A Dose Escalation/Expansion Study of LDK378 in Patients W... | NCT01283516 | Trialant
NCT01283516
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Mar 15, 2019Actual
Enrollment
304Actual
Phase
Phase 1
Conditions
Tumors Characterized by Genetic Abnormalities of ALK
Interventions
LDK378
Countries
United States
Australia
Belgium
Canada
Germany
Italy
Netherlands
Singapore
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01283516
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLDK378X2101
Secondary IDs
ID
Type
Description
Link
2010-019827-70
EudraCT Number
Brief Title
A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase
Official Title
A Phase I, Multi-center, Open Label Dose Escalation Study of LDK378, Administered Orally in Adult Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Nov 2018
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
Jan 24, 2011Actual
Primary Completion Date
May 3, 2016Actual
Completion Date
May 3, 2016Actual
First Submitted Date
Jan 24, 2011
First Submission Date that Met QC Criteria
Jan 24, 2011
First Posted Date
Jan 26, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
May 29, 2014
Results First Submitted that Met QC Criteria
Jul 18, 2014
Results First Posted Date
Aug 11, 2014Estimated
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
Nov 28, 2018
Last Update Posted Date
Mar 15, 2019Actual
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
This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).
Detailed Description
Not provided
Conditions Module
Conditions
Tumors Characterized by Genetic Abnormalities of ALK
Keywords
ALK inhibitor,
NSCLC,
LDK378,
ceritinib,
genetic abnormalities
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
304Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LDK378 750 mg: Arm 1A and Arm 1B
Experimental
NSCLC patients previously treated with an ALK inhibitor
Drug: LDK378
LDK378 750 mg: Arm 2
Experimental
NSCLC patients not previously treated with an ALK inhibitor
Drug: LDK378
LDK378 750 mg: Arm 3
Experimental
Patients with other tumors that are ALK positive other than NSCLC
Drug: LDK378
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LDK378
Drug
LDK378 is a selective and a potent inhibitor of anaplastic lymphoma kinase (ALK) activity, is a capsule and is administered orally.
LDK378 750 mg: Arm 1A and Arm 1B
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.
33 months
Secondary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR) Based on Investigator Assessment
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
ECOG Performance Status of ≤ 2 and life expectancy of ≥ 12 weeks.
Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists. Only patients with tumors characterized by genetic abnormalities in ALK were enrolled.
For NSCLC, an ALK translocation must be detected by FISH in ≥ 15% of tumor cells.
In patients with diseases other than NSCLC, ALK translocation is not required and overexpression of ALK protein may be considered indicative of a genetic abnormality in ALK.
Patients with measurable or non-measurable disease as determined by modified RECIST version 1.0 in dose-escalation phase, and patients with at least one measurable lesion as determined by RECIST 1.0 in expansion phase.
Exclusion Criteria:
Patients with symptomatic central nervous system (CNS) metastases who were neurologically unstable or required increasing doses of steroids to control their CNS disease were excluded.
Patients with a prior or current history of a second malignancy, impaired GI function, history of pancreatitis or increased amylase or lipase, known diagnosis of HIV, and clinically significant cardiac disease were excluded.
Patients treated with chemotherapy or biologic therapy or other investigational agent < 2 weeks prior to starting study drug for compounds with a half-life ≤ 3 days, and < 4 weeks prior to starting study drug for compounds with a prolonged half-life were excluded.
Further, patients treated with medications that were known to be strong inhibitors or inducers of CYP3A4/5 that could not be discontinued at least a week prior to start of treatment with LDK378 and for the duration of the study were also excluded.
Other protocol-defined inclusion/exclusion criteria may apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Colorado School of Medicine Colorado Univ
Tan DS, Thomas M, Kim DW, Szpakowski S, Urban P, Mehra R, Chow LQM, Sharma S, Solomon BJ, Felip E, Camidge DR, Vansteenkiste J, Petruzzelli L, Pantano S, Shaw AT. Genetic landscape of patients with ALK-rearranged non-small-cell lung cancer (NSCLC) and response to ceritinib in ASCEND-1 study. Lung Cancer. 2022 Jan;163:7-13. doi: 10.1016/j.lungcan.2021.11.007. Epub 2021 Nov 20.
