
OG000
ALK-activated Neuroblastoma
Participants with ALK-activated neuroblastoma enrolled in the expansion part of the study and were given ceritinib once daily, continuously
OG001
Secondary
Progression Free Survival (PFS) Based on Investigator Assessment
PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma & other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.
Full Analysis Set (FAS)/MTD/RDE: Efficacy results are presented only for patients who received at least 1 dose of ceritinib in either of the two MTD/RDE groups and were based on combining data from across the dose-escalation & dose-expansion phases, & summarized according to primary diagnosis of tumor.
Posted
Median
95% Confidence Interval
months
30 months
ID
Title
Description
OG000
ALK-activated Neuroblastoma
Participants with ALK-activated neuroblastoma enrolled in the expansion part of the study and were given ceritinib once daily, continuously
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Only PK plasma concentrations with non-missing sampling date and time, and for which the last dose date and time prior to the PK sample draw are non-missing, were included in the PK analysis.
The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
0hr pre-dose, 2hrs post-dose, 4hrs post-dose, 6hrs post-dose & 24hrs post-dose in Cycle1 Day1 & Cycle 2 day 1; 0hr pre-dose in Cycle 1 Day 15, Cycle 2 Day1, Cycle 2 Day 2, Cycle 3 day 1 & Cycle 4 Day 1
ID
Title
Description
OG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
OG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
OG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG003
Secondary
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Only PK plasma concentrations with non-missing sampling date and time, and for which the last dose date and time prior to the PK sample draw are non-missing, were included in the PK analysis.
The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
0hr pre-dose Cycle 1 Day 1, cycle 1 Day 15; 0hr pre-dose, 2hrs post-dose, 4hrs post-dose, 6hrs post-dose & 24hrs post-dose in Cycle2 Day1; 0hr pre-dose in Cycle2 Day2, Cycle 3 Day 1 & Cycle 4 Day 1
ID
Title
Description
OG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
OG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
OG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG003
Secondary
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the concentration-time curve from time zero to the last measureable concentration time AUC0-24h: Area under the plasma concentration-time curve t=0-24 h
The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/mL
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
ID
Title
Description
OG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
OG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
OG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG003
Fasted: Ceritinib 560 mg/m2
Secondary
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the concentration-time curve from time zero to the last measureable concentration time; AUC0-24h: Area under the plasma concentration-time curve t=0-24 h
The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/mL
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
ID
Title
Description
OG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
OG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
OG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG003
Fasted: Ceritinib 560 mg/m2
Secondary
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1.
AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the plasma (serum, or blood) concentration versus time curverea under the concentration-time curve from time zero to the last measureable concentration time AUC0-24h: Area under the plasma concentration-time curve t=0-24 h
The PK analysis set (PAS), MTD/RDE consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/mL
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
ID
Title
Description
OG000
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG001
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Secondary
PK Parameter: Cmax in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Cmax: Maximum (peak) concentration of drug
The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
ID
Title
Description
OG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
OG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
OG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG003
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
Secondary
PK Parameter: Cmax in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Cmax: Maximum (peak) concentration of drug.
The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
ID
Title
Description
OG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
OG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
OG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG003
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
Secondary
PK Parameter: Cmax in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1.
Cmax: Maximum (peak) concentration of drug
The PK analysis set (PAS), MTD/RDE consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
ID
Title
Description
OG000
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG001
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG000
Secondary
PK Parameter: Tmax in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration
The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Median
Full Range
hour (hr)
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
ID
Title
Description
OG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
OG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
OG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG003
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
OG004
Secondary
PK Parameter: Tmax in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration
The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Median
Full Range
hour (hr)
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
ID
Title
Description
OG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
OG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
OG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG003
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
OG004
Secondary
PK Parameter: Tmax in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1.
