Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) (ENHANCE)

• ClinicalTrials.gov Identifier: NCT04313881
• Recruitment Status: Terminated
• First Posted: March 18, 2020
• Results First Posted: March 21, 2024
• Last Update Posted: March 21, 2024
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Myelodysplastic Syndromes
• Interventions: Drug: Magrolimab; Drug: Azacitidine; Drug: Placebo
• Enrollment: 539

Participant Flow

Recruitment Details	Participants were enrolled at study sites in North America, Asia-Pacific Region, and Europe.
Pre-assignment Details	854 participants were screened.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Period Title: Overall Study
Started	268	271
Completed	0	0
Not Completed	268	271
Reason Not Completed
Death	138	126
Study terminated by sponsor	108	129
Consent withdrawn	19	15
Reason not Specified	3	1

Baseline Characteristics

Arm/Group Title		Magrolimab + Azacitidine	Placebo + Azacitidine	Total
Arm/Group Description		Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.	Total of all reporting groups
Overall Number of Baseline Participants		268	271	539
Baseline Analysis Population Description		The Intent-to-treat (ITT) Analysis Set included all participants who were randomized in the study, with treatment assignments designated according to the treatment that participants were randomized to.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	268 participants	271 participants	539 participants
	<=18 years	0	0	0
	Between 18 and 65 years	64	81	145
	>=65 years	204	190	394
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	268 participants	271 participants	539 participants
		70 (9.2)	68 (9.8)	69 (9.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	268 participants	271 participants	539 participants
	Female	87	94	181
	Male	181	177	358
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	268 participants	271 participants	539 participants
	Hispanic or Latino	13	21	34
	Non Hispanic or Latino	227	219	446
	Unknown	5	7	12
	Not Reported / Missing	23	24	47
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	268 participants	271 participants	539 participants
	American Indian Or Alaska Native	0	0	0
	Asian	14	14	28
	Black or African American	11	9	20
	Native Hawaiian Or Other Pacific Islander	0	0	0
	White	209	207	416
	Multiple	1	0	1
	Not reported / Missing	33	41	74
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	268 participants	271 participants	539 participants
Hong Kong		5 1.9%	3 1.1%	8 1.5%
Hungary		0 0.0%	1 0.4%	1 0.2%
United States		175 65.3%	177 65.3%	352 65.3%
United Kingdom		6 2.2%	3 1.1%	9 1.7%
Switzerland		0 0.0%	2 0.7%	2 0.4%
Portugal		2 0.7%	1 0.4%	3 0.6%
Spain		11 4.1%	16 5.9%	27 5.0%
New Zealand		1 0.4%	5 1.8%	6 1.1%
Canada		0 0.0%	2 0.7%	2 0.4%
Turkey		1 0.4%	1 0.4%	2 0.4%
Belgium		1 0.4%	0 0.0%	1 0.2%
Norway		1 0.4%	0 0.0%	1 0.2%
Finland		0 0.0%	2 0.7%	2 0.4%
Poland		3 1.1%	7 2.6%	10 1.9%
Italy		11 4.1%	2 0.7%	13 2.4%
France		9 3.4%	12 4.4%	21 3.9%
Australia		40 14.9%	35 12.9%	75 13.9%
Germany		2 0.7%	2 0.7%	4 0.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Complete Remission (CR)
Description	The percentage of participants (CR rate) are participants who reach morphologic CR (morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast) based on Investigator-assessed International Working Group (IWG) myelodysplastic syndrome (MDS) criteria on or prior to initiation of any new anticancer therapy, including stem cell therapy (SCT). Percentages were rounded off.
Time Frame	From randomization up to 31.01 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	268	271
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	21.3; (16.5 to 26.7)	23.6; (18.7 to 29.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Magrolimab + Azacitidine, Placebo + Azacitidine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5218
	Comments	2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.876
	Confidence Interval	(2-Sided) 95%; 0.585 to 1.312
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Overall Survival (OS)
Description	OS is defined as the number of months measured from the date of randomization to the date of death from any cause. Kaplan Meier (KM) estimates were used for analysis.
Time Frame	From randomization up to 32.62 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	268	271
Median (95% Confidence Interval); Unit of Measure: months
	15.9; (13.3 to 19.5)	18.6; (14.9 to 26.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Magrolimab + Azacitidine, Placebo + Azacitidine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1299
	Comments	2-sided P-value was based on stratified log-rank test, stratified by stratification factors.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.203
	Confidence Interval	(2-Sided) 95%; 0.947 to 1.528
	Estimation Comments	Hazard ratio and its 95% confidence interval (CI) were calculated using the Cox proportional hazards regression model, stratified by stratification factors.