A total of 304 patients were treated with LDK378 in the study, including 59 patients from the dose-escalation phase (including 10 patients at 750 mg) and 245 patients from the expansion phase treated at LDK378 750 mg.
Recruitment Details
Study was considered completed when all patients discontinued ceritinib treatment, & all required follow-up was completed or patient died, was lost to follow-up or withdrew their consent to further participate in study or last patient on treatment was enrolled to a separate protocol to continue receiving ceritinib treatment, whichever came first.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
FG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
Periods
Title
Milestones
Reasons Not Completed
Overall Study
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
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Ireland
New Zealand
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
LDK378 750 mg: Arm 2
LDK378 750 mg: Arm 3
275 weeks
Overall Response Rate Based on Blinded Independent Review Committee (BIRC) Assessment
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).
275 weeks
Duration of Response (DOR) Based on Investigator Assessment
Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.
275 weeks
Duration of Response (DOR) Based on BIRC
Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.
275 weeks
Progression-free Survival Based on Investigator Assessment
Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.0. or death due to any cause.
275 weeks
Progression-free Survival Based on BIRC Assessment
Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.0. or death due to any cause.
The AUC from time zero to the last quantifiable concentration point (Tlast). Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378.
PK run-in of Dose Escalation phase
Primary Pharmacokinetics (PK) Parameter: AUC0-24h
Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. AUC0 - 24 is the AUC calculated to 24 hour. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter AUC0-24.
PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases
Primary Pharmacokinetics (PK) Parameter: Tmax
Tmax is the time to reach Cmax. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Tmax.
PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases
Primary Pharmacokinetics (PK) Parameter: Cmax
Cmax is the maximum observed concentration. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Cmax.
PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation ion phase, Cycle 2 Day 1 of dose escalation & expansion phases
Secondary Pharmacokinetics (PK) Parameter: T1/2
T1/2 is the elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378.
PK Run-in dose escalation phase
Secondary Pharmacokinetics (PK) Parameter: CL/F
CL/F is the apparent total body clearance of drug from the plasma
PK Run-in dose escalation phase
Secondary Pharmacokinetics (PK) Parameter: Vz/F
Vz/F is the apparent volume of distribution during terminal phase (associated with Lambda_z)
PK Run-in dose escalation phase
Secondary Pharmacokinetics (PK) Parameter: CLss/F
CLss/F is the apparent total body clearance of drug from the plasma. There was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter CLss/F.
Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases
Secondary Pharmacokinetics (PK) Parameter: Racc
Racc is the accumulation ratio calculated using AUCtau values obtained from a dosing interval at steady-state divided by AUCtau at day 1 or PK run-in phase. AUCtau is the AUC calculated to the end of the dosing interval, tau. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Racc.
Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases
Boston
Massachusetts
02114
United States
Memorial Sloan Kettering MSK
New York
New York
10017
United States
Fox Chase Cancer Center Fox Chase Cancer (2)
Philadelphia
Pennsylvania
19111
United States
University of Utah / Huntsman Cancer Institute Huntsman
Salt Lake City
Utah
84103
United States
Seattle Cancer Care Alliance
Seattle
Washington
98105
United States
Novartis Investigative Site
Melbourne
Victoria
3000
Australia
Novartis Investigative Site
Leuven
3000
Belgium
Novartis Investigative Site
Toronto
Ontario
M5G 1Z6
Canada
Novartis Investigative Site
Cologne
North Rhine-Westphalia
50937
Germany
Novartis Investigative Site
Essen
45147
Germany
Novartis Investigative Site
Heidelberg
69120
Germany
Novartis Investigative Site
Ulm
89081
Germany
Novartis Investigative Site
Milan
MI
20141
Italy
Novartis Investigative Site
Rozzano
MI
20089
Italy
Novartis Investigative Site
Amsterdam
1066 CX
Netherlands
Novartis Investigative Site
Singapore
169610
Singapore
Novartis Investigative Site
Seoul
Korea
03080
South Korea
Novartis Investigative Site
Barcelona
Catalonia
08035
Spain
Novartis Investigative Site
Glasgow
Scotland
G12 0YN
United Kingdom
Novartis Investigative Site
Leicester
LE1 5WW
United Kingdom
Derived
Kim DW, Mehra R, Tan DSW, Felip E, Chow LQM, Camidge DR, Vansteenkiste J, Sharma S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler M, Liu G, Santoro A, Sutradhar S, Li S, Szczudlo T, Yovine A, Shaw AT. Activity and safety of ceritinib in patients with ALK-rearranged non-small-cell lung cancer (ASCEND-1): updated results from the multicentre, open-label, phase 1 trial. Lancet Oncol. 2016 Apr;17(4):452-463. doi: 10.1016/S1470-2045(15)00614-2. Epub 2016 Mar 11.