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration
The PK analysis set (PAS), MTD/RDE consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Median
Full Range
hour (hr)
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
ID
Title
Description
OG000
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG001
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG000
Secondary
PK Parameter: Racc in Dose Escalation Phase Cycle 2 Day 1
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Racc: Accumulation ratio
The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
ID
Title
Description
OG000
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
OG001
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
OG002
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
OG003
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
OG004
Time Frame
Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
Description
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
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
Fasted Ceritinib 300mg/m2
Participants in the fasted group who took 300 mg of ceritinib
1
5
1
5
5
5
EG001
Fasted Ceritinib 450mg/m2
Participants in the fasted group who took 450 mg of ceritinib
1
12
4
12
12
12
EG002
Fasted Ceritinib 510mg/m2
Participants in the fasted group who took 510 mg of ceritinib
2
13
8
13
13
13
EG003
Fasted Ceritinib 560mg/m2
Participants in the fasted group who took 560 mg of ceritinib
0
2
2
2
2
2
EG004
Fed Ceritinib 320mg/m2
Participants in the fed group who took 320 mg of ceritinib
2
4
3
4
4
4
EG005
Fed Ceritinib 400mg/m2
Participants in the fed group who took 400 mg of ceritinib
1
5
1
5
5
5
EG006
Fed Ceritinib 500mg/m2
Participants in the fed group who took 500 mg of ceritinib
5
42
21
42
42
42
EG007
Fasted+Fed All Patients
All participants in the Fasted and Fed groups
12
83
40
83
83
83
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG0030 affected2 at risk
EG0041 affected4 at risk
EG0050 affected5 at risk
EG0061 affected42 at risk
EG0072 affected83 at risk
Febrile bone marrow aplasia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Chest pain
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
General physical health deterioration
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Device related infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Ear infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Encephalitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Enterovirus infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Influenza
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Sepsis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Septic shock
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Wound infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Amylase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0022 affected13 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Lipase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0022 affected13 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Hemiplegia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Seizure
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Bronchopleural fistula
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Hypotension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0013 affected12 at risk
EG0023 affected13 at risk
EG0031 affected2 at risk
EG0043 affected4 at risk
EG0050 affected5 at risk
EG00611 affected42 at risk
EG00722 affected83 at risk
Bone marrow disorder
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0022 affected13 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected12 at risk
EG0023 affected13 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0022 affected13 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
External ear inflammation
Ear and labyrinth disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Delayed puberty
Endocrine disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0022 affected13 at risk
EG003
Eye pain
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Eye swelling
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Vision blurred
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected5 at risk
EG0016 affected12 at risk
EG0026 affected13 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Anal inflammation
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected5 at risk
EG0012 affected12 at risk
EG0022 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0004 affected5 at risk
EG00112 affected12 at risk
EG00210 affected13 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected5 at risk
EG0018 affected12 at risk
EG00210 affected13 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0004 affected5 at risk
EG00110 affected12 at risk
EG00213 affected13 at risk
EG003
Asthenia
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Catheter site pain
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0021 affected13 at risk
EG003
Chest pain
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0021 affected13 at risk
EG003
Fatigue
General disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected5 at risk
EG0014 affected12 at risk
EG0023 affected13 at risk
EG003
Gait disturbance
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
General physical health deterioration
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Influenza like illness
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Malaise
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Oedema peripheral
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected5 at risk
EG0014 affected12 at risk
EG0026 affected13 at risk
EG003
Secretion discharge
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Ulcer
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Bacterial vulvovaginitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Device related infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Ear infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Human herpesvirus 6 infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Influenza
