A Safety and Efficacy Trial of JCAR017 Combinations in Su... | NCT03310619 | Trialant
NCT03310619
Sponsor
Celgene
Status
Completed
Last Update Posted
Apr 4, 2024Actual
Enrollment
62Actual
Phase
Phase 1Phase 2
Conditions
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Interventions
JCAR017
Durvalumab
CC-122
Ibrutinib
CC-220
Relatlimab
Nivolumab
CC-99282
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03310619
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
JCAR017-BCM-002
Secondary IDs
ID
Type
Description
Link
U1111-1201-2046
Registry Identifier
WHO
Brief Title
A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies
Official Title
An Exploratory Phase 1/2 Trial To Evaluate The Safety And Efficacy Of JCAR017 Combinations In Subjects With Relapsed/Refractory B-Cell Malignancies (PLATFORM)
Acronym
PLATFORM
Organization
CelgeneINDUSTRY
Status Module
Record Verification Date
Mar 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 20, 2017Actual
Primary Completion Date
Feb 15, 2023Actual
Completion Date
Feb 15, 2023Actual
First Submitted Date
Sep 25, 2017
First Submission Date that Met QC Criteria
Oct 13, 2017
First Posted Date
Oct 16, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jan 23, 2024
Results First Submitted that Met QC Criteria
Mar 5, 2024
Results First Posted Date
Apr 4, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 5, 2024
Last Update Posted Date
Apr 4, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelgeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a global, open-label, multi-arm, parallel multi-cohort, multi-center, Phase 1/2 study to determine the safety, tolerability, PK, efficacy and patient-reported quality of life of JCAR017 in combination with various agents. This protocol is intended to evaluate various drug combinations with JCAR017, as separate arms, over the life of the protocol, using the same objectives. Each combination will be evaluated separately (ie, the intention is not to compare between combinations) for the purposes of the objectives, trial design, and statistical analysis. The following combinations will be tested:
Arm A: JCAR017 in combination with durvalumab Arm B: JCAR017 in combination with CC-122 (avadomide) Arm C: JCAR017 in combination with CC-220 (iberdomide) Arm D: JCAR017 in combination with ibrutinib Arm E: JCAR017 in combination with relatlimab and/or nivolumab Arm F: JCAR017 in combination with CC-99282 Additional arms will be added by way of amendment once combination agents have been selected.
The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms.
Detailed Description
During Phase 1, different arms may be opened to test JCAR017 in combination with combination agent(s) in adult subjects with R/R aggressive B-cell NHL. Within each arm, different doses and schedules of JCAR017 and the combination agent(s) may be tested in several cohorts and subcohorts per arm. During Phase 2 of the study, the expansion of any dose level and schedule for any arm that has been shown to be safe may occur.
Arm A will test JCAR017 in combination with Durvalumab Arm B will test JCAR017 in combination with CC-122 Arm C will test JCAR017 in combination with CC-220 (iberdomide ) Arm D will test JCAR017 in combination with ibrutinib. Arm E will test JCAR017 in combination with relatlimab and/or nivolumab Arm F will test JCAR017 in combination with CC-99282 All subjects from Phase 1 and Phase 2 will be followed for 24 months following JCAR017 infusion. Post-study follow-up for survival, relapse, long-term toxicity (including new malignancies), and viral vector safety will continue under a separate long-term follow-up (LTFU) protocol for up to 15 years after the JCAR017 dose as per health authority regulatory guidelines.
Conditions Module
Conditions
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Keywords
JCAR017
B-Cell Malignancies
NHL
non-Hodgkin lymphoma
CAR T cells
chimeric antigen receptor
CC-220
Ibrutinib
relatlimab
nivolumab
CC-99282
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
62Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A: JCAR017 in combination with Durvalumab
Experimental
JCAR017 will be administered at a single flat dose of 50 x 10^6 CAR+T cells or 100 x 10^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules
Biological: JCAR017
Drug: Durvalumab
Arm B: JCAR017 in combination with CC-122
Experimental
This arm will test JCAR017 in combination with the CC-122. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10^6 CAR+T cells. The combination agent will be administered at different doses
Biological: JCAR017
Drug: CC-122
Arm C: JCAR017 in combination with CC-220
Experimental
This arm will test JCAR017 in combination with CC-220. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10^6 CAR+T cells. The combination agent will be administered at different doses
Biological: JCAR017
Drug: CC-220
Arm D: JCAR017 in combination with Ibrutinib
Experimental
This arm will test JCAR017 in combination with ibrutinib. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10^6 CAR+T cells. The combination agent will be administered at a fixed dose of 420 mg daily
Biological: JCAR017
Drug: Ibrutinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
JCAR017
Biological
Gene modified autologous T cells
Arm A: JCAR017 in combination with Durvalumab
Arm B: JCAR017 in combination with CC-122
Arm C: JCAR017 in combination with CC-220
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-Limiting Toxicity (DLT)
Participants enrolled in Phase 1 are considered evaluable for DLTs if they received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent and completed the specified DLT evaluation period or if they have received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent and experience a DLT during the DLT evaluation period.
From first dose of the combination agent until 1 month (28 days) after JCAR017 infusion (pre- JCAR017 cohort) or from JCAR017 infusion until 1 month (28 days) after the first dose of combination agent (post-JCAR017 cohort)
Complete Response Rate (CRR)
Percentage of participants achieving a complete response (CR). CR is complete radiologic response (CRR) and complete metabolic response (CMR). CR was measured using CT and PET and assessed for the presence of index and non-index lesions, spleen size, and the absence of new lesions or diseased bone marrow.
To be considered as having CRR participants had to have all of the following:
Index lesions - longest transverse diameter of nodal lesions ≤ 1.5 cm and the absence of extranodal disease.
Non-index lesions - the absence of non-index lesions.
Spleen size <13 cm
The absence of new lesions
Normal bone marrow assessment
To be considered as having CMR participants had to have all of the following:
A score of 1, 2, or 3 with or without residual mass on 5-PS for index and non-index lesions.
The absence of new lesions
No evidence of FDG-avid disease in marrow and a normal bone marrow assessment
At 3 and 6 months post-JCAR017 infusion.
Secondary Outcomes
Measure
Description
Time Frame
European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores - Phase 2
The EORTC QLQ-C30 is composed of five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire is scored on a 4-point Likert response scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much.
The raw score is calculated as the average of the items that contribute to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100.
For functional scales (physical, role, emotional, social, cognitive and global health) higher scores indicate better QoL.
For symptom scales (fatigue, nausea and vomiting and pain) and single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) lower scores indicate fewer symptoms, i.e. better QoL.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject is ≥ 18 years of age at the time of signing the informed consent form ().
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Subject must have aggressive B-cell NHL according to "the 2016 revision of the WHO classification of lymphoid neoplasms", histologically confirmed at last relapse by the treating institution, defined as:
Diffuse large B-cell lymphoma (DLBCL) Not otherwise specified (NOS) including transformed indolent Non-Hodgkin lymphoma (NHL)
Follicular lymphoma Grade 3B
T cell/histiocyte-rich large B-cell lymphoma
Epstein-Barr virus (EBV) positive DLBCL, NOS
Primary mediastinal (thymic) large B-cell lymphoma
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma)
Subjects disease must have relapsed or be refractory to at least 2 prior lines of therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline.
Subject must have
Positron emission tomography (PET)-positive (Deauville score 4 or 5) and computed tomography (CT) measurable disease as per Lugano Classification
Sum of product of perpendicular diameters (SPD) of up to 6 index lesions ≥ 25 cm2 by CT scan (not applicable to Arm A or B or subjects with Richter's transformation)
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at screening
Adequate organ function
Subjects must agree to not donate blood, organs, sperm or semen, and egg cells for usage in other individuals
Participants must agree to use effective contraception
Exclusion Criteria:
Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study based on investigator´s judgment.
Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study based on investigator´s judgment.
Subject has any condition that confounds the ability to interpret data from the study based on investigator´s judgment.
Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for ≥ 2 years with the exception of the following non-invasive malignancies:
Basal cell carcinoma of the skin
Squamous cell carcinoma of the skin
Carcinoma in situ of the cervix
Carcinoma in situ of the breast
Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative.
Other completely resected stage 1 solid tumor with low risk for recurrence
Prior treatment with any prior gene therap y product
Prior treatment with any adoptive T cell therapy; prior hematopoietic stem cell transplant (HSCT) is allowed
Allogeneic HSCT within 90 days of leukapheresis
Prior treatment with the combination agent from the assigned arm:
Anti PD-1 or PD-L1 (Arm A and E)
CC-122 (Arm B)
CC-220 (Arm C)
Prior treatment with ibrutinib is not exclusionary for subjects on any study arm
Anti LAG-3 targeted agent (Arm E)
CC-99282 (Arm F)
Presence of acute or chronic graft-versus-host disease (GVHD)
Presence of the following:
Active hepatitis B or active hepatitis C infection
History of or active human immunodeficiency virus (HIV) infection
Uncontrolled bacterial, viral or fungal infection at the time of leukapheresis, lymphodepleting chemotherapy or JCAR017 infusion
Any history of myocarditis (Arm E); history of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease (all arms)
History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Subjects with active CNS or cerebrospinal fluid (CSF) involvement by malignancy
Pregnant or nursing (lactating) women.
Subjects with active auto immune disorders/processes or active neurological or inflammatory disorders
For subjects to receive oral combination therapy (Arms B, C, D or F): History of a gastrointestinal (GI) condition or procedure that in the opinion of the investigator may affect oral drug absorption.
Progressive tumor invasion of venous or arterial vessels.
Deep venous thrombosis (DVT)/pulmonary embolism (PE) not managed on a stable regimen of anticoagulation.
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
Within each combination arm, up to 3 cohorts plus various sub cohorts (e.g., additional dose levels and schedules) may be tested. Data was pre-determined to be collected and reported combined as specified per arm and not per cohort.
Recruitment Details
Participants were only enrolled into the following groups:
Arm A: Cohorts1 A and 1B, Arm B: Cohort 1A, Arm C: Cohort 1A, Arm D: Cohort 1A, Arm E: Cohort 1C, Arm F: Cohorts 1A and 1D.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (50 x 10^6 CAR+ T cells). On Day 29 after infusion, Durvalumab was administered at a low dose. On day 43 after infusion Durvalumab was administered at a mid-dose and on days 57 and 85 after infusion was administered at a high dose. Participants who reached a partial response 3 months after JCAR017 infusion could continue Durvalumab until progression for a maximum total duration of 12 months.
Periods
Title
Milestones
Reasons Not Completed
Pre-Treatment Period
Type
Comment
Milestone Data
STARTED
Started = Leukopheresed
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jan 27, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Arm E: JCAR017 in combination with relatlimab and/or nivolumab
Experimental
This arm will test JCAR017 in combination with relatlimab and/or nivolumab in adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10^6 CAR+T cells. The combination agent will be administered at different doses and/or schedules
Biological: JCAR017
Drug: Relatlimab
Drug: Nivolumab
Arm F: JCAR017 in combination with CC-99282
Experimental
This arm will test JCAR017 in combination with CC-99282 in adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10^6 CAR+T cells. The combination agent will be administered at different doses and/or schedules.
Biological: JCAR017
Drug: CC-99282
Arm D: JCAR017 in combination with Ibrutinib
Arm E: JCAR017 in combination with relatlimab and/or nivolumab
Arm F: JCAR017 in combination with CC-99282
Durvalumab
Drug
Anti-PD-L1
Arm A: JCAR017 in combination with Durvalumab
MEDI4736
CC-122
Drug
Pleiotropic Pathway Modifier
Arm B: JCAR017 in combination with CC-122
Ibrutinib
Drug
Ibrutinib
Arm D: JCAR017 in combination with Ibrutinib
CC-220
Drug
CC-220
Arm C: JCAR017 in combination with CC-220
Relatlimab
Drug
Relatlimab
Arm E: JCAR017 in combination with relatlimab and/or nivolumab
Nivolumab
Drug
Nivolumab
Arm E: JCAR017 in combination with relatlimab and/or nivolumab
CC-99282
Drug
CC-99282
Arm F: JCAR017 in combination with CC-99282
At baseline and 29 days and 57 days post JCAR017 dose
EuroQol- 5 Dimensions of Health Visual Analogue Scale (EQ-5D VAS) Scores - Phase 2
The EuroQol- 5 Dimensions of Health Visual Analogue Scale (EQ-5D VAS) records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are scored from 0 to 100 i.e., 'The worst health you can imagine' (score of 0) to 'The best health you can imagine' (score of 100). Higher scores indicate better health outcomes.
At baseline and 1, 29, 57, 85, 180, 270, 365, 545, and 730 days post JCAR017 dose
Number of Participants With Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) is also considered an AE. All participants were monitored for AEs during the study. Assessments included monitoring of any or all of the following parameters: the participant's clinical symptoms, laboratory, pathological, radiological or surgical findings, physical examination findings, or findings from other tests and/or procedures.
Up to 3 months after the dose of JCAR017 or after the last dose of the combination agent, whichever occurred last (an average of 6.5 months up until a max of 9.5 months)
Number of Participants With Severe Adverse Events (SAEs)
An SAE is any AE occurring at any dose that:
Results in death;
Is life-threatening (i.e., in the opinion of the Investigator, the participant is at immediate risk of death from the AE);
Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay);
Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions);
Is a congenital anomaly/birth defect;
Constitutes an important medical event.
Up to 3 months after the dose of JCAR017 or after the last dose of the combination agent, whichever occurred last (an average of 6.5 months up until a max of 9.5 months)
Change From Baseline in White Blood Cell and Platelet Numbers
White blood cell, and platelet counts. Baseline is defined as the last measurement on or prior to any study treatment.
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Percent of White Blood Cells
Change from baseline in percent of white blood cells was measured using differential blood tests. A differential blood test is a blood test that measures the percentage and number of each type of white blood cell (WBC) - neutrophils, lymphocytes, monocytes, eosinophils and basophils - as well as abnormal cell types if they are present. These results are reported as percentages and absolute values, and compared against reference ranges to determine whether the values are normal, low, or high. Baseline is defined as the last measurement on or prior to any study treatment.
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline Erythrocyte Numbers
Change from baseline in erythrocyte (also known as red blood cell) numbers was measured using a test called a red blood cell count. Baseline is defined as the last measurement on or prior to any study treatment.
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline Hematocrit Ratio
The change in the proportion of red blood cells in the blood was measured using a hematocrit test. A hematocrit test measures the volume of packed red blood cells relative to whole blood. This is represented as a ratio. Baseline is defined as the last measurement on or prior to any study treatment.
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Hemoglobin Levels
The change from baseline in hemoglobin levels was measured using a hemoglobin test. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is a protein in red blood cells that carries oxygen from the lungs to the rest of the body. Baseline is defined as the last measurement on or prior to any study treatment.
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Specific Liver Serum Enzyme Levels
Change from baseline in alanine aminotransferase (ALT) alkaline phosphatase (ALP), and aspartate aminotransferase (AST). Baseline is defined as the last measurement on or prior to any study treatment.
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Specific Serum Protein Levels
Change from baseline in serum albumin and protein levels. Serum protein level tests are blood tests that measure the number of proteins in the blood. Baseline is defined as the last measurement on or prior to any study treatment.
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Serum Beta-2-Microglobulin Levels
Change from baseline in serum Beta-2-Microglobulin levels was measured using a beta-2 microglobulin (B2M) tumor marker test. Baseline is defined as the last measurement on or prior to any study treatment.
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Serum Bicarbonate Levels
Change from baseline in serum bicarbonate levels was measured using a serum bicarbonate test. Baseline is defined as the last measurement on or prior to any study treatment.
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Coagulation Times
Change from baseline in activated partial thromboplastin and prothrombin times. Activated partial thromboplastin time and prothrombin time are blood tests that measure how long it takes for blood to form a clot. Baseline is defined as the last measurement on or prior to any study treatment.
