Study of Carfilzomib in Combination With Induction Chemot... | NCT02303821 | Trialant
NCT02303821
Sponsor
Amgen
Status
Completed
Last Update Posted
Jun 4, 2025Actual
Enrollment
141Actual
Phase
Phase 1
Conditions
Acute Lymphoblastic Leukemia (ALL)
Interventions
Carfilzomib
Dexamethasone
Mitoxantrone
PEG-asparaginase
Vincristine
Intrathecal (IT) Methotrexate
Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
6-Mercaptopurine
Cyclophosphamide
Cytarabine
Daunorubicin
Countries
United States
Argentina
Australia
Austria
Brazil
Bulgaria
Canada
Chile
Colombia
Czechia
Denmark
France
Greece
Hong Kong
Israel
Italy
Mexico
Netherlands
Norway
Poland
Portugal
Romania
Russia
Saudi Arabia
Singapore
South Africa
South Korea
Spain
Sweden
Taiwan
Thailand
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02303821
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CFZ008
Secondary IDs
ID
Type
Description
Link
2014-001633-84
EudraCT Number
Brief Title
Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Official Title
Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
May 2025
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
Feb 16, 2015Actual
Primary Completion Date
Jun 28, 2024Actual
Completion Date
Jun 28, 2024Actual
First Submitted Date
Nov 20, 2014
First Submission Date that Met QC Criteria
Nov 25, 2014
First Posted Date
Dec 1, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 12, 2024
Results First Submitted that Met QC Criteria
May 16, 2025
Results First Posted Date
Jun 4, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 16, 2025
Last Update Posted Date
Jun 4, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Name
Class
Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) - Study Design & Execution Collaborator
UNKNOWN
Innovative Therapies For Children with Cancer Consortium
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of Phase 1b of this study is to:
Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).
Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy.
The purpose of Phase 2 of this study is to compare the rate of complete remission (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control.
Detailed Description
Not provided
Conditions Module
Conditions
Acute Lymphoblastic Leukemia (ALL)
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
141Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1b: Dose Escalation 1
Experimental
Subjects will receive carfilzomib in combination with induction chemotherapy, comprising an R3 backbone of dexamethasone, mitoxantrone, PEG asparaginase, and vincristine.
Subjects will have a 1 week carfilzomib single agent Lead in Window prior to the Induction Cycle.
Subjects will receive a 4 week cycle of induction chemotherapy and have the option to receive a 4 week cycle of consolidation chemotherapy (Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if stable disease or better response is achieved at the end of the Induction Cycle.
Drug: Carfilzomib
Drug: Dexamethasone
Drug: Mitoxantrone
Drug: PEG-asparaginase
Drug: Vincristine
Drug: Intrathecal (IT) Methotrexate
Drug: Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
Drug: 6-Mercaptopurine
Drug: Cyclophosphamide
Drug: Cytarabine
Phase 1b: Dose Escalation 2
Experimental
Subjects will receive carfilzomib in combination with induction chemotherapy, comprising a VXLD backbone of vincristine, dexamethasone, PEG asparaginase, and daunorubicin.
Subjects will receive a 4 week cycle of carfilzomib and induction chemotherapy and then have the option to receive a 4 week cycle of consolidation chemotherapy (Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if stable disease or better response is achieved at the end of the Induction Cycle.
Drug: Carfilzomib
Drug: Dexamethasone
Drug: PEG-asparaginase
Drug: Vincristine
Drug: Intrathecal (IT) Methotrexate
Drug: Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
Drug: 6-Mercaptopurine
Drug: Cyclophosphamide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Carfilzomib
Drug
Phase 1b: Dose Escalation 1
Phase 1b: Dose Escalation 2
Phase 2: Aged < 12 months at screening
Phase 2: Aged ≥ 12 months at screening
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are AEs that occurred after the start of study treatment and up to the end of the study or 30 days of the last study treatment, whichever is earlier. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. Treatment-related AEs (TRAEs) were TEAEs considered related to at least one study drug by the investigator, including those with unknown relationship. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks
Phase 1b: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
A DLT was defined as any of the following toxicities assessed by the investigator as possibly, probably, or definitely attributable to carfilzomib, with protocol defined exclusions: Any Grade 4 nonhematologic toxicity, ≥ Grade 4 neutropenia or ≥ Grade 3 thrombocytopenia.
Up to approximately 35 days
Phase 2: Percentage of Participants With Complete Remission (CR) After Induction Therapy
CR was defined as:
Attainment of M1 bone marrow status (less than 5% blasts in a bone marrow aspirate and at least 200 cells counted) with no evidence of circulating blasts or extramedullary disease.
Recovery of peripheral counts:
Absolute neutrophil count (ANC) greater than or equal to 1000/µL
Platelet count greater than or equal to 100000/µL.
Assessed between days 29 and 45
Data was adjusted as inverse probability of treatment weight (IPTW) for the average treatment effect of the treated (IPTW-ATTW).
Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [Day 36 to Day 50 for infants])
Secondary Outcomes
Measure
Description
Time Frame
Phase 1b: Maximum Concentration (Cmax) of Carfilzomib Alone and in Combination
The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.
Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15 minutes (m) after the start of infusion, immediately (within 2m) before the end of infusion (EOI), EOI, 10m, 30m, 1 hour (h), 2 h, and 4h post-dose
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Phase 1b Key Inclusion Criteria:
Age 21 years or younger at the time of initial ALL diagnosis and age > 1 year at the time of study treatment initiation.
Subjects must have a diagnosis of relapsed or refractory ALL with ≥ 5% blasts in the bone marrow (M2 or M3 disease), with or without extramedullary disease.
-To be eligible, subjects must have had 1 or more prior therapeutic attempts, defined as:
Early first relapse (< 36 months from original diagnosis) after achieving a CR (B-ALL) or first relapse any time following the original diagnosis after achieving a CR (T-ALL)
First refractory bone marrow relapse occurring any time after original diagnosis after achieving a CR (ie, ≥1 failed attempt to induce a second remission) OR
Relapse after achieving a CR following the first or subsequent relapse (i.e., ≥ 2 relapses) OR
Failing to achieve a CR from original diagnosis after at least 1 induction attempt
Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment.
Subjects must have a serum creatinine level that is ≤ 1.5 × institutional upper limit of normal (ULN) according to age. If serum creatinine level is > 1.5 × ULN, the subject must have a calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m2.
Adequate liver function, defined as both of the following:
Total bilirubin ≤ 1.5 × institutional ULN except in the presence of Gilbert Syndrome
Performance status: Karnofsky or Lansky scores ≥ 50 for subjects > 16 years old or ≤ 16 years old, respectively.
Phase 2 Inclusion Criteria:
Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated, except for standard of care local testing as permitted per protocol.
Age greater than or equal to 1 month to less than 21 years. Subjects greater than or equal to 18 years must have had their original diagnosis at less than 18 years of age.
Subjects must be diagnosed with relapsed or refractory relapsed ALL.
Subjects must have a documented first remission, less than 5% blasts in the bone marrow (M1 bone marrow) and no evidence of extramedullary disease.
T-cell ALL with bone marrow relapse (defined as greater than or equal to 5% leukemia blasts in bone marrow) or refractory relapse with or without extramedullary disease.
OR B-cell ALL bone marrow relapse or refractory relapse (defined as greater than or equal to 5% leukemia blasts in bone marrow) after having received a targeted B-cell immune therapy (eg, blinatumomab, inotuzumab or a CAR-T therapy) with or without extramedullary disease..
Adequate liver function: bilirubin less than or equal to 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) less than or equal to 5 x ULN.
Adequate renal function: serum creatinine less than or equal to 1.5 x ULN or glomerular filtration rate (GFR) greater than or equal to 70 mL/min/1.73 m^2; or for children less than 2 years of age, greater than or equal to 50 mL/min/1.73 m^2.