Richly H, Kim TM, Schuler M, Kim DW, Harrison SJ, Shaw AT, Boral AL, Yovine A, Solomon B. Ceritinib in patients with advanced anaplastic lymphoma kinase-rearranged anaplastic large-cell lymphoma. Blood. 2015 Sep 3;126(10):1257-8. doi: 10.1182/blood-2014-12-617779. No abstract available.
Shaw AT, Kim DW, Mehra R, Tan DS, Felip E, Chow LQ, Camidge DR, Vansteenkiste J, Sharma S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler M, Liu G, Santoro A, Lau YY, Goldwasser M, Boral AL, Engelman JA. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Mar 27;370(13):1189-97. doi: 10.1056/NEJMoa1311107.
FG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
FG003
LDK378 300 mg
Participants receiving 300 mg of LDK378
FG004
LDK378 400 mg
Participants receiving 400 mg of LDK378
FG005
LDK378 500 mg
Participants receiving 500 mg of LDK378
FG006
LDK378 600 mg
Participants receiving 600 mg of LDK378
FG007
LDK378 700 mg
Participants receiving 700 mg of LDK378
FG008
LDK378 750 mg
Participants receiving 750 mg of LDK378.
FG0002 subjectsStarted = Full Analysis Set and Safety Set
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG00414 subjects
FG00510 subjects
FG00610 subjects
FG0075 subjects
FG008255 subjects
Non-Small Cell Lung Cancer (NSCLC)
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG00412 subjects
FG00510 subjects
FG0069 subjects
FG0075 subjects
FG008246 subjects
Dose-Determining Set (DDS)
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0033 subjects
FG00414 subjects
FG0058 subjects
FG00610 subjects
FG0075 subjects
FG0088 subjects
Non-NSCLC
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0089 subjectsSmall number of patients at 750 mg - non-NSCLC, assessment limited, not included in efficacy tables
COMPLETED
FG0000 subjectsCompleted - see explanation in Recruitment Details.
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG00414 subjects
FG00510 subjects
FG00610 subjects
FG0075 subjects
FG008255 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG00828 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease Progression
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Administrative problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Patients were classified according to the intended treatment dose group.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
BG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
BG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
BG003
LDK378 300 mg
Participants receiving 300 mg of LDK378
BG004
LDK378 400 mg
Participants receiving 400 mg of LDK378
BG005
LDK378 500 mg
Participants receiving 500 mg of LDK378
BG006
LDK378 600 mg
Participants receiving 600 mg of LDK378
BG007
LDK378 700 mg
Participants receiving 700 mg of LDK378
BG008
LDK378 750 mg
Participants receiving 750 mg of LDK378.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0012
BG0023
BG0033
BG00414
BG00510
BG00610
BG0075
BG008255
BG009304
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
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG003
Age, Customized
Number
Participants
Title
Denominators
Categories
<65 years
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Hispanic or Latino
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Predominant Race
Number
Participants
Title
Denominators
Categories
Caucasian
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Weight
Mean
Standard Deviation
Kilograms (kg)
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Height
Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Height was not collected for 1 patient each in the 700 mg arm and the 750 mg arm.
Mean
Standard Deviation
centimenters (cm)
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Body Mass Index
Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Body Mass Index was not collected for 1 patient each in the 700 mg arm and the 750 mg arm.
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
WHO/ECOG Performance status
The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
Number
Participants
Title
Denominators
Categories
0:Fully active,in line with pre-disease activities
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Smoking History
Number
Participants
Title
Denominators
Categories
Never Smoked
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
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
Number of Participants With Dose Limiting Toxicities (DLTs)
The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.
