Study of Magrolimab Combination Therapy in Patients With... | NCT04958785 | Trialant
NCT04958785
Sponsor
Gilead Sciences
Status
Terminated
Last Update Posted
Nov 4, 2025Actual
Enrollment
92Actual
Phase
Phase 2
Conditions
Triple-Negative Breast Cancer
Interventions
Magrolimab
Nab-Paclitaxel
Paclitaxel
Sacituzumab Govitecan-hziy
Countries
United States
Australia
Hong Kong
South Korea
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04958785
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-586-6144
Secondary IDs
ID
Type
Description
Link
2021-001074-27
EudraCT Number
Brief Title
Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
Official Title
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer
Acronym
ELEVATE TNBC
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decision to terminate study.
Expanded Access Info
No
Start Date
Dec 14, 2021Actual
Primary Completion Date
Oct 8, 2024Actual
Completion Date
Oct 8, 2024Actual
First Submitted Date
Jul 1, 2021
First Submission Date that Met QC Criteria
Jul 1, 2021
First Posted Date
Jul 12, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Sep 12, 2025
Results First Submitted that Met QC Criteria
Sep 12, 2025
Results First Posted Date
Oct 3, 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
Oct 30, 2025
Last Update Posted Date
Nov 4, 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 goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with nab-paclitaxel or paclitaxel (cohort 1) or with sacituzumab govitecan-hziy (cohort 2) in participants with non-surgically removable locally advanced or metastatic triple-negative breast cancer.
The primary objective of this study for the safety run-in cohorts of the study is to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with nab-paclitaxel or paclitaxel (Safety Run-In Cohort 1), and sacituzumab govitecan (Safety Run-In Cohort 2) in metastatic triple-negative breast cancer (mTNBC).
This study in the Phase 2 Cohort 1 also compares the efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or paclitaxel alone, as determined by progression-free survival (PFS) by investigator assessment.
This study in the Phase 2 Cohort 2 also evaluates the efficacy of magrolimab in combination with sacituzumab govitecan as determined by confirmed objective response rate (ORR) by investigator assessment.
Detailed Description
Not provided
Conditions Module
Conditions
Triple-Negative Breast Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
92Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel or Paclitaxel
Experimental
Participants will receive magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-days cycle;
Nab-paclitaxel 100 mg/m^2 or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-days cycle.
Drug: Magrolimab
Drug: Nab-Paclitaxel
Drug: Paclitaxel
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Experimental
Participants will receive magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-days cycle;
Nab-paclitaxel 100 mg/m^2 or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-days cycle.
Drug: Magrolimab
Drug: Nab-Paclitaxel
Drug: Paclitaxel
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Active Comparator
Participants will receive nab-paclitaxel IV or paclitaxel IV as mentioned below:
Nab-paclitaxel 100 mg/m^2 or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle.
Participants will receive magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Magrolimab
Drug
Administered intravenously
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
A DLT is defined as any:
Grade 3 or higher hematologic toxicity including:
Hemolytic anemia that is medically significant, requiring hospitalization or prolongation of existing hospitalization, disabling, or limiting self-care activities of daily life.
Event meeting Hy's Law criteria:
Treatment-emergent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (at least 3 x ULN), AND
Treatment-emergent total bilirubin elevation (more than 2 x ULN), and absence of cholestasis (defined as alkaline phosphatase less than 2 x ULN), AND
No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, alcohol ingestion, congestive heart failure, worsening liver metastases).
Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment baseline during the DLT assessment period, and in the opinion of the investigator, the AE is at least possibly related to magrolimab.
First dose date up to 28 days (Cohort 1) and up to 21 days (Cohort 2)
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAEs are defined as any events not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. TEAEs were any AEs with an onset date on or after the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment, or the day before initiation of subsequent anticancer therapy, whichever comes first. An AE is any untoward medical occurrence in a clinical study patient administered a study drug that does not necessarily have a causal relationship with the treatment.
First dose date up to last dose date (up to 73 weeks) plus 30 days
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0
Treatment-emergent laboratory abnormalities according to NCI CTCAE V5.0 are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day before initiation of subsequent anti-cancer therapy. Grade 1 mild, Grade 2 moderate, Grade 3 severe, Grade 4 life-threatening and Grade 5 death.
Percentages were rounded off.
Secondary Outcomes
Measure
Description
Time Frame
Phase 2 Cohort 1: Confirmed ORR as Determined by Investigator Assessment Per RECIST, Version 1.1
ORR is defined as the percentage of participants who achieve a CR or PR that is confirmed at least 4 weeks after initial documentation of response, as measured by RECIST version 1.1, as determined by investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion criteria:
Adequate performance status, hematologic, renal and liver function.
Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
Cohort 1: Individuals with previously untreated with systemic therapy for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) that are considered programmed cell death ligand 1 (PD-L1) negative (as determined by an approved test according to local regulations).
Cohort 2: Individuals with unresectable, locally advanced or metastatic breast cancer with a diagnosis of TNBC who have received at least 1 and no more than 2 prior lines of systemic therapy in the unresectable, locally advanced or metastatic setting. Individuals must have been previously treated with a taxane in any setting. Individuals with tumors that are considered positive for PD-L1 expression (as determined by an approved test according to local regulations) must have received an immune checkpoint inhibitor for a prior-line of treatment for unresectable locally advanced/metastatic TNBC.
Key Exclusion Criteria:
Positive serum pregnancy test or breastfeeding female.
Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (who have been off steroids, radiation and/or surgery and/or other CNS-directed therapy for at least 4 weeks) are allowed.
Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. Red blood cell transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria.
History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha-targeting agents.
Known inherited or acquired bleeding disorders.
Cohort 1 only: Disease progression within 6 months following neoadjuvant/adjuvant therapy.
Cohort 2 only:
Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and Individuals with a history of bowel obstruction or gastrointestinal perforation within 6 months of enrollment.
Individuals who previously received topoisomerase I inhibitors or antibody-drug conjugates containing a topoisomerase inhibitor.
High-dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Cycle 1 Day 1.
Have not recovered (ie, ≥ Grade 2 is considered not recovered) from adverse events (AEs) due to a previously administered agent.
Note: Individuals with any grade of neuropathy, alopecia, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement are an exception to this criterion and will qualify for the study.
Note: if individuals received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks.
Participants did not receive paclitaxel in the Safety Run-in Cohort 1.
Participants will receive magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle.
First dose date up to last dose date (up to 73 weeks) plus 30 days
Phase 2 Cohort 1: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS was defined as the time from the date of randomization until the earliest date of documented disease progression (PD), as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Kaplan-Meier (KM) estimates were used in outcome measure analysis.
Up to 107 weeks
Safety Run-in Cohort 2 and Phase 2 Cohort 2: Confirmed Objective Response Rate (ORR) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as determined at least 4 weeks after initial documentation of response by investigator assessment per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.
Up to 107 weeks
Up to 107 weeks
Safety Run-in Cohort 2 and Phase 2 Cohort 2: PFS as Determined by Investigator Assessment Using RECIST Version 1.1
PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Up to 107 weeks
Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Duration of Response (DOR) as Determined by Investigator Assessment Per RECIST Version 1.1
DOR is defined as time from first documentation of CR or PR to the earliest date of documented PD, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
OS is defined as time from date of randomization to death from any cause.
Up to 107 weeks
Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing TEAEs
TEAEs are defined as any events not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. TEAEs were any AEs with an onset date on or after the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment, or the day before initiation of subsequent anticancer therapy, whichever comes first. An AE is any untoward medical occurrence in a clinical study patient administered a study drug that does not necessarily have a causal relationship with the treatment.
Percentages were rounded-off.
First dose date up to last dose date (up to 73 weeks) plus 30 days
Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI CTCAE, Version 5.0
Treatment-emergent laboratory abnormalities according to NCI CTCAE V5.0 are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day before initiation of subsequent anti-cancer therapy.
Percentages were rounded off.