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Mycoplasma infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected12 at risk
EG0022 affected13 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0021 affected13 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0012 affected12 at risk
EG0023 affected13 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Varicella
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Viral infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Wound infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0018 affected12 at risk
EG0028 affected13 at risk
EG003
Amylase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0016 affected12 at risk
EG0027 affected13 at risk
EG003
Blood albumin decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0014 affected12 at risk
EG0020 affected13 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Blood creatine increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Blood creatine phosphokinase MB increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0002 affected5 at risk
EG0014 affected12 at risk
EG0021 affected13 at risk
EG003
Blood glucose increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0023 affected13 at risk
EG003
Blood magnesium increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Blood pressure increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Blood urea increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0013 affected12 at risk
EG0023 affected13 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Lipase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0022 affected13 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Platelet count decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Prothrombin time shortened
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Troponin increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Tumour marker increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Weight decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0012 affected12 at risk
EG0023 affected13 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
White blood cell count increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected5 at risk
EG0014 affected12 at risk
EG0020 affected13 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected5 at risk
EG0012 affected12 at risk
EG0021 affected13 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0021 affected13 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0015 affected12 at risk
EG0020 affected13 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0021 affected13 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Headache
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected5 at risk
EG0014 affected12 at risk
EG0021 affected13 at risk
EG003
Hypertonia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Migraine
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Syncope
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Tremor
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Irritability
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected12 at risk
EG0022 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0022 affected13 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0013 affected12 at risk
EG0021 affected13 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Embolism
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Haematoma
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Hypertension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Hypotension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Pallor
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected12 at risk
EG0020 affected13 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Participants with ALK-activated IMT enrolled in the expansion part of the study who were given ceritinib once daily, continuously
OG002
ALK-activated Anaplastic Large Cell Lymphoma (ALCL)
Participants with ALK-activated ALCL enrolled in the expansion part of the study who were given ceritinib once daily, continuously
OG003
ALK-activated Other
Participants with other ALK-activated tumors enrolled in the expansion part of the study who were given ceritinib once daily, continuously
Units
Counts
Participants
OG0006
OG0017
OG0026
OG0031
Title
Denominators
Categories
Title
Measurements
OG00015.0(5.8 to 22.2)
OG001NA(3.5 to NA)N/A: Median not reached for subjects with ALCL, IMT \& Other tumor types as most of the subjects did not have a DOR event (progression or death).
OG002NA(2.8 to NA)N/A: Median not reached for subjects with ALCL, IMT \& Other tumor types as most of the subjects did not have a DOR event (progression or death).
OG003NA(NA to NA)N/A: Median not reached for subjects with ALCL, IMT \& Other tumor types as most of the subjects did not have a DOR event (progression or death).
Participants with ALK-activated IMT enrolled in the expansion part of the study who were given ceritinib once daily, continuously
OG002
ALK-activated Anaplastic Large Cell Lymphoma (ALCL)
Participants with ALK-activated ALCL enrolled in the expansion part of the study who were given ceritinib once daily, continuously
OG003
ALK-activated Other
Participants with other ALK-activated tumors enrolled in the expansion part of the study who were given ceritinib once daily, continuously
Units
Counts
Participants
OG00030
OG00110
OG0028
OG0037
Title
Denominators
Categories
Title
Measurements
OG0002.4(1.2 to 6.8)
OG001NA(1.2 to NA)N/A: The median was not reached for subjects with IMT and ALCL
OG002NA(4.1 to NA)N/A: The median was not reached for subjects with IMT and ALCL
OG0031.9(1.2 to NA)N/A: The median was not reached for subjects with IMT and ALCL
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
OG004
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
OG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