Adequate cardiac function: shortening fraction greater than or equal to 30% or ejection fraction greater than or equal to 50%.
Karnofsky (subjects greater than or equal to 16 years of age) or Lansky (subjects 12 months to less than 16 years of age) performance status greater than or equal to 50%.
Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment (for example: recovery from gastrointestinal toxicity may occur more rapidly than less reversible organ toxicities such as sinusoidal obstruction syndrome or non-infectious pneumonitis, for serious prior toxicities recommended discussion with Amgen medical monitor).
Life expectancy of greater than 6 weeks per investigator's judgement at time of screening.
Phase 1b Key Exclusion Criteria:
Known allergy to any of the drugs used in the study (Subjects who have had a previous allergy to PEG-asparaginase and if able, may receive Erwinia asparaginase at the investigator's discretion)
Known allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
Left ventricular fractional shortening < 30%
History of ≥ Grade 2 pancreatitis
Active graft-versus-host disease requiring systemic treatment
Positive culture for or other clinical evidence of infection with bacteria or fungus within 14 days of the initiation of study treatment
Down Syndrome
Prior therapy restrictions:
Subjects must have completed therapy with granulocyte-colony stimulating factor (G-CSF) or other myeloid growth factors at least 7 days before study treatment initiation, or at least 14 days before study treatment initiation, if pegylated myeloid growth factors were administered.
Subjects must have completed any type of active immunotherapy (e.g., tumor vaccines) at least 42 days before study treatment initiation.
Subjects must have received the last dose of a non-monoclonal antibody biologic agent at least 7 days before study treatment initiation.
At least 3 antibody half-lives must have elapsed since the last dose of monoclonal antibody (e.g., 66 days for rituximab and 69 days for epratuzumab) before subjects may initiate study treatment.
Subjects must not have received other antineoplastic agents with therapeutic intent, excluding hydroxyurea and antimetabolites administered as part of maintenance chemotherapy, within 7 days prior to study treatment initiation.
Hepatitis B infection with positive hepatitis B DNA
Phase 2 Exclusion Criteria:
Prior treatment with carfilzomib.
Intolerance, hypersensitivity, or inability to receive any of the chemotherapy components of the VXLD regimen. An exception is allowed for allergy to asparaginase products if Erwinia asparaginase is unable to be administered,
Autologous HSCT within 6 weeks prior to start of study treatment.
Allogeneic HSCT within 3 months prior to start of study treatment.
Active GVHD requiring systemic immune suppression.
Less than 30 days from discontinuation of immune suppressive therapy administered for the treatment of acute or chronic GVHD.
Isolated extramedullary relapse.
Positive bacterial or fungal infection within 14 days of enrollment (except for documented line infection, line has been removed, and blood culture after line removal is negative for 5 days prior to first dose of induction therapy). Antibiotics may be administered for prophylaxis as per institutional standards up to and after enrollment.
Subjects with less than 3 antibody half-lives since the last dose of monoclonal antibody (eg, 66 days for rituximab, 69 days for epratuzumab, inotuzumab for 36 days), prior to first dose of investigational product must be discussed with the Amgen medical monitor and may be allowed to enroll based on extent of disease or evidence of rapidly rising peripheral or bone marrow blast counts.
Cell-based immunotherapy (eg, donor leucocyte infusion, CAR-T cells, tumor vaccines) within 42 days prior to first dose of investigational product. If the Amgen medical monitor agrees, an exception may be granted to the 42-day requirement for subjects with rapidly rising peripheral or bone marrow blast counts.
Down's syndrome.
Presence of another active cancer.
History of grade greater than or equal to 2 pancreatitis within 6 months to screening.
Unresolved toxicities from prior anticancer therapy, defined as not having resolved to CTCAE version 4.03 grade 1 or to levels dictated in the eligibility criteria apart from alopecia or toxicities from prior anticancer therapy that are considered irreversible and do not trigger another exclusion criterion (defined as having been present and stable for greater than 4 weeks).
Antitumor therapy (chemotherapy, investigational agents, molecular-targeted therapy) within 7 days of day 1 of induction. Exception: hydroxyurea to control peripheral blood leukemic cell counts is allowed until start of investigational product.
Active viral infection, including but not limited to cytomegalovirus (CMV), Hepatitis B infection with positive serum hepatitis surface antigen or hepatitis B DNA, HIV, Hepatitis C with detectable hepatitis C RNA. Subjects who have previously received a stem cell transplant must be screened for CMV infection, unless both subject and donor are known to be CMV negative.
Currently receiving treatment in another investigational device or product study, or less than 14 days since ending treatment on another investigational device or product study.
Uncontrolled arrhythmias or screening ECG with corrected QT interval (QTc) of greater than 470 msec.
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of any study treatment or for 12 months after last dose of cyclophosphamide if administered during optional consolidation cycle.
Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 months after the last dose of any study treatment or for 12 months after last dose of cyclophosphamide if administered during optional consolidation cycle.
Female subjects of childbearing potential with a positive pregnancy test assessed at Screening by a serum or urine pregnancy test.
Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use a condom with spermicide during treatment and for an additional 6 months after the last dose of any study treatment, even if they have undergone a successful vasectomy.
Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom with spermicide during treatment, for duration of pregnancy, and for an additional 6 months after the last dose of any study treatment.
Male subjects unwilling to abstain from donating semen or sperm during treatment and for an additional 6 months after the last dose of any study treatment.
Known allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib; for a complete listing of Captisol-enabled drugs, see the Ligand Pharmaceuticals, Inc. website).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
1 Month
Maximum Age
21 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
MD
Amgen
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of California San Francisco Benioff Childrens Hospital Oakland
Locatelli F, Karakukcu M, Huynh V, Gonzalez-Martinez B, Mendes Lins M, Lu MY, Sulis ML, Pauly M, Morris CL, Braunlin M, Talpes M, Gore L. Carfilzomib plus induction chemotherapy in children with relapsed or refractory acute lymphoblastic leukemia. Blood Adv. 2026 Jun 3:bloodadvances.2025019356. doi: 10.1182/bloodadvances.2025019356. Online ahead of print.
Phase 1b: Participants underwent a 4-week induction and 4-week consolidation cycle, receiving two treatments. Phase 2: After a 7-day screening, participants received VXLD (vincristine, PEG-asparaginase, daunorubicin, dexamethasone) with carfilzomib during a 28-day induction. One B-cell group participant did not receive carfilzomib and was excluded from the primary analysis. Participants were followed for up to 2 years post-treatment.
Recruitment Details
Participants were recruited in Australia, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, France, Greece, Hong Kong, Italy, Israel, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, the UK and the US between February 2015 and June 2024.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 in combination with R3 intravenously (IV) for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
FG001
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 28, 2023
Dec 12, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Switzerland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Cytarabine
Drug: Daunorubicin
Phase 2: Aged ≥ 12 months at screening
Experimental
All subjects aged ≥ 12 months at screening.
Subjects will receive the recommended phase 2 dose (RP2D) of carfilzomib determined in Phase 1b.
Subjects will receive a 4 week cycle of carfilzomib and induction chemotherapy comprising of a VXLD backbone of vincristine, dexamethasone, PEG asparaginase and daunorubicin. Subjects will then have the option to receive a 4 week cycle of carfilzomib in combination with consolidation chemotherapy Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine) if subjects showed no disease progression at the end of the Induction Cycle.
Drug: Carfilzomib
Drug: Dexamethasone
Drug: PEG-asparaginase
Drug: Vincristine
Drug: Intrathecal (IT) Methotrexate
Drug: Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
Drug: 6-Mercaptopurine
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin
Phase 2: Aged < 12 months at screening
Experimental
All subjects aged < 12 months at screening.
Subjects will receive the recommended phase 2 dose (RP2D) of carfilzomib determined in Phase 1b.
Subjects will receive a modified 5 week cycle (based on Interfant-06) of carfilzomib and induction chemotherapy comprising of a VXLD backbone of vincristine, dexamethasone, PEG asparaginase and daunorubicin. Subjects will then have the option to receive a 5 week cycle (modified based on Interfant-06) of carfilzomib in combination with consolidation chemotherapy Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if subjects showed no disease progression at the end of the Induction Cycle.
Drug: Carfilzomib
Drug: Dexamethasone
Drug: PEG-asparaginase
Drug: Vincristine
Drug: Intrathecal (IT) Methotrexate
Drug: Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
Drug: 6-Mercaptopurine
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin
PR-171
PR171
Kyprolis® (carfilzomib) for Injection
Dexamethasone
Drug
Phase 1b: Dose Escalation 1
Phase 1b: Dose Escalation 2
Phase 2: Aged < 12 months at screening
Phase 2: Aged ≥ 12 months at screening
Mitoxantrone
Drug
Phase 1b: Dose Escalation 1
PEG-asparaginase
Drug
Phase 1b: Dose Escalation 1
Phase 1b: Dose Escalation 2
Phase 2: Aged < 12 months at screening
Phase 2: Aged ≥ 12 months at screening
Vincristine
Drug
Phase 1b: Dose Escalation 1
Phase 1b: Dose Escalation 2
Phase 2: Aged < 12 months at screening
Phase 2: Aged ≥ 12 months at screening
Intrathecal (IT) Methotrexate
Drug
Phase 1b: Dose Escalation 1
Phase 1b: Dose Escalation 2
Phase 2: Aged < 12 months at screening
Phase 2: Aged ≥ 12 months at screening
Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
Drug
Phase 1b: Dose Escalation 1
Phase 1b: Dose Escalation 2
Phase 2: Aged < 12 months at screening
Phase 2: Aged ≥ 12 months at screening
6-Mercaptopurine
Drug
Phase 1b: Dose Escalation 1
Phase 1b: Dose Escalation 2
Phase 2: Aged < 12 months at screening
Phase 2: Aged ≥ 12 months at screening
Cyclophosphamide
Drug
Phase 1b: Dose Escalation 1
Phase 1b: Dose Escalation 2
Phase 2: Aged < 12 months at screening
Phase 2: Aged ≥ 12 months at screening
Cytarabine
Drug
Phase 1b: Dose Escalation 1
Phase 1b: Dose Escalation 2
Phase 2: Aged < 12 months at screening
Phase 2: Aged ≥ 12 months at screening
Daunorubicin
Drug
Phase 1b: Dose Escalation 2
Phase 2: Aged < 12 months at screening
Phase 2: Aged ≥ 12 months at screening
Phase 1b: Area Under the Curve (AUC) From Time 0 to the Last Quantifiable Timepoint (AUClast) of Carfilzomib
The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.
Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15m after the start of infusion, immediately (within 2m) before the EOI, EOI, 10m, 30m, 1h, 2 h, and 4h post-dose
Phase 1b: AUC From Time 0 to Infinity (AUCinf) of Carfilzomib
The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.
Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15m after the start of infusion, immediately (within 2m) before the EOI, EOI, 10m, 30m, 1h, 2 h, and 4h post-dose
Phase 1b: Percentage of Participants Who Achieved a Combined CR and CR Without Platelet Recovery (CRp) at the End of Induction Cycle
CR was defined as the attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC > 750 mcl and platelet count > 75,000 mcl). CRp was defined as the attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease and with recovery of ANCs (ANC > 750 mcl), but with insufficient recovery of platelets (< 75,000 mcl).
Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day 29)
Phase 1b: Percentage of Participants Achieving Minimal Residual Disease (MRD) Status of <10-³ and <10-⁴ Lymphoblasts at the End of Induction Cycle
MRD was defined as the quantification of residual lymphoblast in the blood. Assessed by next generation sequencing (NGS).
Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day29)
Phase 2: Number of Participants Who Experienced TEAEs
An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are AEs that occurred after the start of study treatment and up to the end of the study or 30 days of the last study treatment, whichever is earlier. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. TRAEs were TEAEs considered related to at least one study drug by the investigator, including those with unknown relationship. An SAE was defined as any untoward medical occurrence that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks
Phase 2: Percentage of Participants With CR With Incomplete Hematologic Recovery (CRi) After Induction Therapy or Better Remission Status
CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL.
CRi was defined as:
Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease
ANC and platelet counts not fulfilling criteria for CR with partial hematologic recovery (CRh), CR without platelet recovery (CRp), or CR.
CRp was defined as:
a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 1000/µL ii. Platelet count < 100 000/µL.
CRh was defined as:
Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease
Recovery of peripheral counts:
i. ANC ≥ 500/µL but < 1000/µL ii. Platelet count ≥ 50 000/µL but < 100 000/µL. Data was IPTW adjusted.
Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
Phase 2: Event Free Survival (EFS)
EFS was defined as time from initiation of therapy until treatment failure (defined as failure to reach at least a CRi after consolidation or after induction in participants that did not receive consolidation), relapse, or death from any cause. CRi was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. ANC and platelet counts not fulfilling criteria for CRh, CRp, or CR.
Data was IPTW adjusted. Medians were estimated using the Kaplan-Meier (KM) method.
Up to approximately 2 years
Phase 2: Overall Survival (OS)
OS was defined as time from initiation of therapy until death from any cause.
Data was IPTW adjusted. Medians were estimated using the KM method.
Up to approximately 2 years
Phase 2: Duration of Remission (DOR)
DOR was defined as time from earliest of CR, CRp, CRh, or CRi to relapse or death from any cause. CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL. CRi was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. ANC and platelet counts not fulfilling criteria for CRh, CRp) or CR. CRp was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 1000/µL ii. Platelet count < 100 000/µL. CRh was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 500/µL but < 1000/µL ii. Platelet count ≥ 50 000/µL but < 100 000/µL.
Up to approximately 2 years
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CR After Induction Therapy
MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with next generation sequencing (NGS).
Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Induction Therapy
MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with NGS.
Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Consolidation Therapy
MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with NGS.
Up to Day 100 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants] + 28-day cycle of consolidation therapy + + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
Phase 2: Percentage of Participants Who Underwent Stem Cell Transplant or Chimeric Antigen Receptor T-cell (CAR-T) Without Intervening Relapse Following Protocol-Specified Therapy
Percentage of participants who successfully underwent stem cell transplant or CAR-T therapy without experiencing a relapse after receiving the protocol-specified treatment.
Up to approximately 2 years
Phase 2: Percentage of Participants With CRi or Better Remission Status After Consolidation Therapy
CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL.
CRi was defined as:
Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease
ANC and platelet counts not fulfilling criteria for CRh, CRp, or CR.
CRp was defined as:
a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ to 1000/µL ii. Platelet count < 100 000/µL.
CRh was defined as:
Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease
Recovery of peripheral counts:
i. ANC ≥ 500/µL but < 1000/µL ii. Platelet count ≥ 50 000/µL but < 100 000/µL.
Data was IPTW adjusted.
Up to Day 100 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants] + 28-day cycle of consolidation therapy + + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
Phase 2: AUClast of Carfilzomib
AUClast refers to the total exposure of a drug in the body over time, calculated from the time of administration until the last measurable concentration in the blood.
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)
Phase 2: AUCinf of Carfilzomib
AUCinf represents the total drug exposure over time, extrapolated from the time of administration until the drug is completely eliminated from the body.
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)
Phase 2: Cmax of Carfilzomib
Cmax is the maximum concentration of a drug in the bloodstream after administration.
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)
Phase 2: Terminal Half-life (t1/2,z) of Carfilzomib
T1/2,z refers to the time required for the plasma concentration of a drug to decrease by half during the final phase of elimination from the body.
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)
Childrens Hospital of Orange County
Orange
California
92868
United States
Childrens Hospital Colorado
Aurora
Colorado
80045
United States
Childrens Healthcare of Atlanta, Egleston
Atlanta
Georgia
30322
United States
Lurie Childrens Hospital of Chicago
Chicago
Illinois
60611
United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore
Maryland
21231
United States
Childrens Hospital and Clinics of Minnesota
Minneapolis
Minnesota
55404
United States
Childrens Mercy Hospital
Kansas City
Missouri
64108
United States
Rutgers Cancer Institute of New Jersey
New Brunswick
New Jersey
08903
United States
Childrens Hospital of New York Presbyterian
New York
New York
10032
United States
Levine Childrens Hospital at Carolinas Medical Center d/b/a Atrium Health
Charlotte
North Carolina
28203
United States
Cincinnati Childrens Hospital Medical Center
Cincinnati
Ohio
45229
United States
The Cleveland Clinic Foundation
Cleveland
Ohio
44195
United States
Nationwide Childrens Hospital
Columbus
Ohio
43205
United States
Childrens Hospital of Philadelphia
Philadelphia
Pennsylvania
19104-4318
United States
Saint Judes Childrens Research Hospital
Memphis
Tennessee
38105
United States
Childrens Medical Center
Dallas
Texas
75390
United States
Texas Childrens Hospital West Tower
Houston
Texas
77030
United States
University of Texas Health Science Center at San Antonio
San Antonio
Texas
78229-4493
United States
University of Utah Medical Center Primary Childrens Medical Center
Salt Lake City
Utah
84113
United States
West Virginia University Medicine Childrens
Morgantown
West Virginia
60637
United States
Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
Hospital Aleman
Ciudad Autonoma de Buenos Aires
Buenos Aires
C1118AAT
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires
Buenos Aires
C1199
Argentina
Hospital Universitario Austral
Pilar
Buenos Aires
B1629ODT
Argentina
Sydney Childrens Hospital
Randwick
New South Wales
2031
Australia
The Childrens Hospital at Westmead
Westmead
New South Wales
2145
Australia
Queensland Childrens Hospital
South Brisbane
Queensland
4101
Australia
The Royal Childrens Hospital
Parkville
Victoria
3052
Australia
Perth Childrens Hospital
Nedlands
Western Australia
6909
Australia
St Anna Kinderspital
Vienna
1090
Austria
Hospital São Rafael - IDOR
Salvador
Estado de Bahia
41253-190
Brazil
Hospital da Crianca de Brasília
Brasília
Federal District
70684-831
Brazil
Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner
Curitba
Paraná
81520-060
Brazil
Hospital Pequeno Principe
Curitiba
Paraná
80250-060
Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife
Pernambuco
50070-550
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre
Rio Grande do Sul
90035-903
Brazil
Hospital da Crianca Santo Antonio Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre
Rio Grande do Sul
90050-170
Brazil
Fundacao Pio 12 Hospital de Amor de Barretos
Barretos
São Paulo
14784-400
Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto
São Paulo
14040-900
Brazil
Itaci Instituto de Tratamento do Cancer Infantil
São Paulo
São Paulo
05403-000
Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo
01323-001
Brazil
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL EAD
Sofia
1527
Bulgaria
Centre Hospitalier Universitaire Sainte-Justine
Montreal
Quebec
H3T 1C5
Canada
Hospital Luis Calvo Mackenna
Santiago
7500539
Chile
Hospital Roberto del Rio
Santiago
Chile
Sociedad de Oncologia y Hematologia del Cesar
Valledupar
Cesar Department
200001
Colombia
Clinica Imbanaco S.A.S
Cali
Valle del Cauca Department
760042
Colombia
Fakultni nemocnice Brno
Brno
613 00
Czechia
University Hospital Rigshospitalet
København Ø
2100
Denmark
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux
33076
France
Centre Hospitalier Regional Universitaire de Lille
Lille
59037
France
Hopital Armand Trousseau
Paris
75012
France
Hopital Robert Debre
Paris
75019
France
Centre Hospitalier Universitaire de Toulouse - Hopital des enfants
Toulouse
31059
France
Centre Hospitalier Universitaire de Nancy - Hopital Enfants de Brabois
Vandœuvre-lès-Nancy
54511
France
Agia Sofia Children Hospital
Athens
11527
Greece
Agia Sofia Children Hospital
Goudi
11527
Greece
General Children Hospital Panagioti and Aglaias Kyriakou
Goudi
11527
Greece
General University Hospital of Patras Panagia i Voithia
Pátrai
26504
Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki
54642
Greece
Hong Kong Childrens Hospital
Kowloon Bay
Hong Kong
Sheba Medical Center
Tel Litwinsky
5262000
Israel
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari
70124
Italy
Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico
Catania
95123
Italy
IRCCS Istituto Giannina Gaslini
Genova
16147
Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza (MB)
20900
Italy
Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon
Naples
80123
Italy
Azienda Ospedaliera di Padova
Padova
35128
Italy
Fondazione IRCCS Policlinico San Matteo
Pavia
27100
Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma
00165
Italy
Azienda Ospedaliera Citta della Salute e della Scienza Torino Ospedale Infantile Regina Margherita
Torino
10126
Italy
BRCR Global Mexico
Guadalajara
Jalisco
44600
Mexico
BRCR Global Mexico
Mexico City
Mexico City
01120
Mexico
Instituto Nacional de Pediatria
Mexico City
Mexico City
04530
Mexico
BRCR Global Mexico
Puebla City
72160
Mexico
Prinses Maxima Centrum voor Kinderoncologie
Utrecht
3584 CS
Netherlands
Oslo Universitetssykehus Rikshospitalet
Oslo
0372
Norway
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow
30-663
Poland
CSK Uniwersytetu Medycznego w Lodzi Uniwersyteckie Centrum Pediatrii im Marii Konopnickiej
Lodz
91-738
Poland
Uniwersytecki szpital dzieciecy
Lublin
20-093
Poland
Uck wum dzieciecy szpital kliniczny im jozefa polikarpa brudzinskiego
Warsaw
02-091
Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw
50-556
Poland
SPSK nr 1 im Prof Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach
Zabrze
41-800
Poland
Centro Hospitalar Universitario de Coimbra
Coimbra
3000-602
Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon
1099-023
Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto
4200-072
Portugal
Institutul Clinic Fundeni
Bucharest
022328
Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca
400015
Romania
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
Timișoara
300011
Romania
FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation
Moscow
115478
Russia
FSBI FSCC of pediatric hematology, oncology and immunology n a Dmitry Rogachev
Moscow
117198
Russia
SBEI of HPE Saint Petersburg State Medical University na academic I P Pavlov of MoH of RF
Saint Petersburg
197022
Russia
King Fahad Medical City
Riyadh
11525
Saudi Arabia
National University Hospital
Singapore
119228
Singapore
KK Womens and Childrens Hospital
Singapore
229899
Singapore
Chris Hani Baragwanath Hospital
Johannesburg
1864
South Africa
Seoul National University Hospital
Seoul
03080
South Korea
Asan Medical Center
Seoul
05505
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Pusan National University Yangsan Hospital
Yangsan-si, Gyeongsangnam-do
50612
South Korea
Hospital Sant Joan de Deu
Esplugues de Llobregat
Catalonia
08950
Spain
Hospital Universitario Infantil Niño Jesus
Madrid
28009
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
Karolinska Universitetssjukhuset Solna
Solna
171 76
Sweden
National Taiwan University Hospital
Taipei
10041
Taiwan
Mackay Memorial Hospital Taipei Branch
Taipei
10449
Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan
33305
Taiwan
King Chulalongkorn Memorial Hospital
Bangkok
10330
Thailand
Phramongkutklao Hospital
Bangkok
10400
Thailand
Ramathibodi Hospital
Bangkok
10400
Thailand
Siriraj Hospital
Bangkok
10700
Thailand
Acibadem Adana Hastanesi
Adana
01130
Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara
06590
Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara
06800
Turkey (Türkiye)
Medical Park Antalya Hastanesi
Antalya
07230
Turkey (Türkiye)
Bursa Uludag Universitesi Tip Fakultesi
Bursa
16059
Turkey (Türkiye)
Medical Park Bahcelievler Hastanesi
Istanbul
34160
Turkey (Türkiye)
Medipol Mega Universite Hastanesi
Istanbul
34214
Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Izmir
35040
Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Mustafa Eraslan ve Fevzi Mercan Cocuk Hastanesi
Kayseri
38039
Turkey (Türkiye)
The Royal Marsden NHS Foundation Trust
Sutton
SM2 5PT
United Kingdom
Derived
Burke MJ, Ziegler DS, Bautista F, Attarbaschi A, Gore L, Locatelli F, M O'Brien M, Pauly M, Kormany WN, Tian S, Morris CL, Baruchel A. Phase 1b study of carfilzomib with induction chemotherapy in pediatric relapsed/refractory acute lymphoblastic leukemia. Pediatr Blood Cancer. 2022 Dec;69(12):e29999. doi: 10.1002/pbc.29999. Epub 2022 Oct 10.
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
FG002
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
FG003
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 36 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
FG004
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 45 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
FG005
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 56 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
FG006
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
FG007
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
FG0005 subjects
FG0016 subjects
FG0023 subjects
FG0037 subjects
FG0044 subjects
FG00510 subjects
FG00662 subjects
FG00744 subjects
Received Carfilzomib During Induction Therapy
FG0005 subjects
FG0016 subjects
FG0023 subjects
FG0037 subjects
FG0044 subjects
FG00510 subjects
FG00661 subjects
FG00744 subjects
Received Carfilzomib During Consolidation Therapy
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0035 subjects
FG0043 subjects
FG0053 subjects
FG00625 subjects
FG00720 subjects
COMPLETED
FG0005 subjects
FG0013 subjects
FG0023 subjects
FG0037 subjects
FG0044 subjects
FG0055 subjects
FG00619 subjects
FG00713 subjects
NOT COMPLETED
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0055 subjects
FG00643 subjects
FG00731 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
Death
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal prior to Carfilzomib dosing
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Decision by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol-specified criteria
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Phase 1b: Safety Analysis Set (SAS): All participants who received any amount of the study treatment regimen.
Phase 2: The baseline population included participants enrolled in 20140106, in the primary analysis set (PAS) who received at least 1 dose of carfilzomib.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
BG001
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
BG002
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
BG003
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 36 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
BG004
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 45 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
BG005
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 56 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
BG006
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
BG007
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG0016
BG0023
BG0037
BG0044
BG00510
BG00661
BG00744
BG008140
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
< 1 month
Title
Measurements
BG0000
BG0010
BG0020
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
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
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
Secondary
Phase 1b: Maximum Concentration (Cmax) of Carfilzomib Alone and in Combination
The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.
Phase 1b PK Analysis Set: All participants who received the study treatment regimen during the lead-in cycle and induction cycles, and had available data. Phase 1b Dose Escalation 2 arms did not have a 1-week lead-in cycle.
Posted
Mean
Standard Deviation
ng/mL
Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15 minutes (m) after the start of infusion, immediately (within 2m) before the end of infusion (EOI), EOI, 10m, 30m, 1 hour (h), 2 h, and 4h post-dose
ID
Title
Description
OG000
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
OG001
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
OG002
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG003
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 36 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG004
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 45 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG005
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 56 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Units
Counts
Participants
OG0005
OG0016
OG0023
OG003
Title
Denominators
Categories
Dose Escalation 1 - Lead in Cycle Day 1
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Phase 1b: Area Under the Curve (AUC) From Time 0 to the Last Quantifiable Timepoint (AUClast) of Carfilzomib
The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.
Phase 1b PK Analysis Set: All participants who received the study treatment regimen during the lead-in cycle and induction cycles, and had available data. Phase 1b Dose Escalation 2 arms did not have a 1-week lead-in cycle.
Posted
Mean
Standard Deviation
hr*ng/mL
Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15m after the start of infusion, immediately (within 2m) before the EOI, EOI, 10m, 30m, 1h, 2 h, and 4h post-dose
ID
Title
Description
OG000
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
OG001
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Secondary
Phase 1b: AUC From Time 0 to Infinity (AUCinf) of Carfilzomib
The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.
Phase 1b PK Analysis Set: All participants who received the study treatment regimen during the lead-in cycle and induction cycles, and had available data. Phase 1b Dose Escalation 2 arms did not have a 1-week lead-in cycle.
Posted
Mean
Standard Deviation
hr*ng/ mL
Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15m after the start of infusion, immediately (within 2m) before the EOI, EOI, 10m, 30m, 1h, 2 h, and 4h post-dose
ID
Title
Description
OG000
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
OG001
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
OG002
Secondary
Phase 1b: Percentage of Participants Who Achieved a Combined CR and CR Without Platelet Recovery (CRp) at the End of Induction Cycle
CR was defined as the attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC > 750 mcl and platelet count > 75,000 mcl). CRp was defined as the attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease and with recovery of ANCs (ANC > 750 mcl), but with insufficient recovery of platelets (< 75,000 mcl).
Phase 1b Induction SAS: All participants who received any amount of the study treatment regimen during the induction period and had available data.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day 29)
ID
Title
Description
OG000
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
OG001
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Secondary
Phase 1b: Percentage of Participants Achieving Minimal Residual Disease (MRD) Status of <10-³ and <10-⁴ Lymphoblasts at the End of Induction Cycle
MRD was defined as the quantification of residual lymphoblast in the blood. Assessed by next generation sequencing (NGS).
Phase 1b Induction SAS: All participants who received any amount of the study treatment regimen during the induction period and had available data.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day29)
ID
Title
Description
OG000
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
OG001
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
OG002
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Secondary
Phase 2: Number of Participants Who Experienced TEAEs
An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are AEs that occurred after the start of study treatment and up to the end of the study or 30 days of the last study treatment, whichever is earlier. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. TRAEs were TEAEs considered related to at least one study drug by the investigator, including those with unknown relationship. An SAE was defined as any untoward medical occurrence that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Phase 2 Safety Analysis Set: All participants enrolled to study 20140106 who received at least 1 dose of carfilzomib.
Posted
Count of Participants
Participants
From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Secondary
Phase 2: Percentage of Participants With CR With Incomplete Hematologic Recovery (CRi) After Induction Therapy or Better Remission Status
CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL.
CRi was defined as:
Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease
ANC and platelet counts not fulfilling criteria for CR with partial hematologic recovery (CRh), CR without platelet recovery (CRp), or CR.
CRp was defined as:
a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 1000/µL ii. Platelet count < 100 000/µL.
CRh was defined as:
Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease
Recovery of peripheral counts:
i. ANC ≥ 500/µL but < 1000/µL ii. Platelet count ≥ 50 000/µL but < 100 000/µL. Data was IPTW adjusted.
Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Secondary
Phase 2: Event Free Survival (EFS)
EFS was defined as time from initiation of therapy until treatment failure (defined as failure to reach at least a CRi after consolidation or after induction in participants that did not receive consolidation), relapse, or death from any cause. CRi was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. ANC and platelet counts not fulfilling criteria for CRh, CRp, or CR.
Data was IPTW adjusted. Medians were estimated using the Kaplan-Meier (KM) method.
Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.
Posted
Median
95% Confidence Interval
Months
Up to approximately 2 years
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
OG001
Phase 2: T-cell (20/56 mg/m^2)
Secondary
Phase 2: Overall Survival (OS)
OS was defined as time from initiation of therapy until death from any cause.
Data was IPTW adjusted. Medians were estimated using the KM method.
Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.