Dose-determining Set (DDS) consists of all patients (NSCLC and non-NSCLC) from the safety set who either meet the minimum exposure criterion and have sufficient safety evaluations or have experienced a dose limiting toxicity (DLT) during Cycle 1 (including the PK run-in period). This constitutes all evaluable patients for the determination of MTD.
Posted
Number
Participants
33 months
ID
Title
Description
OG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
OG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
OG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
OG003
LDK378 300 mg
Participants receiving 300 mg of LDK378
OG004
LDK378 400 mg
Participants receiving 400 mg of LDK378
OG005
LDK378 500 mg
Participants receiving 500 mg of LDK378
OG006
LDK378 600 mg
Participants receiving 600 mg of LDK378
OG007
LDK378 700 mg
Participants receiving 700 mg of LDK378
OG008
LDK378 750 mg
Participants receiving 750 mg of LDK378.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG003
Title
Denominators
Categories
Diarrhea
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Overall Response Rate (ORR) Based on Investigator Assessment
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).
Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.
Posted
Number
95% Confidence Interval
Percentage of Participants
275 weeks
ID
Title
Description
OG000
NSCLC With Prior ALKi (Arms 1A + 1B)
Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.
OG001
NSCLC ALKi Naive (Arm 2)
Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.
Secondary
Overall Response Rate Based on Blinded Independent Review Committee (BIRC) Assessment
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).
Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.
Posted
Number
95% Confidence Interval
Percentage of participants
275 weeks
ID
Title
Description
OG000
NSCLC With Prior ALKi (Arms 1A + 1B)
Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.
OG001
NSCLC ALKi Naive (Arm 2)
Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.
Secondary
Duration of Response (DOR) Based on Investigator Assessment
Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.
Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and had a confirmed overall complete response or partial response after initiation of LDK378.
Posted
Median
95% Confidence Interval
months
275 weeks
ID
Title
Description
OG000
NSCLC With Prior ALKi (Arms 1A + 1B)
Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.
OG001
NSCLC ALKi Naive (Arm 2)
Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.
OG002
All NSCLC
all NSCLC patients.
Secondary
Duration of Response (DOR) Based on BIRC
Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.
Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and had a confirmed overall complete response or partial response after initiation of LDK378.
Posted
Median
95% Confidence Interval
months
275 weeks
ID
Title
Description
OG000
NSCLC With Prior ALKi (Arms 1A + 1B)
Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.
OG001
NSCLC ALKi Naive (Arm 2)
Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.
OG002
All NSCLC
all NSCLC patients.
Units
Secondary
Progression-free Survival Based on Investigator Assessment
Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.0. or death due to any cause.
Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.
Posted
Median
95% Confidence Interval
months
275 weeks
ID
Title
Description
OG000
NSCLC With Prior ALKi (Arms 1A + 1B)
Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.
OG001
NSCLC ALKi Naive (Arm 2)
Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.
OG002
All NSCLC
all NSCLC patients
Units
Counts
Participants
Secondary
Progression-free Survival Based on BIRC Assessment
Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.0. or death due to any cause.
Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.
Posted
Median
95% Confidence Interval
months
275 weeks
ID
Title
Description
OG000
NSCLC With Prior ALKi (Arms 1A + 1B)
Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.
OG001
NSCLC ALKi Naive (Arm 2)
Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor
The AUC from time zero to the last quantifiable concentration point (Tlast). Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378.
Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
PK run-in of Dose Escalation phase
ID
Title
Description
OG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
OG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
OG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
OG003
LDK378 300 mg
Participants receiving 300 mg of LDK378
OG004
LDK378 400 mg
Secondary
Primary Pharmacokinetics (PK) Parameter: AUC0-24h
Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. AUC0 - 24 is the AUC calculated to 24 hour. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter AUC0-24.
Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases
ID
Title
Description
OG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
OG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
OG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
OG003
LDK378 300 mg
Secondary
Primary Pharmacokinetics (PK) Parameter: Tmax
Tmax is the time to reach Cmax. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Tmax.
Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample
Posted
Median
Full Range
hour
PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases
ID
Title
Description
OG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
OG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
OG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
OG003
Secondary
Primary Pharmacokinetics (PK) Parameter: Cmax
Cmax is the maximum observed concentration. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Cmax.
Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation ion phase, Cycle 2 Day 1 of dose escalation & expansion phases
ID
Title
Description
OG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
OG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
OG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
OG003
LDK378 300 mg
Secondary
Secondary Pharmacokinetics (PK) Parameter: T1/2
T1/2 is the elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378.
Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample
Posted
Geometric Mean
Geometric Coefficient of Variation
hour
PK Run-in dose escalation phase
ID
Title
Description
OG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
OG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
OG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
OG003
LDK378 300 mg
Participants receiving 300 mg of LDK378
Secondary
Secondary Pharmacokinetics (PK) Parameter: CL/F
CL/F is the apparent total body clearance of drug from the plasma
Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample
Posted
Geometric Mean
Geometric Coefficient of Variation
Litres/hour
PK Run-in dose escalation phase
ID
Title
Description
OG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
OG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
OG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
OG003
LDK378 300 mg
Participants receiving 300 mg of LDK378
OG004
LDK378 400 mg
Secondary
Secondary Pharmacokinetics (PK) Parameter: Vz/F
Vz/F is the apparent volume of distribution during terminal phase (associated with Lambda_z)
Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample
Posted
Geometric Mean
Geometric Coefficient of Variation
Litre
PK Run-in dose escalation phase
ID
Title
Description
OG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
OG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
OG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
OG003
LDK378 300 mg
Participants receiving 300 mg of LDK378
OG004
LDK378 400 mg
Secondary
Secondary Pharmacokinetics (PK) Parameter: CLss/F
CLss/F is the apparent total body clearance of drug from the plasma. There was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter CLss/F.
Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample
Posted
Geometric Mean
Geometric Coefficient of Variation
Litres/hour
Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases
ID
Title
Description
OG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
OG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
OG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
OG003
LDK378 300 mg
Participants receiving 300 mg of LDK378
OG004
Secondary
Secondary Pharmacokinetics (PK) Parameter: Racc
Racc is the accumulation ratio calculated using AUCtau values obtained from a dosing interval at steady-state divided by AUCtau at day 1 or PK run-in phase. AUCtau is the AUC calculated to the end of the dosing interval, tau. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Racc.
Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample
Posted
Geometric Mean
Geometric Coefficient of Variation
unitless
Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases
ID
Title
Description
OG000
LDK378 50 mg
Participants receiving 50 mg of LDK378
OG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
OG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
Time Frame
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), at least 30 days following the last dose of study treatment . All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
Description
Not provided
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
LDK378 50 mg
Participants receiving 50 mg of LDK378
0
2
2
2
EG001
LDK378 100 mg
Participants receiving 100 mg of LDK378
1
2
2
2
EG002
LDK378 200 mg
Participants receiving 200 mg of LDK378
1
3
3
3
EG003
LDK378 300 mg
Participants receiving 300 mg of LDK378
1
3
3
3
EG004
LDK378 400 mg
Participants receiving 400 mg of LDK378
7
14
14
14
EG005
LDK378 500 mg
Participants receiving 500 mg of LDK378
4
10
10
10
EG006
LDK378 600 mg
Participants receiving 600 mg of LDK378
7
10
10
10
EG007
LDK378 700 mg
Participants receiving 700 mg of LDK378
3
5
5
5
EG008
LDK378 750 mg
Participants receiving 750 mg of LDK378.
