Magrolimab Monotherapy or Magrolimab in Combination With... | NCT03248479 | Trialant
NCT03248479
Sponsor
Gilead Sciences
Status
Terminated
Last Update Posted
Jan 17, 2025Actual
Enrollment
258Actual
Phase
Phase 1
Conditions
Hematological Malignancies
Interventions
Magrolimab
Azacitidine
Countries
United States
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03248479
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
5F9005
Secondary IDs
ID
Type
Description
Link
2017-000678-12
EudraCT Number
Brief Title
Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies
Official Title
A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Patients With Hematological Malignancies
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Nov 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
This study has been discontinued due to futility based on the results of a planned analysis of the ENHANCE trial.
Expanded Access Info
YesNCT05627466No longer available
Start Date
Sep 8, 2017Actual
Primary Completion Date
Sep 5, 2023Actual
Completion Date
Sep 5, 2023Actual
First Submitted Date
Aug 10, 2017
First Submission Date that Met QC Criteria
Aug 10, 2017
First Posted Date
Aug 14, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Aug 12, 2024
Results First Submitted that Met QC Criteria
Nov 28, 2024
Results First Posted Date
Jan 17, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 28, 2024
Last Update Posted Date
Jan 17, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
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
The primary objectives of this study are:
To confirm the safety and tolerability of magrolimab monotherapy in a relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) population, and of magrolimab in combination with azacitidine in previously untreated participants with AML or MDS and participants with R/R AML and MDS
To evaluate the efficacy of magrolimab monotherapy in R/R AML/MDS, and of magrolimab in combination with azacitidine in previously untreated participants with AML/MDS, or R/R AML/MDS as measured by complete remission (CR) rate for participants with AML and higher-risk MDS, and duration of complete response for participants with AML and higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS
To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or combination with azacitidine in low-risk MDS participants as measured by red blood cell (RBC) transfusion independence rate
Detailed Description
Not provided
Conditions Module
Conditions
Hematological Malignancies
Keywords
CD47
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
258Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
TN MDS Cohort Higher Risk QW 30 mg/kg
Experimental
Participants who are treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) will receive 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Drug: Azacitidine
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Experimental
Participants who are TN with higher risk MDS will receive 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Drug: Azacitidine
TN/U AML Cohort: Magrolimab + Azacitidine
Experimental
Participants who are treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) will receive 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Drug: Azacitidine
R/R AML Cohort: Magrolimab + Azacitidine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Magrolimab
Drug
Administered intravenously
Low Risk MDS Cohort: Magrolimab
Low Risk MDS Cohort: Magrolimab + Azacitidine
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and before the first date of new anti-cancer therapy including stem-cell transplant (SCT) and/or any AEs leading to premature discontinuation of study drug.
Up to 4 years
Complete Remission (CR) Rate For Participants With AML
The CR rate is the percentage of participants who achieved CR without minimal residual disease (CRMRD-), and CR as per European Leukemia Net (ELN) AML recommendations. CRMRD- per ELN was defined as neutrophils ≥1.0 × 10^9/L; platelets ≥100 × 10^9/L and <5% bone marrow blasts. If studied pretreatment, CR with negativity for a genetic marker by real-time quantitative polymerase chain reaction (RT-qPCR) or similar modality or CR with negativity by multi-color flow cytometry. CR per ELN criteria is defined as neutrophils ≥1.0 × 10^9/L; platelets ≥100 × 10^9/L and <5% bone marrow blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; MRD positive or unknown.
Up to 5 years
CR Rate for Participants With MDS
The CR rate was the percentage of MDS participants who achieved CR per International Working Group (IWG) 2006 criteria. CR per IWG criteria is defined as bone marrow ≤5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood should have: Hemoglobin (Hgb) ≥11 g/dL, platelets ≥100 × 10^9/L, neutrophils ≥1.0 × 10^9/L and blasts 0%.
Up to 5 years
Percentage of Participants With Red Blood Cell (RBC) Transfusion Independence for Participants With Low-Risk MDS
RBC transfusion independence was defined by the lack of RBC transfusions for at least an 8 week consecutive period at any time after starting therapy.
Up to 8 weeks
Secondary Outcomes
Measure
Description
Time Frame
Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants
Predose and/or after 1 hour of infusion (duration 3 hours (± 30 minutes) for 1mg/kg; 2 hours for 15 mg/kg, 30 mg/kg and 60 mg/kg) in Cycles (each cycle of 28 days) 1 to 7, 9, 11, 13, 15, on Days 1, 2, 3, 4, 8, 11, 15, 16, 17, 18, 22, EOT, Safety Follow-up
Percentage of Participants Who Developed Anti-Magrolimab Antibodies
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Meets the criteria below for the appropriate cohort:
Relapsed/Refractory Cohorts: Pathologically confirmed relapsed or refractory (primary refractory and/or relapsed refractory) acute myeloid leukemia (AML) or confirmed intermediate, high, or very high risk myelodysplastic syndromes (MDS) that is relapsed, refractory or intolerant to conventional therapy.
Treatment-naive/Unfit Cohorts: Previously untreated individuals with histological confirmation of AML who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen; or previously untreated individuals with intermediate, high, or very high risk MDS. Prior and concurrent therapy with hydroxyurea, oral etoposide, erythroid and/or myeloid growth factors is allowed.
Rollover Cohort: Individuals on active magrolimab therapy on the Phase 1 AML (SCI-CD47-002; NCT02678338) trial who are deriving clinical benefit by Investigator assessment.
RBC transfusion dependent low risk MDS cohort: Transfusion-dependent MDS individuals who are very low or low risk by Revised International Prognostic Scoring System (IPSS-R) with previous treatment with an erythroid stimulating agent or lenalidomide.
White blood cell (WBC) count ≤ 20 x 10^3/mcL
Adequate performance status and hematological, liver, and kidney function.
Key Exclusion Criteria:
Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα) targeting agents (with exception of magrolimab for individuals in the Rollover cohort).
Treatment-naive/Unfit Cohorts Only: Any prior anti-leukemic therapy (excluding hydroxyurea or oral etoposide), prior treatment with hypomethylating agents and/or low dose cytarabine.
Acute promyelocytic leukemia.
Known inherited or acquired bleeding disorders.
Previous allogeneic hematopoietic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or requiring transplant-related immunosuppression.
Clinical suspicion of active central nervous system (CNS) involvement by leukemia.
Known active or chronic hepatitis B or C infection or HIV.
Pregnancy or active breastfeeding.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Daver NG, Vyas P, Kambhampati S, Al Malki MM, Larson RA, Asch AS, Mannis G, Chai-Ho W, Tanaka TN, Bradley TJ, Jeyakumar D, Wang ES, Sweet K, Kantarjian HM, Garcia-Manero G, Komrokji R, Xing G, Ramsingh G, Renard C, Zeidner JF, Sallman DA. Tolerability and Efficacy of the Anticluster of Differentiation 47 Antibody Magrolimab Combined With Azacitidine in Patients With Previously Untreated AML: Phase Ib Results. J Clin Oncol. 2023 Nov 1;41(31):4893-4904. doi: 10.1200/JCO.22.02604. Epub 2023 Sep 13.
Background
Sallman DA, Asch AS, Kambhampati S, et al. The first-in-class anti-CD47 antibody magrolimab combined with azacitidine is well tolerated and effective in AML patients: phase 1b results. American Society of Hematology (ASH); 2020 05-08 December. Annual Meeting Virtual.
Background
Sallman DA, Asch AS, Al Malki MM, et al. The first-in-class anti-CD47 antibody magrolimab (5F9) in combination with azacitidine is effective in MDS and AML patients: ongoing phase 1b results [Abstract]. American Society of Hematology (ASH); 2019 07-10 December. Orlando, FL.
Participants were enrolled at study sites in the United States and the United Kingdom. 1 participant with low-risk MDS was accidentally enrolled High-risk MDS group.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
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
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 21, 2022
Apr 17, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Participants with relapsed/refractory (r/r) AML will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Drug: Azacitidine
R/R AML Cohort: Magrolimab
Experimental
Participants with r/r AML will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Rollover AML Cohort: Magrolimab
Experimental
Participants may receive the same dose level and schedule (30 mg/kg) (i.e., twice weekly) of magrolimab monotherapy in each cycle (each cycle was of 28 days) as previously received on the Phase 1 AML study (SCI-CD47-002), or may transition to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Drug: Magrolimab
R/R MDS Cohort: Magrolimab + Azacitidine
Experimental
Participants with r/r MDS will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Drug: Azacitidine
R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Experimental
Participants with r/r MDS will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Participants with r/r MDS who do not have an objective response with magrolimab at the first protocol response assessment can have azacitidine added to magrolimab for subsequent cycles.
Drug: Magrolimab
Drug: Azacitidine
R/R MDS Cohort: Magrolimab
Experimental
Participants with r/r MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Low Risk MDS Cohort: Magrolimab + Azacitidine
Experimental
Participants with low risk MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants will receive azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Drug: Azacitidine
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Experimental
Participants with low risk MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants will receive azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Participants with r/r MDS who do not have an objective response with magrolimab at the first protocol response assessment can have azacitidine added to magrolimab for subsequent cycles.
Drug: Magrolimab
Drug: Azacitidine
Low Risk MDS Cohort: Magrolimab
Experimental
Participants with low risk MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
Drug: Magrolimab
R/R AML Cohort: Magrolimab
R/R AML Cohort: Magrolimab + Azacitidine
R/R MDS Cohort: Magrolimab
R/R MDS Cohort: Magrolimab + Azacitidine
R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Rollover AML Cohort: Magrolimab
TN MDS Cohort Higher Risk Q2W 30 mg/kg
TN MDS Cohort Higher Risk QW 30 mg/kg
TN/U AML Cohort: Magrolimab + Azacitidine
Hu5F9-G4
Azacitidine
Drug
Administered according to region-specific drug labeling either subcutaneously or intravenously
Low Risk MDS Cohort: Magrolimab + Azacitidine
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
R/R AML Cohort: Magrolimab + Azacitidine
R/R MDS Cohort: Magrolimab + Azacitidine
R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine
TN MDS Cohort Higher Risk Q2W 30 mg/kg
TN MDS Cohort Higher Risk QW 30 mg/kg
TN/U AML Cohort: Magrolimab + Azacitidine
VIDAZA
As per the pre-specified analysis, this outcome measure was analyzed based on different dosing regimens and timepoints when magrolimab was given alone and in combination with the azacitidine. Therefore, the data is reported for magrolimab as monotherapy and magrolimab plus azacitidine. Also, the arms are based on the frequency of magrolimab administered: QW, Q2W, QW to Q2W, Q4W, BIW and BIW to QW as applicable in different cohorts.
Up to 5 years
Duration of Complete Remission (DCR) in Participants With AML and MDS
For AML participants: The DCR was defined as the time measurement criteria were first met for CR (including morphologic CR, CRMRD-, cytogenetic complete remission (cCR), and molecular complete remission (mCR) until the first date that recurrent disease or death with evidence of no disease recurrence was objectively documented. CR and CRMRD- were defined in outcome measure 2. cCR was defined as complete disappearance of chromosomal abnormality without appearance of new ones. mCR was defined as morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast.
For MDS participants: The DCR was defined as the time measurement criteria were first met for CR until the first date that recurrent disease or death with evidence of no disease recurrence is objectively documented.
Kaplan-Meier (KM) estimates were used in the outcome measure analysis.
Up to 5 years
Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria
ORR was the percentage of participants who achieved CR, partial remission (PR), marrow CR or hematological improvement (HI) prior to initiation of a new anticancer therapy including SCT per IWG 2006 criteria per investigator's evaluation. CR was defined in outcome measure 2. PR was defined as all CR criteria if abnormal before treatment except the bone marrow blasts decreased by 50% over pretreatment but still > 5% and cellularity and morphology not relevant. Marrow CR is defined as bone marrow ≤5% myeloblasts and decrease by ≥50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR. Stable Disease: Failure to achieve at least PR, but no evidence of progression for > 8 weeks.
Percentages were rounded off.
Up to 5 years
Percentage of AML Participants With Objective Response Rate (ORR)
ORR is the percentage of participants who achieve CR, CR with incomplete hematologic (count) recovery (CRi), CR with partial hematologic (count) recovery (CRh), Partial Response (PR), Morphologic Leukemia-Free State (MLFS) prior to initiation of a new anti-cancer therapy including SCT per European Leukemia Net (ELN) AML 2017 recommendations per investigator's evaluation. CR was defined in outcome measure 2. CRi was defined as neutrophils ≥ 1.0 × 10^9/L or platelets ≥ 100 × 10^9/L bone marrow blasts < 5%. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; MRD positive or unknown. CRh was defined in outcome measure 10. PR was defined in outcome measure 8. MLFS was defined as bone marrow blasts < 5%. Absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; marrow should not merely be "aplastic"; at least 200 cells should be enumerated or cellularity should be at least 10%.
Up to 5 years
Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) for AML Participants
CRh was defined as CR with partial platelet and absolute neutrophil count recovery while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT).
Up to 5 years
Duration of Response (DOR) for Participants With AML
The DOR was defined as time measurement criteria were met for complete remission (CR) (including morphologic CR, CRMRD-, cytogenetic complete remission (cCR), and molecular complete remission (mCR), incomplete blood count recovery (CRi), partial hematologic recovery (CRh), partial remission (PR), marrow CR, or morphologic leukemia-free state (MLFS), whichever was first recorded, until the first date that recurrent or progressive disease, or death with evidence of no disease magrolimab progression is objectively documented. CR and CRMRD- were defined in outcome measure 2. cCR and mCR were defined in outcome measure 7. Marrow CR and PR were defined in outcome measure 8. CRi and MLFS were defined in outcome measure 9. CRh was defined in outcome measure 10.
KM estimates were used in the outcome measure analysis.
Up to 5 years
Duration of Response for Participants With MDS
The DOR was measured from the time measurement criteria were first met for objective response as assessed by IWG MDS criteria until the first date that recurrent disease or death with evidence of no disease recurrence is objectively documented.
KM estimates were used in the outcome measure analysis.
Up to 5 years
Overall Survival (OS) for Participants With AML or MDS
The length of overall survival will be measured from the date of study treatment initiation until the date of death from any cause.
KM estimates were used in the outcome measure analysis.
Up to 5 years
Progression Free Survival (PFS) for Participants With AML or MDS
The length of PFS is defined as the time from the date of study treatment initiation until the date of documented disease progression (PD) or death from any cause, whichever occurs first.
PD for MDS: <5% blasts: if blasts increase ≥50% to >5%; 5%-10% blasts: if blasts increase ≥50% to >10%; 10%-20% blasts: if blasts increase ≥50% to >20%; 20%-30% blasts: if blasts increase ≥50% to >30%. Participants with at least 50% decrement from maximum remission/response in granulocytes / platelets or reduction in Hgb by ≥ 2 g/dL or transfusion dependence. PD for AML was defined as any evidence for an increase in bone marrow blast percentage and/or increase of absolute blast counts in the blood: > 50% increase in marrow blasts over baseline (a minimum 15% point increase is required in cases with < 30% blasts at baseline; or persistent marrow blast percentage of >70% over at least 3 months; without at least a 100% improvement in absolute neutrophil count.
Up to 5 years
Relapse Free Survival (RFS) for Participants With AML or MDS
The length of RFS is defined from the first date of attaining a CR (including morphologic CR, CRMRD-, cCR, and mCR) until the date of AML relapse or death from any cause, whichever occurs first.
Up to 5 years
Event Free Survival (EFS) for Participants With AML or MDS
For AML, EFS was defined as the time from the date of study treatment initiation until the date of documented disease progression, death from any cause, or treatment failure (defined as failure to achieve CR/CRi/CRh by Cycle 5 Day 1), whichever occurred first. CR/CRi/CRh were defined in outcome measures 2, 9 and 10 respectively.
For MDS, EFS was defined as the time from the date of study treatment initiation to transformation to AML or death from any cause, whichever occurred first. Participants who were not observed to have one of these events during the study were censored at their last response assessment date with evidence of no transformation to AML.
KM estimates were used in the outcome measure analysis.
The MRD-negative response rate was defined as the percentage of participants who reach MRD-negative disease status prior to initiation of other new anti-cancer therapy including SCT and achieve a morphologic CR or marrow CR for MDS participants and achieve CR/CRi/CRh/MLFS for AML participants. MRD-negative disease status will be assessed using a multiparameter flow cytometry-based assay performed by a central laboratory. CR/CRi/MLFS/CRh were defined in outcome measures 2, 9, 10 respectively. Marrow CR was defined in outcome measure 8.
Up to 5 years
La Jolla
California
92093
United States
UCLA Clinical and Translational Research Center (CTRC)
Los Angeles
California
90095
United States
Chao Family Comprehensive Cancer Center - UC Irvine Medical Center
Orange
California
92868
United States
University of California Davis Comprehensive Cancer Center
Sacramento
California
95817
United States
Stanford University Medical Center
Stanford
California
94305
United States
University of Colorado Cancer Center
Aurora
Colorado
80045
United States
University Of Miami - Miller School Of Medicine, Sylvester Comprehensive Cancer Center
Miami
Florida
33136
United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa
Florida
33612
United States
The University of Chicago
Chicago
Illinois
60637
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Dana Farber Cancer Institute/ Boston Children's Hospital
Boston
Massachusetts
02215
United States
Mid America Division, Inc.
Kansas City
Missouri
64132
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
Weill Cornell Medical College - New York-Presbyterian Hospital
New York
New York
10021
United States
Icahn School of Medicine at Mount Sinai
New York
New York
10029
United States
Herbert Irving Comprehensive Cancer Center-Columbia University Medical Center
New York
New York
10032
United States
Montefiore Medical Center
The Bronx
New York
10467
United States
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
27599
United States
Duke University Medical Center
Durham
North Carolina
27705
United States
Ohio State University Medical Center
Columbus
Ohio
43210
United States
Stephenson Cancer Center
Oklahoma City
Oklahoma
73104
United States
Tennesssee Oncology - Centennial Clinic Location
Nashville
Tennessee
37203
United States
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas
Texas
75246
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Medical College of WI Froedtert Hospital
Milwaukee
Wisconsin
53226
United States
Oxford Centre for Respiratory Medicine Churchill Hospital, Oxford University Hospitals NHS Trust
Sallman DA, Al Malki MM, Asch AS, Wang ES, Jurcic JG, Bradley TJ, Flinn IW, Pollyea DA, Kambhampati S, Tanaka TN, Zeidner JF, Garcia-Manero G, Jeyakumar D, Komrokji R, Lancet J, Kantarjian HM, Gu L, Zhang Y, Tan A, Chao M, O'Hear C, Ramsingh G, Lal I, Vyas P, Daver NG. Magrolimab in Combination With Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes: Final Results of a Phase Ib Study. J Clin Oncol. 2023 May 20;41(15):2815-2826. doi: 10.1200/JCO.22.01794. Epub 2023 Mar 8.
FG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
FG002
TN MDS Cohort Low Risk QW 30 mg/kg
Participants who were TN with low risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
FG003
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
FG004
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days).
Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
FG005
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
FG006
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002), or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
FG007
R/R MDS Cohort: Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days).
Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
FG008
R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days).
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
FG009
R/R MDS Cohort: Magrolimab
Participants with r/r MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
FG010
Low Risk MDS Cohort: Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
FG011
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
FG012
Low Risk MDS Cohort: Magrolimab
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
FG00032 subjects
FG00163 subjects
FG0021 subjects
FG00387 subjects
FG00419 subjects
FG0056 subjects
FG0061 subjects
FG00717 subjects
FG0085 subjects
FG00910 subjects
FG0109 subjects
FG0115 subjects
FG0123 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG00032 subjects
FG00163 subjects
FG0021 subjects
FG00387 subjects
FG00419 subjects
FG0056 subjects
FG0061 subjects
FG00717 subjects
FG0085 subjects
FG00910 subjects
FG0109 subjects
FG0115 subjects
FG0123 subjects
Type
Comment
Reasons
Death
FG00012 subjects
FG00144 subjects
FG0021 subjects
FG00372 subjects
FG00417 subjects
FG0056 subjects
FG0061 subjects
FG00714 subjects
FG0083 subjects
FG0097 subjects
FG0103 subjects
FG0111 subjects
FG0121 subjects
Study terminated by sponsor
FG00012 subjects
FG00115 subjects
FG0020 subjects
FG0035 subjects
FG004
Consent withdrawn
FG0006 subjects
FG0013 subjects
FG0020 subjects
FG0039 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Not reported
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Safety Analysis Set included all participants who received ≥ 1 dose of magrolimab.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
BG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
BG002
TN MDS Cohort Low Risk QW 30 mg/kg
Participants who were TN with low risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
BG003
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
BG004
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
BG005
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
BG006
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002), or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
BG007
R/R MDS Cohort: Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
BG008
R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days).
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles. Maximum treatment duration was up to 4 years.
BG009
R/R MDS Cohort: Magrolimab
Participants with r/r MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
BG010
Low Risk MDS Cohort: Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
BG011
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles. Maximum treatment duration was up to 4 years.
BG012
Low Risk MDS Cohort: Magrolimab
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day
1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00032
BG00163
BG0021
BG00387
BG00419
BG0056
BG0061
BG00717
BG0085
BG00910
BG0109
BG0115
BG0123
BG013258
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00067± 9.1
BG00167± 11.6
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG00124
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00031
BG00163
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and before the first date of new anti-cancer therapy including stem-cell transplant (SCT) and/or any AEs leading to premature discontinuation of study drug.
Safety Analysis Set included all participants who received ≥ 1 dose of magrolimab.
Posted
Number
percentage of participants
Up to 4 years
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG002
TN MDS Cohort Low Risk QW 30 mg/kg
Participants who were TN with low risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG004
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG005
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG006
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
OG007
R/R MDS Cohort: Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG008
R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
OG009
R/R MDS Cohort: Magrolimab
Participants with r/r MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG010
Low Risk MDS Cohort: Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
OG011
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
OG012
Low Risk MDS Cohort: Magrolimab
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00032
OG00163
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG000100
OG00196.8
OG002100
OG003
Primary
Complete Remission (CR) Rate For Participants With AML
The CR rate is the percentage of participants who achieved CR without minimal residual disease (CRMRD-), and CR as per European Leukemia Net (ELN) AML recommendations. CRMRD- per ELN was defined as neutrophils ≥1.0 × 10^9/L; platelets ≥100 × 10^9/L and <5% bone marrow blasts. If studied pretreatment, CR with negativity for a genetic marker by real-time quantitative polymerase chain reaction (RT-qPCR) or similar modality or CR with negativity by multi-color flow cytometry. CR per ELN criteria is defined as neutrophils ≥1.0 × 10^9/L; platelets ≥100 × 10^9/L and <5% bone marrow blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; MRD positive or unknown.
Full Analysis Set included participants with AML who received ≥1 dose of magrolimab. As per the pre-specified analysis, this outcome measure was applicable only for the AML cohorts.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 5 years
ID
Title
Description
OG000
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG001
R/R AML Cohort: Magrolimab + Azacitidine
Primary
CR Rate for Participants With MDS
The CR rate was the percentage of MDS participants who achieved CR per International Working Group (IWG) 2006 criteria. CR per IWG criteria is defined as bone marrow ≤5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood should have: Hemoglobin (Hgb) ≥11 g/dL, platelets ≥100 × 10^9/L, neutrophils ≥1.0 × 10^9/L and blasts 0%.
Full Analysis Set included participants with MDS who received ≥1 dose of magrolimab. As per the pre-specified analysis, this outcome measure was applicable only for the MDS cohorts.
For the TN MDS Cohort, only participants with higher MDS risk were included for the analyses of this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 5 years
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Primary
Percentage of Participants With Red Blood Cell (RBC) Transfusion Independence for Participants With Low-Risk MDS
RBC transfusion independence was defined by the lack of RBC transfusions for at least an 8 week consecutive period at any time after starting therapy.
Full Analysis Set included participants with low-risk MDS who received ≥1 dose of magrolimab. As per the pre-specified analysis, this outcome measure was applicable only for the low risk MDS cohorts.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 8 weeks
ID
Title
Description
OG000
Low Risk MDS Cohort: Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
OG001
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
Secondary
Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants
The Pharmacokinetic (PK) Analysis Set included participants in All Enrolled Analysis Set, who took at least 1 dose of magrolimab and had at least 1 detectable postdose magrolimab concentration value reported by the PK laboratory at the given timepoint.
As per the pre-specified analysis, this outcome measure was applicable only for the TN/U AML and TN MDS cohorts. Data is reported according to the frequency of magrolimab administered: QW, Q2W, QW to Q2W for both TN/U AML and TN MDS cohorts.
Posted
Mean
Standard Deviation
ug/mL
Predose and/or after 1 hour of infusion (duration 3 hours (± 30 minutes) for 1mg/kg; 2 hours for 15 mg/kg, 30 mg/kg and 60 mg/kg) in Cycles (each cycle of 28 days) 1 to 7, 9, 11, 13, 15, on Days 1, 2, 3, 4, 8, 11, 15, 16, 17, 18, 22, EOT, Safety Follow-up
ID
Title
Description
OG000
TN/U AML Cohort: Magrolimab + Azacitidine QW
Participants received magrolimab 1 mg/kg on Cycle 1 Days 1 and 4, (C1D1,4) 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15, and 22 and 30 mg/kg QW from Cycle 3 onwards. Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG001
TN/U AML Cohort: Magrolimab + Azacitidine Q2W
Participants received magrolimab 1 mg/kg on Cycle 1 Days 1 and 4, (C1D1,4) 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15, and 22 and 30 mg/kg Q2W from Cycle 3 onwards. Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
Secondary
Percentage of Participants Who Developed Anti-Magrolimab Antibodies
As per the pre-specified analysis, this outcome measure was analyzed based on different dosing regimens and timepoints when magrolimab was given alone and in combination with the azacitidine. Therefore, the data is reported for magrolimab as monotherapy and magrolimab plus azacitidine. Also, the arms are based on the frequency of magrolimab administered: QW, Q2W, QW to Q2W, Q4W, BIW and BIW to QW as applicable in different cohorts.
The Immunogenicity Analysis Set included participants in All Enrolled Analysis Set, who took at least 1 dose of magrolimab and have at least 1 anti-drug antibody (ADA) sample result reported.
Posted
Number
percentage of participants
Up to 5 years
ID
Title
Description
OG000
R/R AML Cohort: Magrolimab + Azacitidine QW
Participants received magrolimab 1 mg/kg on Cycle 1 Days 1 and 4, (C1D1,4) 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15, and 22 and 30 mg/kg QW from Cycle 3 onwards. Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG001
R/R AML Cohort: Magrolimab + Azacitidine Q2W
Participants received magrolimab 1 mg/kg on Cycle 1 Days 1 and 4, (C1D1,4) 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15, and 22 and 30 mg/kg Q2W from Cycle 3 onwards. Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
Secondary
Duration of Complete Remission (DCR) in Participants With AML and MDS
For AML participants: The DCR was defined as the time measurement criteria were first met for CR (including morphologic CR, CRMRD-, cytogenetic complete remission (cCR), and molecular complete remission (mCR) until the first date that recurrent disease or death with evidence of no disease recurrence was objectively documented. CR and CRMRD- were defined in outcome measure 2. cCR was defined as complete disappearance of chromosomal abnormality without appearance of new ones. mCR was defined as morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast.
For MDS participants: The DCR was defined as the time measurement criteria were first met for CR until the first date that recurrent disease or death with evidence of no disease recurrence is objectively documented.
Kaplan-Meier (KM) estimates were used in the outcome measure analysis.
Participants in the Full Analysis Set with CR were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included. As per the pre-specified analysis, this outcome measure was applicable only for the all AML and TN MDS cohorts.
Posted
Median
95% Confidence Interval
months
Up to 5 years
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Secondary
Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria
ORR was the percentage of participants who achieved CR, partial remission (PR), marrow CR or hematological improvement (HI) prior to initiation of a new anticancer therapy including SCT per IWG 2006 criteria per investigator's evaluation. CR was defined in outcome measure 2. PR was defined as all CR criteria if abnormal before treatment except the bone marrow blasts decreased by 50% over pretreatment but still > 5% and cellularity and morphology not relevant. Marrow CR is defined as bone marrow ≤5% myeloblasts and decrease by ≥50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR. Stable Disease: Failure to achieve at least PR, but no evidence of progression for > 8 weeks.
Percentages were rounded off.
Participants with MDS in the Full Analysis Set with data available were analyzed. For the TN MDS Cohort, only participants with higher risk MDS were included. As per the pre-specified analysis, this outcome measure was applicable only the MDS cohorts.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 5 years
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Secondary
Percentage of AML Participants With Objective Response Rate (ORR)
ORR is the percentage of participants who achieve CR, CR with incomplete hematologic (count) recovery (CRi), CR with partial hematologic (count) recovery (CRh), Partial Response (PR), Morphologic Leukemia-Free State (MLFS) prior to initiation of a new anti-cancer therapy including SCT per European Leukemia Net (ELN) AML 2017 recommendations per investigator's evaluation. CR was defined in outcome measure 2. CRi was defined as neutrophils ≥ 1.0 × 10^9/L or platelets ≥ 100 × 10^9/L bone marrow blasts < 5%. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; MRD positive or unknown. CRh was defined in outcome measure 10. PR was defined in outcome measure 8. MLFS was defined as bone marrow blasts < 5%. Absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; marrow should not merely be "aplastic"; at least 200 cells should be enumerated or cellularity should be at least 10%.
Participants in the Full Analysis Set with AML were analyzed. As per the pre-specified analysis, this outcome measure was applicable only for all AML cohorts.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 5 years
ID
Title
Description
OG000
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Secondary
Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) for AML Participants
CRh was defined as CR with partial platelet and absolute neutrophil count recovery while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT).
Participants in the Full Analysis Set with AML were analyzed. As per the pre-specified analysis, this outcome measure was applicable only for all AML cohorts.
Posted
Number
percentage of participants
Up to 5 years
ID
Title
Description
OG000
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG001
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Secondary
Duration of Response (DOR) for Participants With AML
The DOR was defined as time measurement criteria were met for complete remission (CR) (including morphologic CR, CRMRD-, cytogenetic complete remission (cCR), and molecular complete remission (mCR), incomplete blood count recovery (CRi), partial hematologic recovery (CRh), partial remission (PR), marrow CR, or morphologic leukemia-free state (MLFS), whichever was first recorded, until the first date that recurrent or progressive disease, or death with evidence of no disease magrolimab progression is objectively documented. CR and CRMRD- were defined in outcome measure 2. cCR and mCR were defined in outcome measure 7. Marrow CR and PR were defined in outcome measure 8. CRi and MLFS were defined in outcome measure 9. CRh was defined in outcome measure 10.
KM estimates were used in the outcome measure analysis.
Participants in the Full Analysis Set with AML who achieved ORR were analyzed. As per the pre-specified analysis, this outcome measure was applicable only for the AML cohorts.
Posted
Median
95% Confidence Interval
months
Up to 5 years
ID
Title
Description
OG000
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Secondary
Duration of Response for Participants With MDS
The DOR was measured from the time measurement criteria were first met for objective response as assessed by IWG MDS criteria until the first date that recurrent disease or death with evidence of no disease recurrence is objectively documented.
KM estimates were used in the outcome measure analysis.
Participants in the Full Analysis Set with TN MDS who achieved ORR were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included.
As per the pre-specified analysis, this outcome measure was applicable for only TN MDS cohorts.
Posted
Median
95% Confidence Interval
months
Up to 5 years
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Secondary
Overall Survival (OS) for Participants With AML or MDS
The length of overall survival will be measured from the date of study treatment initiation until the date of death from any cause.
KM estimates were used in the outcome measure analysis.
Participants in the Full Analysis Set were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included.
Posted
Median
Inter-Quartile Range
months
Up to 5 years
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Secondary
Progression Free Survival (PFS) for Participants With AML or MDS
The length of PFS is defined as the time from the date of study treatment initiation until the date of documented disease progression (PD) or death from any cause, whichever occurs first.
PD for MDS: <5% blasts: if blasts increase ≥50% to >5%; 5%-10% blasts: if blasts increase ≥50% to >10%; 10%-20% blasts: if blasts increase ≥50% to >20%; 20%-30% blasts: if blasts increase ≥50% to >30%. Participants with at least 50% decrement from maximum remission/response in granulocytes / platelets or reduction in Hgb by ≥ 2 g/dL or transfusion dependence. PD for AML was defined as any evidence for an increase in bone marrow blast percentage and/or increase of absolute blast counts in the blood: > 50% increase in marrow blasts over baseline (a minimum 15% point increase is required in cases with < 30% blasts at baseline; or persistent marrow blast percentage of >70% over at least 3 months; without at least a 100% improvement in absolute neutrophil count.
Participants in the Full Analysis Set were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included.
As per the pre-specified analysis, this outcome measure was applicable only for all AML and TN MDS cohorts.
KM estimates were used in the outcome measure analysis.
Posted
Median
95% Confidence Interval
months
Up to 5 years
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Secondary
Relapse Free Survival (RFS) for Participants With AML or MDS
The length of RFS is defined from the first date of attaining a CR (including morphologic CR, CRMRD-, cCR, and mCR) until the date of AML relapse or death from any cause, whichever occurs first.
Participants in the Full Analysis Set with CR were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included. As per the pre-specified analysis, this outcome measure was applicable only for the all AML and TN MDS cohorts.
Posted
Mean
95% Confidence Interval
months
Up to 5 years
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Secondary
Event Free Survival (EFS) for Participants With AML or MDS
For AML, EFS was defined as the time from the date of study treatment initiation until the date of documented disease progression, death from any cause, or treatment failure (defined as failure to achieve CR/CRi/CRh by Cycle 5 Day 1), whichever occurred first. CR/CRi/CRh were defined in outcome measures 2, 9 and 10 respectively.
For MDS, EFS was defined as the time from the date of study treatment initiation to transformation to AML or death from any cause, whichever occurred first. Participants who were not observed to have one of these events during the study were censored at their last response assessment date with evidence of no transformation to AML.
KM estimates were used in the outcome measure analysis.
Participants in the Full Analysis Set were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included.
As per the pre-specified analysis, this outcome measure was applicable only for all AML and TN MDS cohorts.
Posted
Median
95% Confidence Interval
months
Up to 5 years
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG001
Secondary
Change From Baseline in Hemoglobin on Therapy
Participants in the Safety Analysis Set were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included. As per the pre-specified analysis, this outcome measure was applicable only for the R/R AML and TN MDS cohorts.
Posted
Mean
Standard Deviation
g/dL
Baseline and Day 1
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG002
TN MDS Cohort Low Risk QW 30 mg/kg
Secondary
12-week RBC Transfusion Independence Rates
Data was not collected for this outcome measure.
Posted
Up to 12 Weeks
ID
Title
Description
OG000
Low Risk MDS Cohort: Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
OG001
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
The MRD-negative response rate was defined as the percentage of participants who reach MRD-negative disease status prior to initiation of other new anti-cancer therapy including SCT and achieve a morphologic CR or marrow CR for MDS participants and achieve CR/CRi/CRh/MLFS for AML participants. MRD-negative disease status will be assessed using a multiparameter flow cytometry-based assay performed by a central laboratory. CR/CRi/MLFS/CRh were defined in outcome measures 2, 9, 10 respectively. Marrow CR was defined in outcome measure 8.
Participants in the Full Analysis Set with MDS were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included.
As per the pre-specified analysis, this outcome measure was applicable only for all AML and TN MDS cohorts.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 5 years
ID
Title
Description
OG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Time Frame
All-cause mortality: Up to 5 years; Adverse events: Up to 4 years
Description
All-cause mortality: All Enrolled Analysis Set included all participants who were enrolled into the study.
Adverse events: Safety Analysis Set included all participants who received ≥ 1 dose of magrolimab.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
12
32
20
32
32
32
EG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
44
63
40
63
60
63
EG002
TN MDS Cohort Low Risk QW 30 mg/kg
Participants who were TN with low risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
1
1
0
1
1
1
EG003
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
72
87
64
87
84
87
EG004
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
18
19
17
19
19
19
EG005
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
6
6
4
6
6
6
EG006
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
1
1
1
1
1
1
EG007
R/R MDS Cohort: Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
15
17
12
17
17
17
EG008
R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
3
5
2
5
5
5
EG009
R/R MDS Cohort: Magrolimab
Participants with r/r MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
7
10
7
10
10
10
EG010
Low Risk MDS Cohort: Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
3
9
8
9
9
9
EG011
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
1
5
3
5
5
5
EG012
Low Risk MDS Cohort: Magrolimab
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
1
3
1
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0016 affected63 at risk
EG0020 affected1 at risk
EG0033 affected87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0072 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0101 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
Febrile neutropenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0007 affected32 at risk
EG00116 affected63 at risk
EG0020 affected1 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Red blood cell agglutination
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Acute myocardial infarction
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Angina pectoris
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Cardiac arrest
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Cardiac failure
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Cardiac failure acute
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Cardiac failure congestive
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Chronic left ventricular failure
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Dilated cardiomyopathy
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Myocardial infarction
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Myocardial ischaemia
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Pericardial effusion
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Vertigo
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Thyroid mass
Endocrine disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Colitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Enteritis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Enterocutaneous fistula
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Enterovesical fistula
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Gastric antral vascular ectasia
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Ileus
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Intestinal pseudo-obstruction
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Mesenteric panniculitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Pancreatitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Proctitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Stomatitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Asthenia
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Death
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Disease progression
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Fatigue
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Malaise
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Non-cardiac chest pain
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Pyrexia
General disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Cholecystitis
Hepatobiliary disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Hepatic failure
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Cytokine release syndrome
Immune system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Haemophagocytic lymphohistiocytosis
Immune system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Hypersensitivity
Immune system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Abdominal abscess
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Abdominal infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Abscess limb
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Anal abscess
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Anal fistula infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Anorectal infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0016 affected63 at risk
EG0020 affected1 at risk
EG003
Bronchitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Cellulitis
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Clostridium bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Colonic abscess
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Coronavirus infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Covid-19
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Cystitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Device related infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Diverticulitis
Infections and infestations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Enterococcal infection
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Enterocolitis infectious
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Escherichia bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Fungal skin infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Klebsiella infection
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Muscle abscess
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Neutropenic sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Osteomyelitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Periorbital cellulitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Perirectal abscess
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pneumonia
Infections and infestations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0016 affected63 at risk
EG0020 affected1 at risk
EG003
Pneumonia aspiration
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pneumonia bacterial
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pneumonia fungal
Infections and infestations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Pseudomonas infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pulmonary sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Respiratory tract infection
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Sepsis
Infections and infestations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Septic shock
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Sinusitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Skin infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Soft tissue infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Staphylococcal infection
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Staphylococcal sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Tooth infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Vascular device infection
Infections and infestations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Wound infection
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Fracture
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blood bilirubin increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Ejection fraction decreased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Haemoglobin decreased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Platelet count decreased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Sars-cov-2 test positive
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Transaminases increased
Investigations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Troponin I increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Cerebrovascular accident
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Depressed level of consciousness
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Headache
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Ischaemic stroke
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Seizure
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Syncope
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Confusional state
Psychiatric disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Suicidal ideation
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Acute kidney injury
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Haematuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Renal amyloidosis
Renal and urinary disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Renal colic
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Renal failure
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Prostatitis
Reproductive system and breast disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Deep vein thrombosis
Vascular disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Embolism
Vascular disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Haematoma
Vascular disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hypotension
Vascular disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG00015 affected32 at risk
EG00131 affected63 at risk
EG0020 affected1 at risk
EG00330 affected87 at risk
EG0041 affected19 at risk
EG0052 affected6 at risk
EG0061 affected1 at risk
EG0078 affected17 at risk
EG0083 affected5 at risk
EG0094 affected10 at risk
EG0104 affected9 at risk
EG0114 affected5 at risk
EG0121 affected3 at risk
Coagulopathy
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0017 affected63 at risk
EG0020 affected1 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0005 affected32 at risk
EG0019 affected63 at risk
EG0021 affected1 at risk
EG003
Red blood cell agglutination
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0012 affected63 at risk
EG0021 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0005 affected32 at risk
EG0019 affected63 at risk
EG0020 affected1 at risk
EG003
Angina pectoris
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Arrhythmia
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Bradycardia
Cardiac disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Cardiac discomfort
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Cardiogenic shock
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Diastolic dysfunction
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pericardial effusion
Cardiac disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Sinus bradycardia
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Sinus tachycardia
Cardiac disorders
26.0
Systematic Assessment
EG0004 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Tachycardia
Cardiac disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Porokeratosis
Congenital, familial and genetic disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Deafness
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Ear pain
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Vertigo
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Cataract
Eye disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Conjunctival haemorrhage
Eye disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Diplopia
Eye disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Dry eye
Eye disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Eye discharge
Eye disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Eye haemorrhage
Eye disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Eye pruritus
Eye disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Eyelid ptosis
Eye disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Lacrimation increased
Eye disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Periorbital oedema
Eye disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Photophobia
Eye disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Vision blurred
Eye disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Visual impairment
Eye disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Vitreous floaters
Eye disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Abdominal distension
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG00114 affected63 at risk
EG0020 affected1 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Anal incontinence
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Ascites
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Colitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
26.0
Systematic Assessment
EG00026 affected32 at risk
EG00140 affected63 at risk
EG0021 affected1 at risk
EG003
Dental discomfort
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
26.0
Systematic Assessment
EG00014 affected32 at risk
EG00127 affected63 at risk
EG0020 affected1 at risk
EG003
Dry mouth
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Dyspepsia
Gastrointestinal disorders
26.0
Systematic Assessment
EG0005 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Dysphagia
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Flatulence
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Gingival erythema
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Gingival pain
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Haematochezia
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0015 affected63 at risk
EG0020 affected1 at risk
EG003
Ileus
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Lip dry
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Melaena
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
26.0
Systematic Assessment
EG00011 affected32 at risk
EG00133 affected63 at risk
EG0021 affected1 at risk
EG003
Oral blood blister
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Oral disorder
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Oral mucosal blistering
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Oral pain
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Rectal lesion
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Stomatitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0015 affected63 at risk
EG0020 affected1 at risk
EG003
Toothache
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
26.0
Systematic Assessment
EG0005 affected32 at risk
EG00117 affected63 at risk
EG0021 affected1 at risk
EG003
Asthenia
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0018 affected63 at risk
EG0020 affected1 at risk
EG003
Catheter site bruise
General disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Catheter site erythema
General disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Catheter site haemorrhage
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Catheter site pain
General disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Catheter site rash
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Chest discomfort
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Chest pain
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Chills
General disorders
26.0
Systematic Assessment
EG0006 affected32 at risk
EG00114 affected63 at risk
EG0020 affected1 at risk
EG003
Complication associated with device
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Cyst
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Face oedema
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Facial pain
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Fatigue
General disorders
26.0
Systematic Assessment
EG00015 affected32 at risk
EG00120 affected63 at risk
EG0020 affected1 at risk
EG003
Gait disturbance
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hypothermia
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Influenza like illness
General disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Injection site pruritus
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Injection site reaction
General disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Localised oedema
General disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Malaise
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Mucosal inflammation
General disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Non-cardiac chest pain
General disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Oedema
General disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Oedema peripheral
General disorders
26.0
Systematic Assessment
EG0006 affected32 at risk
EG00115 affected63 at risk
EG0020 affected1 at risk
EG003
Pain
General disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Peripheral swelling
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Pyrexia
General disorders
26.0
Systematic Assessment
EG00011 affected32 at risk
EG00111 affected63 at risk
EG0020 affected1 at risk
EG003
Suprapubic pain
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Vaccination site pain
General disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hepatic lesion
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Hypersensitivity
Immune system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Abscess limb
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Acute sinusitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Candida infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Cellulitis
Infections and infestations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Clostridium difficile infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Covid-19
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Device related bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Gingivitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Influenza
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Localised infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Metapneumovirus infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Oral candidiasis
Infections and infestations
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Osteomyelitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Otitis externa
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pneumonia
Infections and infestations
26.0
Systematic Assessment
EG0004 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pneumonia bacterial
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Pneumonia fungal
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Sinusitis
Infections and infestations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Soft tissue infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Subcutaneous abscess
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Tooth infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Upper respiratory tract infection
Infections and infestations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
26.0
Systematic Assessment
EG0004 affected32 at risk
EG0015 affected63 at risk
EG0020 affected1 at risk
EG003
Vaginal cellulitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Wound infection
Infections and infestations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Contusion
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0019 affected63 at risk
EG0020 affected1 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Dental restoration failure
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0005 affected32 at risk
EG00112 affected63 at risk
EG0020 affected1 at risk
EG003
Fracture
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Head injury
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hyphaema
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0005 affected32 at risk
EG00115 affected63 at risk
EG0020 affected1 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Periorbital haemorrhage
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0015 affected63 at risk
EG0020 affected1 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Wound
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
26.0
Systematic Assessment
EG0008 affected32 at risk
EG00112 affected63 at risk
EG0020 affected1 at risk
EG003
Aspartate aminotransferase decreased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Aspartate aminotransferase increased
Investigations
26.0
Systematic Assessment
EG0004 affected32 at risk
EG00112 affected63 at risk
EG0020 affected1 at risk
EG003
Blood alkaline phosphatase increased
Investigations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Blood bilirubin decreased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blood bilirubin increased
Investigations
26.0
Systematic Assessment
EG00011 affected32 at risk
EG00123 affected63 at risk
EG0021 affected1 at risk
EG003
Blood cholesterol increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blood creatinine decreased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blood creatinine increased
Investigations
26.0
Systematic Assessment
EG0006 affected32 at risk
EG0016 affected63 at risk
EG0020 affected1 at risk
EG003
Blood fibrinogen decreased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blood glucose increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blood phosphorus increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blood sodium decreased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blood test abnormal
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blood urea increased
Investigations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blood uric acid increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Brain natriuretic peptide increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Electrocardiogram QT prolonged
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Electrocardiogram abnormal
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Fibrin D dimer increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Haptoglobin decreased
Investigations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
International normalised ratio increased
Investigations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Klebsiella test positive
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Lymphocyte count decreased
Investigations
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Neutrophil count decreased
Investigations
26.0
Systematic Assessment
EG00017 affected32 at risk
EG00119 affected63 at risk
EG0020 affected1 at risk
EG003
Platelet count decreased
Investigations
26.0
Systematic Assessment
EG00014 affected32 at risk
EG00127 affected63 at risk
EG0020 affected1 at risk
EG003
Troponin T increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Troponin increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Weight decreased
Investigations
26.0
Systematic Assessment
EG0005 affected32 at risk
EG0019 affected63 at risk
EG0020 affected1 at risk
EG003
Weight increased
Investigations
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
White blood cell count decreased
Investigations
26.0
Systematic Assessment
EG00015 affected32 at risk
EG00115 affected63 at risk
EG0020 affected1 at risk
EG003
White blood cell count increased
Investigations
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0007 affected32 at risk
EG00122 affected63 at risk
EG0020 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0018 affected63 at risk
EG0020 affected1 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0014 affected63 at risk
EG0021 affected1 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0005 affected32 at risk
EG0012 affected63 at risk
EG0021 affected1 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0009 affected32 at risk
EG00115 affected63 at risk
EG0021 affected1 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0005 affected32 at risk
EG0017 affected63 at risk
EG0020 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0006 affected32 at risk
EG0018 affected63 at risk
EG0021 affected1 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0008 affected32 at risk
EG00111 affected63 at risk
EG0021 affected1 at risk
EG003
Iron overload
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0004 affected32 at risk
EG00111 affected63 at risk
EG0020 affected1 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0005 affected32 at risk
EG0018 affected63 at risk
EG0020 affected1 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Deep tissue injury
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Fracture pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0013 affected63 at risk
EG0021 affected1 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG00110 affected63 at risk
EG0020 affected1 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Aphasia
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Brain fog
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Disturbance in attention
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Dizziness
Nervous system disorders
26.0
Systematic Assessment
EG0007 affected32 at risk
EG00116 affected63 at risk
EG0020 affected1 at risk
EG003
Dizziness postural
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Dysgeusia
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0017 affected63 at risk
EG0020 affected1 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Headache
Nervous system disorders
26.0
Systematic Assessment
EG0009 affected32 at risk
EG00122 affected63 at risk
EG0021 affected1 at risk
EG003
Hypoaesthesia
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Lethargy
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Memory impairment
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Movement disorder
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Neuropathy peripheral
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Paraesthesia
Nervous system disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Presyncope
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0015 affected63 at risk
EG0020 affected1 at risk
EG003
Restless legs syndrome
Nervous system disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Somnolence
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Spinal cord compression
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Syncope
Nervous system disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Tremor
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Vith nerve paralysis
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Agitation
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Anxiety
Psychiatric disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Confusional state
Psychiatric disorders
26.0
Systematic Assessment
EG0004 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Delirium
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Depression
Psychiatric disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Hallucination
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Insomnia
Psychiatric disorders
26.0
Systematic Assessment
EG0005 affected32 at risk
EG0019 affected63 at risk
EG0020 affected1 at risk
EG003
Post-traumatic stress disorder
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Restlessness
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Acute kidney injury
Renal and urinary disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Chromaturia
Renal and urinary disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Dysuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Haematuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Micturition urgency
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Nocturia
Renal and urinary disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pollakiuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Polyuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Urinary incontinence
Renal and urinary disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Urinary retention
Renal and urinary disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0021 affected1 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0021 affected1 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0008 affected32 at risk
EG00116 affected63 at risk
EG0020 affected1 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG00011 affected32 at risk
EG00122 affected63 at risk
EG0021 affected1 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0015 affected63 at risk
EG0020 affected1 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0015 affected63 at risk
EG0020 affected1 at risk
EG003
Oropharyngeal oedema
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pharyngeal lesion
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Pulmonary alveolar haemorrhage
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Respiratory acidosis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0003 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0017 affected63 at risk
EG0020 affected1 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0017 affected63 at risk
EG0020 affected1 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0002 affected32 at risk
EG0013 affected63 at risk
EG0020 affected1 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0014 affected63 at risk
EG0020 affected1 at risk
EG003
Precancerous skin lesion
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0008 affected32 at risk
EG00113 affected63 at risk
EG0020 affected1 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0005 affected32 at risk
EG0019 affected63 at risk
EG0020 affected1 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0015 affected63 at risk
EG0020 affected1 at risk
EG003
Skin necrosis
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Deep vein thrombosis
Vascular disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Embolism
Vascular disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Flushing
Vascular disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected63 at risk
EG0020 affected1 at risk
EG003
Haematoma
Vascular disorders
26.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Haemorrhage
Vascular disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Hypertension
Vascular disorders
26.0
Systematic Assessment
EG0008 affected32 at risk
EG0015 affected63 at risk
EG0021 affected1 at risk
EG003
Hypotension
Vascular disorders
26.0
Systematic Assessment
EG0007 affected32 at risk
EG0018 affected63 at risk
EG0020 affected1 at risk
EG003
Pallor
Vascular disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected63 at risk
EG0020 affected1 at risk
EG003
Venous thrombosis limb
Vascular disorders
26.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected63 at risk
EG0020 affected1 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years.