3. Secondary Outcome

Title	Duration of CR (DOCR)
Description	DOCR=Time from first CR date to the first date of relapse, disease progression (PD) or death, whichever occurs earlier. PD is defined as: <5% blasts: ≥50 increase in blasts to >5% blasts,5%-10% blasts: ≥50% increase in blasts to >10% blasts, 10%-20% blasts: ≥50% increase in blasts to >20% blasts,20%-30% blasts: ≥50% increase in blasts to >30% blasts, any of the following: at least 50% decrement from maximum remission/response in granulocytes or platelets. Reduction in Hgb by ≥2 g/dL / Transfusion dependence. Relapse is defined as return to pretreatment bone marrow blast percentage / decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets/ reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependence. CR is defined in outcome measure 1. KM estimates were used for analysis.
Time Frame	From randomization up to 31.01 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set who achieved CR were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	57	64
Median (95% Confidence Interval); Unit of Measure: months
	10.9; (8.9 to 16.7)	11.1 [1]; (8.1 to NA)

[1]

Upper limit of CI was not estimable due to low number of participants with events.

4. Secondary Outcome

Title	Objective Response Rate (ORR)
Description	ORR is defined as the percentage of participants who reach objective response including CR, partial remission (PR), marrow CR or hematological improvement prior to initiation of any new anticancer therapy including SCT for MDS per IWG 2006 criteria per investigator's evaluation. CR is defined in outcome measure 1. PR is defined as all CR criteria if abnormal before treatment except, one marrow blasts decreased by ≥ 50% over pretreatment but still > 5% cellularity and morphology not relevant. Marrow CR is defined as bone marrow ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR. Stable Disease: Failure to achieve at least PR, but no evidence of progression for > 8 weeks. Percentages were rounded off.
Time Frame	From randomization up to 31.01 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	268	271
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	53.7; (47.6 to 59.8)	58.7; (52.6 to 64.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Magrolimab + Azacitidine, Placebo + Azacitidine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2563
	Comments	2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.821
	Confidence Interval	(2-Sided) 95%; 0.584 to 1.155
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Duration of Response (DOR)
Description	DOR is measured from time measurement criteria are first met for objective response to first date of relapse, disease progression (PD) /death, whichever occurs earlier. Disease progression and relapse have been defined in outcome measure number 3. KM estimates were used for analysis.
Time Frame	From randomization up to 31.01 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set with objective response were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	144	159
Median (95% Confidence Interval); Unit of Measure: months
	10.1; (8.1 to 12.5)	10.2; (7.6 to 12.9)

6. Secondary Outcome

Title	Red Blood Cell (RBC) Transfusion Independence Rate
Description	RBC transfusion independence rate is defined as the percentage of participants who have a 56-day or longer period with no RBC transfusions at any time between randomization and initiation of any new anticancer therapy, including SCT, among all participants who were RBC transfusion-dependent at Baseline. Percentages were rounded off.
Time Frame	From randomization up to 31.01 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set who were RBC transfusion-dependent at baseline were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	140	125
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	27.9; (20.6 to 36.1)	35.2; (26.9 to 44.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Magrolimab + Azacitidine, Placebo + Azacitidine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2191
	Comments	95% CI for transfusion independence rate was based on Clopper-Pearson exact method. 2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.720
	Confidence Interval	(2-Sided) 95%; 0.427 to 1.212
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Event Free Survival (EFS)
Description	EFS is defined as the time from randomization to transformation to acute myeloid leukemia (AML) or death from any cause, whichever occurs first. Transformation assessments and deaths post SCT were included in the analysis. KM estimates were used for analysis
Time Frame	From randomization up to 31.01 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	268	271
Median (95% Confidence Interval); Unit of Measure: months
	13.0; (10.2 to 15.9)	12.9; (10.8 to 14.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Magrolimab + Azacitidine, Placebo + Azacitidine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8788
	Comments	2-sided P-value was based on stratified log-rank test, stratified by stratification factors.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.979
	Confidence Interval	(2-Sided) 95%; 0.746 to 1.285
	Estimation Comments	Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.

8. Secondary Outcome

Title	Percentage of Participants With CR Rate in Participants With TP53 Mutation
Description	CR in TP53 mutant population is defined as the percentage of participants who achieve a morphologic CR based on investigator assessments using IWG criteria on or prior to initiation of any new anticancer therapy, including SCT in TP53 mutant population. Percentages were rounded off.
Time Frame	From randomization up to 31.01 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set with TP53 mutation were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	79	64
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	17.7; (10.0 to 27.9)	32.8; (21.6 to 45.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Magrolimab + Azacitidine, Placebo + Azacitidine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0375
	Comments	2-sided P-value, odds ratio and its 95% CI were based on unstratified Cochran-Mantel-Haenszel (CMH) method.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.441
	Confidence Interval	(2-Sided) 95%; 0.203 to 0.960
	Estimation Comments	95% CI for response rate was based on Clopper-Pearson exact method.

9. Secondary Outcome

Title	Minimal Residual Disease (MRD)-Negative Response Rate
Description	The MRD-negative response rate is defined as the percentage of participants who achieved a morphologic CR or marrow CR based on Investigator-assessed IWG criteria and reached MRD-negative disease status prior to initiation of any new anticancer therapy, including SCT. MRD-negative disease status was assessed using a multiparameter flow cytometry-based assay performed by a central laboratory. Transformation assessments post SCT were to be included in the analysis. Morphologic CR and marrow CR are defined in outcome measures 1 and 4, respectively. Percentages were rounded off.
Time Frame	From randomization up to 31.01 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	268	271
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	21.6; (16.9 to 27.1)	22.5; (17.7 to 28.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Magrolimab + Azacitidine, Placebo + Azacitidine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7950
	Comments	2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.947
	Confidence Interval	(2-Sided) 95%; 0.629 to 1.426
	Estimation Comments	95% CI for response rate was based on Clopper-Pearson exact method.

10. Secondary Outcome

Title	Time to Transformation to AML
Description	Time to transformation to AML is defined as the time from randomization to the collection date of bone marrow sample leading to documented AML diagnosis. KM estimates were used for analysis.
Time Frame	From randomization up to 31.01 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	268	271
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (21.2 to NA)	25.5 [2]; (25.5 to NA)

[1]

Median and upper limit of CI was not estimable due to low number of participants with events.

[2]

Upper limit of CI was not estimable due to low number of participants with events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Magrolimab + Azacitidine, Placebo + Azacitidine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4610
	Comments	2-sided P-value was based on stratified log-rank test, stratified by stratification factors.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.837
	Confidence Interval	(2-Sided) 95%; 0.522 to 1.343
	Estimation Comments	Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.

11. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	PFS is defined as the time from randomization to the date of documented DP (including treatment failure by IWG criteria or relapse after PR/CR), or death from any cause, whichever occurs first. Response assessments and deaths post SCT were included in the analysis. CR, PR and PD are defined in outcome measures 1, 4 and 5 respectively. KM estimates were used for analysis.
Time Frame	From randomization up to 31.01 months

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	268	271
Median (95% Confidence Interval); Unit of Measure: months
	9.0; (8.3 to 10.9)	9.4; (8.6 to 11.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Magrolimab + Azacitidine, Placebo + Azacitidine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8720
	Comments	2-sided P-value was based on stratified log-rank test, stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.020
	Confidence Interval	(2-Sided) 95%; 0.802 to 1.297
	Estimation Comments	Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.

12. Secondary Outcome

Title	Functional Assessment of Cancer Therapy-Anemia (FACT-Anemia) Response Rate
Description	The FACT-Anemia response rate is defined as the percentage of participants who showed clinically meaningful improvement in health-related quality of life (HRQoL) based on the score from the FACT-Anemia instrument prior to initiation of any new anticancer therapy, including SCT. The minimal clinically meaningful difference of 7.0 was used as cutoff for clinically meaningful improvement. The FACT-Anemia instrument consists of 5 subscales, including physical well-being, emotional well-being, functional well-being, social well-being, and anemia symptoms. Each subscale measures items on a 5-point Likert scale from 0 to 4, where 0 = not at all and 4 = very much. The subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest quality of life (QOL) and 100 denotes the highest QOL. Percentages were rounded off.
Time Frame	Up to week 136

Outcome Measure Data

Analysis Population Description

Participants from intent-to-treat analysis set were analyzed.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	268	271
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	37.7; (31.9 to 43.8)	49.8; (43.7 to 55.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Magrolimab + Azacitidine, Placebo + Azacitidine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors
Statistical Test of Hypothesis	P-Value	0.0048
	Comments	2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.605
	Confidence Interval	(2-Sided) 95%; 0.428 to 0.857
	Estimation Comments	95% CI for response rate was based on Clopper-Pearson exact method.

13. Secondary Outcome

Title	Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Description	Treatment-emergent adverse events (TEAEs) are defined as any AEs with an onset date on or after the study drug start date and no later than 70 days after the study drug last dose date or the day before initiation of new anticancer therapy including SCT (whichever is earlier). If the AE onset date is on or before the last dose date, the AE is considered as TEAE regardless of the start of new anticancer therapy. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol imposed intervention, regardless of attribution. An event is considered "serious", if it results in any of the following outcomes: death, life-threatening, inpatient or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, and important medical events.
Time Frame	First dose date up to 135.9 weeks plus 70 days (Up to 2.8 years)

Outcome Measure Data

Analysis Population Description

Participants from safety analysis set with data available were analyzed. The safety analysis set included all randomized participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.

Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
Overall Number of Participants Analyzed	263	264
Measure Type: Number; Unit of Measure: percentage of participants
TEAE	100	99.6
Serious TEAE	71.9	51.5

14. Secondary Outcome

Title	Serum Concentration of Magrolimab
Description	Pretreatment assessments for the initial dose may be collected up to 72 hours before administration of study treatment; thereafter, pretreatment assessments are to be collected within 24 hours prior to study treatment administration.
Time Frame	Preinfusion on Days 0, 7, 28, 56, 112, 168, 252 and 336

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) analysis set included all participants who took at least 1 dose of magrolimab and had at least 1 measurable post-treatment serum concentration of magrolimab. Participants with data available at the given timepoint were analyzed.

Arm/Group Title		Magrolimab + Azacitidine
Arm/Group Description:		Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.
Overall Number of Participants Analyzed		218
Mean (Standard Deviation); Unit of Measure: μg/mL
Preinfusion Day 0	Number Analyzed	216 participants
		0 (0)
Preinfusion Day 7	Number Analyzed	205 participants
		1.09 (15.575)
Preinfusion Day 28	Number Analyzed	197 participants
		500.13 (256.129)
Preinfusion Day 56	Number Analyzed	180 participants
		612.53 (315.037)
Preinfusion Day 112	Number Analyzed	125 participants
		295.64 (178.952)
Preinfusion Day 168	Number Analyzed	88 participants
		258.70 (150.259)
Preinfusion Day 252	Number Analyzed	58 participants
		299.63 (168.944)
Preinfusion Day 336	Number Analyzed	42 participants
		336.57 (241.789)

15. Secondary Outcome

Title	Percentage of Participants With Positive Anti-magrolimab Antibodies
Description	Percentages were rounded off.
Time Frame	Up to 72 hours before administration of any treatment at Day 1, Cycle 1; within 24 hours prior to any study drug administration at Day 1 of Cycles 2, 3, 5, 7, 10, and 13 and End of Treatment (± 7 Days after last study drug dose); Cycle length is 28 Days

Outcome Measure Data

Analysis Population Description

Participants in Immunogenicity Analysis Set with at least 1 baseline anti-drug antibody (ADA) sample and at least post-treatment ADA Sample were analyzed. Immunogenicity Analysis Set includes participants who took at least 1 dose of magrolimab and have at least 1 reported ADA result.

Arm/Group Title	Magrolimab + Azacitidine
Arm/Group Description:	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.
Overall Number of Participants Analyzed	230
Measure Type: Number; Unit of Measure: percentage of participants
	3.5

Adverse Events

Time Frame	Up to 135.9 weeks plus 70 days (Up to 2.8 years)
Adverse Event Reporting Description	All cause mortality: The intent-to-treat (ITT) analysis set included all participants who were randomized in the study, with treatment assignments designated according to the treatment that participants were randomized to. Adverse Events: The safety analysis set included all randomized participants who received at least 1 dose of any study treatment, with treatment assignments designated according to the actual treatment received.
Arm/Group Title	Magrolimab + Azacitidine	Placebo + Azacitidine
Arm/Group Description	Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years.	Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years.
All-Cause Mortality
	Magrolimab + Azacitidine	Placebo + Azacitidine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	145/268 (54.10%)	132/271 (48.71%)
Serious Adverse Events
	Magrolimab + Azacitidine	Placebo + Azacitidine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	189/263 (71.86%)	136/264 (51.52%)
Blood and lymphatic system disorders
Anaemia † 1	25/263 (9.51%)	7/264 (2.65%)
Aplastic anaemia † 1	0/263 (0.00%)	1/264 (0.38%)
Cold type haemolytic anaemia † 1	1/263 (0.38%)	0/264 (0.00%)
Extravascular haemolysis † 1	1/263 (0.38%)	0/264 (0.00%)
Febrile bone marrow aplasia † 1	2/263 (0.76%)	1/264 (0.38%)
Febrile neutropenia † 1	58/263 (22.05%)	44/264 (16.67%)
Haemolysis † 1	9/263 (3.42%)	0/264 (0.00%)
Haemolytic anaemia † 1	1/263 (0.38%)	0/264 (0.00%)
Heparin-induced thrombocytopenia † 1	1/263 (0.38%)	0/264 (0.00%)
Neutropenia † 1	1/263 (0.38%)	0/264 (0.00%)
Red blood cell agglutination † 1	1/263 (0.38%)	0/264 (0.00%)
Splenic infarction † 1	1/263 (0.38%)	0/264 (0.00%)
Splenomegaly † 1	1/263 (0.38%)	0/264 (0.00%)
Thrombocytopenia † 1	5/263 (1.90%)	1/264 (0.38%)
Cardiac disorders
Acute myocardial infarction † 1	1/263 (0.38%)	0/264 (0.00%)
Angina pectoris † 1	0/263 (0.00%)	1/264 (0.38%)
Atrial fibrillation † 1	6/263 (2.28%)	1/264 (0.38%)
Atrial flutter † 1	2/263 (0.76%)	0/264 (0.00%)
Atrial tachycardia † 1	1/263 (0.38%)	0/264 (0.00%)
Atrioventricular block complete † 1	0/263 (0.00%)	1/264 (0.38%)
Cardiac arrest † 1	3/263 (1.14%)	4/264 (1.52%)
Cardiac failure † 1	4/263 (1.52%)	0/264 (0.00%)
Cardiac failure acute † 1	0/263 (0.00%)	1/264 (0.38%)
Cardiac failure congestive † 1	1/263 (0.38%)	0/264 (0.00%)
Cardio-respiratory arrest † 1	0/263 (0.00%)	1/264 (0.38%)
Coronary artery disease † 1	1/263 (0.38%)	1/264 (0.38%)
Left ventricular dysfunction † 1	1/263 (0.38%)	0/264 (0.00%)
Myocardial infarction † 1	1/263 (0.38%)	0/264 (0.00%)
Myocarditis † 1	1/263 (0.38%)	0/264 (0.00%)
Pericarditis † 1	0/263 (0.00%)	1/264 (0.38%)
Pulseless electrical activity † 1	1/263 (0.38%)	0/264 (0.00%)
Sinus bradycardia † 1	1/263 (0.38%)	1/264 (0.38%)
Sinus tachycardia † 1	0/263 (0.00%)	1/264 (0.38%)
Stress cardiomyopathy † 1	1/263 (0.38%)	0/264 (0.00%)
Supraventricular tachycardia † 1	1/263 (0.38%)	1/264 (0.38%)
Ventricular fibrillation † 1	1/263 (0.38%)	0/264 (0.00%)
Ventricular tachycardia † 1	1/263 (0.38%)	0/264 (0.00%)
Eye disorders
Retinal haemorrhage † 1	1/263 (0.38%)	0/264 (0.00%)
Gastrointestinal disorders
Abdominal distension † 1	0/263 (0.00%)	1/264 (0.38%)
Abdominal pain † 1	3/263 (1.14%)	3/264 (1.14%)
Anal fistula † 1	0/263 (0.00%)	1/264 (0.38%)
Anal haemorrhage † 1	0/263 (0.00%)	1/264 (0.38%)
Anal ulcer † 1	0/263 (0.00%)	1/264 (0.38%)
Colitis † 1	1/263 (0.38%)	0/264 (0.00%)
Constipation † 1	2/263 (0.76%)	3/264 (1.14%)
Dental caries † 1	1/263 (0.38%)	0/264 (0.00%)
Diarrhoea † 1	3/263 (1.14%)	3/264 (1.14%)
Dysphagia † 1	0/263 (0.00%)	1/264 (0.38%)
Enteritis † 1	0/263 (0.00%)	1/264 (0.38%)
Enterocolitis † 1	0/263 (0.00%)	1/264 (0.38%)
Faecaloma † 1	1/263 (0.38%)	0/264 (0.00%)
Gastric haemorrhage † 1	2/263 (0.76%)	1/264 (0.38%)
Gastrointestinal haemorrhage † 1	2/263 (0.76%)	2/264 (0.76%)
Gastrointestinal inflammation † 1	1/263 (0.38%)	0/264 (0.00%)
Gastrointestinal ischaemia † 1	1/263 (0.38%)	0/264 (0.00%)
Haematochezia † 1	1/263 (0.38%)	0/264 (0.00%)
Ileus † 1	1/263 (0.38%)	1/264 (0.38%)
Intestinal obstruction † 1	1/263 (0.38%)	0/264 (0.00%)
Lower gastrointestinal haemorrhage † 1	0/263 (0.00%)	1/264 (0.38%)
Mouth swelling † 1	0/263 (0.00%)	1/264 (0.38%)
Mouth ulceration † 1	0/263 (0.00%)	1/264 (0.38%)
Nausea † 1	2/263 (0.76%)	2/264 (0.76%)
Neutropenic colitis † 1	0/263 (0.00%)	1/264 (0.38%)
Pancreatitis † 1	2/263 (0.76%)	0/264 (0.00%)
Pancreatitis acute † 1	0/263 (0.00%)	1/264 (0.38%)
Proctalgia † 1	1/263 (0.38%)	1/264 (0.38%)
Rectal haemorrhage † 1	3/263 (1.14%)	3/264 (1.14%)
Small intestinal haemorrhage † 1	0/263 (0.00%)	1/264 (0.38%)
Upper gastrointestinal haemorrhage † 1	1/263 (0.38%)	0/264 (0.00%)
Vomiting † 1	5/263 (1.90%)	1/264 (0.38%)
General disorders
Asthenia † 1	1/263 (0.38%)	1/264 (0.38%)
Catheter site haemorrhage † 1	1/263 (0.38%)	0/264 (0.00%)
Chest pain † 1	3/263 (1.14%)	0/264 (0.00%)
Chills † 1	1/263 (0.38%)	0/264 (0.00%)
Death † 1	1/263 (0.38%)	0/264 (0.00%)
Fatigue † 1	2/263 (0.76%)	4/264 (1.52%)
General physical health deterioration † 1	1/263 (0.38%)	0/264 (0.00%)
Generalised oedema † 1	1/263 (0.38%)	0/264 (0.00%)
Hyperthermia † 1	0/263 (0.00%)	1/264 (0.38%)
Influenza like illness † 1	0/263 (0.00%)	1/264 (0.38%)
Injection site irritation † 1	0/263 (0.00%)	1/264 (0.38%)
Localised oedema † 1	2/263 (0.76%)	0/264 (0.00%)
Multiple organ dysfunction syndrome † 1	2/263 (0.76%)	0/264 (0.00%)
Oedema peripheral † 1	0/263 (0.00%)	2/264 (0.76%)
Pain † 1	0/263 (0.00%)	1/264 (0.38%)
Pyrexia † 1	17/263 (6.46%)	16/264 (6.06%)
Sudden death † 1	1/263 (0.38%)	0/264 (0.00%)
Swelling face † 1	0/263 (0.00%)	1/264 (0.38%)
Systemic inflammatory response syndrome † 1	1/263 (0.38%)	0/264 (0.00%)
Hepatobiliary disorders
Acute hepatic failure † 1	1/263 (0.38%)	0/264 (0.00%)
Bile duct stone † 1	1/263 (0.38%)	0/264 (0.00%)
Cholangitis acute † 1	1/263 (0.38%)	0/264 (0.00%)
Cholecystitis acute † 1	0/263 (0.00%)	1/264 (0.38%)
Cholelithiasis † 1	1/263 (0.38%)	0/264 (0.00%)