57 days after the dose of JCAR017
Change From Baseline in D-Dimer Levels
D-dimer is a substance that is produced in the body when blood clots are broken down. The D-dimer laboratory test measures the level of D-dimer in the blood and is often used to help diagnose or rule out conditions related to blood clotting, such as deep vein thrombosis (DVT) or pulmonary embolism (PE). Elevated levels of D-dimer may indicate the presence of a blood clot, but other factors can also cause an increase in D-dimer levels. Therefore, the D-dimer test is typically used in combination with other diagnostic tests to help make an accurate diagnosis. Baseline is defined as the last measurement on or prior to any study treatment.
57 days after the dose of JCAR017
Change From Baseline in Fibrinogen Levels
Fibrinogen is a protein that plays a role in a number of processes in the body, including blood clot formation, wound healing, inflammation, and blood vessel growth. Baseline is defined as the last measurement on or prior to any study treatment.
57 days after the dose of JCAR017
Change From Baseline in Prothrombin International Normalized Ratio
The Prothrombin International Normalized Ratio (INR) is used to determine the clotting tendency of blood. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT. Baseline is defined as the last measurement on or prior to any study treatment.
57 days after the dose of JCAR017
Progression-Free Survival (PFS)
PFS is defined as time from JCAR017 infusion to disease progression or death from any cause.
Progressive disease (PD) was measured using CT and PET as an increase in size index and non-index lesions, spleen size, and the presence of new lesions or diseased bone marrow.
Summarized using Kaplan-Meier estimates.
From JCAR017 infusion to disease progression or death from any cause (up to approximately 62 months)
Overall Survival (OS)
Time from JCAR017 infusion to death. Data from surviving participants was censored at the last time that the participant was known to be alive.
Summarized using Kaplan-Meier estimates.
From start of JCAR017 to time of death from any cause, or data cut-off date, whichever occurred first (up to approximately 62 months)
Overall Response Rate (ORR)
The ORR is the percent of participants achieving an objective response of partial response (PR) or better according to the Lugano Criteria for Response Assessment (Cheson, 2014), prior to start of another non-study anticancer therapy.
Complete response (CR) assessed by CT-scan:
Index lesions: Nodal Disease: ≤ 1.5 cm in largest transverse diameter, Extranodal Disease: Absent
Non-index lesions: Absent,
Spleen: <13 cm
New lesions: None
Bone marrow: Normal
Partial response (PR) assessed by CT-scan:
Index lesions: >=50% decrease from baseline in shortest diameter
Non-index lesions: No increase,
Spleen: >50% decrease from baseline in enlarged portion
New lesions: None
Bone marrow: N/A Overall Response (OR) = CR + PR
At 1, 3, 6, 9, 12, 18 and 24 months post-JCAR017 infusion
Duration of Response (DOR)
DOR is defined as the time from first response to disease progression or death from any cause.
Summarized using Kaplan-Meier estimates.
From JCAR017 infusion to disease progression or death from any cause (up to approximately 62 months)
Event-Free Survival (EFS)
EFS is defined as time from JCAR017 infusion to disease progression, starting a new antilymphoma therapy, or death from any cause, whichever occurred first.
From JCAR017 infusion to disease progression or death from any cause (up to approximately 62 months)
Maximum Concentration (Cmax) of JCAR017 by qPCR
Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug.
qPCR was used to determine Cmax by detecting the JCAR017 transgene.
Up to 24 months post- JCAR017 infusion
Time to Maximum Concentration (Tmax) of JCAR017 by qPCR
Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration.
qPCR was used to determine Tmax by detecting the JCAR017 transgene.
Up to 24 months post- JCAR017 infusion
Total Exposure to JCAR017 as Measured by the Area Under the Curve (AUC) by qPCR
Area Under the Curve" (AUC) represents the total exposure of participants to study drug. qPCR was used to determine AUC by detecting the JCAR017 transgene.
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (100 x 10^6 CAR+ T cells). On Day 29 after infusion, Durvalumab was administered at a low dose. On day 43 after infusion Durvalumab was administered at a mid-dose and on days 57 and 85 after infusion was administered at a high dose. Participants who reached a partial response 3 months after JCAR017 infusion could continue Durvalumab until progression for a maximum total duration of 12 months.
FG002
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells. Between days 29 and 180 after infusion participants received a standard dose of CC-122, 5 out of 7 days. Participants who reached a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
FG003
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells. Between Days 15 -21 post infusion, CC-220 was administered at a standard dose. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
FG004
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered from 35 days before to 85 days post JCAR017 infusion which was administered at a dose of 100 x 10^6 CAR+T cells. Participants received ibrutinib until 85 days post-infusion (Month 3).
FG005
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells. On days 8, 22, 36 post infusion, nivolumab was administered at a low dose. On days 57 and 85 post infusion, participants received nivolumab at a higher dose. Participants received nivolumab until Day 85 (Month 3).
FG006
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (100 x 10^6 CAR+ T cells). Starting on Day 8 post infusion, CC-99282 was administered every 7 days. Participants received CC-99282 until Day 85 (Month 3)
FG007
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (100 x 10^6 CAR+ T cells). Starting on Day 1 post infusion, CC-99282 was administered every 7 days. Participants received CC-99282 until Day 85 (Month 3)
FG00011 subjects
FG0019 subjects
FG00213 subjects
FG0031 subjects
FG00417 subjects
FG0052 subjects
FG0067 subjects
FG0072 subjects
COMPLETED
FG0008 subjects
FG0018 subjects
FG00211 subjects
FG0031 subjects
FG00416 subjects
FG0052 subjects
FG0065 subjects
FG0072 subjects
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Other reasons
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Treatment Period
Type
Comment
Milestone Data
STARTED
Started = entered treatment period
FG0008 subjects
FG0018 subjects
FG00211 subjects
FG0031 subjects
FG00416 subjects
FG0052 subjects
FG0065 subjects
FG0072 subjects
Safety Set
Received a dose of JCAR017 Cell Product or at least one dose of the combination agent.
FG0008 subjects
FG0018 subjects
FG00211 subjects
FG003
COMPLETED
FG0006 subjects
FG0015 subjects
FG0024 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0027 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Death
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (50 x 10^6 CAR+ T cells). On Day 29 after infusion, Durvalumab was administered at a low dose. On day 43 after infusion Durvalumab was administered at a mid-dose and on days 57 and 85 after infusion was administered at a high dose. Participants who reached a partial response 3 months after JCAR017 infusion could continue Durvalumab until progression for a maximum total duration of 12 months.
BG001
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (100 x 10^6 CAR+ T cells). On Day 29 after infusion, Durvalumab was administered at a low dose. On day 43 after infusion Durvalumab was administered at a mid-dose and on days 57 and 85 after infusion was administered at a high dose. Participants who reached a partial response 3 months after JCAR017 infusion could continue Durvalumab until progression for a maximum total duration of 12 months.
BG002
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells. Between days 29 and 180 after infusion participants received a standard dose of CC-122, 5 out of 7 days. Participants who reached a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
BG003
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells. Between Days 15 -21 post infusion, CC-220 was administered at a standard dose. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
BG004
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered from 35 days before to 85 days post JCAR017 infusion which was administered at a dose of 100 x 10^6 CAR+T cells. Participants received ibrutinib until 85 days post-infusion (Month 3).
BG005
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells. On days 8, 22, 36 post infusion, nivolumab was administered at a low dose. On days 57 and 85 post infusion, participants received nivolumab at a higher dose. Participants received nivolumab until Day 85 (Month 3).