First dose date up to last dose date (up to 73 weeks) plus 30 days
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time
Cohort 1: Predose - Day 1, 8, 22, 43, 85, 127, 190 and 253, Postdose 1 hour - Day 8 and 43; Cohort 2: Predose - Day 1, 8, 22, 43, 64, 85, 127, 190 and 253, Postdose 1 hour - Day 43 and 64
Percentage of Participants With Antidrug Antibodies (ADA) to Magrolimab
Up to 73 weeks
Fresno
California
93710
United States
Providence Medical Foundation
Fullerton
California
92835
United States
University of California San Francisco
San Francisco
California
94115
United States
Saint John's Cancer Institute
Santa Monica
California
90404
United States
Providence Medical Foundation
Santa Rosa
California
95403
United States
Mayo Clinic
Jacksonville
Florida
32224
United States
University Cancer & Blood Center,LLC
Athens
Georgia
30607
United States
Winship Cancer Institute Emory University
Atlanta
Georgia
30322
United States
Southeastern Regional Medical Center, LLC
Newnan
Georgia
30265
United States
Orchard Healthcare Research Inc
Skokie
Illinois
60077
United States
Ochsner Clinic Foundation
New Orleans
Louisiana
70121
United States
Allina Health Cancer Institute
Minneapolis
Minnesota
55407
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Astera Cancer Care
East Brunswick
New Jersey
08816
United States
NYU Investigational Pharmacy, Laura & Isaac Perlmutter Cancer Center
New York
New York
10016
United States
Stony Brook University
Stony Brook
New York
11794
United States
Charleston Oncology
Charleston
South Carolina
29414
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City
Utah
84112
United States
Cairns and Hinterland Hospital and Health Service
Cairns
Queensland
4870
Australia
University of the Sunshine Coast
Sippy Downs
Queensland
4556
Australia
Princess Alexandra Hospital
Woolloongabba
Queensland
4102
Australia
Cancer Research SA
Adelaide
South Australia
5000
Australia
Flinders Medical Centre
Bedford Park
South Australia
5042
Australia
Box Hill Hospital
Box Hill
Victoria
3128
Australia
St Vincent's Hospital Melbourne
Fitzroy
Victoria
3065
Australia
Peninsula Health
Frankston
Victoria
3199
Australia
Barwon Health- University Hospital Geelong
Geelong
Victoria
'03220
Australia
Ballarat Oncology & Haematology Services
Wendouree
Victoria
3355
Australia
Queen Mary Hospital
Hong Kong
Hong Kong
Princess Margaret Hospital
Kowloon
Hong Kong
Prince of Wales Hospital
New Territories
Hong Kong
Samsung Medical Center
Gangnam-Gu
06351
South Korea
National Cancer Center
Goyang-si
10408
South Korea
Seoul National University Hospital
Jongrogu
110-744
South Korea
Severance Hospital Yonsei University Health System
Seoul
03722
South Korea
Asan Medical Center
Seoul
5505
South Korea
Taipei Veterans General Hospital
Beitou District
11257
Taiwan
Changhua Christian Hospital
Changhua
50006
Taiwan
Chang Gung Memorial Hospital, Linkou
Guishan District
131
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Sanmin District
80778
Taiwan
National Taiwan University Hospital
Tapiei
Taiwan
University Hospitals of Leicester NHS Trust
Leicester
LE1 5WW
United Kingdom
University College London
London
WC1E 6BT
United Kingdom
The Christie NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
FG001
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks;
FG002
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below:
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks;
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks;
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks;
FG0008 subjects
FG00114 subjects
FG00214 subjects
FG00313 subjects
FG00443 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0008 subjects
FG00114 subjects
FG00214 subjects
FG00313 subjects
FG00443 subjects
Type
Comment
Reasons
Study Terminated by Sponsor
FG0004 subjects
FG00110 subjects
FG0027 subjects
FG0036 subjects
FG00434 subjects
Death
FG0002 subjects
FG0013 subjects
FG0024 subjects
FG0035 subjects
FG004
Withdrew consent
FG0002 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
Investigator's discretion
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participants in the Intent-To-Treat (ITT) Analysis Set (Phase 2 Cohort 1) and modified Intent-To-Treat (mITT) Analysis Set (Safety Run-in Cohort 1 and Cohort 2) were analyzed.
The ITT Analysis Set included all participants who were randomized in the Phase 2 Cohort 1.
The mITT Analysis Set included all enrolled participants who took at least 1 dose of study drug in Safety Run-in Cohort 1 and Cohort 2.
Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks.
Participants did not receive paclitaxel in the Safety Runi-in Cohort 1.
BG001
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.
BG002
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below:
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG00114
BG00214
BG00313
BG00442
BG00591
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
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054± 11.5
BG00158± 12.8
BG002
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG00113
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
South Korea
Title
Measurements
BG0000
BG0012
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
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
A DLT is defined as any:
Grade 3 or higher hematologic toxicity including:
Hemolytic anemia that is medically significant, requiring hospitalization or prolongation of existing hospitalization, disabling, or limiting self-care activities of daily life.
Event meeting Hy's Law criteria:
Treatment-emergent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (at least 3 x ULN), AND
Treatment-emergent total bilirubin elevation (more than 2 x ULN), and absence of cholestasis (defined as alkaline phosphatase less than 2 x ULN), AND
No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, alcohol ingestion, congestive heart failure, worsening liver metastases).
Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment baseline during the DLT assessment period, and in the opinion of the investigator, the AE is at least possibly related to magrolimab.
DLT-Evaluable Analysis Set included all participants who meet 1 of the following criteria:
Participant experienced a DLT at any time after initiation of the first infusion of magrolimab.
Participant did not experience a DLT and completed at least 3 infusions of magrolimab (28-day cycle), and at least 2 doses of nab-paclitaxel or paclitaxel (Safety Run-in Cohort 1 (SRiC1)), at least 2 infusions of magrolimab (21-day cycle), and at least 2 infusions of sacituzumab govitecan (SRiC2).
Posted
Number
percentage of participants
First dose date up to 28 days (Cohort 1) and up to 21 days (Cohort 2)
Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks.
Participants did not receive paclitaxel in the Safety Run-in Cohort 1.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.
Units
Counts
Participants
OG0006
OG00113
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Primary
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAEs are defined as any events not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. TEAEs were any AEs with an onset date on or after the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment, or the day before initiation of subsequent anticancer therapy, whichever comes first. An AE is any untoward medical occurrence in a clinical study patient administered a study drug that does not necessarily have a causal relationship with the treatment.
The Safety Analysis Set in the Safety Run-in Cohorts 1 and 2 included all participants who took at least 1 dose of any study drug.
Posted
Number
percentage of participants
First dose date up to last dose date (up to 73 weeks) plus 30 days
Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks.
Participants did not receive paclitaxel in the Safety Run-in Cohort 1.
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0
Treatment-emergent laboratory abnormalities according to NCI CTCAE V5.0 are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day before initiation of subsequent anti-cancer therapy. Grade 1 mild, Grade 2 moderate, Grade 3 severe, Grade 4 life-threatening and Grade 5 death.
Percentages were rounded off.
Participants in the Safety Run-in Cohorts 1 and 2 in the Safety Analysis Set were analyzed.
Posted
Number
percentage of participants
First dose date up to last dose date (up to 73 weeks) plus 30 days
Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks.
Participants did not receive paclitaxel in the Safety Run-in Cohort 1.
Phase 2 Cohort 1: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS was defined as the time from the date of randomization until the earliest date of documented disease progression (PD), as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Kaplan-Meier (KM) estimates were used in outcome measure analysis.
Participants from Phase 2 Cohort 1 in the Intent-to-treat (ITT) Analysis Set were analyzed.
Posted
Median
95% Confidence Interval
months
Up to 107 weeks
ID
Title
Description
OG000
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.
OG001
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Primary
Safety Run-in Cohort 2 and Phase 2 Cohort 2: Confirmed Objective Response Rate (ORR) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as determined at least 4 weeks after initial documentation of response by investigator assessment per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.
Participants in the modified Intent-To-Treat (mITT) Analysis Set (Cohort 2) were analyzed.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.
Phase 2 Cohort 1: Confirmed ORR as Determined by Investigator Assessment Per RECIST, Version 1.1
ORR is defined as the percentage of participants who achieve a CR or PR that is confirmed at least 4 weeks after initial documentation of response, as measured by RECIST version 1.1, as determined by investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.
Participants from the Phase 2 Cohort 1 in the ITT Analysis Set were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 107 weeks
ID
Title
Description
OG000
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.
OG001
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Secondary
Safety Run-in Cohort 2 and Phase 2 Cohort 2: PFS as Determined by Investigator Assessment Using RECIST Version 1.1
PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Participants in the mITT Analysis Set (Cohort 2) were analyzed.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Secondary
Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Duration of Response (DOR) as Determined by Investigator Assessment Per RECIST Version 1.1
DOR is defined as time from first documentation of CR or PR to the earliest date of documented PD, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Participants in the ITT Analysis Set (Cohort 1) and mITT Analysis Set (Cohort 2) with objective response were analyzed.
Posted
Median
95% Confidence Interval
months
Up to 107 weeks
ID
Title
Description
OG000
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.
OS is defined as time from date of randomization to death from any cause.
Participants in the ITT Analysis Set (Cohort 1) and mITT Analysis Set (Cohort 2) were analyzed.
Posted
Median
95% Confidence Interval
months
Up to 107 weeks
ID
Title
Description
OG000
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.
OG001
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below:
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.
Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing TEAEs
TEAEs are defined as any events not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. TEAEs were any AEs with an onset date on or after the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment, or the day before initiation of subsequent anticancer therapy, whichever comes first. An AE is any untoward medical occurrence in a clinical study patient administered a study drug that does not necessarily have a causal relationship with the treatment.
Percentages were rounded-off.
Participants in the Safety Analysis Set were analyzed.
Posted
Number
percentage of participants
First dose date up to last dose date (up to 73 weeks) plus 30 days
ID
Title
Description
OG000
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.
OG001
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Secondary
Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI CTCAE, Version 5.0
Treatment-emergent laboratory abnormalities according to NCI CTCAE V5.0 are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day before initiation of subsequent anti-cancer therapy.
Percentages were rounded off.
Participants in the Safety Analysis Set were analyzed.
Posted
Number
percentage of participants
First dose date up to last dose date (up to 73 weeks) plus 30 days
ID
Title
Description
OG000
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.
OG001
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below:
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.
Secondary
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time
Participants in the Pharmacokinetic (PK) Analysis set with available data were analyzed. The PK Analysis Set included all participants who received any amount of magrolimab and have at least 1 evaluable post-treatment serum concentration of magrolimab.
PK of magrolimab was evaluated in 2 combination therapy cohorts: Cohort 1 (Safety Run-in Cohort 1, and Phase 2 Cohort 1 Arm A), and Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2). The combined PK data were summarized and reported.
Posted
Mean
Standard Deviation
μg/mL
Cohort 1: Predose - Day 1, 8, 22, 43, 85, 127, 190 and 253, Postdose 1 hour - Day 8 and 43; Cohort 2: Predose - Day 1, 8, 22, 43, 64, 85, 127, 190 and 253, Postdose 1 hour - Day 43 and 64
Participants in the Safety Run-in Cohort 1 and Phase 2 Cohort 1 received magrolimab intravenous IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks;
Nab-paclitaxel 100 mg/m^2 or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks or
paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.
Percentage of Participants With Antidrug Antibodies (ADA) to Magrolimab
Participants in the Immunogenicity Analysis Set with available data were analyzed. The Immunogenicity Analysis Set included all participants who received any amount of magrolimab and have at least 1 evaluable anti-magrolimab antibody test results.
Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks.
Participants did not receive paclitaxel in the Safety Run-in Cohort 1.
OG001
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.
Time Frame
All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days
Description
All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening.
Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks.
Participants did not receive paclitaxel in the Safety Run-in Cohort 1.
2
8
5
8
8
8
EG001
Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks;
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.
3
14
4
14
14
14
EG002
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below:
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
5
43
7
42
41
42
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG0033 affected13 at risk
EG0041 affected42 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Breast abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Covid-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Haematoma
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0007 affected8 at risk
EG0015 affected14 at risk
EG0021 affected13 at risk
EG00311 affected13 at risk
EG00420 affected42 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected8 at risk
EG0015 affected14 at risk
EG0022 affected13 at risk
EG003
Red blood cell agglutination
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Dry eye
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Eye pain
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Vision blurred
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0022 affected13 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected14 at risk
EG0021 affected13 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0023 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected8 at risk
EG0015 affected14 at risk
EG0023 affected13 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected8 at risk
EG0014 affected14 at risk
EG0023 affected13 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0005 affected8 at risk
EG0012 affected14 at risk
EG0021 affected13 at risk
EG003
Chest discomfort
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected8 at risk
EG0013 affected14 at risk
EG0023 affected13 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0013 affected14 at risk
EG0024 affected13 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0004 affected8 at risk
EG0012 affected14 at risk
EG0023 affected13 at risk
EG003
Swelling face
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Covid-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 affected8 at risk
EG0011 affected14 at risk
EG0022 affected13 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0021 affected13 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0021 affected13 at risk
EG003
Otitis media
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0022 affected13 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Viral infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Wound infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Axillary web syndrome
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0002 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected14 at risk
EG0021 affected13 at risk
EG003
Basophil count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0021 affected13 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0013 affected14 at risk
EG0020 affected13 at risk
EG003
Blood iron decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Blood urea increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Culture urine positive
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Haptoglobin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Monocyte count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Red cell distribution width increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0022 affected13 at risk
EG003
Weight increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0022 affected13 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0021 affected13 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0022 affected13 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0021 affected13 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected14 at risk
EG0021 affected13 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0013 affected14 at risk
EG0021 affected13 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0013 affected14 at risk
EG0021 affected13 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0022 affected13 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0013 affected14 at risk
EG0024 affected13 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0022 affected13 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0022 affected13 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0022 affected13 at risk
EG003
Tenosynovitis stenosans
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Akathisia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Aura
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Cerebral venous sinus thrombosis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0014 affected14 at risk
EG0021 affected13 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0005 affected8 at risk
EG0016 affected14 at risk
EG0021 affected13 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0023 affected13 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected8 at risk
EG0013 affected14 at risk
EG0022 affected13 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0014 affected14 at risk
EG0022 affected13 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Device occlusion
Product Issues
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0022 affected13 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Urinary tract disorder
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0022 affected13 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected14 at risk
EG0023 affected13 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0013 affected14 at risk
EG0021 affected13 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0021 affected13 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Nasal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected8 at risk
EG0015 affected14 at risk
EG0026 affected13 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0021 affected13 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Nail bed bleeding
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Nail bed tenderness
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0022 affected13 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0014 affected14 at risk
EG0023 affected13 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected14 at risk
EG0022 affected13 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected14 at risk
EG0020 affected13 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected14 at risk
EG0020 affected13 at risk
EG003
Hot flush
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected14 at risk
EG0020 affected13 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected14 at risk
EG0021 affected13 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.
Units
Counts
Participants
OG0008
OG00113
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.
Units
Counts
Participants
OG0008
OG00113
Title
Denominators
Categories
Any Grade
Title
Measurements
OG000100.0
OG001100.0
Grade 3 or 4
Title
Measurements
OG00062.5
OG00184.6
Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below:
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.
Units
Counts
Participants
OG00014
OG00114
Title
Denominators
Categories
Title
Measurements
OG00013.9(3.5 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG00110.0(1.0 to NA)Upper limit of CI was not estimable due to low number of participants with events.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.1617
Hazard Ratio (HR)
0.456
2-Sided
95
0.147
1.409
Hazard Ratio (HR) along with its 2-sided 95% confidence interval (CI) were estimated using the Cox proportional hazards regression model.
Superiority
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Units
Counts
Participants
OG00013
OG00142
Title
Denominators
Categories
Title
Measurements
OG00030.8(9.1 to 61.4)
OG00138.1(23.6 to 54.4)
Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below:
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.
Units
Counts
Participants
OG00014
OG00114
Title
Denominators
Categories
Title
Measurements
OG00035.7(12.8 to 64.9)
OG00121.4(4.7 to 50.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds Ratio (OR)
2.037
2-Sided
95
0.379
10.938
Odds ratios and corresponding 95% CIs were estimated using chi-square test.
Superiority
Units
Counts
Participants
OG00013
OG00142
Title
Denominators
Categories
Title
Measurements
OG0007.1(1.4 to NA)Upper limit of confidence interval (CI) was not estimable due to low number of participants with events.
OG0015.5(4.0 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG001
Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below:
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG00316
Title
Denominators
Categories
Title
Measurements
OG00012.2(3.1 to NA)Upper limit of CI were not estimable due to low number of participants with events.
OG001NA(9.2 to NA)Median and upper limit of CI were not estimable due to low number of participants with events.
OG002NA(9.0 to NA)Median and upper limit of CI were not estimable due to low number of participants with events.
OG003NA(2.8 to NA)Median and upper limit of CI were not estimable due to low number of participants with events.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Units
Counts
Participants
OG00014
OG00114
OG00213
OG00342
Title
Denominators
Categories
Title
Measurements
OG000NA(8.9 to NA)Median and upper limit of CI were not estimable due to low number of participants with events.
OG001NA(2.4 to NA)Median and upper limit of CI were not estimable due to low number of participants with events.
OG00215.7(8.5 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG003NA(NA to NA)Median, lower and upper limit of CI were not estimable due to low number of participants with events.
Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below:
Nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Units
Counts
Participants
OG00014
OG00113
OG00242
Title
Denominators
Categories
Any Grade
Title
Measurements
OG000100.0
OG00184.6
OG002100.0
Grade 3 or 4
Title
Measurements
OG00064.3
OG0017.7
OG00278.6
Participants in the Safety Run-in Cohort 2 and Phase 2 Cohort 2 received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.
