First-in-human Study of SAR443579 Infusion in Male and Fe... | NCT05086315 | Trialant
NCT05086315
Sponsor
Sanofi
Status
Terminated
Last Update Posted
Jul 6, 2026Actual
Enrollment
101Actual
Phase
Phase 1Phase 2
Conditions
Acute Lymphocytic Leukaemia
Acute Myeloid Leukaemia Refractory
Myelodysplastic Syndromes
Blastic Plasmacytoid Dendritic Cell Neoplasia
Interventions
SAR443579
Countries
United States
Australia
China
France
Netherlands
Protocol Section
Identification Module
NCT ID
NCT05086315
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TCD17197
Secondary IDs
ID
Type
Description
Link
U1111-1266-7399
Registry Identifier
ICTRP
2023-508357-58
Registry Identifier
CTIS
2021-004287-98
EudraCT Number
Brief Title
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Official Title
An Open-label, First-in-human, Dose-escalation/Expansion Study of SAR443579 Administered as Single Agent by Intravenous Infusion in Adult and Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Jun 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
Expanded Access Info
No
Start Date
Dec 8, 2021Actual
Primary Completion Date
Jun 13, 2025Actual
Completion Date
Jun 13, 2025Actual
First Submitted Date
Oct 19, 2021
First Submission Date that Met QC Criteria
Oct 19, 2021
First Posted Date
Oct 20, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jun 8, 2026
Results First Submitted that Met QC Criteria
Jun 8, 2026
Results First Posted Date
Jul 6, 2026Actual
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
Jun 8, 2026
Last Update Posted Date
Jul 6, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.
Detailed Description
Study duration per participant is 2.5 years.
Conditions Module
Conditions
Acute Lymphocytic Leukaemia
Acute Myeloid Leukaemia Refractory
Myelodysplastic Syndromes
Blastic Plasmacytoid Dendritic Cell Neoplasia
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
101Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
SAR443579
Experimental
Dose Escalation: SAR443579 administered intravenously at escalating dose levels.
Dose Expansion: SAR443579 administered intravenously at the recommended dose and schedule determined from the dose escalation.
Drug: SAR443579
Interventions
Name
Type
Description
Arm Group Labels
Other Names
SAR443579
Drug
Powder for solution for infusion; by IV infusion
SAR443579
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
The DLT was defined as any of the following events during Cycle 1 (first 28 days) using NCI CTCAE v5.0 or ASTCT criteria, whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to disease progression. Hematologic DLTs included hematologic toxicities, bone marrow hypocellularity, decreased neutrophils lasting, febrile neutropenia, decreased platelet count lasting, anemia (all Grade 4), and Grade 3 thrombocytopenia. Non-hematologic DLTs included any Grade >=3 toxicities except alopecia, Grade 3 fatigue, asthenia, fever, anorexia, constipation, nausea, vomiting, diarrhea, total parenteral nutrition, hospitalization related events, infection, bleeding, Grade 3 infusion related reaction and laboratory abnormalities, Grade 3 or 4 tumor lysis syndrome and isolated electrolyte abnormalities. Also, DLTs were any treatment related toxicity causing >2 week delay in recovery to baseline/Grade <=1 or requiring dose reduction.
Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
Dose Escalation (Cohort C): Number of Participants With Dose Limiting Toxicities
The DLT was defined as any of the following events during Cycle 1 (first 28 days) using NCI CTCAE v5.0 or ASTCT criteria, whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to disease progression. Hematologic DLTs included hematologic toxicities, bone marrow hypocellularity, decreased neutrophils lasting, febrile neutropenia, decreased platelet count lasting, anemia (all Grade 4), and Grade 3 thrombocytopenia. Non-hematologic DLTs included any Grade >=3 toxicities except alopecia, Grade 3 fatigue, asthenia, fever, anorexia, constipation, nausea, vomiting, diarrhea, total parenteral nutrition, hospitalization related events, infection, bleeding, Grade 3 infusion related reaction and laboratory abnormalities, Grade 3 or 4 tumor lysis syndrome and isolated electrolyte abnormalities. Also, DLTs were any treatment related toxicity causing >2 week delay in recovery to baseline/Grade <=1 or requiring dose reduction.
Cycle 1 Day 1 to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
Dose Expansion (Cohorts A1, A2, B and D): Recommended Dose for Expansion (RDE)
The RDE of SAR443579 was determined based on the occurrence of DLTs in Cycle 1.
Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
Dose Escalation and Dose Expansion (Cohort A1): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be at least 1 year (for France: 2 years) old at the time the trial participant or legal guardian signs the informed consent form and will be assigned as follows:
Adult arm: aged at least 18 years old.
Pediatric arm: aged 1 (for France: 2 years) to less than 18 years old.
Adult and Pediatric Arms: Escalation and Expansion/Optimization Cohorts A1, A2, C, D: Confirmed diagnosis of primary or secondary AML (any subtype) according to World Health Organization (WHO) 2022 classification. Participants with AML must meet one of the following criteria, a), b), c) or d) and are limited to those with no available (or are ineligible) therapy with known clinical benefit.
a) Primary Induction Failure (PIF) AML, defined as disease refractory to one of the following, i or ii.
i) An intensive induction attempt, per institution. Induction attempts include high-dose and/or standard-dose cytarabine ± an anthracyclines/anthracenedione ± an anti-metabolite, with or without growth factor or targeted therapy containing regimens.
ii) For adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimens, 1 or 2:
4 cycles of hypomethylating agents (HMA) or
2 cycles HMA + venetoclax b) Early relapse (ER) AML, defined as AML in relapse with CR, CRh or CRi duration less than 6 months on prior induction treatment c) Leukemia in first or higher relapse d) For participants aged 1 (for France: 2 years) to less than 18 years old, primary induction failure is defined as disease refractory after two cycles of induction therapy.
Adult Arm (Escalation and Expansion/Optimization Cohorts B and Japan Cohort C only): Confirmed diagnosis of MDS, meeting the following criteria:
intermediate or high-risk category as per a Revised International Prognostic Scoring System (IPSS-R) AND
confirmed CD123 + expression status determined by local institutional standards AND
limited to those with no available (or are ineligible) therapy with known clinical benefit.
Pediatric arms escalation part and Japan Cohort C only: Confirmed diagnosis of CD123+ BALL without extramedullary lesions that have no available (or are ineligible) therapy with known clinical benefit. Participants with non-CNS chloromatous disease are not allowed in the study.
Body weight at least 10 kg.
Pediatric arm and escalation part only: Confirmed diagnosis of BPDCN according to World Health Organization (WHO) 2022 classification, who have relapsed or refractory disease with no available (or are ineligible) therapy with known clinical benefit.
Japan participants (Cohort C): Participant must be at least 18 years old at the time the trial participant signs the informed consent form
Exclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status greater than 2 (at least 18 years-old). Karnofsky Scale (16 to 17 years-old) less than 50% or Lansky Scale (less than 16 years-old) less than 50%.
Ongoing or recent (within 5 years) evidence of significant autoimmune disease that requires or required treatment with systemic immunosuppressive treatments, which may suggest a risk for immune-related adverse events. The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
History of an invasive malignancy within the last 3 years prior to first IMP administration that requires active therapy (adjuvant hormonal therapy is allowed) other than the one treated in this study.
Evidence of active central nervous system leukemia at the time of enrollment as evidenced by cytology or pathology. Except for participants aged 1 (for France: 2 years) to less than 18 years, central nervous system 1 disease (CNS1) and CNS2 disease are allowed.
Known acquired immunodeficiency syndrome (AIDS-related illnesses) or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or having active hepatitis B or C infection, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Prior treatment with an anti-CD123-directed agent (except for participants with BPDCN in the pediatric arm).
Prior HSCT with relapse beyond 3 months or prior CAR-T therapy in B-ALL with relapse beyond 2 months may be included only if off immunosuppression for a minimum of 4 weeks and no evidence of GVHD.
Receiving at the time of first investigational medicinal product (IMP) administration corticosteroid as a concomitant medication with corticosteroid dose more than 10 mg/day of oral prednisone or the equivalent.
AML, BPDCN, or HR-MDS participants with prior treatment with cellular therapy, eg, chimeric antigen receptor T cell (CAR-T) or chimeric antigen receptor NK cell (CAR-NK). Prior CAR-T therapy is allowed for participants with B-ALL.
Concurrent treatment with other investigational drugs.
Pregnant and breast-feeding women.
History of solid organ transplant, including corneal transplant.
Average QTc (using the Fridericia correction calculation) greater than 470 millisecond (msec) at screening.
Pediatric arm only: Participants with known inherited bone marrow failure syndromes (e.g., bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome). Participants with Down syndrome with adequate organ function as per Investigator discretion are allowed to participate in the study.
Adult arm Expansion/Optimization- Participants with MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), unclassifiable MDS/MPN and therapy-related MDS (t-MDS).
Confirmed diagnosis of acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML) according to WHO 2022 classification.
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
1 Year
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Sciences & Operations
Sanofi
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
City of Hope-Site Number:8400002
Duarte
California
91010
United States
Emory University School of Medicine- Grady Campus- Site Number : 8400006
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Study included adult (>=18 years) and pediatric (1 to <18 years; >=2 years in France) arms with dose escalation and dose expansion/optimization phases. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohorts A2, B and C) and pediatric arms (Cohort D) were not initiated. Only results from completed parts are reported.
Recruitment Details
The study was conducted at 21 centers across 5 countries between 08 December 2021 and 13 June 2025. A total of 101 eligible participants were enrolled, including 69 in the Dose Escalation - Adult arm, 12 in the Dose Escalation - Pediatric arm, and 20 in the Dose Expansion - Adult arm. All enrolled participants received the study treatment.
Adult participants with either relapsed or refractory acute myeloid leukemia (R/R AML) or high-risk myelodysplastic syndrome (HR-MDS) received SAR443579 intravenous (IV) infusion of 10 microgram per kilogram (mcg/kg) on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
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
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
Jul 23, 2024
Jun 8, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
The CRc rate was defined as the percentage of participants who had a response of complete remission (CR), CR with partial hematologic recovery (CRh) or CR with incomplete hematologic recovery (CRi) according to modified AML International Working Group (IWG) 2003 response criteria.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
The ORR was defined as the percentage of participants who had a response of CR, CR equivalent, partial remission (PR), CR with limited count recovery (CRL), CRh or hematologic improvement (HI) according to IWG 2023 myelodysplastic syndrome (MDS) response criteria.
Tumors were planned to assess on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any AE that: resulted in death; or was life-threatening; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity; or was a congenital anomaly/birth defect; or was an important medical event. The TEAEs were defined as events that were newly reported or reported to worsen in severity after the first administration of study treatment up to 30 days after the last administration of study treatment.
From the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation (adult), 12 weeks for dose escalation (pediatric) and 20.9 for dose expansion (Cohort A1).
Dose Escalation and Dose Expansion (Cohort A1): Minimum Plasma Concentration (Ctrough) of SAR443579
Blood samples are collected just before treatment administration during repeated dosing to determine the Ctrough of SAR443579.
At Days 1, 4, 8, 11, 15, 22, and 28 of Cycle 1
Dose Escalation and Dose Expansion (Cohort A1): Percentage of Participants With Anti-drug Antibodies (ADA) Against SAR443579
Plasma samples were collected to assess the antibodies to SAR443579. Treatment-emergent ADA was defined as a participant with at least 1 treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period. Non-treatment emergent ADA was defined as participant without any treatment-induced, treatment-boosted ADA-positive or ADA-inconclusive sample during the treatment or follow-up observation period.
From the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation (adult), 12 weeks for dose escalation (pediatric) and 20.9 for dose expansion (Cohort A1).
Dose Escalation and Dose Expansion (Cohort C): Composite Complete Remission Rate Assessed by Acute Myeloid Leukemia 2003 Modified International Working Group Response Criteria and National Comprehensive Cancer Network (NCCN)
The CRc rate was defined as the percentage of participants who had a response of CR, CRh or CRi according to modified AML IWG 2003 response criteria. For Dose Expansion (Cohort C), the CRc rate was planned to be assessed according to NCCN.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Dose Escalation and Dose Expansion (Cohort C): Alternative Complete Remission Rate
Alternative CR rate was defined as percentage of participants with CR and CRh according to modified AML IWG 2003 response criteria.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Dose Escalation and Dose Expansion (Cohort C): Overall Response Rate
Overall response rate was defined as percentage of participants who had a CR or CRi or CRh or PR or morphological leukemia-free state (MLFS) according to modified AML IWG 2003 response criteria.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Dose Expansion (Cohorts A1, A2 and D): Overall Response Rate
Overall response rate was defined as percentage of participants who had a CR or CRi or CRh or PR or MLFS according to modified AML IWG 2003 response criteria.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2 and D): Duration of Composite Complete Remission Rate
Duration of CRc was defined as the time interval from first documented evidence of CRc (CR, CRh or CRi) until disease relapse (DR) or death due to any cause, whichever comes first.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Duration of Overall Response Rate
Duration of overall response rate was defined as the time from the first documented evidence of CR or CRi or CRh or PR or MLFS until DR or death due to any cause, whichever comes first.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Alternative Complete Remission Rate
Alternative CR rate was defined as percentage of participants with CR and CRh according to modified AML IWG 2003 response criteria.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Duration of Alternative Complete Remission Rate
Duration of alternative CR was defined as the time from the first documented evidence of CR or CRh until DR or death due to any cause, whichever comes first.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Event-Free Survival (EFS)
The EFS was defined as the time interval from the first day of treatment assignment to the date of earliest evidence of relapse, treatment failure, or death.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Overall Survival (OS)
The OS was defined as time interval from the first day of treatment assignment to death from any cause.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Rate of Hematopoietic Stem Cell Transplantation (HSCT)
The HSCT rate was defined as the percentage of participants who had received HSCT immediately following study treatment administration but prior to subsequent therapy for treatment of AML.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Time to Treatment Failure (TTF)
The TTF was defined as the time from first day of treatment assignment to discontinuation for any reason excluding remission, example, relapsed disease, refractory disease, unacceptable AE, participant preference or death.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
The TI rate was defined differently for participants who were transfusion dependency (TD) at baseline and participants who were transfusion independency (TI) at baseline. For subgroup of participants with TD at baseline, the TI rate was defined as the percentage of participants who convert from baseline TD to TI during on treatment period; For subgroup of participants with TI at baseline, the TI rate was defined as the percentage of participants who remain TI during 56-day post baseline period during treatment.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
The PFS was defined as the time interval from the first day of treatment assignment to the date of disease progression, relapse from CR (or CR equivalent), PR, CRL, CRh, or HI, death due to any cause, whichever comes first.
Tumors were planned to assess on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first.
Atlanta
Georgia
30303
United States
Beth Israel Deaconess Medical Center-Site Number:8400004
Boston
Massachusetts
02215
United States
Weill Cornell Medical College-Site Number:8400003
New York
New York
10021
United States
Montefiore Hutchinson Campus- Site Number : 8400012
The Bronx
New York
10461
United States
The Ohio State University- Site Number : 8400009
Columbus
Ohio
43210
United States
Oregon Health and Science University-Site Number:8400011
Portland
Oregon
97239
United States
The Children's Hospital of Philadelphia- Site Number : 8400013
Philadelphia
Pennsylvania
19104
United States
MD Anderson Cancer Center-Site Number:8400001
Houston
Texas
77030
United States
Seattle Children's Hospital- Site Number : 8400014
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
FG002
Dose Escalation - Adult Arm: SAR443579 750 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
FG003
Dose Escalation - Adult Arm: SAR443579 800 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-cell acute lymphoblastic leukemia (B-ALL) or blastic plasmacytoid dendritic cell neoplasm (BPDCN) received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
FG014
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
FG0003 subjects
FG0014 subjects
FG0026 subjects
FG00310 subjects
FG0044 subjects
FG0054 subjects
FG0068 subjects
FG0076 subjects
FG0084 subjects
FG0094 subjects
FG0108 subjects
FG0118 subjects
FG0126 subjects
FG0136 subjects
FG01420 subjects
COMPLETED
Reason for not completed = Reason for permanent treatment discontinuation.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0026 subjects
FG00310 subjects
FG0044 subjects
FG0053 subjects
FG0068 subjects
FG0076 subjects
FG0084 subjects
FG0094 subjects
FG0108 subjects
FG0118 subjects
FG0126 subjects
FG0136 subjects
FG01420 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0034 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0143 subjects
Progressive disease
FG0003 subjects
FG0013 subjects
FG0022 subjects
FG0034 subjects
FG004
Poor compliance to protocol
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
BG002
Dose Escalation - Adult Arm: SAR443579 750 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
BG003
Dose Escalation - Adult Arm: SAR443579 800 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
BG014
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0014
BG0026
BG00310
BG0044
BG0054
BG0068
BG0076
BG0084
BG0094
BG0108
BG0118
BG0126
BG0136
BG01420
BG015101
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00056.3± 16.6
BG00165.3± 19.6
BG00258.3± 13.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
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
Dose Expansion (Cohorts A1, A2, B and D): Recommended Dose for Expansion (RDE)
The RDE of SAR443579 was determined based on the occurrence of DLTs in Cycle 1.
All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.
Posted
Number
mcg/kg
Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Adult Arm (Cohort B): SAR443579
Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG00020
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG0001000
Secondary
Dose Escalation and Dose Expansion (Cohort A1): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any AE that: resulted in death; or was life-threatening; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity; or was a congenital anomaly/birth defect; or was an important medical event. The TEAEs were defined as events that were newly reported or reported to worsen in severity after the first administration of study treatment up to 30 days after the last administration of study treatment.
All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment.
Posted
Count of Participants
Participants
From the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation (adult), 12 weeks for dose escalation (pediatric) and 20.9 for dose expansion (Cohort A1).
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Secondary
Dose Escalation and Dose Expansion (Cohort A1): Minimum Plasma Concentration (Ctrough) of SAR443579
Blood samples are collected just before treatment administration during repeated dosing to determine the Ctrough of SAR443579.
The Pharmacokinetic (PK) population included all participants from all treated population with at least 1 post-baseline PK sample result with adequate documentation of dosing and sampling dates and times. During the study, participants miss few scheduled site visits for sample collection and only participants with data collected at specific timepoints are reported. The PK results for participants who received the same dose in Dose Escalation and Dose Expansion phases are presented together.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Escalation and Dose Expansion (Cohort A1): Percentage of Participants With Anti-drug Antibodies (ADA) Against SAR443579
Plasma samples were collected to assess the antibodies to SAR443579. Treatment-emergent ADA was defined as a participant with at least 1 treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period. Non-treatment emergent ADA was defined as participant without any treatment-induced, treatment-boosted ADA-positive or ADA-inconclusive sample during the treatment or follow-up observation period.
The immunogenicity population included all participants from all treated population with at least 1 ADA result (positive, negative or inconclusive) post-baseline.
Posted
Number
percentage of participants
From the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation (adult), 12 weeks for dose escalation (pediatric) and 20.9 for dose expansion (Cohort A1).
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Secondary
Dose Escalation and Dose Expansion (Cohort C): Composite Complete Remission Rate Assessed by Acute Myeloid Leukemia 2003 Modified International Working Group Response Criteria and National Comprehensive Cancer Network (NCCN)
The CRc rate was defined as the percentage of participants who had a response of CR, CRh or CRi according to modified AML IWG 2003 response criteria. For Dose Expansion (Cohort C), the CRc rate was planned to be assessed according to NCCN.
All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort C) was not initiated. Therefore, no analyses were conducted.
Posted
Number
90% Confidence Interval
percentage of participants
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Secondary
Dose Escalation and Dose Expansion (Cohort C): Alternative Complete Remission Rate
Alternative CR rate was defined as percentage of participants with CR and CRh according to modified AML IWG 2003 response criteria.
All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort C) was not initiated. Therefore, no analyses were conducted.
Posted
Number
90% Confidence Interval
percentage of participants
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Secondary
Dose Escalation and Dose Expansion (Cohort C): Overall Response Rate
Overall response rate was defined as percentage of participants who had a CR or CRi or CRh or PR or morphological leukemia-free state (MLFS) according to modified AML IWG 2003 response criteria.
All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort C) was not initiated. Therefore, no analyses were conducted.
Posted
Number
90% Confidence Interval
percentage of participants
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Secondary
Dose Expansion (Cohorts A1, A2 and D): Overall Response Rate
Overall response rate was defined as percentage of participants who had a CR or CRi or CRh or PR or MLFS according to modified AML IWG 2003 response criteria.
All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2 and D) was not initiated. Therefore, no analyses were conducted.
Posted
Number
90% Confidence Interval
percentage of participants
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Secondary
Dose Expansion (Cohorts A1, A2 and D): Duration of Composite Complete Remission Rate
Duration of CRc was defined as the time interval from first documented evidence of CRc (CR, CRh or CRi) until disease relapse (DR) or death due to any cause, whichever comes first.
All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Only participants with CRc are analyzed. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2 and D) was not initiated. Therefore, no analyses were conducted.
Posted
Median
Full Range
days
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Secondary
Dose Expansion (Cohorts A1, A2, B and D): Duration of Overall Response Rate
Duration of overall response rate was defined as the time from the first documented evidence of CR or CRi or CRh or PR or MLFS until DR or death due to any cause, whichever comes first.
All treated population included all participants who had given their informed consent and received at least any dose of study treatment.Only participants with response are analyzed.Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1) for non-safety related reasons.Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated.Therefore, no analysis was conducted.
Posted
Median
Full Range
days
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Secondary
Dose Expansion (Cohorts A1, A2, B and D): Alternative Complete Remission Rate
Alternative CR rate was defined as percentage of participants with CR and CRh according to modified AML IWG 2003 response criteria.
All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.
Posted
Number
90% Confidence Interval
percentage of participants
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Secondary
Dose Expansion (Cohorts A1, A2, B and D): Duration of Alternative Complete Remission Rate
Duration of alternative CR was defined as the time from the first documented evidence of CR or CRh until DR or death due to any cause, whichever comes first.
All treated population included all participants who had given their informed consent and received at least any dose of study treatment.Only participants with alternative CR are analyzed.Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1) for non-safety related reasons.Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated.Therefore, no analyses was conducted.
Posted
Median
Full Range
days
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Secondary
Dose Expansion (Cohorts A1, A2, B and D): Event-Free Survival (EFS)
The EFS was defined as the time interval from the first day of treatment assignment to the date of earliest evidence of relapse, treatment failure, or death.
All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.
Posted
Median
Full Range
days
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Secondary
Dose Expansion (Cohorts A1, A2, B and D): Overall Survival (OS)
The OS was defined as time interval from the first day of treatment assignment to death from any cause.
All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.
Posted
Median
90% Confidence Interval
months
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Secondary
Dose Expansion (Cohorts A1, A2, B and D): Rate of Hematopoietic Stem Cell Transplantation (HSCT)
The HSCT rate was defined as the percentage of participants who had received HSCT immediately following study treatment administration but prior to subsequent therapy for treatment of AML.
All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.
Posted
Number
percentage of participants
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Secondary
Dose Expansion (Cohorts A1, A2, B and D): Time to Treatment Failure (TTF)
The TTF was defined as the time from first day of treatment assignment to discontinuation for any reason excluding remission, example, relapsed disease, refractory disease, unacceptable AE, participant preference or death.
All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.
Posted
Median
Full Range
days
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
The TI rate was defined differently for participants who were transfusion dependency (TD) at baseline and participants who were transfusion independency (TI) at baseline. For subgroup of participants with TD at baseline, the TI rate was defined as the percentage of participants who convert from baseline TD to TI during on treatment period; For subgroup of participants with TI at baseline, the TI rate was defined as the percentage of participants who remain TI during 56-day post baseline period during treatment.
All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2 and D) was not initiated. Therefore, no analyses were conducted.
Posted
Number
90% Confidence Interval
percentage of participants
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
The PFS was defined as the time interval from the first day of treatment assignment to the date of disease progression, relapse from CR (or CR equivalent), PR, CRL, CRh, or HI, death due to any cause, whichever comes first.
Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort B) was not initiated. Therefore, no analyses were conducted.
Posted
Tumors were planned to assess on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort B): SAR443579
Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
Primary
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
The DLT was defined as any of the following events during Cycle 1 (first 28 days) using NCI CTCAE v5.0 or ASTCT criteria, whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to disease progression. Hematologic DLTs included hematologic toxicities, bone marrow hypocellularity, decreased neutrophils lasting, febrile neutropenia, decreased platelet count lasting, anemia (all Grade 4), and Grade 3 thrombocytopenia. Non-hematologic DLTs included any Grade >=3 toxicities except alopecia, Grade 3 fatigue, asthenia, fever, anorexia, constipation, nausea, vomiting, diarrhea, total parenteral nutrition, hospitalization related events, infection, bleeding, Grade 3 infusion related reaction and laboratory abnormalities, Grade 3 or 4 tumor lysis syndrome and isolated electrolyte abnormalities. Also, DLTs were any treatment related toxicity causing >2 week delay in recovery to baseline/Grade <=1 or requiring dose reduction.
All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment.
Posted
Count of Participants
Participants
Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Primary
Dose Escalation (Cohort C): Number of Participants With Dose Limiting Toxicities
The DLT was defined as any of the following events during Cycle 1 (first 28 days) using NCI CTCAE v5.0 or ASTCT criteria, whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to disease progression. Hematologic DLTs included hematologic toxicities, bone marrow hypocellularity, decreased neutrophils lasting, febrile neutropenia, decreased platelet count lasting, anemia (all Grade 4), and Grade 3 thrombocytopenia. Non-hematologic DLTs included any Grade >=3 toxicities except alopecia, Grade 3 fatigue, asthenia, fever, anorexia, constipation, nausea, vomiting, diarrhea, total parenteral nutrition, hospitalization related events, infection, bleeding, Grade 3 infusion related reaction and laboratory abnormalities, Grade 3 or 4 tumor lysis syndrome and isolated electrolyte abnormalities. Also, DLTs were any treatment related toxicity causing >2 week delay in recovery to baseline/Grade <=1 or requiring dose reduction.
Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort C) was not initiated. Therefore, no analyses were conducted.
Posted
Cycle 1 Day 1 to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort C): SAR443579
Adult participants with R/R AML, B-ALL, HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
The CRc rate was defined as the percentage of participants who had a response of complete remission (CR), CR with partial hematologic recovery (CRh) or CR with incomplete hematologic recovery (CRi) according to modified AML International Working Group (IWG) 2003 response criteria.
All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2 and D) was not initiated. Therefore, no analyses were conducted.
Posted
Number
90% Confidence Interval
percentage of participants
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
The ORR was defined as the percentage of participants who had a response of CR, CR equivalent, partial remission (PR), CR with limited count recovery (CRL), CRh or hematologic improvement (HI) according to IWG 2023 myelodysplastic syndrome (MDS) response criteria.
Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort B) was not initiated. Therefore, no analyses were conducted.
Posted
Tumors were planned to assess on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first.
ID
Title
Description
OG000
Dose Expansion - Adult Arm (Cohort B): SAR443579
Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
Time Frame
SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks.
Description
Analysis was performed on the all treated population.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
3
4
3
4
4
4
EG002
Dose Escalation - Adult Arm: SAR443579 750 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
5
6
4
6
6
6
EG003
Dose Escalation - Adult Arm: SAR443579 800 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
6
6
5
6
6
6
EG014
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
16
20
14
20
19
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bacterial Sepsis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0141 events1 affected20 at risk
Covid-19
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis Orbital
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Diverticulitis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Enterococcal Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal Viral Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Kidney Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Localised Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Metapneumovirus Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Otitis Media
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Perineal Cellulitis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Perirectal Abscess
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Pneumocystis Jirovecii Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Pulmonary Sepsis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Septic Shock
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Submandibular Abscess
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Thrombophlebitis Septic
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urosepsis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Viral Sepsis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acute Myeloid Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Metastases To Meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Febrile Neutropenia
Blood and lymphatic system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cytokine Release Syndrome
Immune system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cerebellar Haemorrhage
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Haemorrhage Intracranial
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ischaemic Stroke
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vith Nerve Disorder
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gastric Haemorrhage
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Mouth Haemorrhage
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic Failure
Hepatobiliary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Disease Progression
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
General Physical Health Deterioration
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Multiple Organ Dysfunction Syndrome
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oedema Peripheral
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Platelet Count Decreased
Investigations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Allergic Transfusion Reaction
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Euthanasia
Surgical and medical procedures
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bacteraemia
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
Covid-19
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Catheter Site Cellulitis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ear Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Erysipelas
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hcov-Hku1 Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hcov-Oc43 Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oral Herpes
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Parainfluenzae Virus Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Paronychia
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Pneumonia Fungal
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Salmonellosis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis Aspergillus
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Staphylococcal Sepsis
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Streptococcal Bacteraemia
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tooth Abscess
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tooth Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0023 events2 affected6 at risk
EG003
Vascular Device Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Viral Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Metastases To Meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Febrile Neutropenia
Blood and lymphatic system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cytokine Release Syndrome
Immune system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected6 at risk
EG003
Confusional State
Psychiatric disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Irritability
Psychiatric disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Aphasia
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Facial Paresis
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Restless Legs Syndrome
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blepharitis
Eye disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctival Haemorrhage
Eye disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eye Swelling
Eye disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bradycardia
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Mitral Valve Incompetence
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sinus Bradycardia
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ventricular Extrasystoles
Cardiac disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Aortitis
Vascular disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Flushing
Vascular disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haematoma
Vascular disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Orthostatic Hypotension
Vascular disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral Vein Thrombosis
Vascular disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lung Infiltration
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nasal Dryness
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nasal Inflammation
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Paranasal Sinus Discomfort
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pleuritic Pain
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary Fibrosis
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary Mass
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rhinalgia
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anal Fissure
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anal Haemorrhage
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Anal Incontinence
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Aphthous Ulcer
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gingival Bleeding
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gingival Hypertrophy
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gingival Oedema
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Gingival Pain
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lip Dry
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Lip Swelling
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Mouth Haemorrhage
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Oral Purpura
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Post-Tussive Vomiting
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Tongue Haemorrhage
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic Cytolysis
Hepatobiliary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Ingrowing Nail
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash Morbilliform
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin Haemorrhage
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected6 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Bone Cyst
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Crystal Arthropathy
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Greater Trochanteric Pain Syndrome
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Micturition Urgency
Renal and urinary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Factor Xiii Deficiency
Congenital, familial and genetic disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Catheter Site Irritation
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Catheter Site Oedema
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Catheter Site Pain
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Chest Discomfort
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Chills
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Face Oedema
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Generalised Oedema
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hypothermia
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Influenza Like Illness
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Infusion Site Extravasation
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Localised Oedema
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Malaise
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Oedema Peripheral
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pain
General disorders
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Peripheral Swelling
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Swelling Face
General disorders
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac Murmur
Investigations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Compression Fracture
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events3 affected4 at risk
EG0023 events2 affected6 at risk
EG003
Post Procedural Haematoma
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Procedural Site Reaction
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Subcutaneous Haematoma
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Subdural Haemorrhage
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
Transfusion Reaction
Injury, poisoning and procedural complications
MedDra 28.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected6 at risk
EG003
The study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohorts A2, B and C) and pediatric arms (Cohort D) were not initiated.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Escalation - Adult Arm: SAR443579 750 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Escalation - Adult Arm: SAR443579 800 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG014
Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg
Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG0003
OG0014
OG0026
OG00310
OG0044
OG0054
OG0068
OG0076
OG0084
OG0094
OG0108
OG0118
OG0126
OG0136
OG01420
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG0003
OG0014
OG0026
OG00310
OG0044
OG0054
OG0068
OG0076
OG0084
OG0094
OG0107
OG0118
OG0126
OG0136
OG01419
Any treatment emergent SAE
Title
Measurements
OG0002
OG0013
OG0024
OG003
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Escalation - Adult Arm: SAR443579 750 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Escalation - Adult Arm: SAR443579 800 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Escalation - Adult Arm: SAR443579 750 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Escalation - Adult Arm: SAR443579 800 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Escalation - Adult Arm: SAR443579 750 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Escalation - Adult Arm: SAR443579 800 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG014
Dose Expansion - Adult Arm (Cohort C): SAR443579
Adult participants with R/R AML, B-ALL, HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Escalation - Adult Arm: SAR443579 750 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Escalation - Adult Arm: SAR443579 800 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG014
Dose Expansion - Adult Arm (Cohort C): SAR443579
Adult participants with R/R AML, B-ALL, HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Escalation - Adult Arm: SAR443579 750 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Escalation - Adult Arm: SAR443579 800 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG014
Dose Expansion - Adult Arm (Cohort C): SAR443579
Adult participants with R/R AML, B-ALL, HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG0003
OG0014
OG0026
OG00310
OG0044
OG0054
OG0067
OG0076
OG0084
OG0094
OG0108
OG0118
OG0125
OG0136
OG0140
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 63.2)
OG0010(0.0 to 52.7)
OG0020(0.0 to 39.3)
OG00310.0(0.5 to 39.4)
OG00450.0(9.8 to 90.2)
OG00525.0(1.3 to 75.1)
OG00628.6(5.3 to 65.9)
OG0070(0.0 to 39.3)
OG0080(0.0 to 52.7)
OG0090(0.0 to 52.7)
OG0100(0.0 to 31.2)
OG0110(0.0 to 31.2)
OG01220.0(1.0 to 65.7)
OG0130(0.0 to 39.3)
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG00020
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG0005.0(0.3 to 21.6)
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG0001
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG00029.0(29 to 29)
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Adult Arm (Cohort B): SAR443579
Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG0001
OG0010
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG00029.0(29 to 29)
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Adult Arm (Cohort B): SAR443579
Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG00020
OG0010
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0005.0(0.3 to 21.6)
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Adult Arm (Cohort B): SAR443579
Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG0001
OG0010
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG00029.0(29 to 29)
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Adult Arm (Cohort B): SAR443579
Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG00020
OG0010
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0001.0(1 to 56)
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Adult Arm (Cohort B): SAR443579
Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG00020
OG0010
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0002.46(1.478 to 5.520)
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Adult Arm (Cohort B): SAR443579
Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG00020
OG0010
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0005.0
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Adult Arm (Cohort B): SAR443579
Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG00020
OG0010
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG00050.5(15 to 145)
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG00020
OG0010
OG0020
Title
Denominators
Categories
Rate of conversion from TD to TI
Title
Measurements
OG0000(0.0 to 13.9)
Rate of participants who are TI at baseline and remain independent during treatment period
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Escalation - Adult Arm: SAR443579 750 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG003
Dose Escalation - Adult Arm: SAR443579 800 mcg/kg
Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG0003
OG0014
OG0026
OG00310
OG0044
OG0054
OG0068
OG0076
OG0084
OG0094
OG0108
OG0118
OG0126
OG0136
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0131
Units
Counts
Participants
OG0000
OG001
Dose Expansion - Adult Arm (Cohort A2): SAR443579
Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
OG002
Dose Expansion - Pediatric Arm (Cohort D): SAR443579
Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Units
Counts
Participants
OG00020
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG0005.0(0.3 to 21.6)
OG0000
1 events
1 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
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0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected6 at risk
EG0132 events2 affected6 at risk
EG0140 events0 affected20 at risk
5 events
3 affected
10 at risk
EG0041 events1 affected4 at risk
EG0053 events1 affected4 at risk
EG0060 events0 affected8 at risk
EG0072 events2 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0131 events1 affected6 at risk
EG0143 events3 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0132 events2 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0131 events1 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0131 events1 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected4 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0141 events1 affected20 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0062 events2 affected8 at risk
EG0073 events2 affected6 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0122 events2 affected6 at risk
EG0131 events1 affected6 at risk
EG0148 events6 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0053 events2 affected4 at risk
EG0060 events0 affected8 at risk
EG0072 events2 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected8 at risk
EG0122 events2 affected6 at risk
EG0136 events2 affected6 at risk
EG0143 events3 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0131 events1 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0123 events1 affected6 at risk
EG0131 events1 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0131 events1 affected6 at risk
EG0140 events0 affected20 at risk
6 events
6 affected
10 at risk
EG0041 events1 affected4 at risk
EG0058 events4 affected4 at risk
EG00612 events7 affected8 at risk
EG0073 events3 affected6 at risk
EG0087 events2 affected4 at risk
EG0093 events2 affected4 at risk
EG0107 events4 affected8 at risk
EG0118 events6 affected8 at risk
EG0122 events2 affected6 at risk
EG0138 events4 affected6 at risk
EG01415 events13 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0121 events1 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected20 at risk
2 events
1 affected
10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected6 at risk
EG0131 events1 affected6 at risk
EG0140 events0 affected20 at risk
7
OG0043
OG0053
OG0063
OG0075
OG0082
OG0093
OG0105
OG0112
OG0124
OG0135
OG01414
123.667
± 50.791
OG0040.100± 0.000
OG00575.000± 0.000
OG00690.536± 82.207
OG00775.000± 0.000
OG00875.000± 0.000
OG00975.000± 0.000
OG01075.000± 0.000
OG01175.000± 0.000
OG01275.000± 0.000
OG01375.000± 0.000
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
Title
Measurements
OG0000.471± 0.155
OG0011.271± 0.637
OG0046.190± 7.161
Participants
OG004
3
ParticipantsOG0053
ParticipantsOG00625
ParticipantsOG0076
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0108
ParticipantsOG0118
ParticipantsOG0126
ParticipantsOG0133
Title
Measurements
OG0000.885± 0.549
OG0014.453± 1.650
OG0021286.483± 2079.551
OG003600.875± 649.031
OG004218.817± 357.961
OG00575.000± 0.000
OG0062135.040± 3833.753
OG0074610.000± 5125.703
OG0087760.000± 4910.961
OG0091236.750± 1276.491
OG0108004.375± 5247.014
OG01128500.000± 7205.950
OG012576.167± 887.893
OG01375.000± 0.000
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
Title
Measurements
OG0004.560± 2.307
OG00142.600± 11.314
Participants
OG004
3
ParticipantsOG0053
ParticipantsOG00626
ParticipantsOG0076
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0117
ParticipantsOG0125
ParticipantsOG0133
Title
Measurements
OG0004.265± 4.148
OG00137.185± 34.864
OG0022972.350± 4515.051
OG003701.500± 931.399
OG0041936.233± 2742.950
OG00575.000± 0.000
OG0063030.154± 3161.210
OG0077864.333± 7975.105
OG00813454.250± 14473.476
OG00916595.000± 7374.738
OG01016626.667± 7714.056
OG01164371.429± 26631.480
OG0122645.600± 5235.389
OG0131343.333± 2196.818
Participants
OG004
0
ParticipantsOG0053
ParticipantsOG00624
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0094
ParticipantsOG0108
ParticipantsOG0116
ParticipantsOG0126
ParticipantsOG0134
Title
Measurements
OG0001.528± 1.391
OG0017.007± 5.511
OG0023311.600± 5057.742
OG0031307.125± 1619.001
OG005476.667± 695.707
OG0064091.042± 4203.693
OG00716064.250± 11077.517
OG00814025.000± 15940.887
OG00928700.000± 12493.465
OG01022053.750± 13262.028
OG01188400.000± 28175.450
OG012391.500± 521.596
OG01385.000± 20.000
Participants
OG004
2
ParticipantsOG0052
ParticipantsOG00613
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0092
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0121
ParticipantsOG0131
Title
Measurements
OG0000.241± NAStandard deviation could not be calculated as only 1 participant had analyzable data.
OG0022537.000± 2408.406
OG0032797.500± 3737.059
OG0048533.500± 11266.332
OG00575.000± 0.000
OG0065269.692± 5758.287
OG0074922.500± 6855.400
OG00828650.000± 18879.751
OG00923850.000± 14354.268
OG01025150.000± 5586.144
OG01193825.000± 18315.453
OG012621.000± NAStandard deviation could not be calculated as only 1 participant had analyzable data.
OG01375.000± NAStandard deviation could not be calculated as only 1 participant had analyzable data.