BG006
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (100 x 10^6 CAR+ T cells). Starting on Day 8 post infusion, CC-99282 was administered every 7 days. Participants received CC-99282 until Day 85 (Month 3)
BG007
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (100 x 10^6 CAR+ T cells). Starting on Day 1 post infusion, CC-99282 was administered every 7 days. Participants received CC-99282 until Day 85 (Month 3)
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG0019
BG00213
BG0031
BG00417
BG0052
BG0067
BG0072
BG00862
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
BG00061.9± 8.40
BG00168.6± 6.65
BG00260.8± 14.66
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race/Ethnicity, Customized
Race
Number
Participants
Title
Denominators
Categories
AMERICAN INDIAN OR ALASKA NATIVE
Title
Measurements
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
Number of Participants With Dose-Limiting Toxicity (DLT)
Participants enrolled in Phase 1 are considered evaluable for DLTs if they received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent and completed the specified DLT evaluation period or if they have received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent and experience a DLT during the DLT evaluation period.
Dose-Limiting Toxicity Evaluable Participants. Prespecified to be reported per Arm and not per cohort.
Posted
Count of Participants
Participants
From first dose of the combination agent until 1 month (28 days) after JCAR017 infusion (pre- JCAR017 cohort) or from JCAR017 infusion until 1 month (28 days) after the first dose of combination agent (post-JCAR017 cohort)
ID
Title
Description
OG000
Arm A: Cohort 1A and 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00014
OG0018
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0021
OG003
Primary
Complete Response Rate (CRR)
Percentage of participants achieving a complete response (CR). CR is complete radiologic response (CRR) and complete metabolic response (CMR). CR was measured using CT and PET and assessed for the presence of index and non-index lesions, spleen size, and the absence of new lesions or diseased bone marrow.
To be considered as having CRR participants had to have all of the following:
Index lesions - longest transverse diameter of nodal lesions ≤ 1.5 cm and the absence of extranodal disease.
Non-index lesions - the absence of non-index lesions.
Spleen size <13 cm
The absence of new lesions
Normal bone marrow assessment
To be considered as having CMR participants had to have all of the following:
A score of 1, 2, or 3 with or without residual mass on 5-PS for index and non-index lesions.
The absence of new lesions
No evidence of FDG-avid disease in marrow and a normal bone marrow assessment
All participants in the combination treated set. The combination treated set included all participants who received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent. Prespecified to be reported per Arm and not per cohort.
Posted
Number
95% Confidence Interval
Percent of Participants
At 3 and 6 months post-JCAR017 infusion.
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
Secondary
European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores - Phase 2
The EORTC QLQ-C30 is composed of five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire is scored on a 4-point Likert response scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much.
The raw score is calculated as the average of the items that contribute to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100.
For functional scales (physical, role, emotional, social, cognitive and global health) higher scores indicate better QoL.
For symptom scales (fatigue, nausea and vomiting and pain) and single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) lower scores indicate fewer symptoms, i.e. better QoL.
All participants in the combination treated set with baseline or on treatment HRQoL Scores. The combination treated set included all participants who received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent. Data was not, nor will ever be collected for Arms C, D, E, and F since participants in these arms did not enter phase 2. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
Score on a scale
At baseline and 29 days and 57 days post JCAR017 dose
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Secondary
EuroQol- 5 Dimensions of Health Visual Analogue Scale (EQ-5D VAS) Scores - Phase 2
The EuroQol- 5 Dimensions of Health Visual Analogue Scale (EQ-5D VAS) records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are scored from 0 to 100 i.e., 'The worst health you can imagine' (score of 0) to 'The best health you can imagine' (score of 100). Higher scores indicate better health outcomes.
All participants in the combination treated set with baseline or on treatment HRQoL Scores. The combination treated set included all participants who received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent. Data was not, nor will ever be collected for Arms C, D, E, and F as participants in these Arms did not enter phase 2. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
Score on a Scale
At baseline and 1, 29, 57, 85, 180, 270, 365, 545, and 730 days post JCAR017 dose
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
Secondary
Number of Participants With Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) is also considered an AE. All participants were monitored for AEs during the study. Assessments included monitoring of any or all of the following parameters: the participant's clinical symptoms, laboratory, pathological, radiological or surgical findings, physical examination findings, or findings from other tests and/or procedures.
Safety Set - All participants who received an infusion of conforming JCAR017 cell product or at least one dose of the combination agent. Prespecified to be reported per Arm and not per cohort.
Posted
Count of Participants
Participants
Up to 3 months after the dose of JCAR017 or after the last dose of the combination agent, whichever occurred last (an average of 6.5 months up until a max of 9.5 months)
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
Secondary
Number of Participants With Severe Adverse Events (SAEs)
An SAE is any AE occurring at any dose that:
Results in death;
Is life-threatening (i.e., in the opinion of the Investigator, the participant is at immediate risk of death from the AE);
Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay);
Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions);
Is a congenital anomaly/birth defect;
Constitutes an important medical event.
Safety Set - All participants who received an infusion of conforming JCAR017 cell product or at least one dose of the combination agent. Prespecified to be reported per Arm and not per cohort.
Posted
Count of Participants
Participants
Up to 3 months after the dose of JCAR017 or after the last dose of the combination agent, whichever occurred last (an average of 6.5 months up until a max of 9.5 months)
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
Secondary
Change From Baseline in White Blood Cell and Platelet Numbers
White blood cell, and platelet counts. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 85/Day 57 hematology laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
10^9 cells/L
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
OG002
Secondary
Change From Baseline in Percent of White Blood Cells
Change from baseline in percent of white blood cells was measured using differential blood tests. A differential blood test is a blood test that measures the percentage and number of each type of white blood cell (WBC) - neutrophils, lymphocytes, monocytes, eosinophils and basophils - as well as abnormal cell types if they are present. These results are reported as percentages and absolute values, and compared against reference ranges to determine whether the values are normal, low, or high. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 85/Day 57 hematology laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
Percent
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Change From Baseline Erythrocyte Numbers
Change from baseline in erythrocyte (also known as red blood cell) numbers was measured using a test called a red blood cell count. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 85/Day 57 hematology laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
10^12 cells/L
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Change From Baseline Hematocrit Ratio
The change in the proportion of red blood cells in the blood was measured using a hematocrit test. A hematocrit test measures the volume of packed red blood cells relative to whole blood. This is represented as a ratio. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 85/Day 57 hematology laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
Ratio
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Change From Baseline in Hemoglobin Levels
The change from baseline in hemoglobin levels was measured using a hemoglobin test. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is a protein in red blood cells that carries oxygen from the lungs to the rest of the body. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 85/Day 57 hematology laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
g/L
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Change From Baseline in Specific Liver Serum Enzyme Levels
Change from baseline in alanine aminotransferase (ALT) alkaline phosphatase (ALP), and aspartate aminotransferase (AST). Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 85/Day 57 serum chemistry laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
U/L
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Change From Baseline in Specific Serum Protein Levels
Change from baseline in serum albumin and protein levels. Serum protein level tests are blood tests that measure the number of proteins in the blood. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 85/Day 57 serum chemistry laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
g/L
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Change From Baseline in Serum Beta-2-Microglobulin Levels
Change from baseline in serum Beta-2-Microglobulin levels was measured using a beta-2 microglobulin (B2M) tumor marker test. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 85/Day 57 serum chemistry laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
mg/L
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Change From Baseline in Serum Bicarbonate Levels
Change from baseline in serum bicarbonate levels was measured using a serum bicarbonate test. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 85/Day 57 serum chemistry laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
mmol/L
85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Change From Baseline in Coagulation Times
Change from baseline in activated partial thromboplastin and prothrombin times. Activated partial thromboplastin time and prothrombin time are blood tests that measure how long it takes for blood to form a clot. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 57 coagulation laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
Seconds
57 days after the dose of JCAR017
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Change From Baseline in D-Dimer Levels
D-dimer is a substance that is produced in the body when blood clots are broken down. The D-dimer laboratory test measures the level of D-dimer in the blood and is often used to help diagnose or rule out conditions related to blood clotting, such as deep vein thrombosis (DVT) or pulmonary embolism (PE). Elevated levels of D-dimer may indicate the presence of a blood clot, but other factors can also cause an increase in D-dimer levels. Therefore, the D-dimer test is typically used in combination with other diagnostic tests to help make an accurate diagnosis. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 57 coagulation laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
mg/L
57 days after the dose of JCAR017
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Change From Baseline in Fibrinogen Levels
Fibrinogen is a protein that plays a role in a number of processes in the body, including blood clot formation, wound healing, inflammation, and blood vessel growth. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 57 coagulation laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
g/L
57 days after the dose of JCAR017
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
OG002
Secondary
Change From Baseline in Prothrombin International Normalized Ratio
The Prothrombin International Normalized Ratio (INR) is used to determine the clotting tendency of blood. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT. Baseline is defined as the last measurement on or prior to any study treatment.
All treated participants with baseline and Day 57 coagulation laboratory values. Prespecified to be reported per Arm and not per cohort.
Posted
Mean
Standard Deviation
Ratio
57 days after the dose of JCAR017
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Progression-Free Survival (PFS)
PFS is defined as time from JCAR017 infusion to disease progression or death from any cause.
Progressive disease (PD) was measured using CT and PET as an increase in size index and non-index lesions, spleen size, and the presence of new lesions or diseased bone marrow.
Summarized using Kaplan-Meier estimates.
All participants in the combination treated set. The combination treated set included all participants who received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent. Prespecified to be reported per Arm and not per cohort.
Posted
Median
95% Confidence Interval
Months
From JCAR017 infusion to disease progression or death from any cause (up to approximately 62 months)
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Overall Survival (OS)
Time from JCAR017 infusion to death. Data from surviving participants was censored at the last time that the participant was known to be alive.
Summarized using Kaplan-Meier estimates.
All participants in the combination treated set. The combination treated set included all participants who received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent. Prespecified to be reported per Arm and not per cohort.
Posted
Median
95% Confidence Interval
Months
From start of JCAR017 to time of death from any cause, or data cut-off date, whichever occurred first (up to approximately 62 months)
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Overall Response Rate (ORR)
The ORR is the percent of participants achieving an objective response of partial response (PR) or better according to the Lugano Criteria for Response Assessment (Cheson, 2014), prior to start of another non-study anticancer therapy.
Complete response (CR) assessed by CT-scan:
Index lesions: Nodal Disease: ≤ 1.5 cm in largest transverse diameter, Extranodal Disease: Absent
Non-index lesions: Absent,
Spleen: <13 cm
New lesions: None
Bone marrow: Normal
Partial response (PR) assessed by CT-scan:
Index lesions: >=50% decrease from baseline in shortest diameter
Non-index lesions: No increase,
Spleen: >50% decrease from baseline in enlarged portion
New lesions: None
Bone marrow: N/A Overall Response (OR) = CR + PR
All participants in the combination treated set. The combination treated set included all participants who received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent. Prespecified to be reported per Arm and not per cohort.
Posted
Number
95% Confidence Interval
Percent of Participants
At 1, 3, 6, 9, 12, 18 and 24 months post-JCAR017 infusion
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
Secondary
Duration of Response (DOR)
DOR is defined as the time from first response to disease progression or death from any cause.
Summarized using Kaplan-Meier estimates.
All Responders in Combination Treated Set. The combination treated set included all participants who received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent. Prespecified to be reported per Arm and not per cohort.
Posted
Median
95% Confidence Interval
Months
From JCAR017 infusion to disease progression or death from any cause (up to approximately 62 months)
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Event-Free Survival (EFS)
EFS is defined as time from JCAR017 infusion to disease progression, starting a new antilymphoma therapy, or death from any cause, whichever occurred first.
All participants in the combination treated set. The combination treated set included all participants who received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent. Prespecified to be reported per Arm and not per cohort.
Posted
Median
95% Confidence Interval
Months
From JCAR017 infusion to disease progression or death from any cause (up to approximately 62 months)
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Maximum Concentration (Cmax) of JCAR017 by qPCR
Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug.
qPCR was used to determine Cmax by detecting the JCAR017 transgene.
All participants who received an infusion of conforming JCAR017 cell product with baseline and on-study PK measurements. Prespecified to be reported per Arm and not per cohort.
Posted
Geometric Mean
Geometric Coefficient of Variation
Copies/ug
Up to 24 months post- JCAR017 infusion
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
OG002
Secondary
Time to Maximum Concentration (Tmax) of JCAR017 by qPCR
Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration.
qPCR was used to determine Tmax by detecting the JCAR017 transgene.
All participants who received an infusion of conforming JCAR017 cell product (JCAR017 PK analysis) or at least 1 dose of combination agent (combination agent analysis) with baseline and on-study PK measurements. Prespecified to be reported per Arm and not per cohort.
Posted
Median
Full Range
Days
Up to 24 months post- JCAR017 infusion
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Secondary
Total Exposure to JCAR017 as Measured by the Area Under the Curve (AUC) by qPCR
Area Under the Curve" (AUC) represents the total exposure of participants to study drug. qPCR was used to determine AUC by detecting the JCAR017 transgene.
All participants who received an infusion of conforming JCAR017 cell product with baseline and on-study PK measurements. Prespecified to be reported per Arm and not per cohort.
Posted
Geometric Mean
Geometric Coefficient of Variation
Copies/ug*day
Up to 24 months post- JCAR017 infusion
ID
Title
Description
OG000
Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
Time Frame
Participants were assessed for All-Cause Mortality from the date of leukapheresis until study completion (assessed up to approximately 62 months). SAEs and Other AEs were assessed from leukapheresis to 90 days after last dose of study therapy (an average of 7.5 months up until a max of 10.5 months).
Description
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017. Data is shown per cohort.
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
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (50 x 10^6 CAR+ T cells). On Day 29 after infusion, Durvalumab was administered at a low dose. On day 43 after infusion Durvalumab was administered at a mid-dose and on days 57 and 85 after infusion was administered at a high dose. Participants who reached a partial response 3 months after JCAR017 infusion could continue Durvalumab until progression for a maximum total duration of 12 months.
7
11
4
11
8
11
EG001
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (100 x 10^6 CAR+ T cells). On Day 29 after infusion, Durvalumab was administered at a low dose. On day 43 after infusion Durvalumab was administered at a mid-dose and on days 57 and 85 after infusion was administered at a high dose. Participants who reached a partial response 3 months after JCAR017 infusion could continue Durvalumab until progression for a maximum total duration of 12 months.
7
9
6
9
8
9
EG002
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells. Between days 29 and 180 after infusion participants received a standard dose of CC-122, 5 out of 7 days. Participants who reached a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
8
13
7
13
11
13
EG003
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells. Between Days 15 -21 post infusion, CC-220 was administered at a standard dose. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
1
1
1
1
1
1
EG004
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered from 35 days before to 85 days post JCAR017 infusion which was administered at a dose of 100 x 10^6 CAR+T cells. Participants received ibrutinib until 85 days post-infusion (Month 3).
5
17
6
17
17
17
EG005
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells. On days 8, 22, 36 post infusion, nivolumab was administered at a low dose. On days 57 and 85 post infusion, participants received nivolumab at a higher dose. Participants received nivolumab until Day 85 (Month 3).
1
2
2
2
2
2
EG006
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (100 x 10^6 CAR+ T cells). Starting on Day 8 post infusion, CC-99282 was administered every 7 days. Participants received CC-99282 until Day 85 (Month 3)
4
7
3
7
4
7
EG007
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of (100 x 10^6 CAR+ T cells). Starting on Day 1 post infusion, CC-99282 was administered every 7 days. Participants received CC-99282 until Day 85 (Month 3)
1
2
0
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG0030 affected1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0012 affected9 at risk
EG0020 affected13 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0023 affected13 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Colon cancer stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Agraphia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected9 at risk
EG0022 affected13 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected9 at risk
EG0020 affected13 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected11 at risk
EG0017 affected9 at risk
EG0025 affected13 at risk
EG0031 affected1 at risk
EG00410 affected17 at risk
EG0052 affected2 at risk
EG0062 affected7 at risk
EG0071 affected2 at risk
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Hypofibrinogenaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected11 at risk
EG0013 affected9 at risk
EG0024 affected13 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected9 at risk
EG0023 affected13 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0015 affected9 at risk
EG0028 affected13 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected11 at risk
EG0014 affected9 at risk
EG0027 affected13 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Dry eye
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Eye irritation
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Vision blurred
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0012 affected9 at risk
EG0020 affected13 at risk
EG003
Visual impairment
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Chapped lips
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0013 affected9 at risk
EG0023 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0023 affected13 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Mesenteric artery stenosis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected11 at risk
EG0012 affected9 at risk
EG0025 affected13 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected11 at risk
EG0010 affected9 at risk
EG0022 affected13 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Chills
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected11 at risk
EG0014 affected9 at risk
EG0026 affected13 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Physical deconditioning
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected9 at risk
EG0020 affected13 at risk
EG003
Suprapubic pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Ocular icterus
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0013 affected9 at risk
EG0022 affected13 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Candida infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0022 affected13 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected9 at risk
EG0020 affected13 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0022 affected13 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Vulvitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0022 affected13 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Vascular access site bruising
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Liver function test increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0022 affected13 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0012 affected9 at risk
EG0023 affected13 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected11 at risk
EG0012 affected9 at risk
EG0021 affected13 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0014 affected9 at risk
EG0021 affected13 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0013 affected9 at risk
EG0023 affected13 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected9 at risk
EG0023 affected13 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected9 at risk
EG0024 affected13 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Mastication disorder
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected9 at risk
EG0022 affected13 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Colorectal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Brain fog
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0025 affected13 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0022 affected13 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Hyporeflexia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hypotonia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Intention tremor
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0022 affected13 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Resting tremor
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Tremor
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0022 affected13 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0014 affected9 at risk
EG0022 affected13 at risk
EG003
Diaphragmalgia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0022 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0012 affected9 at risk
EG0020 affected13 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0022 affected13 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0022 affected13 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Aneurysm
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0020 affected13 at risk
EG003
Bloody discharge
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Embolism
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Flushing
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Haematoma
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0012 affected9 at risk
EG0022 affected13 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected9 at risk
EG0021 affected13 at risk
EG003
Appetite disorder
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0020 affected13 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected9 at risk
EG0021 affected13 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
FG00417 subjects1 Participant who died in pre-treatment period received Ibrutinib prior to entering the treatment period and was thus included in the safety set.
FG0052 subjects
FG0064 subjects
FG0072 subjects
12 subjects
FG0052 subjects
FG0063 subjects
FG0070 subjects
4 subjects
FG0050 subjects
FG0062 subjects
FG0072 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Withdrawal by participant
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Study terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Other reasons
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
69.0
± NA
Insufficient number of participants to calculate SD.
BG00456.5± 12.19
BG00566.5± 2.12
BG00666.6± 14.14
BG00755.0± 19.8
BG00861.7± 11.92
1
BG0030
BG0047
BG0050
BG0064
BG0071
BG00819
Male
BG0008
BG0016
BG00212
BG0031
BG00410
BG0052
BG0063
BG0071
BG00843
0
BG0030
BG0042
BG0050
BG0061
BG0070
BG0085
Not Hispanic or Latino
BG00010
BG0018
BG00213
BG0031
BG00415
BG0052
BG0066
BG0072
BG00857
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
0
BG0030
BG0041
BG0050
BG0060
BG0070
BG0081
ASIAN
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0042
BG0050
BG0060
BG0071
BG0083
BLACK OR AFRICAN AMERICAN
Title
Measurements
BG0001
BG0010
BG0021
BG0030
BG0041
BG0050
BG0060
BG0070
BG0083
WHITE
Title
Measurements
BG0009
BG0019
BG00212
BG0031
BG00411
BG0052
BG0066
BG0071
BG00851
OTHER
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0042
BG0050
BG0061
BG0070
BG0084
8
OG0042
OG0055
1
OG0040
OG0050
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00014
OG0018
OG0021
OG00315
OG0042
OG0055
Title
Denominators
Categories
CRR at 3 Months
Title
Measurements
OG00071.4(41.9 to 91.6)
OG00162.5(24.5 to 91.5)
OG0020.0(0.0 to 97.5)
OG00346.7(21.3 to 73.4)
OG0040.0(0.0 to 84.2)
OG00560.0(14.7 to 94.7)
CRR at 6 Months
Title
Measurements
OG00078.6(49.2 to 95.3)
OG00162.5(24.5 to 91.5)
OG0020.0(0.0 to 97.5)
OG003
JCAR017 was administered at a dose of 50 x 10^6 CAR+T cells (dose level 1 [DL1]) or 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, Durvalumab was administered at different doses and/ or schedules. Participants from both phases and all cohorts who reached a partial response 3 months after JCAR017 infusion could continue durvalumab until progression for a maximum total duration of 12 months.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00014
OG0017
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Global Health Status - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00072.92± 20.140
OG00180.95± 16.467
Global Health Status - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Global Health Status - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Physical Functioning - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Physical Functioning - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Physical Functioning - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Role Functioning - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Role Functioning - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Role Functioning - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Emotional Functioning - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Emotional Functioning -JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Emotional Functioning - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Cognitive Functioning - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Cognitive Functioning - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Cognitive Functioning - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Social Functioning - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Social Functioning - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Social Functioning - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Fatigue - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Fatigue - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Fatigue - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Nausea and Vomiting - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Nausea and Vomiting - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Nausea and Vomiting - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Pain - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Pain - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Pain - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Dyspnea - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Dyspnea - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Dyspnea - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Insomnia - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Insomnia - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Insomnia - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Appetite Loss - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Appetite Loss - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Appetite Loss - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Constipation - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Constipation - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Constipation - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Diarrhea - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Diarrhea - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Diarrhea - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Financial Difficulties - Baseline