145
255
254
255
EG009
All Participants
All participants enrolled in the study
169
304
303
304
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected14 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected5 at risk
EG0082 affected255 at risk
EG0092 affected304 at risk
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cardiac Tamponade
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cardio-Respiratory Arrest
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Stress Cardiomyopathy
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Supraventricular Extrasystoles
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Atrial Septal Defect
Congenital, familial and genetic disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hearing Impaired
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cataract
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Diabetic Retinopathy
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastric Ulcer
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastritis Haemorrhagic
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Intestinal Perforation
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Intra-Abdominal Haemorrhage
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Chest Pain
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Drug Withdrawal Syndrome
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gait Disturbance
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Multi-Organ Failure
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bile Duct Obstruction
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Drug-Induced Liver Injury
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gallbladder Fistula
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gallbladder Oedema
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gallbladder Perforation
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hepatitis Cholestatic
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Appendicitis Perforated
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bacterial Sepsis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cranial Nerve Infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Empyema
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ludwig Angina
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lung Infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neutropenic Sepsis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pulmonary Tuberculosis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Septic Shock
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Compression Fracture
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Eye Injury
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Facial Bones Fracture
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pelvic Fracture
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Spinal Fracture
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Toxicity To Various Agents
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Amylase Increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood Urea Increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ejection Fraction Decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lipase Increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oxygen Saturation Decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Transaminases Increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Diabetic Ketoacidosis
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Fracture Pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tendon Disorder
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Malignant Neoplasm Of Thorax
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Malignant Pleural Effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Metastases To Central Nervous System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Metastases To Meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Akathisia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Complex Partial Seizures
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Migraine
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peripheral Motor Neuropathy
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sensory Loss
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sinus Headache
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Mood Altered
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Breast Oedema
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Retracted Nipple
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vaginal Odour
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0022 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pigmentation Disorder
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Haemodynamic Instability
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hot Flush
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Jugular Vein Thrombosis
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
ID
Term
D002289
Carcinoma, Non-Small-Cell Lung
Ancestor Terms
ID
Term
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C586847
ceritinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG00812 subjects
13 subjects
FG0058 subjects
FG0066 subjects
FG0073 subjects
FG008139 subjects
1 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG00836 subjects
0 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG00839 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
3
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG00046.5± 23.33
BG00130.5± 12.02
BG00253.7± 10.69
BG00358.7± 5.03
BG00448.7± 15.62
BG00555.0± 15.99
BG00654.6± 13.22
BG00756.4± 4.67
BG00851.9± 12.08
BG00952.0± 12.41
3
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0002
BG0012
BG0022
BG0033
BG00412
BG0057
BG0067
BG0075
BG008215
BG009255
>=65 years
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0000
BG0010
BG0021
BG003
3
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
Female
BG0001
BG0011
BG0023
BG0032
BG00410
BG0056
BG0067
BG0074
BG008136
BG009170
Male
BG0001
BG0011
BG0020
BG0031
BG004
3
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
BG0063
BG0071
BG00826
BG00932
Chinese
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0000
BG0010
BG0020
BG003
Indian (Indian subcontinent)
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0000
BG0010
BG0020
BG003
Mixed Ethnicity
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0000
BG0010
BG0020
BG003
Other
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0002
BG0012
BG0022
BG003
3
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0002
BG0012
BG0022
BG0032
BG00412
BG0058
BG0068
BG0073
BG008160
BG009199
Black
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0000
BG0010
BG0020
BG003
Asian
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0000
BG0010
BG0020
BG003
Native American
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0000
BG0010
BG0020
BG003
Pacific Islander
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0000
BG0010
BG0021
BG003
Other
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0000
BG0010
BG0020
BG003
3
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG00060.8± 19.80
BG00167.8± 5.94
BG00269.2± 17.20
BG00354.1± 9.70
BG00469.2± 15.91
BG00572.2± 18.74
BG00663.8± 13.23
BG00761.6± 16.05
BG00869.2± 15.64
BG00968.8± 15.61
3
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0074
ParticipantsBG008254
ParticipantsBG009302
Title
Measurements
BG000169.0± 7.07
BG001178.0± 14.14
BG002161.3± 3.04
BG003164.6± 5.82
BG004169.9± 9.35
BG005166.4± 12.24
BG006165.1± 8.67
BG007163.6± 5.05
BG008167.5± 9.87
BG009167.5± 9.78
3
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0074
ParticipantsBG008254
ParticipantsBG009302
Title
Measurements
BG00021.1± 5.16
BG00121.8± 5.30
BG00226.5± 5.69
BG00320.2± 5.08
BG00424.0± 5.38
BG00525.9± 5.41
BG00623.1± 2.78
BG00724.3± 6.06
BG00824.5± 4.40
BG00924.4± 4.48
3
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0001
BG0011
BG0021
BG0030
BG0043
BG0052
BG0062
BG0071
BG00865
BG00976
1: Able to carry out light work
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0023
ParticipantsBG0033
ParticipantsBG00414
ParticipantsBG00510
ParticipantsBG00610
ParticipantsBG0075
ParticipantsBG008255
ParticipantsBG009304
Title
Measurements
BG0001
BG0011
BG0022
BG003
2:Capable of self-care up & about >50% of the time