Standard deviation cannot be calculated for 1 participant.
BG00371± 10.0
BG00473± 7.4
BG00577± 6.3
BG00679± NAStandard deviation cannot be calculated for 1 participant.
BG00772± 7.2
BG00877± 1.7
BG00973± 5.3
BG01075± 5.9
BG01174± 7.7
BG01279± 6.4
BG01370± 9.8
1
BG00337
BG0045
BG0053
BG0061
BG0075
BG0084
BG0093
BG0106
BG0111
BG0121
BG013100
Male
BG00023
BG00139
BG0020
BG00350
BG00414
BG0053
BG0060
BG00712
BG0081
BG0097
BG0103
BG0114
BG0122
BG013158
1
BG0035
BG0041
BG0050
BG0060
BG0072
BG0080
BG0090
BG0101
BG0110
BG0120
BG01317
Not Hispanic or Latino
BG00029
BG00154
BG0020
BG00381
BG00418
BG0056
BG0061
BG00714
BG0085
BG0099
BG0108
BG0115
BG0123
BG013233
Unknown or Not Reported
BG0002
BG0013
BG0020
BG0031
BG0040
BG0050
BG0060
BG0071
BG0080
BG0091
BG0100
BG0110
BG0120
BG0138
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0131
Asian
BG0000
BG0012
BG0020
BG0034
BG0042
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0138
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
Black or African American
BG0000
BG0013
BG0020
BG0033
BG0042
BG0051
BG0060
BG0070
BG0080
BG0090
BG0102
BG0110
BG0120
BG01311
White
BG00031
BG00154
BG0020
BG00375
BG00415
BG0055
BG0061
BG00716
BG0084
BG00910
BG0106
BG0115
BG0123
BG013225
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
Unknown or Not Reported
BG0001
BG0013
BG0021
BG0035
BG0040
BG0050
BG0060
BG0071
BG0081
BG0090
BG0101
BG0110
BG0120
BG01313
1
BG00385
BG00419
BG0056
BG0060
BG00717
BG0085
BG00910
BG0108
BG0115
BG0123
BG013253
United Kingdom
Title
Measurements
BG0001
BG0010
BG0020
BG0032
BG0040
BG0050
BG0061
BG0070
BG0080
BG0090
BG0101
BG0110
BG0120
BG0135
87
OG00419
OG0056
OG0061
OG00717
OG0085
OG00910
OG0109
OG0115
OG0123
100
OG004100
OG005100
OG006100
OG007100
OG008100
OG009100
OG010100
OG011100
OG012100
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG002
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00087
OG00119
OG0026
OG0031
Title
Denominators
Categories
Title
Measurements
OG00032.2(22.6 to 43.1)
OG0010.0(0.0 to 17.6)
OG0020.0(0.0 to 45.9)
OG0030.0(0.0 to 97.5)
OG002
R/R MDS Cohort: Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
OG004
R/R MDS Cohort: Magrolimab
Participants with r/r MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG005
Low Risk MDS Cohort: Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
OG006
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
OG007
Low Risk MDS Cohort: Magrolimab
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00032
OG00163
OG00217
OG0035
OG00410
OG0059
OG0065
OG0073
Title
Denominators
Categories
Title
Measurements
OG00037.5(21.1 to 56.3)
OG00130.2(19.2 to 43.0)
OG0020.0(0.0 to 19.5)
OG0030.0(0.0 to 52.2)
OG0040.0(0.0 to 30.8)
OG00511.1(0.3 to 48.2)
OG0060.0(0.0 to 52.2)
OG0070.0(0.0 to 70.8)
OG002
Low Risk MDS Cohort: Magrolimab
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG0009
OG0015
OG0023
Title
Denominators
Categories
Title
Measurements
OG00044.4(13.7 to 78.8)
OG00140.0(5.3 to 85.3)
OG0020.0(0.0 to 70.8)
OG002
TN/U AML Cohort: Magrolimab to Magrolimab + Azacitidine QW to Q2W
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, 30 mg/kg QW on C2D1, 8, 15 and 22. From Cycle 3 participants received ≥ 1 dose of 30 mg/kg QW and switched to magrolimab 30 mg/kg Q2W.
Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG003
TN MDS Cohort: Magrolimab + Azacitidine QW
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15 and 22, and 30 mg/kg QW. From Cycle 3 onwards. Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG004
TN MDS Cohort: Magrolimab + Azacitidine Q2W
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15 and 22, and 30mg/kg Q2W from Cycle 3 onwards. Aza was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG005
TN MDS Cohort: Magrolimab to Magrolimab + Azacitidine QW to Q2W
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, 30 mg/kg QW on C2D1, 8, 15 and 22. From Cycle 3 participants received ≥ 1 dose of 30 mg/kg QW and switched to magrolimab 30 mg/kg Q2W.
Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00029
OG00142
OG0029
OG00324
OG00456
OG00514
Title
Denominators
Categories
C1D1 Predose
ParticipantsOG00029
ParticipantsOG00142
ParticipantsOG0029
ParticipantsOG00324
ParticipantsOG00452
ParticipantsOG00513
Title
Measurements
OG0000.18± 0.958
OG0010.00± 0.00
OG0020.00± 0.00
OG003
C1D1 1 hour
ParticipantsOG00027
ParticipantsOG00136
ParticipantsOG0026
ParticipantsOG00323
C1D4 Predose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C1D4 1 hour
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C1D8 Predose
ParticipantsOG00027
ParticipantsOG00136
ParticipantsOG0029
ParticipantsOG00323
C1D8 1 hour
ParticipantsOG00024
ParticipantsOG00136
ParticipantsOG0027
ParticipantsOG00322
C1D11 Predose
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
C1D11 1 hour
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
C1D15 Predose
ParticipantsOG00024
ParticipantsOG00136
ParticipantsOG0028
ParticipantsOG00318
C1D15 1 hour
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0034
C1D16 Predose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C1D17 Predose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C1D18 Predose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C1D22 Predose
ParticipantsOG00020
ParticipantsOG00135
ParticipantsOG0028
ParticipantsOG00319
C1D22 1 hour
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG0033
C2D1 Predose
ParticipantsOG00020
ParticipantsOG00134
ParticipantsOG0028
ParticipantsOG00320
C2D1 1 hour
ParticipantsOG00022
ParticipantsOG00133
ParticipantsOG0028
ParticipantsOG00320
C2D2 Predose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C2D3 Predose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C2D4 Predose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C2D4 1 hour
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C2D8 Predose
ParticipantsOG00018
ParticipantsOG00135
ParticipantsOG0028
ParticipantsOG00319
C2D15 Predose
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C2D22 Predose
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C3D1 Predose
ParticipantsOG00015
ParticipantsOG00131
ParticipantsOG0028
ParticipantsOG00314
C3D1 1 hour
ParticipantsOG00012
ParticipantsOG00127
ParticipantsOG0027
ParticipantsOG00315
C4D1 Predose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C5D1 Predose
ParticipantsOG0007
ParticipantsOG00122
ParticipantsOG0028
ParticipantsOG0038
C5D1 1 hour
ParticipantsOG0006
ParticipantsOG00121
ParticipantsOG0028
ParticipantsOG0037
C6D1 Predose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
C7D1 Predose
ParticipantsOG0006
ParticipantsOG00116
ParticipantsOG0029
ParticipantsOG0033
C7D1 1 hour
ParticipantsOG0006
ParticipantsOG00114
ParticipantsOG0026
ParticipantsOG0033
C9D1 Predose
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0032
C9D1 1 hour
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0028
ParticipantsOG0032
C11D1 Predose
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0030
C11D1 1 hour
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0030
C13D1 Predose
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0030
C13D1 1 hour
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0030
C15D1 Predose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
End of Treatment (EOT, Up to 4 years)
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG0025
ParticipantsOG00315
Safety Follow-up (FU, Up to 4 years plus 30 days)
ParticipantsOG0005
ParticipantsOG00114
ParticipantsOG0022
ParticipantsOG003
OG002
R/R MDS Cohort: Magrolimab + Azacitidine QW
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15 and 22, and 30 mg/kg QW. From Cycle 3 onwards. Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG003
R/R MDS Cohort: Magrolimab + Azacitidine Q2W
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15 and 22, and 30mg/kg Q2W from Cycle 3 onwards. Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG004
TN/U AML Cohort: Magrolimab + Azacitidine QW
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15 and 22, and 30 mg/kg QW. From Cycle 3 onwards. Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG005
TN/U AML Cohort: Magrolimab + Azacitidine Q2W
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15 and 22, and 30mg/kg Q2W from Cycle 3 onwards. Aza was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG006
TN/U AML Cohort: Magrolimab to Magrolimab + Azacitidine QW to Q2W
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, 30 mg/kg QW on C2D1, 8, 15 and 22. From Cycle 3 participants received ≥ 1 dose of 30 mg/kg QW and switched to magrolimab 30 mg/kg Q2W.
Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG007
TN MDS Cohort: Magrolimab + Azacitidine QW
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15 and 22, and 30 mg/kg QW. From Cycle 3 onwards. Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG008
TN MDS Cohort: Magrolimab + Azacitidine Q2W
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, then 30 mg/kg QW on C2D1, 8, 15 and 22, and 30mg/kg Q2W from Cycle 3 onwards. Aza was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG009
TN MDS Cohort: Magrolimab to Magrolimab + Azacitidine QW to Q2W
Participants received magrolimab 1 mg/kg on C1D1, 4, 15 mg/kg on C1D8, 30 mg/kg on C1D11,15 and 22, 30 mg/kg QW on C2D1, 8, 15 and 22. From Cycle 3 participants received ≥ 1 dose of 30 mg/kg QW and switched to magrolimab 30 mg/kg Q2W.
Azacitidine was given based on approved labeling at standard dose of 75 mg/m^2 on Days 1-7 of each 28-day cycle. Maximum treatment duration was up to 4 years.
OG010
R/R AML Cohort: Magrolimab BIW or BIW to QW
Participants received magrolimab 1 mg/kg on Days 1 and 4, 15 mg/kg on Day 8, and 30 mg/kg on Day 11 and twice weekly (BIW) thereafter for magrolimab monotherapy. From Cycle 3 participants switched from 30 mg/kg BIW to magrolimab 30 mg/kg QW. Maximum treatment duration was up to 4 years.
OG011
R/R MDS Cohort: Magrolimab BIW or BIW to QW
Participants received magrolimab 1 mg/kg on Days 1 and 4, 15 mg/kg on Day 8, and 30 mg/kg on Day 11 and twice weekly thereafter for magrolimab monotherapy. From Cycle 3 participants switched from 30 mg/kg BIW to magrolimab 30 mg/kg QW. Maximum treatment duration was up to 4 years.
OG012
R/R MDS Cohort: Magrolimab Q2W
Participants received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Day 11, 15, 22, and then weekly starting Cycle 2 and given as Q2W from Cycle 3 up to end of the study. Maximum treatment duration was up to 4 years.
OG013
Low-Risk MDS Cohort: Magrolimab Q4W
Participants received magrolimab 1 mg/kg on Day 1, 30 mg/kg QW for Cycle 1, followed by 60 mg/kg every 4 weeks (Q4W) from Cycle 2 onward. Maximum treatment duration was up to 4 years.
OG014
Rollover AML Cohort: Magrolimab QW
Dosing schedule may be twice weekly (Day 1, 4, 8, 11, 15, 18, 22, and 25), once weekly (Day 1, 8, 15, 22), or in accordance with a modified recommended Phase 2 dose and schedule determined by the Clinical Trial Steering Committee (CTSC).
Participants may receive the same dose level and schedule (i.e., twice weekly) of magrolimab monotherapy in each cycle (each cycle was of 28 days) as previously received on the Phase 1 AML study (SCI-CD47-002) or may transition to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG0009
OG00110
OG0025
OG00312
OG00430
OG00548
OG0069
OG00726
OG00856
OG00914
OG0106
OG0114
OG01211
OG01316
OG0141
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0046.7
OG0054.7
OG00611.1
OG0070
OG0083.9
OG0090
OG01016.7
OG0110
OG01218.2
OG0136.7
OG0140
OG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG002
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG004
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG005
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00012
OG00119
OG00228
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG00014.4(3.7 to NA)Upper limit of confidence interval (CI) was not reached due to insufficient number of events.
OG0018.5(7.3 to 12.9)
OG0029.4(5.1 to 11.6)
OG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG002
R/R MDS Cohort: Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
OG004
R/R MDS Cohort: Magrolimab
Participants with r/r MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG005
Low Risk MDS Cohort: Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
OG006
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
OG007
Low Risk MDS Cohort: Magrolimab
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00032
OG00163
OG00217
OG0035
OG00410
OG0059
OG0065
OG0073
Title
Denominators
Categories
Title
Measurements
OG00081.3(63.6 to 92.8)
OG00169.8(57.0 to 80.8)
OG00223.5(6.8 to 49.9)
OG0030.0(0.0 to 52.2)
OG00410.0(0.3 to 44.5)
OG00533.3(7.5 to 70.1)
OG00640.0(5.3 to 85.3)
OG0070.0(0.0 to 70.8)
OG001
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG002
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00087
OG00119
OG0026
OG0031
Title
Denominators
Categories
Title
Measurements
OG00047.1(36.3 to 58.1)
OG00121.1(6.1 to 45.6)
OG00216.7(0.4 to 64.1)
OG0030.0(0.0 to 97.5)
OG002
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00087
OG00119
OG0026
OG0031
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG001
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG002
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00041
OG0014
OG0021
OG0031
Title
Denominators
Categories
Title
Measurements
OG0008.7(7.4 to 10.4)
OG0012.7(0.7 to NA)Upper limit of CI was not reached due to insufficient number of events.
OG0022.1(NA to NA)Lower and upper limit of CI were not reached due to insufficient number of events.
OG003NA(NA to NA)Median, lower and upper limit of CI were not reached due to insufficient number of events.
Units
Counts
Participants
OG00026
OG00144
Title
Denominators
Categories
Title
Measurements
OG00012.9(7.6 to NA)Upper limit of CI was not reached due to insufficient number of events.
OG0019.5(7.9 to 12.9)
OG002
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG004
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG005
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
OG006
R/R MDS Cohort: Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG007
R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days).
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
OG008
R/R MDS Cohort: Magrolimab
Participants with r/r MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG009
Low Risk MDS Cohort: Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
OG010
Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles.
OG011
Low Risk MDS Cohort: Magrolimab
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00032
OG00163
OG00287
OG00319
OG0046
OG0051
OG00617
OG0075
OG00810
OG0099
OG0105
OG0113
Title
Denominators
Categories
Title
Measurements
OG000NA(17.7 to NA)Median and upper limit of CI were not reached due to insufficient number of events.
OG00119.4(13.4 to 24.7)
OG00210.8(7.2 to 12.8)
OG0035.2(1.4 to 9.9)
OG0048.5(4.5 to NA)Upper limit of CI was not reached due to insufficient number of events.
OG00533.6(NA to NA)Lower and upper limit of CI were not reached due to insufficient number of events.
OG0068.5(3.7 to 14.7)
OG00714.1(7.8 to NA)Upper limit of CI was not reached due to insufficient number of events.
OG0084.2(2.3 to NA)Upper limit of CI was not reached due to insufficient number of events.
OG009NA(0.6 to NA)Median and upper limit of CI were not reached due to insufficient number of events.
OG010NA(3.5 to NA)Median and upper limit of CI were not reached due to insufficient number of events.
OG01130.6(30.6 to NA)Upper limit of CI was not reached due to insufficient number of events.
OG001
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG002
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG004
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG005
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00032
OG00163
OG00287
OG00319
OG0046
OG0051
Title
Denominators
Categories
Title
Measurements
OG00014.0(8.6 to 20.4)
OG00110.7(7.6 to 11.8)
OG0027.3(4.4 to 9.7)
OG0032.6(1.0 to 6.0)
OG0045.2(0.9 to NA)Upper limit of CI was not reached due to insufficient number of events.
OG0051.9(NA to NA)Lower and upper limit of CI were not reached due to insufficient number of events.
OG002
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG004
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG005
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00012
OG00119
OG00228
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG00014.4(3.7 to NA)Upper limit of confidence interval (CI) was not reached due to insufficient number of participants with events.
OG0018.5(7.3 to 12.9)
OG0029.4(5.1 to 11.6)
TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG002
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG004
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG005
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00032
OG00163
OG00287
OG00319
OG0046
OG0051
Title
Denominators
Categories
Title
Measurements
OG00018.2(12.9 to NA)Upper limit of CI were not reached due to insufficient number of events.
OG00123.1(11.8 to NA)Upper limit of CI were not reached due to insufficient number of events.
OG0023.7(2.1 to 7.3)
OG0031.7(0.8 to 3.5)
OG0041.4(0.0 to NA)Upper limit of CI were not reached due to insufficient number of events.
OG0051.9(NA to NA)Lower and upper limit of CI were not reached due to insufficient number of events.
Participants who were TN with low risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG004
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG005
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG006
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00032
OG00163
OG0021
OG00387
OG00419
OG0056
OG0061
Title
Denominators
Categories
Baseline
ParticipantsOG00032
ParticipantsOG00163
ParticipantsOG0021
ParticipantsOG00387
ParticipantsOG00419
ParticipantsOG0056
ParticipantsOG0061
Title
Measurements
OG0008.5± 1.56
OG0019.0± 1.50
OG00210.1± NAStandard deviation cannot be calculated for 1 participant.
OG003
Change at Day 1
ParticipantsOG00031
ParticipantsOG00161
ParticipantsOG0021
ParticipantsOG00384
Low Risk MDS Cohort: Magrolimab
Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG0000
OG0010
OG0020
Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG002
TN/U AML Cohort: Magrolimab + Azacitidine
Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG003
R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG004
R/R AML Cohort: Magrolimab
Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
OG005
Rollover AML Cohort: Magrolimab
Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002) or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Units
Counts
Participants
OG00032
OG00163
OG00287
OG00319
OG0046
OG0051
Title
Denominators
Categories
Title
Measurements
OG00028.1(13.7 to 46.7)
OG00120.6(11.5 to 32.7)
OG00221.8(13.7 to 32.0)
OG0035.3(0.1 to 26.0)
OG0040.0(0.0 to 45.9)
OG0050.0(0.0 to 97.5)
21 affected
87 at risk
EG0046 affected19 at risk
EG0052 affected6 at risk
EG0061 affected1 at risk
EG0074 affected17 at risk
EG0081 affected5 at risk
EG0092 affected10 at risk
EG0101 affected9 at risk
EG0111 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
3 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
3 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
3 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
3 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0051 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0121 affected3 at risk
1 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0092 affected10 at risk
EG0100 affected9 at risk
EG0111 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0111 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0101 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0042 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0121 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0081 affected5 at risk
EG0091 affected10 at risk
EG0101 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0111 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0111 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
4 affected
87 at risk
EG0042 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0072 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0101 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0051 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0101 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
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EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
5 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0072 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
4 affected
87 at risk
EG0040 affected19 at risk
EG0051 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0042 affected19 at risk
EG0051 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0101 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0051 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
4 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0092 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0111 affected5 at risk
EG0120 affected3 at risk
10 affected
87 at risk
EG0045 affected19 at risk
EG0051 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0101 affected9 at risk
EG0112 affected5 at risk
EG0120 affected3 at risk
2 affected
87 at risk
EG0041 affected19 at risk
EG0051 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
7 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0074 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0112 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
10 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0101 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0072 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
6 affected
87 at risk
EG0041 affected19 at risk
EG0051 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0072 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
6 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
3 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0121 affected3 at risk
0 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
1 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0070 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
6 affected
87 at risk
EG0042 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0072 affected17 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
EG0101 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
17 affected
87 at risk
EG0047 affected19 at risk
EG0051 affected6 at risk
EG0060 affected1 at risk
EG0074 affected17 at risk
EG0081 affected5 at risk
EG0093 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0121 affected3 at risk
4 affected
87 at risk
EG0041 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0 affected
87 at risk
EG0040 affected19 at risk
EG0050 affected6 at risk
EG0060 affected1 at risk
EG0071 affected17 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
EG0100 affected9 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
0.00
± 0.00
OG0040.00± 0.00
OG0050.00± 0.00
Participants
OG004
56
ParticipantsOG00512
Title
Measurements
OG0000.41± 0.830
OG0010.29± 0.377
OG0020.19± 0.218
OG00316.54± 76.838
OG0040.40± 0.615
OG0050.77± 0.696
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.00± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.32± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
47
ParticipantsOG00514
Title
Measurements
OG0000.00± 0.00
OG0010.07± 0.398
OG0020.00± 0.00
OG00317.39± 83.188
OG0040.00± 0.00
OG0050.00± 0.00
Participants
OG004
43
ParticipantsOG00513
Title
Measurements
OG000254.58± 53.242
OG001309.17± 103.697
OG002258.43± 72.514
OG003304.36± 49.765
OG004293.09± 75.213
OG005262.54± 68.001
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG00038.50± 4.384
OG0010.00± 0.00
OG00395.70± NAStandard deviation cannot be calculated for 1 participant.
OG005189.00± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000318.00± NAStandard deviation cannot be calculated for 1 participant.
OG001338.00± 0.00
Participants
OG004
47
ParticipantsOG00514
Title
Measurements
OG000320.62± 166.137
OG001348.98± 138.719
OG002237.01± 109.654
OG003360.06± 115.170
OG004349.13± 93.294
OG005348.64± 142.833
Participants
OG004
4
ParticipantsOG0051
Title
Measurements
OG000778.88± 268.194
OG001732.50± 335.509
OG002578.00± NAStandard deviation cannot be calculated for 1 participant.
OG0031016.75± 131.801
OG004754.00± 207.456
OG005887.00± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000351.00± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000278.00± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000249.00± NAStandard deviation cannot be calculated for 1 participant.
ParticipantsOG00447
ParticipantsOG00514
Title
Measurements
OG000416.80± 131.60
OG001374.63± 183.020
OG002308.33± 99.219
OG003490.05± 151.489
OG004437.63± 183.664
OG005447.93± 163.772
Participants
OG004
3
ParticipantsOG0050
Title
Measurements
OG000873.17± 217.208
OG001999.00± 517.850
OG0031253.33± 123.423
OG004790.00± 72.187
Participants
OG004
44
ParticipantsOG00514
Title
Measurements
OG000398.05± 251.639
OG001408.84± 216.656
OG002390.50± 104.538
OG003480.74± 206.793
OG004487.42± 205.862
OG005496.57± 179.237
Participants
OG004
44
ParticipantsOG00511
Title
Measurements
OG000807.67± 419.553
OG001919.33± 313.966
OG002948.50± 88.695
OG0031009.00± 333.772
OG0041078.64± 332.665
OG0051064.00± 216.115
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.00± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.00± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.00± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0001.09± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
39
ParticipantsOG00514
Title
Measurements
OG000440.64± 274.761
OG001528.31± 244.068
OG002458.63± 156.315
OG003554.06± 228.605
OG004573.62± 213.474
OG005491.43± 167.348
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000294.00± 213.546
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000325.50± 178.898
Participants
OG004
49
ParticipantsOG00513
Title
Measurements
OG000494.00± 222.682
OG001549.52± 260.353
OG002507.50± 188.883
OG003631.87± 216.160
OG004597.71± 324.158
OG005602.77± 253.499
Participants
OG004
40
ParticipantsOG00512
Title
Measurements
OG000971.76± 462.426
OG0011245.85± 449.410
OG002994.86± 273.703
OG0031306.13± 396.321
OG0041272.23± 402.487
OG0051062.00± 328.337
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000336.00± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
34
ParticipantsOG00511
Title
Measurements
OG000673.29± 183.521
OG001301.28± 143.219
OG002513.38± 238.555
OG003666.38± 317.290
OG004246.76± 164.420
OG005542.00± 319.484
Participants
OG004
33
ParticipantsOG00513
Title
Measurements
OG0001150.50± 342.217
OG0011063.43± 445.885
OG0021140.78± 343.685
OG0031242.99± 691.574
OG004917.67± 318.951
OG0051104.69± 488.709
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG003850.00± NAStandard deviation cannot be calculated for 1 participant.
Participants
OG004
27
ParticipantsOG00510
Title
Measurements
OG000781.83± 256.528
OG001274.20± 148.275
OG002629.56± 268.028
OG003628.00± 504.250
OG004281.01± 190.602
OG005495.76± 352.143
Participants
OG004
25
ParticipantsOG00511
Title
Measurements
OG0001243.17± 344.023
OG001932.50± 270.978
OG0021297.50± 310.962
OG0031325.33± 673.298
OG0041007.87± 365.807
OG0051039.36± 312.776
Participants
OG004
19
ParticipantsOG0059
Title
Measurements
OG000584.00± 318.198
OG001250.71± 122.473
OG002522.56± 266.403
OG003712.50± 689.429
OG004339.06± 170.950
OG005401.78± 283.485
Participants
OG004
16
ParticipantsOG0058
Title
Measurements
OG0001290.00± 608.112
OG001772.50± 296.855
OG0021146.88± 304.099
OG0031170.50± 635.689
OG0041218.19± 245.934
OG0051036.63± 313.181
Participants
OG004
11
ParticipantsOG0057
Title
Measurements
OG001172.40± 111.157
OG002422.29± 315.174
OG004511.27± 360.621
OG005545.81± 332.891
Participants
OG004
10
ParticipantsOG0056
Title
Measurements
OG001542.50± 365.574
OG002988.63± 372.345
OG0041367.50± 343.182
OG0051352.83± 389.004
Participants
OG004
8
ParticipantsOG0056
Title
Measurements
OG001349.50± 204.719
OG002422.00± 174.360
OG004370.75± 138.914
OG005291.67± 177.293
Participants
OG004
8
ParticipantsOG0055
Title
Measurements
OG001998.25± 111.870
OG0021210.00± 223.756
OG0041212.88± 531.496
OG005968.20± 249.544
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG002443.00± NAStandard deviation cannot be calculated for 1 participant.
ParticipantsOG00437
ParticipantsOG0058
Title
Measurements
OG000298.96± 203.651
OG001231.47± 203.912
OG002290.82± 138.712
OG003611.91± 411.501
OG004311.15± 307.602
OG005288.39± 184.303
11
ParticipantsOG00421
ParticipantsOG0053
Title
Measurements
OG00029.36± 33.138
OG00178.26± 90.758
OG002152.00± 57.983
OG003235.96± 189.895
OG004106.45± 198.336
OG00532.97± 44.045
8.8
± 1.27
OG0049.1± 1.39
OG00510.3± 1.74
OG0068.9± NAStandard deviation cannot be calculated for 1 participant.
ParticipantsOG00419
ParticipantsOG0056
ParticipantsOG0061
Title
Measurements
OG000-0.1± 1.23
OG001-0.7± 1.10
OG002-0.7± NAStandard deviation cannot be calculated for 1 participant.
OG003-0.8± 1.08
OG004-0.9± 0.92
OG005-1.3± 1.32
OG0060.1± NAStandard deviation cannot be calculated for 1 participant.