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Financial Difficulties - JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Financial Difficulties - JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00014
OG0017
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Baseline
ParticipantsOG00013
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00069.5± 21.83
OG00182.6± 12.31
JCAR017 Day 1
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
JCAR017 Day 29
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
JCAR017 Day 57
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
JCAR017 Day 85
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
JCAR017 Day 180
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG0030
Follow-up - Day 270
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
Follow-up - Day 365
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
Follow-up - Day 545
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Follow-up - Day 730/EOS
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00016
OG00111
OG0021
OG00317
OG0042
OG0056
Title
Denominators
Categories
Title
Measurements
OG00016
OG00111
OG0021
OG00317
OG0042
OG0056
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00016
OG00111
OG0021
OG00317
OG0042
OG0056
Title
Denominators
Categories
Title
Measurements
OG00010
OG0017
OG0021
OG0036
OG0042
OG0053
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00011
OG0017
OG0021
OG00312
OG0042
OG0054
Title
Denominators
Categories
BASOPHILS (10^9/L)
Title
Measurements
OG0000.00± 0.009
OG0010.03± 0.050
OG0020.10± NAInsufficient number of participants to calculate SD
OG003-0.02± 0.038
OG0040.05± 0.071
OG0050.00± 0.075
EOSINOPHILS (10^9/L)
Title
Measurements
OG0000.20± 0.134
OG0010.20± 0.282
OG0020.00± NAInsufficient number of participants to calculate SD
OG003
LYMPHOCYTES (10^9/L)
Title
Measurements
OG0000.40± 0.359
OG0010.29± 0.138
OG002-0.60± NAInsufficient number of participants to calculate SD
OG003
MONOCYTES (10^9/L)
Title
Measurements
OG0000.19± 0.209
OG0010.38± 0.295
OG0020.20± NAInsufficient number of participants to calculate SD
OG003
NEUTROPHILS (10^9/L)
Title
Measurements
OG000-1.69± 1.940
OG001-1.74± 1.312
OG0022.30± NAInsufficient number of participants to calculate SD
OG003
PLATELETS (10^9/L)
Title
Measurements
OG000-6.91± 59.184
OG00125.57± 28.547
OG002-77.00± NAInsufficient number of participants to calculate SD
OG003
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00011
OG0017
OG0021
OG00312
OG0042
OG0054
Title
Denominators
Categories
BASOPHILS/LEUKOCYTES (%)
Title
Measurements
OG0000.40± 0.420
OG0010.89± 1.002
OG0020.00± NAInsufficient number of participants to calculate SD
OG0030.20± 0.558
OG0040.15± 0.778
OG0050.88± 1.450
EOSINOPHILS/LEUKOCYTES (%)
Title
Measurements
OG0001.24± 2.455
OG0015.20± 6.491
OG002-1.00± NAInsufficient number of participants to calculate SD
OG003
LYMPHOCYTES/LEUKOCYTES (%)
Title
Measurements
OG00011.59± 7.902
OG0019.29± 4.870
OG002-37.00± NAInsufficient number of participants to calculate SD
OG003
MONOCYTES/LEUKOCYTES (%)
Title
Measurements
OG0007.13± 3.955
OG00111.43± 6.574
OG002-8.00± NAInsufficient number of participants to calculate SD
OG003
NEUTROPHILS/LEUKOCYTES (%)
Title
Measurements
OG000-20.69± 8.997
OG001-26.81± 13.462
OG00245.00± NAInsufficient number of participants to calculate SD
OG003
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00011
OG0017
OG0021
OG00312
OG0042
OG0054
Title
Denominators
Categories
Title
Measurements
OG000-0.11± 0.507
OG001-0.21± 0.376
OG002-0.34± NAInsufficient number of participants to calculate SD
OG003-0.10± 0.476
OG0040.05± 0.148
OG005-0.10± 0.281
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00011
OG0017
OG0021
OG00312
OG0042
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000.01± 0.048
OG001-0.02± 0.028
OG002-0.04± NAInsufficient number of participants to calculate SD
OG0030.01± 0.048
OG0040.02± 0.020
OG005-0.01± 0.039
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00011
OG0017
OG0021
OG00312
OG0042
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000.45± 16.688
OG001-5.43± 12.869
OG002-12.00± NAInsufficient number of participants to calculate SD
OG0031.38± 17.207
OG0049.50± 13.435
OG005-2.50± 18.502
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00011
OG0017
OG0021
OG00312
OG0042
OG0054
Title
Denominators
Categories
ALANINE AMINOTRANSFERASE (U/L)
Title
Measurements
OG0005.45± 5.429
OG001-2.86± 7.105
OG002-1.00± NAInsufficient number of participants to calculate SD
OG003-0.58± 11.237
OG0040.50± 4.950
OG0052.50± 2.082
ALKALINE PHOSPHATASE (U/L)
Title
Measurements
OG00012.09± 47.526
OG001-2.43± 24.234
OG00222.00± NAInsufficient number of participants to calculate SD
OG003
ASPARTATE AMINOTRANSFERASE (U/L)
Title
Measurements
OG0002.91± 5.467
OG001-4.43± 6.373
OG002-1.00± NAInsufficient number of participants to calculate SD
OG003
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00011
OG0017
OG0021
OG00312
OG0042
OG0054
Title
Denominators
Categories
ALBUMIN (g/L)
Title
Measurements
OG0004.09± 5.281
OG0012.29± 3.450
OG0029.00± NAInsufficient number of participants to calculate SD
OG0031.42± 4.926
OG0046.00± 4.243
OG0053.50± 9,747
PROTEIN (g/L)
Title
Measurements
OG0003.91± 8.166
OG0010.00± 3.697
OG00216.00± NAInsufficient number of participants to calculate SD
OG003
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00011
OG0017
OG0021
OG00312
OG0042
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000.33± 0.735
OG0010.06± 0.221
OG002-0.10± NAInsufficient number of participants to calculate SD
OG003-0.04± 1.019
OG004-0.65± 1.577
OG0050.29± 0.654
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00011
OG0017
OG0021
OG00312
OG0042
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000.91± 3.270
OG0010.00± 4.509
OG0020.00± NAInsufficient number of participants to calculate SD
OG003-0.50± 4.079
OG0043± 2.828
OG005-0.50± 2.646
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00012
OG0017
OG0021
OG00310
OG0042
OG0054
Title
Denominators
Categories
ACTIVATED PARTIAL THROMBOPLASTIN TIME (SEC)
Title
Measurements
OG000-5.70± 21.348
OG001-0.31± 5.423
OG0022.40± NAInsufficient number of participants to calculate SD.
OG003-2.25± 1.566
OG0044.25± 6.859
OG005-2.10± 2.364
PROTHROMBIN TIME (SEC)
Title
Measurements
OG000-0.02± 0.732
OG0011.07± 2.974
OG0020.40± NAInsufficient number of participants to calculate SD.
OG003
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00012
OG0017
OG0021
OG00310
OG0042
OG0054
Title
Denominators
Categories
Title
Measurements
OG000-0.92± 1.789
OG001-0.13± 0.311
OG002-0.46± NAInsufficient number of participants to calculate SD.
OG003-0.69± 1.601
OG004-0.39± 0.746
OG0050.13± 0.241
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00012
OG0017
OG0021
OG00310
OG0042
OG0054
Title
Denominators
Categories
Title
Measurements
OG000-0.23± 1.379
OG001-0.65± 1.697
OG0022.59± NAInsufficient number of participants to calculate SD.
OG003-2.04± 2.012
OG004-5.12± 1.888
OG005-1.77± 0.525
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00012
OG0017
OG0021
OG00310
OG0042
OG0054
Title
Denominators
Categories
Title
Measurements
OG000-0.01± 0.079
OG0010.08± 0.234
OG0020.10± NAInsufficient number of participants to calculate SD.
OG003-0.01± 0.066
OG004-0.20± 0.283
OG0050.10± 0.198
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00014
OG0018
OG0021
OG00315
OG0042
OG0055
Title
Denominators
Categories
Title
Measurements
OG00020.90(2.96 to NA)Upper CI could not be calculated due to insufficient number of events.
OG001NA(2.30 to NA)PFS could not be calculated due to insufficient number of events.
OG0022.86(NA to NA)Upper and lower CI could not be calculated due to insufficient number of events.
OG003NA(1.91 to NA)PFS could not be calculated due to insufficient number of events.
OG0044.07(2.17 to NA)Upper CI could not be calculated due to insufficient number of events.
OG0053.06(2.79 to NA)Upper CI could not be calculated due to insufficient number of events.
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00014
OG0018
OG0021
OG00315
OG0042
OG0055
Title
Denominators
Categories
Title
Measurements
OG00031.34(4.50 to 38.08)
OG001NA(3.22 to NA)Insufficient number of events to calculate Median OS and upper CI limit.
OG0022.86(NA to NA)Insufficient participants calculate lower and upper CI limits.
OG003NA(9.46 to NA)Insufficient number of events to calculate Median OS and upper CI limit.
OG004NA(7.26 to NA)Insufficient number of events to calculate Median OS and upper CI limit.
OG0056.60(4.27 to NA)Insufficient number of events to calculate upper CI limit.
OG001
Arm B: Cohort 1A
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On Day 29 after infusion, CC-122 was administered at different doses. Participants who reach a partial response or stable disease 6 months (Day 180) after JCAR017 infusion could continue CC-122 until progression or for up to Month 24, whatever was earlier.
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00014
OG0018
OG0021
OG00315
OG0042
OG0055
Title
Denominators
Categories
Month 1
Title
Measurements
OG00092.9(66.1 to 99.8)
OG00175.0(34.9 to 96.8)
OG002100.0(2.5 to 100.0)
OG00360.0(32.3 to 83.7)
OG004100.00(15.8 to 100.0)
OG00560.0(14.7 to 94.7)
Month 3
Title
Measurements
OG00092.9(66.1 to 99.8)
OG00175.0(34.9 to 96.8)
OG002100.0(2.5 to 100.0)
OG003
Month 6
Title
Measurements
OG00092.9(66.1 to 99.8)
OG00175.0(34.9 to 96.8)
OG002100.0(2.5 to 100.0)
OG003
Month 9
Title
Measurements
OG00092.9(66.1 to 99.8)
OG00175.0(34.9 to 96.8)
OG002100.0(2.5 to 100.0)
OG003
Month 12
Title
Measurements
OG00092.9(66.1 to 99.8)
OG00175.0(34.9 to 96.8)
OG002100.0(2.5 to 100.0)
OG003
Month 18
Title
Measurements
OG00092.9(66.1 to 99.8)
OG00175.0(34.9 to 96.8)
OG002100.0(2.5 to 100.0)
OG003
Month 24
Title
Measurements
OG00092.9(66.1 to 99.8)
OG00175.0(34.9 to 96.8)
OG002100.0(2.5 to 100.0)
OG003
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00013
OG0016
OG0021
OG00311
OG0042
OG0053
Title
Denominators
Categories
Title
Measurements
OG00021.45(2.43 to NA)Insufficient number of events to calculate upper CI limit.