Posted
Median
95% Confidence Interval
Months
Up to approximately 2 years
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
OG001
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Secondary
Phase 2: Duration of Remission (DOR)
DOR was defined as time from earliest of CR, CRp, CRh, or CRi to relapse or death from any cause. CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL. CRi was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. ANC and platelet counts not fulfilling criteria for CRh, CRp) or CR. CRp was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 1000/µL ii. Platelet count < 100 000/µL. CRh was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 500/µL but < 1000/µL ii. Platelet count ≥ 50 000/µL but < 100 000/µL.
Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib. Only participants who achieved CRi or a better remission status were included in the analysis. Data was IPTW adjusted. Medians were estimated using the KM method.
Posted
Median
95% Confidence Interval
Months
Up to approximately 2 years
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Secondary
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CR After Induction Therapy
MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with next generation sequencing (NGS).
Phase 2 Induction Safety Analysis Set: All participants who started the induction cycle and received at least 1 dose of carfilzomib during the induction period.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
OG001
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Secondary
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Induction Therapy
MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with NGS.
Phase 2 Induction Safety Analysis Set: All participants who started the induction cycle and received at least 1 dose of carfilzomib during the induction period.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
OG001
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Secondary
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Consolidation Therapy
MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with NGS.
Phase 2 Consolidation Safety Analysis Set: All participants who started the consolidation cycle and received at least 1 dose of study treatment during the consolidation period.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to Day 100 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants] + 28-day cycle of consolidation therapy + + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
OG001
Phase 2: T-cell (20/56 mg/m^2)
Secondary
Phase 2: Percentage of Participants Who Underwent Stem Cell Transplant or Chimeric Antigen Receptor T-cell (CAR-T) Without Intervening Relapse Following Protocol-Specified Therapy
Percentage of participants who successfully underwent stem cell transplant or CAR-T therapy without experiencing a relapse after receiving the protocol-specified treatment.
Phase 2: Safety analysis set: All participants who received at least 1 dose of carfilzomib.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 2 years
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
OG001
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Secondary
Phase 2: Percentage of Participants With CRi or Better Remission Status After Consolidation Therapy
CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL.
CRi was defined as:
Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease
ANC and platelet counts not fulfilling criteria for CRh, CRp, or CR.
CRp was defined as:
a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ to 1000/µL ii. Platelet count < 100 000/µL.
CRh was defined as:
Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease
Recovery of peripheral counts:
i. ANC ≥ 500/µL but < 1000/µL ii. Platelet count ≥ 50 000/µL but < 100 000/µL.
Data was IPTW adjusted.
Phase 2 Consolidation Safety Analysis Set: All participants who started the consolidation cycle and received at least 1 dose of study treatment during the consolidation period.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to Day 100 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants] + 28-day cycle of consolidation therapy + + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Secondary
Phase 2: AUClast of Carfilzomib
AUClast refers to the total exposure of a drug in the body over time, calculated from the time of administration until the last measurable concentration in the blood.
Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell.
Posted
Mean
Standard Deviation
hr*ng/mL
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)
ID
Title
Description
OG000
Carfilzomib - Day 8 Induction Cycle
Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had pharmacokinetic (PK) assessments on Day 8 of the induction cycle.
OG001
Carfilzomib - Day 1 Consolidation Cycle
Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 1 of the consolidation cycle.
Units
Counts
Participants
Secondary
Phase 2: AUCinf of Carfilzomib
AUCinf represents the total drug exposure over time, extrapolated from the time of administration until the drug is completely eliminated from the body.
Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell.
Posted
Mean
Standard Deviation
hr*ng/mL
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)
ID
Title
Description
OG000
Carfilzomib - Day 8 Induction Cycle
Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 8 of the induction cycle.
OG001
Carfilzomib - Day 1 Consolidation Cycle
Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 1 of the consolidation cycle.
Units
Counts
Participants
Secondary
Phase 2: Cmax of Carfilzomib
Cmax is the maximum concentration of a drug in the bloodstream after administration.
Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell.
Posted
Mean
Standard Deviation
ng/mL
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)
ID
Title
Description
OG000
Carfilzomib - Day 8 Induction Cycle
Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 8 of the induction cycle.
OG001
Carfilzomib - Day 1 Consolidation Cycle
Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 1 of the consolidation cycle.
Units
Counts
Participants
OG000
Secondary
Phase 2: Terminal Half-life (t1/2,z) of Carfilzomib
T1/2,z refers to the time required for the plasma concentration of a drug to decrease by half during the final phase of elimination from the body.
Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell.
Posted
Mean
Standard Deviation
hour
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)
ID
Title
Description
OG000
Carfilzomib - Day 8 Induction Cycle
Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 8 of the induction cycle.
OG001
Carfilzomib - Day 1 Consolidation Cycle
Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 1 of the consolidation cycle.
Units
Counts
Participants
Primary
Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are AEs that occurred after the start of study treatment and up to the end of the study or 30 days of the last study treatment, whichever is earlier. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. Treatment-related AEs (TRAEs) were TEAEs considered related to at least one study drug by the investigator, including those with unknown relationship. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Phase 1b Safety Analysis Set: All participants who received any amount of the study treatment regimen.
Posted
Count of Participants
Participants
From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks
ID
Title
Description
OG000
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Primary
Phase 1b: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
A DLT was defined as any of the following toxicities assessed by the investigator as possibly, probably, or definitely attributable to carfilzomib, with protocol defined exclusions: Any Grade 4 nonhematologic toxicity, ≥ Grade 4 neutropenia or ≥ Grade 3 thrombocytopenia.
Phase 1b DLT Evaluable Analysis Set: All participants who received all planned dose of carfilzomib and the chemotherapy backbone per protocol during the lead-in window and induction cycle, or received at least one dose of carfilzomib and the chemotherapy backbone per protocol and experienced a DLT prior to completion of the lead-in window or induction cycle, or as clinically indicated.
Posted
Count of Participants
Participants
Up to approximately 35 days
ID
Title
Description
OG000
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
OG001
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Primary
Phase 2: Percentage of Participants With Complete Remission (CR) After Induction Therapy
CR was defined as:
Attainment of M1 bone marrow status (less than 5% blasts in a bone marrow aspirate and at least 200 cells counted) with no evidence of circulating blasts or extramedullary disease.
Recovery of peripheral counts:
Absolute neutrophil count (ANC) greater than or equal to 1000/µL
Platelet count greater than or equal to 100000/µL.
Assessed between days 29 and 45
Data was adjusted as inverse probability of treatment weight (IPTW) for the average treatment effect of the treated (IPTW-ATTW).
Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [Day 36 to Day 50 for infants])
ID
Title
Description
OG000
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Time Frame
Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks
Description
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
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
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
0
5
4
5
5
5
EG001
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
2
6
4
6
6
6
EG002
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
0
3
3
3
3
3
EG003
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 36 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
0
7
6
7
7
7
EG004
Phase 1b: Dose Escalation 2 (20/45 mg/m^2
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 45 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
0
4
4
4
4
4
EG005
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 56 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
3
10
7
10
9
10
EG006
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
41
62
44
61
61
61
EG007
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Clonic convulsion
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dyspnoea at rest
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0004 affected5 at risk
EG0015 affected6 at risk
EG0022 affected3 at risk
EG0034 affected7 at risk
EG0043 affected4 at risk
EG0053 affected10 at risk
EG00637 affected61 at risk
EG00723 affected44 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0003 affected5 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0004 affected5 at risk
EG0010 affected6 at risk
EG0022 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0004 affected5 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Face oedema
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Pain
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0014 affected6 at risk
EG0022 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0003 affected5 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Antithrombin III decreased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0003 affected5 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0003 affected5 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0003 affected5 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0003 affected5 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0022 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Myelosuppression
Blood and lymphatic system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Diplopia
Eye disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Eye irritation
Eye disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Eye pain
Eye disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Periorbital swelling
Eye disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0022 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Oral mucosal erythema
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Catheter site erythema
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Catheter site pain
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Oedema
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hepatic lesion
Hepatobiliary disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Immunodeficiency common variable
Immune system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Device related bacteraemia
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Fungal sepsis
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Infection in an immunocompromised host
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Paronychia
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pseudomembranous colitis
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Stomatococcal infection
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Varicella zoster virus infection
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Foreign body ingestion
Injury, poisoning and procedural complications
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Ammonia
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Aspartate aminotransferase decreased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Bacterial test positive
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Blood creatine increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Blood fibrinogen decreased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Blood urea increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Candida test positive
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Immunoglobulins decreased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Protein total abnormal
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Staphylococcus test positive
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Urine protein/creatinine ratio increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0004 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Chloroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dyspnoea at rest
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 23.1/27.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases
D000429
Alcohol Oxidoreductases
D010088
Oxidoreductases
D004798
Enzymes
D045762
Enzymes and Coenzymes
D025521
Tumor Suppressor Proteins
D009363
Neoplasm Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D011246
Pregnadienetriols
D011245
Pregnadienes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D013259
Steroids, Fluorinated
D000880
Anthraquinones
D000095322
Anthrones
D000873
Anthracenes
D011084
Polycyclic Aromatic Hydrocarbons
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D011809
Quinones
D014748
Vinca Alkaloids
D046948
Secologanin Tryptamine Alkaloids
D026121
Indole Alkaloids
D000470
Alkaloids
D006571
Heterocyclic Compounds
D007211
Indoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D054836
Indolizidines
D007212
Indolizines
D000630
Aminopterin
D011622
Pterins
D011621
Pteridines
D011282
Pregnenediones
D011283
Pregnenes
D015062
11-Hydroxycorticosteroids
D006889
Hydroxycorticosteroids
D000305
Adrenal Cortex Hormones
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
D015065
17-Hydroxycorticosteroids
D013438
Sulfhydryl Compounds
D013457
Sulfur Compounds
D011687
Purines
D010752
Phosphoramide Mustards
D009588
Nitrogen Mustard Compounds
D009150
Mustard Compounds
D006846
Hydrocarbons, Halogenated
D063088
Phosphoramides
D009943
Organophosphorus Compounds
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D001087
Arabinonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D018943
Anthracyclines
D009279
Naphthacenes
D000617
Aminoglycosides
D006027
Glycosides
D002241
Carbohydrates
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0053 subjects
FG00641 subjects
FG00729 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
1 month - <= 17 years
Title
Measurements
BG0005
BG0016
BG0023
BG0037
BG0043
BG0059
BG00657
BG00741
BG008131
> 17 years
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
BG0064
BG0073
BG0089
0
BG0031
BG0041
BG0053
BG00619
BG0075
BG00835
Male
BG0002
BG0013
BG0023
BG0036
BG0043
BG0057
BG00642
BG00739
BG008105
1
BG0032
BG0040
BG0050
BG00628
BG00711
BG00843
Not Hispanic or Latino
BG0004
BG0016
BG0022
BG0035
BG0044
BG00510
BG00633
BG00733
BG00897
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
0
BG0030
BG0040
BG0050
BG0062
BG0072
BG0084
Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0069
BG0076
BG00816
Black or African American
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0052
BG0062
BG0072
BG0087
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
White
Title
Measurements
BG0005
BG0015
BG0022
BG0037
BG0043
BG0056
BG00638
BG00733
BG00899
Other (Indian, Brown, Brazilian indigenous, Hispanic Mestizo, Mestizo breed, Hispanic, and Mixed)
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
BG0051
BG0069
BG0071
BG00813
Multiple
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0081
Unknown
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
6
OG0043
OG0059
0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000927± 259
OG001637± 241
Induction cycle Day 8
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0043
ParticipantsOG0059
Title
Measurements
OG000771± 151
OG001792± 580
OG002445± 260
OG003
OG002
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG003
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 36 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG004
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 45 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG005
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 56 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Units
Counts
Participants
OG0005
OG0016
OG0023
OG0036
OG0043
OG0059
Title
Denominators
Categories
Dose Escalation 1 - Lead in Cycle Day 1
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000387± 125
OG001240± 113
Induction Cycle Day 8
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0036
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG003
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 36 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG004
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 45 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG005
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 56 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Units
Counts
Participants
OG0005
OG0015
OG0021
OG0035
OG0043
OG0055
Title
Denominators
Categories
Dose Escalation 1 - Lead in Cycle Day 1
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000387± 124
OG001268± 101
Induction Cycle Day 8
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0035
OG002
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG003
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 36 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG004
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 45 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG005
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 56 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Units
Counts
Participants
OG0005
OG0015
OG0023
OG0037
OG0044
OG00510
Title
Denominators
Categories
Title
Measurements
OG00040.0(5.3 to 85.3)
OG00120.0(0.5 to 71.6)
OG00233.3(0.8 to 90.6)
OG00328.6(3.7 to 71.0)
OG00425.0(0.6 to 80.6)
OG00520.0(2.5 to 55.6)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG003
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 36 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG004
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 45 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG005
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 56 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Units
Counts
Participants
OG0005
OG0015
OG0023
OG0037
OG0044
OG00510
Title
Denominators
Categories
Achieved MRD status < 10^3 lymphoblasts
Title
Measurements
OG0000(NA to NA)Dispersion was not estimable as 0 participants achieved MRD status
OG0010(NA to NA)Dispersion was not estimable as 0 participants achieved MRD status
OG0020(NA to NA)Dispersion was not estimable as 0 participants achieved MRD status
OG00314.3(0.4 to 57.9)
OG00425.0(0.6 to 80.6)
OG0050(NA to NA)Dispersion was not estimable as 0 participants achieved MRD status
Achieved MRD status < 10^4 lymphoblasts
Title
Measurements
OG0000(NA to NA)Dispersion was not estimable as 0 participants achieved MRD status
OG0010(NA to NA)Dispersion was not estimable as 0 participants achieved MRD status
OG0020(NA to NA)Dispersion was not estimable as 0 participants achieved MRD status
OG003
OG001
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Units
Counts
Participants
OG00061
OG00144
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00061
OG00144
SAEs
Title
Measurements
OG00044
OG00131
Fatal TEAEs
Title
Measurements
OG00015
OG0013
TRAEs
Title
Measurements
OG00050
OG00139
Serious TRAEs
Title
Measurements
OG00025
OG00124
Fatal TRAEs
Title
Measurements
OG0005
OG0011
OG001
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Units
Counts
Participants
OG00061
OG00144
Title
Denominators
Categories
Title
Measurements
OG00042.6(30.2 to 55.0)
OG00127.3(14.1 to 40.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Other
The objective of this endpoint was to compare the rate of CRi or better status against an external control arm selected from an observational study (Amgen 20180065). The rate of CRi or better status in the external control arm was 26.3% (95% CI: 15.1, 37.5) for B-Cell participants with treatment difference odds ratio of 2.082 (95% CI: 0.968, 4.477). For T-Cell participants the rate of CRi or better status was 18.6% (95% CI: 7.1, 30.0) with treatment difference odds ratio of 1.646 (95% CI: 0.639. 4.245).
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Units
Counts
Participants
OG00061
OG00144
Title
Denominators
Categories
Title
Measurements
OG0001.18(0.95 to 2.24)
OG0011.20(0.95 to 1.48)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Other
The objective of this endpoint was to compare EFS in study 20140106 with EFS in an external control arm selected from an observational study (Amgen 20180065). The median duration in months in the external control arm was 3.62 (95% CI: 1.55, 5.36) for B-cell participants, with a treatment difference hazard ration of 1.435 (95% CI: 0.976, 2.111). For T-Cell participants the median in months was 2.93 (95% CI: 0.95, 5.10) with a treatment difference hazard ratio of 1.404 (95% CI: 0.869, 2.270).
Units
Counts
Participants
OG00061
OG00144
Title
Denominators
Categories
Title
Measurements
OG0005.23(2.93 to 9.24)
OG0014.51(3.49 to 9.18)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Other
The objective of this endpoint was to compare the OS in study 20140106 with OS in an external control arm selected from an observational study (Amgen 20180065). The median OS in months for the B-Cell participants in the external control arm was 8.59 (95% CI: 5.26, 10.59) with a treatment difference hazard ratio of 1.245 (95% CI: 0.805, 1.927). For the T-Cell participants the median OS in months was 7.04 (95% CI: 7.04, NE) with a treatment difference hazard ratio of 1.040 (95% CI: 0.641, 1.688).
OG001
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Units
Counts
Participants
OG00026
OG00114
Title
Denominators
Categories
Title
Measurements
OG0007.55(3.42 to 22.20)
OG0019.01(2.57 to NA)Upper CI limit not evaluable due to insufficient observations occurring above the median.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Other
The DOR in study 20140106 was estimated relative to the DOR in an external control arm selected from an observational study (Amgen 20180065). The median DOR in months in the external control arm was 8.72 (95% CI: 5.07, 32.24) in B-Cell participants. For T-Cell participants the median DOR in months was 5.82 (95% CI: 1.22, 19.80).
Units
Counts
Participants
OG00061
OG00144
Title
Denominators
Categories
Percentage of Participants Achieving MRD <10-³ Cells
Title
Measurements
OG0008.2(2.7 to 18.1)
OG0014.5(0.6 to 15.5)
Percentage of Participants Achieving MRD <10-⁴ Cells
Title
Measurements
OG0003.3(0.4 to 11.3)
OG0014.5(0.6 to 15.5)
Units
Counts
Participants
OG00061
OG00144
Title
Denominators
Categories
Percentage of Participants Achieving MRD <10-³ Cells
Title
Measurements
OG00018.0(9.4 to 30.0)
OG0019.1(2.5 to 21.7)
Percentage of Participants Achieving MRD <10-⁴ Cells
Title
Measurements
OG0009.8(3.7 to 20.2)
OG0016.8(1.4 to 18.7)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Units
Counts
Participants
OG00025
OG00120
Title
Denominators
Categories
Percentage of Participants Achieving MRD <10-³ Cells
Title
Measurements
OG00016.0(4.5 to 36.1)
OG00120.0(5.7 to 43.7)
Percentage of Participants Achieving MRD <10-⁴ Cells
Title
Measurements
OG00016.0(4.5 to 36.1)
OG00120.0(5.7 to 43.7)
Units
Counts
Participants
OG00061
OG00144
Title
Denominators
Categories
Title
Measurements
OG00019.7(10.6 to 31.8)
OG00127.3(15.0 to 42.8)
OG001
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Units
Counts
Participants
OG00025
OG00120
Title
Denominators
Categories
Title
Measurements
OG00036.0(18.0 to 57.5)
OG00150.0(27.2 to 72.8)
OG00083
OG00134
Title
Denominators
Categories
Title
Measurements
OG0004330± 10300
OG0019410± 36200
OG000
46
OG00123
Title
Denominators
Categories
Title
Measurements
OG0004070± 11000
OG0011200± 2480
83
OG00134
Title
Denominators
Categories
Title
Measurements
OG0009590± 27800
OG00113800± 44200
OG00046
OG00123
Title
Denominators
Categories
Title
Measurements
OG0000.371± 0.162
OG0010.332± 0.0894
OG001
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
OG002
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG003
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 36 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG004
Phase 1b: Dose Escalation 2 (20/45 mg/m^2
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 45 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG005
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 56 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Units
Counts
Participants
OG0005
OG0016
OG0023
OG0037
OG0044
OG00510
Title
Denominators
Categories
All TEAEs
Title
Measurements
OG0005
OG0016
OG0023
OG0037
OG0044
OG0059
All fatal TEAEs
Title
Measurements
OG0000
OG0012
OG0020
OG003
All TRAEs
Title
Measurements
OG0005
OG0014
OG0023
OG003
All fatal TRAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
All SAEs
Title
Measurements
OG0004
OG0014
OG0023
OG003
OG002
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 27 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG003
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 36 mg/m^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG004
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 45 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
OG005
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m^2 for the first dose, followed by the target 56 mg/m^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Units
Counts
Participants
OG0004
OG0014
OG0022
OG0034
OG0043
OG0058
Title
Denominators
Categories
Haemolytic uraemic syndrome
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
Platelet count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pulmonary haemorrhage
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Units
Counts
Participants
OG00061
OG00144
Title
Denominators
Categories
Title
Measurements
OG00014.8(5.9 to 23.7)
OG00113.6(3.5 to 23.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Other
The primary objective of this endpoint was to compare the percentage of participants achieving CR after the end of induction therapy in study 20140106 with the percentage of participants achieving CR in an external control arm selected from an observational study (Amgen 20180065). In the external control arm, 7.8% of B-Cell participants (95% confidence interval [CI]: 1.0%, 14.7%) achieved CR, with a treatment difference odds ratio of 2.04 (95% CI: 0.54, 7.66). For T-Cell participants, 9.1% (95% CI: 0.7%, 17.5%) achieved CR, with an odds ratio of 1.58 (95% CI: 0.47, 5.31).
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EG0050 affected10 at risk
EG0065 affected61 at risk
EG0073 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0064 affected61 at risk
EG0070 affected44 at risk
6 affected
7 at risk
EG0042 affected4 at risk
EG0057 affected10 at risk
EG00625 affected61 at risk
EG00713 affected44 at risk
0 affected
7 at risk
EG0043 affected4 at risk
EG0052 affected10 at risk
EG0063 affected61 at risk
EG0074 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0062 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0072 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0062 affected61 at risk
EG0072 affected44 at risk
2 affected
7 at risk
EG0042 affected4 at risk
EG0051 affected10 at risk
EG0062 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
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7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
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7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
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7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
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7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
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7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
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7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0063 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0063 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0062 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0042 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
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7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0072 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0062 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0042 affected4 at risk
EG0053 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
2 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
1 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0062 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0062 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
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7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
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7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
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7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0072 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0063 affected61 at risk
EG0071 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
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7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0063 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
2 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0072 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0072 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0062 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0062 affected61 at risk
EG0072 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0072 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0041 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0072 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0063 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0063 affected61 at risk
EG0072 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0062 affected61 at risk
EG0071 affected44 at risk
1 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0062 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0072 affected44 at risk
1 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0041 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0062 affected61 at risk
EG0071 affected44 at risk
1 affected
7 at risk
EG0042 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0072 affected44 at risk
1 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0072 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0072 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0052 affected10 at risk
EG0061 affected61 at risk
EG0072 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0072 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0041 affected4 at risk
EG0053 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
1 affected
7 at risk
EG0041 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
2 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0061 affected61 at risk
EG0070 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0061 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1 affected
7 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected61 at risk
EG0071 affected44 at risk
0 affected
7 at risk
EG0040 affected4 at risk
EG0051 affected10 at risk
EG0060 affected61 at risk
EG0070 affected44 at risk
1070
± 359
OG0041630± 875
OG00511200± 16400
ParticipantsOG0043
ParticipantsOG0059
Title
Measurements
OG000361± 160
OG001374± 273
OG002214± 155
OG003529± 210
OG004829± 479
OG0054000± 6370
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000368± 184
OG001374± 273
OG002406± 0.0
OG003565± 243
OG004848± 510
OG0051300± 1440
14.3
(0.4 to 57.9)
OG00425.0(0.6 to 80.6)
OG0050(NA to NA)Dispersion was not estimable as 0 participants achieved MRD status