OG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG0005
OG00112
OG0026
OG0032
OG0044
OG0055
OG0065
Title
Denominators
Categories
Cycle1 Day1 (C1D1) 0 hr pre-dose
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0026
ParticipantsOG0032
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0065
Title
Measurements
OG0000.0± 0.0
OG0010.0± 0.0
OG0020.0± 0.0
OG003
C1D1 2 hrs post-dose
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG0026
ParticipantsOG0032
C1D1 4 hrs post-dose
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG0026
ParticipantsOG0032
C1D1 6 hrs post-dose
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG0026
ParticipantsOG0032
C1D1 24 hrs post-dose
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG0026
ParticipantsOG0032
C1D2 0 hr pre-dose
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG0026
ParticipantsOG0032
C1D15 0 hr pre-dose
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0026
ParticipantsOG0032
C2D1 0 hr pre-dose
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG0032
C2D1 2 hrs post-dose
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG0032
C2D1 4 hrs post-dose
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG0032
C2D1 6 hrs post-dose
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG0032
C2D1 24 hrs post-dose
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG0032
C2D2 0 hr pre-dose
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG0032
C3D1 0 hr pre-dose
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0024
ParticipantsOG0031
C4D1 0 hr pre-dose
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0024
ParticipantsOG0031
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
OG004
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
OG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
OG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG0000
OG0010
OG0027
OG0030
OG0040
OG0050
OG00616
Title
Denominators
Categories
C1D1 0 hr pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0069
Title
Measurements
OG0020.0± 0.0
OG0060.0± 0.0
C1D15 0 hr post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
C2D1 0 hr pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG0030
C2D1 2 hrs post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG0030
C2D1 4 hrs post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG0030
C2D1 6 hrs post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG0030
C2D1 24 hrs post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0030
C2D2 0 hr pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0030
C3D1 0 hr pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
C4D1 0 hr pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
Participants in the fasted group who took 560 mg of ceritinib
OG004
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
OG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
OG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG0005
OG00110
OG0023
OG0031
OG0043
OG0054
OG0063
Title
Denominators
Categories
AUC0-24h
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0062
Title
Measurements
OG0003920± 39.9
OG0015220± 58.0
OG0028750± 11.1
OG004
AUClast
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0023
ParticipantsOG0031
Participants in the fasted group who took 560 mg of ceritinib
OG004
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
OG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
OG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG0005
OG00112
OG0025
OG0032
OG0043
OG0054
OG0062
Title
Denominators
Categories
AUC0-24h
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG0008160± 44.0
OG00116900± 59.1
OG00221000± 20.8
OG003
AUClast
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG0032
Participants
OG0004
OG00114
Title
Denominators
Categories
AUC0-24h
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG00115900± 93.8
AUClast
ParticipantsOG0004
ParticipantsOG00114
Title
Measurements
OG00024100± 38.9
OG00116100± 61.2
OG004
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
OG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
OG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG0005
OG00110
OG0023
OG0031
OG0043
OG0054
OG0063
Title
Denominators
Categories
Title
Measurements
OG000258± 39.0
OG001270± 82.1
OG002537± 22.2
OG003265± 0.0
OG004251± 37.0
OG005341± 34.2
OG006204± 54.6
OG004
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
OG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
OG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG0005
OG00112
OG0025
OG0032
OG0043
OG0054
OG0062
Title
Denominators
Categories
Title
Measurements
OG000427± 38.5
OG001870± 48.7
OG0021020± 32.1
OG0031300± 21.4
OG004300± 130.3
OG005674± 93.8
OG006804± 10.4
4
OG00114
Title
Denominators
Categories
Title
Measurements
OG0001220± 40.2
OG001890± 50.9
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
OG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
OG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG0005
OG00110
OG0023
OG0031
OG0043
OG0054
OG0063
Title
Denominators
Categories
Title
Measurements
OG0004.20(1.90 to 24.0)
OG0014.25(0.00 to 6.10)
OG0024.30(4.10 to 6.00)
OG0036.10(6.10 to 6.10)
OG0046.10(5.70 to 6.30)
OG0056.00(4.30 to 6.20)
OG0065.80(4.10 to 6.10)
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
OG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
OG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Units
Counts
Participants
OG0005
OG00112
OG0025
OG0032
OG0043
OG0054
OG0062
Title
Denominators
Categories
Title
Measurements
OG0006.00(4.10 to 6.70)
OG0015.10(2.00 to 6.60)
OG0024.00(2.10 to 6.00)
OG0033.95(0.00 to 6.70)
OG0045.90(5.80 to 6.10)
OG0056.00(4.00 to 6.10)
OG0062.20(2.00 to 2.40)
4
OG00114
Title
Denominators
Categories
Title
Measurements
OG0006.20(3.80 to 23.8)
OG0015.90(1.90 to 23.6)
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
OG005
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
OG006
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib