Study to Assess Safety, Pharmacokinetics, and Efficacy of... | NCT01177397 | Trialant
NCT01177397
Sponsor
Celgene
Status
Completed
Last Update Posted
Dec 13, 2022Actual
Enrollment
226Actual
Phase
Phase 1Phase 2
Conditions
Multiple Myeloma
Diffuse Large B-Cell Lymphoma
Glioblastoma Multiforme
Hepatocellular Carcinoma
Non-Small Cell Lung Cancer
Neuroendocrine Tumors of Non-Pancreatic Origin
Hormone Receptor-Positive Breast Cancer
Interventions
CC-223
Countries
United States
France
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01177397
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CC-223-ST-001
Secondary IDs
Not provided
Brief Title
Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
Official Title
A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Multiple Myeloma
Acronym
Not provided
Organization
CelgeneINDUSTRY
Status Module
Record Verification Date
Dec 2022
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
Jul 20, 2010Actual
Primary Completion Date
Nov 15, 2016Actual
Completion Date
Dec 9, 2016Actual
First Submitted Date
Aug 5, 2010
First Submission Date that Met QC Criteria
Aug 6, 2010
First Posted Date
Aug 9, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 30, 2022
Results First Submitted that Met QC Criteria
Oct 21, 2022
Results First Posted Date
Nov 15, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 13, 2017
Certification/Extension First Submitted that Passed QC Review
Nov 13, 2017
Certification/Extension First Posted Date
Nov 14, 2017Actual
Last Update Submitted Date
Dec 9, 2022
Last Update Posted Date
Dec 13, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelgeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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 main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.
Detailed Description
Initially, patients will be treated with oral CC-223 for one month. During this time, various tests (involving blood and urine collections, ECGs, etc) will be performed. Those whose tumors stabilize or regress may continue receiving treatment for as long as they benefit from CC-223. Different dose levels of CC-223 will be tested in a dose-rising study design.
All patients will receive CC-223, but serial patient groups will receive different dose levels in Phase 1. The number of groups will be determined by the number of dose levels required to establish dose-limiting toxicity.
Drug: CC-223
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CC-223
Drug
Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants With Dose-limiting Toxicities
A dose-limiting toxicity was defined as: - ≥ Grade 3 (per Common Terminology Criteria for Adverse Events [CTCAE] Version 4) clinically relevant adverse event (AE) or laboratory abnormality suspected to be related to CC-223 that commenced within 30 days of first dose, except alopecia, Grade 3 rash of the acneiform or maculopapular type for < 5 days, Grade 3 diarrhea or vomiting lasting < 72 hours, repeated occurrence of Grade 3 hyperuricaemia in subjects with Grade 3 hyperuricemia at baseline, hyperglycemia, hematologic and liver function test (LFT) abnormalities due to disease progression. - Grade 2 fasting hyperglycemia lasting > 14 days or ≥ Grade 3 lasting > 4 days despite optimal medical treatment. - Hematological toxicities including febrile neutropenia, Grade 4 neutropenia or thrombocytopenia for > 7 days, or Grade 3/4 thrombocytopenia with clinically significant bleeding. - Grade 4 LTFs - AE suspected to be CC-223 related necessitating dose reduction during cycle 1.
From first dose up to 30 days after first dose
Maximum Observed Plasma Concentration (Cmax) of CC-223
Cmax is defined as the maximum observed concentration (in plasma), obtained directly from the observed concentration versus time data. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
Time to Maximum Concentration (Tmax) of CC-223
Tmax is defined as the time to Cmax, obtained directly from the observed concentration versus time data. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) for CC-223
Secondary Outcomes
Measure
Description
Time Frame
Part A: Percent Change From Baseline in Levels of Phosphorylated Ribosomal Protein S6 (pS6RP) in Stimulated B Cells
Phosphorylated S6RP is a biomarker for inhibition of the mammalian target of rapamycin complex 1 (mTORC1). Phosphorylated S6RP was measured in stimulated B cells via flow cytometry. The raw measurements were expressed as median fluorescence intensity (MFI). MFI values were normalized against calibration beads using a linear regression transformation carried out on a log-log scale and reported as equivalent reference fluorophores (ERF). The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Results were not available for the single subject treated in the 7.5-mg dose group and for one of the two subjects treated in the 15-mg dose group.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically-confirmed advanced solid tumor, Non-Hodgkin Lymphoma or multiple myeloma
Patients have not tolerated or progressed on standard therapy, and no further standard therapy is available
Archival and screening tumor biopsy
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (solid tumors), 0-2 (hematologic malignancy)
Adequate organ function
Exclusion Criteria:
Prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy. Subjects must have recovered from any effects of recent radiotherapy that might confound the safety evaluation of study drug
Symptomatic brain metastases (prior Rx and stable metastases are OK)
Acute or chronic liver or renal disease or pancreatitis
Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in subjects with HCC
Pregnant, inadequate contraception
Most concurrent second malignancies
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
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Cedars-Sinai Medical Center
Los Angeles
California
90048
United States
UCLA Neuro-Oncology Program
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
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
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
CC-223
Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
Area Under the Concentration Time-Curve From 0-24 Hours After a Dose (AUC0-24) for CC-223
AUC0-24 is defined as the area under the concentration-time curve from Time 0 to 24 hours after a dose. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
0 to 24 hours post-dose on Day -1 and Day 15
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) For CC-223
AUCinf is defined as the area under the concentration-time curve from Time 0 extrapolated to infinity. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. AUCinf was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
Part A: Terminal Elimination Phase Half-Life (T1/2) of CC-223
Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. T1/2 was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose
Apparent Total Body Clearance (CL/F) of CC-223
CL/F is defined as the apparent total body clearance when dosed orally, calculated as Dose/AUCinf. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
Apparent Volume of Distribution (Vz/F) of CC-223
Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. VZ/F was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose
Part B: Progression Free Survival (PFS) Rate at 6 Months for GBM Participants
Progression free survival rate of GBM participants at 6 months is defined as the percentage of participants without progressive disease per Evaluation Criteria in Solid Tumors (RECIST) 1.1 6 months after starting study treatment. Progressive disease is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
From first dose to 6 months
Cycle 1 Day -1: 3 hours post-dose and Day 15: 1.5 hours post-dose
Part A: Percent Change From Baseline in Levels of Phosphorylated Elongation I Initiation Binding Protein (p4E-BP1) in Stimulated T Cells
Phosphorylated 4E-BP1 is a biomarker for inhibition of the mammalian target of rapamycin complex 1 (mTORC1). Phosphorylated 4E-BP1 was measured in stimulated T cells via flow cytometry. The raw measurements were expressed as median fluorescence intensity (MFI). MFI values were normalized against calibration beads using a linear regression transformation carried out on a log-log scale and reported as equivalent reference fluorophores (ERF). The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Results were not available for the single subject treated in the 7.5-mg dose group and for one of the two subjects treated in the 15-mg dose group.
Cycle 1 Day -1: 3 hours post-dose and Day 15: 1.5 hours post-dose
Part A: Percent Change From Baseline in Levels of Phosphorylated Protein Kinase B (pAKT) in Stimulated Monocytes
Phosphorylated AKT is a biomarker for inhibition of the mammalian target of rapamycin complex 2 (mTORC2). Phosphorylated AKT was measured in stimulated monocytes via flow cytometry. The raw measurements were expressed as median fluorescence intensity (MFI). MFI values were normalized against calibration beads using a linear regression transformation carried out on a log-log scale and reported as equivalent reference fluorophores (ERF). The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Results were not available for the single subject treated in the 7.5-mg dose group and for one of the two subjects treated in the 15-mg dose group.
Cycle 1 Day -1: 3 hours post-dose and Day 15: 1.5 hours post-dose
Part B: Percent Change From Baseline in p4E-BP1 in Monocytes by Tumor Cohort
Phosphorylated 4E-BP1 is a biomarker for inhibition of the mammalian target of rapamycin complex 1 (mTORC1). Phosphorylated 4E-BP1 was measured in stimulated monocytes via flow cytometry. MFI values were determined and converted to molecules of equivalent fluorescence label (MEFL) by normalizing against calibration beads. The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Data is reported by T-cell subsets known as clusters of differentiation (CD).
Cycle 1 Day 1: 1.5 hours post-dose and Day 15: 1.5 hours post-dose
Part B: Percent Change From Baseline in p4E-BP1 in Monocytes in the HCC and NET Cohorts by Dose
Phosphorylated 4E-BP1 is a biomarker for inhibition of the mammalian target of rapamycin complex 1 (mTORC1). Phosphorylated 4E-BP1 was measured in stimulated monocytes via flow cytometry. MFI values were determined and converted to molecules of equivalent fluorescence label (MEFL) by normalizing against calibration beads. The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Data is reported by T-cell subsets known as clusters of differentiation (CD).
Cycle 1 Day 1: 1.5 hours post-dose and Day 15: 1.5 hours post-dose
Part B: Percent Change From Baseline in Levels of pAKT in Monocytes by Tumor Cohort
Phosphorylated AKT is a biomarker for inhibition of the mammalian target of rapamycin complex 2 (mTORC2). Phosphorylated AKT was measured in stimulated monocytes via flow cytometry. MFI values were determined and converted to molecules of equivalent fluorescence label (MEFL) by normalizing against calibration beads. The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment.
Cycle 1 Day 1: 1.5 hours post-dose and Day 15: 1.5 hours post-dose
Part B: Percent Change From Baseline in Levels of pAKT in Monocytes in the HCC and NET Cohorts by Dose
Phosphorylated AKT is a biomarker for inhibition of the mammalian target of rapamycin complex 2 (mTORC2). Phosphorylated AKT was measured in stimulated monocytes via flow cytometry. MFI values were determined and converted to molecules of equivalent fluorescence label (MEFL) by normalizing against calibration beads. The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment.
Cycle 1 Day 1: 1.5 hours post-dose and Day 15: 1.5 hours post-dose
Part B: Percent Change From Baseline in pS6RP Levels in Tumor Tissue by Tumor Type
Tumor tissue biopsies were performed at Baseline and on Day 15 3 hours post dose. Levels of pS6RP were quantified using immunohistochemical (IHC) methods.
Up to Cycle 1 Day 15 3 hours post dose
Part A: Overall Response Rate
Tumor response was based on Investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors (NSCLC, HCC, NET, and HRPBC), and the International Working Group Criteria (IWC) for DLBCL. Overall Response Rate is defined as the percentage of participants with a best overall response of complete response or partial response. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. In Part A, participants with MM and participants with GBM were not evaluated for tumor response.
From first dose up to tumor response (approximately 11 months)
Part B: Overall Response Rate
Tumor response was based on Investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors (NSCLC, HCC, NET, and HRPBC), International Working Group Criteria (IWC) for DLBCL, and the International Myeloma Working Group (IMWG) criteria for MM. For GBM, Responses Assessment for Neuro-Oncology Working Group (RANO) criteria were used for tumor response, using the post resection MRI scan as the baseline. Overall Response Rate is defined as the percentage of participants with a best overall response of complete response or partial response. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose up to tumor response (approximately 36 months)
Maximum Observed Concentration (Cmax) of Metabolite M1
Cmax is defined as the maximum observed concentration (in plasma), obtained directly from the observed concentration versus time data. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
Time to Maximum Concentration (Tmax) of Metabolite M1
Tmax is defined as the time to Cmax, obtained directly from the observed concentration versus time data. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) for Metabolite M1
AUCt is defined as the area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
Area Under the Concentration Time-Curve From 0-24 Hours After a Dose (AUC0-24) for Metabolite M1
AUC0-24 is defined as the area under the concentration-time curve from Time 0 to 24 hours after a dose. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.
0 to 24 hours post-dose on Day -1 and Day 15
Los Angeles
California
90095
United States
University of California, San Francisco Hellen Diller Family Comprehensive Cancer Center
San Francisco
California
94115
United States
Moffitt Cancer Center
Tampa
Florida
33612
United States
Mayo Clinic Cancer Clinical Studies Unit
Rochester
Minnesota
55905
United States
Billings Clinic
Billings
Montana
59102
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
NYU Cancer Institute - Bellevue Hospital
New York
New York
10016
United States
Sarah Cannon Research Institute Drug Development Unit
Nashville
Tennessee
37203
United States
Mary Crowley Medical Research Center
Dallas
Texas
75201
United States
Institut Claudius Regaud
Toulouse
31052
France
Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie
Villejuif
94800
France
Hospital Universitario de Salamanca
Salamanca
37007
Spain
Hospital Universitario Virgen Del Rocio
Seville
41013
Spain
Sarah Cannon Research Institute UK
London
W1G 6AD
United Kingdom
UCL Cancer Institute
London
WC1E 6BT
United Kingdom
FG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
FG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
FG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
FG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
FG005
Part B: Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
FG006
Part B: Glioblastoma Multiforme (GBM)
Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
FG007
Part B: Hepatocellular Carcinoma (HCC)
Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
FG008
Part B: Neuroendocrine Tumor (NET)
Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
FG009
Part B: Diffuse Large B-cell Lymphoma (DLBCL)
Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
FG010
Part B: Multiple Myeloma (MM)
Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
FG011
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
FG0001 subjects
FG0012 subjects
FG0029 subjects
FG0039 subjects
FG0047 subjects
FG00526 subjects
FG00613 subjects
FG00753 subjects
FG00847 subjects
FG00928 subjects
FG01014 subjects
FG01117 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0029 subjects
FG0039 subjects
FG0047 subjects
FG00526 subjects
FG00613 subjects
FG00753 subjects
FG00847 subjects
FG00928 subjects
FG01014 subjects
FG01117 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Disease progression
FG0001 subjects
FG0012 subjects
FG0025 subjects
FG0035 subjects
FG004
Other reasons
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
All treated participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
BG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
BG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
BG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
BG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
BG005
Part B: Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
BG006
Part B: Glioblastoma Multiforme (GBM)
Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
BG007
Part B: Hepatocellular Carcinoma (HCC)
Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
BG008
Part B: Neuroendocrine Tumor (NET)
Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
BG009
Part B: Diffuse Large B-cell Lymphoma (DLBCL)
Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
BG010
Part B: Multiple Myeloma (MM)
Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
BG011
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0012
BG0029
BG0039
BG0047
BG00526
BG00613
BG00753
BG00847
BG00928
BG01014
BG01117
BG012226
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
BG00055.0± NAStandard Deviation not calculable because data were only collected for 1 participant
BG00154.5± 10.61
BG00253.8± 11.57
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0000
BG0010
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
Part A: Number of Participants With Dose-limiting Toxicities
A dose-limiting toxicity was defined as: - ≥ Grade 3 (per Common Terminology Criteria for Adverse Events [CTCAE] Version 4) clinically relevant adverse event (AE) or laboratory abnormality suspected to be related to CC-223 that commenced within 30 days of first dose, except alopecia, Grade 3 rash of the acneiform or maculopapular type for < 5 days, Grade 3 diarrhea or vomiting lasting < 72 hours, repeated occurrence of Grade 3 hyperuricaemia in subjects with Grade 3 hyperuricemia at baseline, hyperglycemia, hematologic and liver function test (LFT) abnormalities due to disease progression. - Grade 2 fasting hyperglycemia lasting > 14 days or ≥ Grade 3 lasting > 4 days despite optimal medical treatment. - Hematological toxicities including febrile neutropenia, Grade 4 neutropenia or thrombocytopenia for > 7 days, or Grade 3/4 thrombocytopenia with clinically significant bleeding. - Grade 4 LTFs - AE suspected to be CC-223 related necessitating dose reduction during cycle 1.
All treated participants in Part A.
Posted
Count of Participants
Participants
From first dose up to 30 days after first dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Maximum Observed Plasma Concentration (Cmax) of CC-223
Cmax is defined as the maximum observed concentration (in plasma), obtained directly from the observed concentration versus time data. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
All treated participants with available pharmacokinetic data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Primary
Time to Maximum Concentration (Tmax) of CC-223
Tmax is defined as the time to Cmax, obtained directly from the observed concentration versus time data. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
All treated participants with available pharmacokinetic data in Part A.
Posted
Median
Full Range
Hours
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Part A: CC-223 30 mg
Primary
Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) for CC-223
Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
All treated participants with available pharmacokinetic data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Part A: CC-223 30 mg
Primary
Area Under the Concentration Time-Curve From 0-24 Hours After a Dose (AUC0-24) for CC-223
AUC0-24 is defined as the area under the concentration-time curve from Time 0 to 24 hours after a dose. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
All treated participants with available pharmacokinetic data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
0 to 24 hours post-dose on Day -1 and Day 15
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Part A: CC-223 30 mg
Primary
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) For CC-223
AUCinf is defined as the area under the concentration-time curve from Time 0 extrapolated to infinity. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. AUCinf was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.
All treated participants with available pharmacokinetic data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Primary
Part A: Terminal Elimination Phase Half-Life (T1/2) of CC-223
Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. T1/2 was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.
All treated participants with available pharmacokinetic data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Primary
Apparent Total Body Clearance (CL/F) of CC-223
CL/F is defined as the apparent total body clearance when dosed orally, calculated as Dose/AUCinf. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
All treated participants with available pharmacokinetic data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Primary
Apparent Volume of Distribution (Vz/F) of CC-223
Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. VZ/F was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.
All treated participants with available pharmacokinetic data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
L
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Secondary
Part A: Percent Change From Baseline in Levels of Phosphorylated Ribosomal Protein S6 (pS6RP) in Stimulated B Cells
Phosphorylated S6RP is a biomarker for inhibition of the mammalian target of rapamycin complex 1 (mTORC1). Phosphorylated S6RP was measured in stimulated B cells via flow cytometry. The raw measurements were expressed as median fluorescence intensity (MFI). MFI values were normalized against calibration beads using a linear regression transformation carried out on a log-log scale and reported as equivalent reference fluorophores (ERF). The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Results were not available for the single subject treated in the 7.5-mg dose group and for one of the two subjects treated in the 15-mg dose group.
All biomarker evaluable participants who received treatment in Part A.
Posted
Median
Full Range
Percent change
Cycle 1 Day -1: 3 hours post-dose and Day 15: 1.5 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Secondary
Part A: Percent Change From Baseline in Levels of Phosphorylated Elongation I Initiation Binding Protein (p4E-BP1) in Stimulated T Cells
Phosphorylated 4E-BP1 is a biomarker for inhibition of the mammalian target of rapamycin complex 1 (mTORC1). Phosphorylated 4E-BP1 was measured in stimulated T cells via flow cytometry. The raw measurements were expressed as median fluorescence intensity (MFI). MFI values were normalized against calibration beads using a linear regression transformation carried out on a log-log scale and reported as equivalent reference fluorophores (ERF). The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Results were not available for the single subject treated in the 7.5-mg dose group and for one of the two subjects treated in the 15-mg dose group.
All biomarker evaluable participants who received treatment in Part A.
Posted
Median
Full Range
Percent change in p4E-BP1
Cycle 1 Day -1: 3 hours post-dose and Day 15: 1.5 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Secondary
Part A: Percent Change From Baseline in Levels of Phosphorylated Protein Kinase B (pAKT) in Stimulated Monocytes
Phosphorylated AKT is a biomarker for inhibition of the mammalian target of rapamycin complex 2 (mTORC2). Phosphorylated AKT was measured in stimulated monocytes via flow cytometry. The raw measurements were expressed as median fluorescence intensity (MFI). MFI values were normalized against calibration beads using a linear regression transformation carried out on a log-log scale and reported as equivalent reference fluorophores (ERF). The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Results were not available for the single subject treated in the 7.5-mg dose group and for one of the two subjects treated in the 15-mg dose group.
All biomarker evaluable participants who received treatment in Part A.
Posted
Median
Full Range
Percent change in pAKT
Cycle 1 Day -1: 3 hours post-dose and Day 15: 1.5 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Secondary
Part B: Percent Change From Baseline in p4E-BP1 in Monocytes by Tumor Cohort
Phosphorylated 4E-BP1 is a biomarker for inhibition of the mammalian target of rapamycin complex 1 (mTORC1). Phosphorylated 4E-BP1 was measured in stimulated monocytes via flow cytometry. MFI values were determined and converted to molecules of equivalent fluorescence label (MEFL) by normalizing against calibration beads. The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Data is reported by T-cell subsets known as clusters of differentiation (CD).
All biomarker evaluable participants who received treatment in Part B.
Posted
Median
Full Range
Percent change in p4E-BP1
Cycle 1 Day 1: 1.5 hours post-dose and Day 15: 1.5 hours post-dose
ID
Title
Description
OG000
Part B: Glioblastoma Multiforme (GBM)
Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part B: Hepatocellular Carcinoma (HCC)
Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Secondary
Part B: Percent Change From Baseline in p4E-BP1 in Monocytes in the HCC and NET Cohorts by Dose
Phosphorylated 4E-BP1 is a biomarker for inhibition of the mammalian target of rapamycin complex 1 (mTORC1). Phosphorylated 4E-BP1 was measured in stimulated monocytes via flow cytometry. MFI values were determined and converted to molecules of equivalent fluorescence label (MEFL) by normalizing against calibration beads. The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Data is reported by T-cell subsets known as clusters of differentiation (CD).
All biomarker evaluable participants who received treatment in Part B.
Posted
Median
Full Range
Percent change in p4E-BP1
Cycle 1 Day 1: 1.5 hours post-dose and Day 15: 1.5 hours post-dose
ID
Title
Description
OG000
HCC 30 mg
Participants with HCC received a daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
HCC 45 mg
Participants with HCC received a daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Secondary
Part B: Percent Change From Baseline in Levels of pAKT in Monocytes by Tumor Cohort
Phosphorylated AKT is a biomarker for inhibition of the mammalian target of rapamycin complex 2 (mTORC2). Phosphorylated AKT was measured in stimulated monocytes via flow cytometry. MFI values were determined and converted to molecules of equivalent fluorescence label (MEFL) by normalizing against calibration beads. The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment.
All biomarker evaluable participants who received treatment in Part B.
Posted
Median
Full Range
Percent change in pAKT
Cycle 1 Day 1: 1.5 hours post-dose and Day 15: 1.5 hours post-dose
ID
Title
Description
OG000
Part B: Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part B: Glioblastoma Multiforme (GBM)
Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Secondary
Part B: Percent Change From Baseline in Levels of pAKT in Monocytes in the HCC and NET Cohorts by Dose
Phosphorylated AKT is a biomarker for inhibition of the mammalian target of rapamycin complex 2 (mTORC2). Phosphorylated AKT was measured in stimulated monocytes via flow cytometry. MFI values were determined and converted to molecules of equivalent fluorescence label (MEFL) by normalizing against calibration beads. The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment.
All biomarker evaluable participants who received treatment in Part B.
Posted
Median
Full Range
Percent change in pAKT
Cycle 1 Day 1: 1.5 hours post-dose and Day 15: 1.5 hours post-dose
ID
Title
Description
OG000
HCC 30mg
Participants with HCC received a daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
HCC 45mg
Participants with HCC received a daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Secondary
Part B: Percent Change From Baseline in pS6RP Levels in Tumor Tissue by Tumor Type
Tumor tissue biopsies were performed at Baseline and on Day 15 3 hours post dose. Levels of pS6RP were quantified using immunohistochemical (IHC) methods.
All biomarker evaluable participants who received treatment in Part B.
Posted
Median
Full Range
Percent change in pS6RP
Up to Cycle 1 Day 15 3 hours post dose
ID
Title
Description
OG000
Part B: Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part B: Glioblastoma Multiforme (GBM)
Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Part B: Hepatocellular Carcinoma (HCC)
Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Secondary
Part A: Overall Response Rate
Tumor response was based on Investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors (NSCLC, HCC, NET, and HRPBC), and the International Working Group Criteria (IWC) for DLBCL. Overall Response Rate is defined as the percentage of participants with a best overall response of complete response or partial response. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. In Part A, participants with MM and participants with GBM were not evaluated for tumor response.
Participants who received treatment in Part A
Posted
Number
90% Confidence Interval
Percentage of participants
From first dose up to tumor response (approximately 11 months)
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Secondary
Part B: Overall Response Rate
Tumor response was based on Investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors (NSCLC, HCC, NET, and HRPBC), International Working Group Criteria (IWC) for DLBCL, and the International Myeloma Working Group (IMWG) criteria for MM. For GBM, Responses Assessment for Neuro-Oncology Working Group (RANO) criteria were used for tumor response, using the post resection MRI scan as the baseline. Overall Response Rate is defined as the percentage of participants with a best overall response of complete response or partial response. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Participants who received treatment in Part B reported by tumor cohort
Posted
Number
95% Confidence Interval
Percentage of participants
From first dose up to tumor response (approximately 36 months)
ID
Title
Description
OG000
Part B: Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part B: Glioblastoma Multiforme (GBM)
Secondary
Maximum Observed Concentration (Cmax) of Metabolite M1
Cmax is defined as the maximum observed concentration (in plasma), obtained directly from the observed concentration versus time data. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.
All treated participants with available pharmacokinetic data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Secondary
Time to Maximum Concentration (Tmax) of Metabolite M1
Tmax is defined as the time to Cmax, obtained directly from the observed concentration versus time data. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.
All treated participants with available pharmacokinetic data in Part A.
Posted
Median
Full Range
Hours
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Secondary
Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) for Metabolite M1
AUCt is defined as the area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.
All treated participants with available pharmacokinetic data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Secondary
Area Under the Concentration Time-Curve From 0-24 Hours After a Dose (AUC0-24) for Metabolite M1
AUC0-24 is defined as the area under the concentration-time curve from Time 0 to 24 hours after a dose. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.
All treated participants with available pharmacokinetic data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
0 to 24 hours post-dose on Day -1 and Day 15
ID
Title
Description
OG000
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Part A: CC-223 30 mg
Primary
Part B: Progression Free Survival (PFS) Rate at 6 Months for GBM Participants
Progression free survival rate of GBM participants at 6 months is defined as the percentage of participants without progressive disease per Evaluation Criteria in Solid Tumors (RECIST) 1.1 6 months after starting study treatment. Progressive disease is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
All treated participants in Part B with GBM without progression per RECIST 1.0 at 6 months
Posted
Number
95% Confidence Interval
Percentage of participants
From first dose to 6 months
ID
Title
Description
OG000
Part B: Glioblastoma Multiforme (GBM)
Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG000
Time Frame
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
Description
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
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
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
0
1
0
1
1
1
EG001
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
0
2
0
2
2
2
EG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
2
9
4
9
8
9
EG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
3
9
4
9
9
9
EG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
1
7
2
7
7
7
EG005
Part B: Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
10
26
15
26
26
26
EG006
Part B: Glioblastoma Multiforme (GBM)
Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
3
13
6
13
13
13
EG007
Part B: Hepatocellular Carcinoma (HCC)
Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
24
53
29
53
53
53
EG008
Part B: Neuroendocrine Tumor (NET)
Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
2
47
23
47
47
47
EG009
Part B: Diffuse Large B-cell Lymphoma (DLBCL)
Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
5
28
17
28
28
28
EG010
Part B: Multiple Myeloma (MM)
Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
2
14
6
14
14
14
EG011
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
4
17
11
17
17
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymph node pain
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0091 events1 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Autoimmune pancreatitis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Colonic obstruction
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Asthenia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
General physical health deterioration
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected9 at risk
EG003
Impaired healing
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Abscess
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Brain abscess
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cystitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hepatitis B
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Herpes simplex pneumonia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Incision site infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Lung infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Meningitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Perihepatic abscess
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pneumococcal sepsis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Sepsis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Septic shock
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ammonia increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Non-small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Syncope
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Delusional disorder, persecutory type
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Mania
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Alveolitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected7 at risk
EG00512 events8 affected26 at risk
EG0060 events0 affected13 at risk
EG0075 events5 affected53 at risk
EG0083 events3 affected47 at risk
EG0099 events8 affected28 at risk
EG01024 events7 affected14 at risk
EG01110 events5 affected17 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Goitre
Endocrine disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Blindness unilateral
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Scintillating scotoma
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Vision blurred
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected9 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Visual impairment
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Abdominal rigidity
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0024 events4 affected9 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0025 events4 affected9 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0024 events3 affected9 at risk
EG003
Asthenia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events2 affected2 at risk
EG0023 events3 affected9 at risk
EG003
Chest discomfort
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Chest pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Chills
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Discomfort
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Face oedema
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0012 events1 affected2 at risk
EG0027 events4 affected9 at risk
EG003
Feeling cold
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Feeling jittery
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Gait disturbance
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Influenza like illness
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Malaise
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Medical device pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0023 events2 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Oedema
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0024 events3 affected9 at risk
EG003
Pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Peripheral swelling
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Thirst decreased
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Xerosis
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Angular cheilitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Candida infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cystitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ear infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Eyelid infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Incision site infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Influenza
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Paronychia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Perineal abscess
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected9 at risk
EG003
Skin infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Post procedural swelling
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Scar
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Traumatic fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ammonia increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Amylase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Blood urea increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Escherichia test positive
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Lipase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Platelet count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pulse pressure increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Tandem gait test abnormal
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Thyroxine free increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Weight decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected9 at risk
EG003
Weight increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cell death
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0026 events4 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected9 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0028 events4 affected9 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hyperphagia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Metabolic alkalosis
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cerebral atrophy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0022 events2 affected9 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Dystonia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Facial paresis
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Incoherent
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected9 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Quadrantanopia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Seizure
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Sensory loss
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Syncope
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Tremor
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Upper motor neurone lesion
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
White matter lesion
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Anhedonia
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Depression
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0022 events2 affected9 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Mania
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Persistent depressive disorder
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Substance-induced psychotic disorder
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected2 at risk
EG0024 events4 affected9 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0024 events3 affected9 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Nasal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0023 events2 affected9 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected2 at risk
EG0022 events1 affected9 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected9 at risk
EG003
Flushing
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Haematoma
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected9 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
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Please email
Clinical.Trails@bms.com
ID
Term
D009101
Multiple Myeloma
D016403
Lymphoma, Large B-Cell, Diffuse
D005909
Glioblastoma
D006528
Carcinoma, Hepatocellular
D002289
Carcinoma, Non-Small-Cell Lung
Ancestor Terms
ID
Term
D054219
Neoplasms, Plasma Cell
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D020141
Hemostatic Disorders
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
D010265
Paraproteinemias
D001796
Blood Protein Disorders
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D006474
Hemorrhagic Disorders
D008232
Lymphoproliferative Disorders
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D016393
Lymphoma, B-Cell
D008228
Lymphoma, Non-Hodgkin
D008223
Lymphoma
D008206
Lymphatic Diseases
D001254
Astrocytoma
D005910
Glioma
D018302
Neoplasms, Neuroepithelial
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009375
Neoplasms, Glandular and Epithelial
D009380
Neoplasms, Nerve Tissue
D000230
Adenocarcinoma
D002277
Carcinoma
D008113
Liver Neoplasms
D004067
Digestive System Neoplasms
D009371
Neoplasms by Site
D004066
Digestive System Diseases
D008107
Liver Diseases
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000601736
CC-223
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0075 subjects
FG0082 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
1 subjects
FG0052 subjects
FG0060 subjects
FG0075 subjects
FG0089 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
0 subjects
FG00512 subjects
FG0061 subjects
FG00714 subjects
FG0088 subjects
FG0096 subjects
FG0103 subjects
FG0117 subjects
4 subjects
FG00510 subjects
FG00610 subjects
FG00721 subjects
FG00818 subjects
FG00912 subjects
FG01010 subjects
FG0118 subjects
1 subjects
FG0051 subjects
FG0062 subjects
FG0076 subjects
FG00810 subjects
FG0098 subjects
FG0100 subjects
FG0112 subjects
BG00346.0± 12.86
BG00449.9± 11.65
BG00562.8± 10.72
BG00655.6± 9.46
BG00760.0± 11.41
BG00862.6± 9.87
BG00953.9± 14.51
BG01060.4± 10.00
BG01153.9± 7.79
BG01258.2± 11.77
6
BG0035
BG0046
BG00512
BG0065
BG00710
BG00828
BG00911
BG0106
BG01117
BG012108
Male
BG0001
BG0010
BG0023
BG0034
BG0041
BG00514
BG0068
BG00743
BG00819
BG00917
BG0108
BG0110
BG012118
0
BG0030
BG0040
BG0052
BG0061
BG0074
BG0082
BG0094
BG0102
BG0111
BG01216
Not Hispanic or Latino
BG0001
BG0012
BG0029
BG0039
BG0047
BG00520
BG00612
BG00744
BG00845
BG00922
BG0106
BG01111
BG012188
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0054
BG0060
BG0075
BG0080
BG0092
BG0106
BG0115
BG01222
1
BG0032
BG0041
BG0052
BG0061
BG00710
BG0082
BG0090
BG0100
BG0111
BG01220
Black or African American
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0075
BG0081
BG0092
BG0100
BG0110
BG0129
White
BG0001
BG0012
BG0027
BG0037
BG0046
BG00520
BG00612
BG00731
BG00843
BG00924
BG0108
BG01110
BG012171
Other
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0072
BG0081
BG0090
BG0100
BG0111
BG0124
Missing
BG0000
BG0010
BG0020
BG0030
BG0040
BG0054
BG0060
BG0075
BG0080
BG0092
BG0106
BG0115
BG01222
9
OG0047
1
OG0042
OG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0039
OG0047
Title
Denominators
Categories
Day -1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG0047
Title
Measurements
OG00045.8± NACoefficient of Variation not calculable because data were only collected for 1 participant.
OG00197.4± 57.5
OG002188± 41.8
OG003
Day 15
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0039
OG0047
Title
Denominators
Categories
Day -1/1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG0047
Title
Measurements
OG0001.00(1.00 to 1.00)
OG0011.25(1.00 to 1.50)
OG0021.55(1.00 to 3.20)
OG003
Day 15
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0039
OG0047
Title
Denominators
Categories
Day -1/Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG0047
Title
Measurements
OG000318± NAInsufficient data values to calculate coefficient of variation.
OG001347± 60.2
OG0021204± 37.8
OG003
Day 15
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0039
OG0047
Title
Denominators
Categories
Day -1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG0047
Title
Measurements
OG000319± NAInsufficient data values to calculate coefficient of variation.
OG001379± 45.2
OG0021144± 36.5
OG003
Day 15
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
OG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0038
OG0046
Title
Denominators
Categories
Day -1/1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0046
Title
Measurements
OG000353± NAInsufficient data values to calculate coefficient of variation.
OG001378± 49.7
OG0021234± 38.9
OG003
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0038
OG0046
Title
Denominators
Categories
Title
Measurements
OG0007.68± NAInsufficient data values to calculate coefficient of variation.
OG0013.35± 54.1
OG0025.57± 38.4
OG0034.86± 25.9
OG0045.64± 16.7
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0038
OG0046
Title
Denominators
Categories
Day -1/1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0046
Title
Measurements
OG00021.2± NAInsufficient data values to calculate coefficient of variation.
OG00139.7± 49.7
OG00224.3± 38.9
OG003
Day 15
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0038
OG0046
Title
Denominators
Categories
Title
Measurements
OG000235± NAInsufficient data values to calculate coefficient of variation.
OG001192± 3.70
OG002195± 36.7
OG003186± 27.1
OG004236± 107.5
OG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0000
OG0011
OG0026
OG0038
OG0047
Title
Denominators
Categories
Day -1 3 hours post-dose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0038
ParticipantsOG0047
Title
Measurements
OG001-19.4(-19.4 to -19.4)
OG002-73.6(-86.1 to -58.5)
OG003-79.8(-87.5 to -34.7)
OG004
Day 15 1.5 hours post-dose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0000
OG0011
OG0029
OG0038
OG0047
Title
Denominators
Categories
Day -1 3 hours post-dose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
Title
Measurements
OG001-20.7(-20.7 to -20.7)
OG002-44.0(-65.1 to -28.7)
OG003-55.7(-71.2 to -26.4)
OG004
Day 15 1.5 hours post-dose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0034
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0000
OG0011
OG0029
OG0038
OG0047
Title
Denominators
Categories
Day -1 3 hours post-dose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
Title
Measurements
OG001-26.9(-26.9 to -26.9)
OG002-56.5(-72.2 to -31.7)
OG003-59.7(-74.6 to -23.0)
OG004
Day 15 1.5 hours post-dose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0033
OG002
Part B: Neuroendocrine Tumor (NET)
Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part B: Diffuse Large B-cell Lymphoma (DLBCL)
Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG005
Part B: Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG006
Part B: Multiple Myeloma (MM)
Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG00010
OG00144
OG00234
OG00315
OG0046
OG00518
OG0063
Title
Denominators
Categories
Day 1,1.5 hours post-dose - CD3+
ParticipantsOG0000
ParticipantsOG00124
ParticipantsOG00233
ParticipantsOG00315
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG001-23.5(-100.0 to 157.1)
OG002-50.0(-93.6 to 114.3)
OG003-61.6(-100.0 to 19.8)
OG004
Day 15, 1.5 hours post-dose - CD3+
ParticipantsOG0000
ParticipantsOG00118
ParticipantsOG00222
ParticipantsOG00310
Day 1,1.5 hours post-dose - CD14+
ParticipantsOG0001
ParticipantsOG00144
ParticipantsOG00234
ParticipantsOG00315
Day 15, 1.5 hours post-dose - CD14+
ParticipantsOG0001
ParticipantsOG00119
ParticipantsOG00223
ParticipantsOG00310
Day 1,1.5 hours post-dose - CD19+
ParticipantsOG0001
ParticipantsOG00125
ParticipantsOG00234
ParticipantsOG0033
Day 15, 1.5 hours post-dose - CD19+
ParticipantsOG0001
ParticipantsOG00118
ParticipantsOG00223
ParticipantsOG0033
Day 1,1.5 hours post-dose - CD91+
ParticipantsOG00010
ParticipantsOG00116
ParticipantsOG0026
ParticipantsOG0032
Day 15, 1.5 hours post-dose - CD91+
ParticipantsOG0009
ParticipantsOG00144
ParticipantsOG0020
ParticipantsOG0031
OG002
NET 30 mg
Participants with NET received a daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
NET 45 mg
Participants with NET received a daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG00020
OG0016
OG00221
OG00313
Title
Denominators
Categories
Day 1 1.5 hours post-dose - CD3+
ParticipantsOG00020
ParticipantsOG0014
ParticipantsOG00221
ParticipantsOG00312
Title
Measurements
OG000-28.3(-100.0 to 127.6)
OG00120.0(-69.1 to 157.1)
OG002-40.4(-93.6 to 11.6)
OG003
Day 15 1.5 hours post-dose - CD3+
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG0037
Day 1 1.5 hours post-dose - CD14+
ParticipantsOG00020
ParticipantsOG0016
ParticipantsOG00221
ParticipantsOG00313
Day 15 1.5 hours post-dose - CD14+
ParticipantsOG00015
ParticipantsOG0014
ParticipantsOG00215
ParticipantsOG0038
Part B: Hepatocellular Carcinoma (HCC)
Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part B: Neuroendocrine Tumor (NET)
Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part B: Diffuse Large B-cell Lymphoma (DLBCL)
Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG005
Part B: Multiple Myeloma (MM)
Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG006
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG00016
OG0018
OG00216
OG0034
OG0042
OG0054
OG0061
Title
Denominators
Categories
Day 1 1.5 hours post-dose
ParticipantsOG00016
ParticipantsOG0018
ParticipantsOG00216
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0054
ParticipantsOG0061
Title
Measurements
OG000-68.1(-86.5 to 43.9)
OG001-28.0(-73.0 to 130.1)
OG002-55.5(-86.2 to 27.1)
OG003
Day 15 1.5 hours post-dose
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0031
OG002
NET 30mg
Participants with NET received a daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
NET 45mg
Participants with NET received a daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0000
OG00116
OG0020
OG0034
Title
Denominators
Categories
Day 1 1.5 hours post-dose
ParticipantsOG0000
ParticipantsOG00116
ParticipantsOG0020
ParticipantsOG0034
Title
Measurements
OG001-55.5(-86.2 to 27.1)
OG003-70.3(-83.7 to -51.2)
Day 15 1.5 hours post-dose
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0031
OG003
Part B: Neuroendocrine Tumor (NET)
Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part B: Diffuse Large B-cell Lymphoma (DLBCL)
Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG005
Part B: Multiple Myeloma (MM)
Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG006
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0006
OG0011
OG0023
OG0031
OG0049
OG0050
OG0063
Title
Denominators
Categories
Title
Measurements
OG00022± -37(-37 to 66)
OG001-36± -36(-36 to -36)
OG002-19± -37(-37 to 24)
OG003-30± -30(-30 to -30)
OG004-21± -43(-43 to 12)
OG006-15± -17(-17 to 6)
OG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0029
OG0039
OG0047
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010(NA to NA)Lower and upper limit not calculated due to insufficient number of events
OG00211.1(0.6 to 42.9)
OG0030(NA to NA)Lower and upper limit not calculated due to insufficient number of events
OG0040(NA to NA)Lower and upper limit not calculated due to insufficient number of events
Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG002
Part B: Hepatocellular Carcinoma (HCC)
Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part B: Neuroendocrine Tumor (NET)
Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part B: Diffuse Large B-cell Lymphoma (DLBCL)
Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG005
Part B: Multiple Myeloma (MM)
Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
OG006
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG00026
OG00113
OG00253
OG00347
OG00428
OG00514
OG00617
Title
Denominators
Categories
Title
Measurements
OG0003.8(0.1 to 19.6)
OG0010(NA to NA)Lower and upper limit not calculated due to insufficient number of events
OG0025.7(1.2 to 15.7)
OG0036.4(1.3 to 17.5)
OG00410.7(2.3 to 28.2)
OG0050(NA to NA)Lower and upper limit not calculated due to insufficient number of events
OG00611.8(1.5 to 36.4)
OG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0039
OG0047
Title
Denominators
Categories
Day -1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG0047
Title
Measurements
OG000143± NAInsufficient data values to calculate coefficient of variation.
OG001284± 64.6
OG002729± 40.3
OG003
Day 15
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0037
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0039
OG0047
Title
Denominators
Categories
Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG0047
Title
Measurements
OG0008.00(8.00 to 8.00)
OG0012.28(1.50 to 3.05)
OG0026.51(1.50 to 8.00)
OG003
Day 15
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0037
OG002
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0039
OG0047
Title
Denominators
Categories
Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG0047
Title
Measurements
OG0004583± NAInsufficient data values to calculate coefficient of variation.
OG0013788± 121.2
OG00218964± 45.1
OG003
Day 15
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0037
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG003
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
OG004
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Units
Counts
Participants
OG0001
OG0012
OG0028
OG0039
OG0047
Title
Denominators
Categories
Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG0047
Title
Measurements
OG0002712± NAInsufficient data values to calculate coefficient of variation.
OG0013207± 82.5
OG00212328± 39.4
OG003
Day 15
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0037
13
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)Lower and upper limit not reached to insufficient number of events
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0081 events1 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0112 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0081 events1 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0091 events1 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0072 events1 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected26 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected53 at risk
EG0082 events2 affected47 at risk
EG0092 events2 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected26 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected53 at risk
EG0081 events1 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0112 events2 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0091 events1 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0081 events1 affected47 at risk
EG0091 events1 affected28 at risk
EG0101 events1 affected14 at risk
EG0112 events2 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
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EG0101 events1 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0084 events3 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
2 events
2 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0073 events3 affected53 at risk
EG0085 events4 affected47 at risk
EG0092 events2 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG00715 events7 affected53 at risk
EG0087 events5 affected47 at risk
EG0090 events0 affected28 at risk
EG0102 events2 affected14 at risk
EG0112 events2 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0095 events2 affected28 at risk
EG0107 events2 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0092 events2 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
2 events
1 affected
9 at risk
EG0042 events2 affected7 at risk
EG0057 events5 affected26 at risk
EG0060 events0 affected13 at risk
EG00711 events8 affected53 at risk
EG00812 events9 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0113 events3 affected17 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
2 events
2 affected
9 at risk
EG0042 events2 affected7 at risk
EG00529 events15 affected26 at risk
EG0063 events1 affected13 at risk
EG00713 events10 affected53 at risk
EG00815 events10 affected47 at risk
EG0093 events3 affected28 at risk
EG0101 events1 affected14 at risk
EG0119 events7 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0054 events3 affected26 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0041 events1 affected7 at risk
EG0052 events2 affected26 at risk
EG0062 events2 affected13 at risk
EG0074 events3 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0105 events5 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0053 events3 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0085 events5 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0084 events3 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0054 events4 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0102 events2 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0083 events3 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0077 events4 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0041 events1 affected7 at risk
EG0059 events7 affected26 at risk
EG0060 events0 affected13 at risk
EG00713 events8 affected53 at risk
EG0088 events8 affected47 at risk
EG0090 events0 affected28 at risk
EG0102 events2 affected14 at risk
EG0114 events4 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0075 events5 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0110 events0 affected17 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0083 events3 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0112 events1 affected17 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0093 events2 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG00711 events5 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
2 events
2 affected
9 at risk
EG0040 events0 affected7 at risk
EG00521 events9 affected26 at risk
EG0061 events1 affected13 at risk
EG00741 events18 affected53 at risk
EG00847 events21 affected47 at risk
EG0095 events5 affected28 at risk
EG0102 events2 affected14 at risk
EG0118 events6 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0110 events0 affected17 at risk
4 events
2 affected
9 at risk
EG0044 events3 affected7 at risk
EG00513 events8 affected26 at risk
EG0065 events4 affected13 at risk
EG00718 events12 affected53 at risk
EG00839 events18 affected47 at risk
EG0096 events5 affected28 at risk
EG0106 events3 affected14 at risk
EG01119 events4 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0086 events4 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
1 events
1 affected
9 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0057 events4 affected26 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected53 at risk
EG00826 events7 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0042 events1 affected7 at risk
EG0058 events3 affected26 at risk
EG0062 events2 affected13 at risk
EG00722 events7 affected53 at risk
EG00822 events12 affected47 at risk
EG0092 events2 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0075 events3 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0043 events2 affected7 at risk
EG0050 events0 affected26 at risk
EG0067 events2 affected13 at risk
EG0077 events3 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0074 events3 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0111 events1 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected53 at risk
EG0088 events6 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected17 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected26 at risk
EG0061 events1 affected13 at risk
EG00715 events3 affected53 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected28 at risk
EG0101 events1 affected14 at risk
EG0110 events0 affected17 at risk
1 events
1 affected
9 at risk
EG0041 events1 affected7 at risk
EG0053 events3 affected26 at risk
EG0061 events1 affected13 at risk
EG0076 events5 affected53 at risk
EG0084 events4 affected47 at risk
EG0092 events2 affected28 at risk
EG0101 events1 affected14 at risk
EG0112 events2 affected17 at risk
269
± 65.7
OG004319± 70.0
Participants
OG004
4
Title
Measurements
OG00050.8± NACoefficient of Variation not calculable because data were only collected for 1 participant.
OG00192.0± 162.6
OG002293± 38.8
OG003417± 61.6
OG004480± 88.9
3.00
(0.967 to 3.00)
OG0041.50(1.00 to 5.00)
Participants
OG004
4
Title
Measurements
OG0001.50(1.50 to 1.50)
OG0012.00(1.00 to 3.00)
OG0021.28(0.500 to 3.03)
OG0031.63(0.500 to 8.00)
OG0041.58(1.00 to 3.00)
1493
± 54.3
OG0042080± 100.8
Participants
OG004
4
Title
Measurements
OG000179± NAInsufficient data values to calculate coefficient of variation.
OG001282± 100.7
OG0021016± 39.2
OG0031351± 45.0
OG0041900± 93.5
1497
± 45.5
OG0042031± 96.3
Participants
OG004
4
Title
Measurements
OG000299± NAInsufficient data values to calculate coefficient of variation.
OG001383± 88.8
OG0021443± 41.4
OG0032082± 29.3
OG0042954± 106.2
1694
± 41.8
OG0042074± 111.4
Participants
OG004
0
26.6
± 41.8
OG00428.9± 111.4
Participants
OG004
4
Title
Measurements
OG00025.1± NAInsufficient data values to calculate coefficient of variation.
OG00139.2± 88.8
OG00220.8± 41.4
OG00321.6± 29.3
OG00420.3± 106.2
-76.6
(-83.4 to -60.2)
ParticipantsOG0044
Title
Measurements
OG001174.0(174.0 to 174.0)
OG002-59.0(-77.5 to -41.3)
OG003-80.5(-84.6 to -80.0)
OG004-69.3(-86.2 to -61.7)
-44.3
(-63.7 to -1.0)
ParticipantsOG0044
Title
Measurements
OG001-14.4(-14.4 to -14.4)
OG002-61.1(-92.8 to -44.5)
OG003-54.8(-61.8 to -34.4)
OG004-46.4(-69.8 to -26.3)
-48.4
(-53.6 to -26.7)
ParticipantsOG0044
Title
Measurements
OG00158.3(58.3 to 58.3)
OG002-70.5(-81.1 to -39.6)
OG003-55.8(-70.1 to -42.0)
OG004-45.7(-56.5 to -31.6)
-63.3
(-93.8 to 122.5)
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG001-38.9(-100.0 to 445.8)
OG002-51.8(-98.9 to 105.0)
OG003-58.7(-100.0 to 42.1)
OG004-58.4(-100.0 to 79.3)
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000-28.7(-28.7 to -28.7)
OG001-17.3(-87.0 to 66.6)
OG002-11.7(-85.3 to 46.3)
OG003-44.5(-85.1 to 438.9)
OG004-49.4(-68.4 to 31.7)
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000-61.3(-61.3 to -61.3)
OG001-58.1(-91.7 to 528.1)
OG002-39.1(-78.7 to 26.0)
OG003-74.1(-94.1 to 210.2)
OG004-35.8(-70.0 to 154.7)
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000-15.3(-15.3 to -15.3)
OG001-44.3(-100.0 to 266.7)
OG002-39.4(-93.7 to 34.3)
OG003-44.5(-71.9 to -36.0)
OG004-44.8(-88.3 to 58.2)
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000-0.3(-0.3 to -0.3)
OG001-48.0(-91.0 to 844.4)
OG002-51.1(-86.1 to 18.1)
OG003-27.3(-32.7 to -5.0)
OG004-12.0(-77.2 to 229.7)
ParticipantsOG0041
ParticipantsOG00518
ParticipantsOG0063
Title
Measurements
OG000-39.4(-69.2 to 20.1)
OG001-20.0(-58.1 to 8.3)
OG002-49.4(-63.7 to -13.2)
OG003-24.5(-32.4 to -16.6)
OG004-43.0(-43.0 to -43.0)
OG005-24.9(-57.6 to 28.1)
OG006-51.4(-64.2 to -25.1)
ParticipantsOG0040
ParticipantsOG0059
ParticipantsOG0062
Title
Measurements
OG000-22.4(-53.7 to 151.3)
OG001-24.7(-39.7 to 16.8)
OG003-6.9(-6.9 to -6.9)
OG005-24.8(-38.4 to 77.5)
OG00619.6(-7.9 to 47.2)
-70.6
(-90.0 to 114.3)
Title
Measurements
OG000-34.0(-100.0 to 445.8)
OG001-52.8(-62.6 to 52.4)
OG002-39.7(-95.7 to 33.8)
OG003-70.2(-98.9 to 105.0)
Title
Measurements
OG000-22.1(-87.0 to 28.9)
OG0017.0(-50.6 to 66.6)
OG002-8.7(-54.7 to 25.8)
OG003-36.6(-85.3 to 46.3)
Title
Measurements
OG000-58.1(-91.7 to 528.1)
OG001-28.4(-67.5 to 111.6)
OG002-25.6(-78.7 to 26.0)
OG003-47.4(-68.3 to 23.2)
-70.3
(-83.7 to -51.2)
OG004-54.3(-89.0 to -19.6)
OG005-78.8(-86.2 to -27.1)
OG006-53.8(-53.8 to -53.8)
ParticipantsOG0041
ParticipantsOG0052
ParticipantsOG0060
Title
Measurements
OG000-76.1(-93.0 to -27.5)
OG001-34.1(-89.8 to 48.6)
OG002-84.1(-87.7 to -19.5)
OG003-52.2(-52.2 to -52.2)
OG004-88.6(-88.6 to -88.6)
OG005-52.9(-77.5 to -28.2)
Title
Measurements
OG001-84.1(-87.7 to -19.5)
OG003-52.2(-52.2 to -52.2)
1002
± 37.2
OG0041174± 86.0
Participants
OG004
5
Title
Measurements
OG000363± NAInsufficient data values to calculate coefficient of variation.
OG001357± 139.8
OG0021681± 34.5
OG0032061± 23.1
OG0041946± 78.9
5.00
(1.60 to 8.00)
OG0045.00(1.67 to 8.00)
Participants
OG004
5
Title
Measurements
OG0001.50(1.50 to 1.50)
OG0013.25(1.50 to 5.00)
OG0021.58(1.00 to 3.03)
OG0031.71(0.00 to 3.20)
OG0043.00(0.00 to 5.00)
19938
± 30.1
OG00423702± 98.1
Participants
OG004
5
Title
Measurements
OG0006401± NAInsufficient data values to calculate coefficient of variation.
OG0014388± 133.8
OG00227389± 48.5
OG00330823± 38.3
OG00433070± 101.6
14107
± 26.9
OG00416926± 89.2
Participants
OG004
5
Title
Measurements
OG0006401± NAInsufficient data values to calculate coefficient of variation.