Units
Counts
Participants
OG00021
OG00153
Title
Denominators
Categories
Day 1 Predose
ParticipantsOG00021
ParticipantsOG00153
Title
Measurements
OG000NA± NAPredose data was not reported as it was below the limit of quantification.
OG001NA± NAPredose data was not reported as it was below the limit of quantification.
Day 8 Predose
ParticipantsOG00014
ParticipantsOG00149
Title
Measurements
OG0000.0700± 0.263
OG001
Day 8 1-Hour Postdose
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG000289± 164
Day 22 Predose
ParticipantsOG00016
ParticipantsOG00148
Title
Measurements
OG000559± 218
OG001
Day 43 Predose
ParticipantsOG00017
ParticipantsOG00141
Title
Measurements
OG000862± 322
OG001
Day 43 1-Hour Postdose
ParticipantsOG00013
ParticipantsOG00139
Title
Measurements
OG0001520± 415
OG001
Day 64 Predose
ParticipantsOG0000
ParticipantsOG0011
Title
Measurements
OG001490± NAStandard deviation cannot be calculated for one participant.
Day 64 1-Hour Postdose
ParticipantsOG0000
ParticipantsOG0011
Title
Measurements
OG001424± NAStandard deviation cannot be calculated for one participant.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.
Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below:
Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks;
Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Units
Counts
Participants
OG0008
OG00114
OG00213
OG00342
Title
Denominators
Categories
ADA Prevalence
ParticipantsOG0008
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG00342
Title
Measurements
OG00012.5
OG0017.1
OG00215.4
OG003
ADA Incidence
ParticipantsOG0007
ParticipantsOG00114
ParticipantsOG00212
ParticipantsOG00342
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
7 affected
13 at risk
EG00412 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
2 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0042 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0043 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0042 affected42 at risk
2 affected
13 at risk
EG0047 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
4 affected
13 at risk
EG00417 affected42 at risk
11 affected
13 at risk
EG00424 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
2 affected
13 at risk
EG0047 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
2 affected
13 at risk
EG0042 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0043 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
10 affected
13 at risk
EG00430 affected42 at risk
1 affected
13 at risk
EG00410 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
4 affected
13 at risk
EG0045 affected42 at risk
1 affected
13 at risk
EG0042 affected42 at risk
0 affected
13 at risk
EG0046 affected42 at risk
10 affected
13 at risk
EG00422 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0043 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0046 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
4 affected
13 at risk
EG0043 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0044 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0042 affected42 at risk
2 affected
13 at risk
EG0041 affected42 at risk
4 affected
13 at risk
EG0045 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
2 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
2 affected
13 at risk
EG0045 affected42 at risk
2 affected
13 at risk
EG0044 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0043 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0042 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
6 affected
13 at risk
EG00416 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0042 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0044 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
3 affected
13 at risk
EG0045 affected42 at risk
6 affected
13 at risk
EG00412 affected42 at risk
2 affected
13 at risk
EG0045 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
2 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
2 affected
13 at risk
EG0044 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
2 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0043 affected42 at risk
3 affected
13 at risk
EG0047 affected42 at risk
3 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0044 affected42 at risk
0 affected
13 at risk
EG0042 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0043 affected42 at risk
2 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0042 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
2 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG00413 affected42 at risk
1 affected
13 at risk
EG0043 affected42 at risk
3 affected
13 at risk
EG00414 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
2 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0043 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0045 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
2 affected
13 at risk
EG0042 affected42 at risk
1 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
3 affected
13 at risk
EG00410 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
4 affected
13 at risk
EG0047 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0043 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0043 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
3 affected
13 at risk
EG0045 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0044 affected42 at risk
2 affected
13 at risk
EG0041 affected42 at risk
2 affected
13 at risk
EG0044 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
3 affected
13 at risk
EG00411 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0041 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
2 affected
13 at risk
EG0046 affected42 at risk
2 affected
13 at risk
EG0044 affected42 at risk
1 affected
13 at risk
EG0042 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
0 affected
13 at risk
EG0040 affected42 at risk
1 affected
13 at risk
EG0042 affected42 at risk
1 affected
13 at risk
EG0040 affected42 at risk
2 affected
13 at risk
EG0043 affected42 at risk
0 affected
13 at risk
EG0043 affected42 at risk
NA
± NA
Predose data was not reported as it was below the limit of quantification.