OG001NA(1.45 to NA)Insufficient number of events to calculate DoR and upper CI limit.
OG0021.91(NA to NA)Insufficient number of participants to calculate upper and lower CI limits.
OG003NA(17.71 to NA)Insufficient number of events to calculate DoR upper CI limit.
OG0043.15(1.22 to NA)Insufficient number of events to calculate upper CI limit.
OG0053.29(1.87 to NA)Insufficient number of events to calculate upper CI limit
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00014
OG0018
OG0021
OG00315
OG0042
OG0055
Title
Denominators
Categories
Title
Measurements
OG00020.90(2.96 to NA)Insufficient number of events to calculate upper CI limit.
OG001NA(2.30 to NA)Insufficient number of events to calculate EFS and upper CI limit.
OG0022.86(NA to NA)Insufficient number of participants to calculate lower and upper CI limits.
OG00318.76(1.91 to NA)Insufficient number of events to calculate upper CI limit.
OG0044.07(2.17 to NA)Insufficient number of events to calculate upper CI limit.
OG0053.06(2.79 to NA)Insufficient number of events to calculate upper CI limit.
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00015
OG00110
OG0021
OG00313
OG0042
OG0055
Title
Denominators
Categories
Title
Measurements
OG00011464.7± 305.8
OG00114087.1± 434.7
OG00228845.0± NAInsufficient number of participants to calculate geometric CV.
OG00328877.7± 314.2
OG00458522.9± 63.5
OG00518003.4± 343.4
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00015
OG00110
OG0021
OG00313
OG0042
OG0055
Title
Denominators
Categories
Title
Measurements
OG00010.0(7.0 to 42.0)
OG00110.0(7.0 to 19.0)
OG00229.0(29.0 to 29.0)
OG00314.0(7.0 to 28.0)
OG00410.0(10.0 to 10.0)
OG0058.5(7.0 to 10.0)
OG002
Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). Between Days 1 -21 post infusion, CC-220 was administered at different doses and/or schedules. Participants who reached a partial response or stable disease at Day 85 (Month 3) after JCAR017 infusion could continue CC-220 until progression or for up to Month 12, whichever was earlier.
OG003
Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Ibrutinib was administered at different doses on Day 1. On day 35, JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2), followed again by Ibrutinib at different doses. Participants received ibrutinib until 85 days post-infusion (Month 3).
OG004
Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 8 or day 15 post infusion, relatlimab and nivolumab were administered at different doses and/or schedules. Participants received relatlimab and/or nivolumab until Day 85 (Month 3).
OG005
Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
JCAR017 was administered at a dose of 100 x 10^6 CAR+T cells (DL2). On day 1, 8, or day 15 post infusion CC-99282 was administered at different doses and/or schedules. Participants received CC-99282 until Day 85 (Month 3).
Units
Counts
Participants
OG00015
OG00110
OG0021
OG00313
OG0042
OG0055
Title
Denominators
Categories
Title
Measurements
OG00085169.458± 237.850
OG00183155.476± 473.149
OG002288951.250± NAInsufficient number of participants to calculate geometric CV.
OG003281265.838± 360.545
OG004529755.009± 9.534
OG005190904.832± 224.399
0 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0051 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0045 affected17 at risk
EG0052 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0042 affected17 at risk
EG0052 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0041 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0043 affected17 at risk
EG0051 affected2 at risk
EG0061 affected7 at risk
EG0071 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0071 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0071 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0043 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0051 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0072 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0071 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0071 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0047 affected17 at risk
EG0052 affected2 at risk
EG0061 affected7 at risk
EG0071 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG00410 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0071 affected2 at risk
0 affected
1 at risk
EG00411 affected17 at risk
EG0050 affected2 at risk
EG0063 affected7 at risk
EG0072 affected2 at risk
0 affected
1 at risk
EG0049 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0072 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG00412 affected17 at risk
EG0050 affected2 at risk
EG0062 affected7 at risk
EG0071 affected2 at risk
1 affected
1 at risk
EG0045 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0051 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0042 affected17 at risk
EG0051 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0041 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0041 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0071 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0043 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0071 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0043 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0071 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0043 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0071 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0043 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0071 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0051 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0051 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0043 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0042 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0061 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0043 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
1 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0072 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0041 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
0 affected
1 at risk
EG0040 affected17 at risk
EG0050 affected2 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
53.3
(26.6 to 78.7)
OG0040.0(0.0 to 84.2)
OG00560.0(14.7 to 94.7)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00070.24± 12.957
OG00185.71± 20.813
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00075.60± 13.660
OG00189.29± 12.467
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00080.00± 23.613
OG00186.67± 13.333
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00080.48± 22.716
OG00191.43± 10.690
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00081.90± 22.710
OG00187.62± 15.119
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00068.06± 35.858
OG00178.57± 28.406
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00075.00± 30.487
OG00188.10± 18.545
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00077.38± 27.431
OG00183.33± 25.459
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00077.08± 21.059
OG00185.71± 12.467
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00086.90± 16.894
OG00191.67± 12.729
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00085.71± 16.803
OG00189.29± 10.446
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00081.94± 18.060
OG00195.24± 8.133
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00088.10± 13.757
OG00192.86± 13.113
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00094.05± 12.416
OG00192.86± 13.113
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00069.44± 36.121
OG00176.19± 23.288
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00069.05± 21.540
OG00188.10± 15.853
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00080.95± 20.524
OG00185.71± 20.250
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00037.96± 30.506
OG00114.29± 16.623
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00026.98± 18.853
OG00123.81± 18.624
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00032.54± 19.715
OG00122.22± 22.222
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00011.11± 28.721
OG0017.14± 13.113
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0009.52± 15.627
OG0017.14± 8.909
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0009.52± 14.194
OG0010.00± 0.00
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00034.72± 35.146
OG00116.67± 19.245
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00020.24± 29.365
OG00116.67± 19.245
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00022.62± 30.387
OG00114.29± 20.250
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00016.67± 17.408
OG0014.76± 12.599
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00021.43± 21.111
OG0014.76± 12.599
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00014.29± 17.118
OG0014.76± 12.599
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00041.67± 35.176
OG00123.81± 25.198
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00016.67± 28.495
OG00119.05± 14.29
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00035.71± 33.242
OG00119.05± 17.817
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00025.00± 32.177
OG00114.29± 17.817
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00026.19± 26.726
OG0019.52± 16.265
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00021.43± 28.063
OG0014.76± 12.599
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00013.89± 30.011
OG0014.76± 12.599
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00011.90± 28.063
OG0014.76± 12.599
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00014.29± 17.118
OG0010.00± 0.000
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0005.56± 12.975
OG0019.52± 16.265
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0007.14± 14.194
OG0014.76± 12.599
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0000.00± 0.000
OG0019.52± 16.265
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00030.56± 36.121
OG00128.57± 29.991
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00019.05± 31.254
OG00123.81± 31.706
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00021.43± 30.959
OG00128.57± 29.991
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00075.1± 13.62
OG00189.1± 12.13
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00077.5± 18.93
OG00190.9± 10.33
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00081.2± 16.20
OG00190.3± 9.43
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00088.4± 8.47
OG00193.0± 4.98
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00086.0± 10.68
OG00190.8± 13.96
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00088.7± 7.50
OG00196.0± 1.41
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00089.2± 15.22
OG00198.0± 2.83
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00089.7± 0.58
OG00195.0± NAInsufficient number of participants to calculate SD.