Hepatosplenomegaly † 1	1/263 (0.38%)	0/264 (0.00%)
Hyperbilirubinaemia † 1	1/263 (0.38%)	0/264 (0.00%)
Immune system disorders
Haemophagocytic lymphohistiocytosis † 1	2/263 (0.76%)	0/264 (0.00%)
Hypersensitivity † 1	1/263 (0.38%)	0/264 (0.00%)
Infections and infestations
Abdominal infection † 1	1/263 (0.38%)	0/264 (0.00%)
Appendicitis † 1	1/263 (0.38%)	0/264 (0.00%)
Arthritis bacterial † 1	0/263 (0.00%)	1/264 (0.38%)
Arthritis infective † 1	1/263 (0.38%)	0/264 (0.00%)
Bacteraemia † 1	5/263 (1.90%)	2/264 (0.76%)
Bacterial infection † 1	0/263 (0.00%)	1/264 (0.38%)
Bacterial sepsis † 1	1/263 (0.38%)	1/264 (0.38%)
Bronchopulmonary aspergillosis † 1	2/263 (0.76%)	0/264 (0.00%)
Catheter site infection † 1	0/263 (0.00%)	1/264 (0.38%)
Cellulitis † 1	4/263 (1.52%)	7/264 (2.65%)
Clostridium difficile colitis † 1	1/263 (0.38%)	0/264 (0.00%)
Clostridium difficile infection † 1	1/263 (0.38%)	1/264 (0.38%)
Covid-19 † 1	5/263 (1.90%)	10/264 (3.79%)
Covid-19 pneumonia † 1	1/263 (0.38%)	2/264 (0.76%)
Device related infection † 1	0/263 (0.00%)	1/264 (0.38%)
Diverticulitis † 1	5/263 (1.90%)	1/264 (0.38%)
Empyema † 1	1/263 (0.38%)	0/264 (0.00%)
Enterocolitis infectious † 1	2/263 (0.76%)	0/264 (0.00%)
Escherichia urinary tract infection † 1	1/263 (0.38%)	0/264 (0.00%)
Furuncle † 1	1/263 (0.38%)	0/264 (0.00%)
Gastroenteritis † 1	1/263 (0.38%)	0/264 (0.00%)
Gastrointestinal infection † 1	1/263 (0.38%)	0/264 (0.00%)
Hcov-oc43 infection † 1	1/263 (0.38%)	0/264 (0.00%)
Incision site cellulitis † 1	1/263 (0.38%)	0/264 (0.00%)
Infection † 1	1/263 (0.38%)	1/264 (0.38%)
Influenza † 1	1/263 (0.38%)	0/264 (0.00%)
Injection site cellulitis † 1	1/263 (0.38%)	0/264 (0.00%)
Lower respiratory tract infection † 1	0/263 (0.00%)	1/264 (0.38%)
Lymph node tuberculosis † 1	0/263 (0.00%)	1/264 (0.38%)
Meningitis † 1	0/263 (0.00%)	1/264 (0.38%)
Mucormycosis † 1	0/263 (0.00%)	1/264 (0.38%)
Necrotising fasciitis † 1	0/263 (0.00%)	1/264 (0.38%)
Neutropenic infection † 1	0/263 (0.00%)	1/264 (0.38%)
Neutropenic sepsis † 1	6/263 (2.28%)	1/264 (0.38%)
Oral candidiasis † 1	0/263 (0.00%)	1/264 (0.38%)
Osteomyelitis † 1	1/263 (0.38%)	1/264 (0.38%)
Perirectal abscess † 1	0/263 (0.00%)	1/264 (0.38%)
Pneumocystis jirovecii pneumonia † 1	1/263 (0.38%)	0/264 (0.00%)
Pneumonia † 1	24/263 (9.13%)	11/264 (4.17%)
Pneumonia aspiration † 1	2/263 (0.76%)	1/264 (0.38%)
Pneumonia bacterial † 1	1/263 (0.38%)	0/264 (0.00%)
Pneumonia fungal † 1	0/263 (0.00%)	2/264 (0.76%)
Pneumonia viral † 1	1/263 (0.38%)	1/264 (0.38%)
Post procedural cellulitis † 1	1/263 (0.38%)	0/264 (0.00%)
Post procedural infection † 1	0/263 (0.00%)	1/264 (0.38%)
Postoperative wound infection † 1	1/263 (0.38%)	0/264 (0.00%)
Pseudomonal bacteraemia † 1	2/263 (0.76%)	0/264 (0.00%)
Rash pustular † 1	1/263 (0.38%)	0/264 (0.00%)
Respiratory tract infection viral † 1	0/263 (0.00%)	1/264 (0.38%)
Sepsis † 1	20/263 (7.60%)	13/264 (4.92%)
Septic shock † 1	6/263 (2.28%)	4/264 (1.52%)
Sinusitis † 1	2/263 (0.76%)	1/264 (0.38%)
Skin infection † 1	3/263 (1.14%)	2/264 (0.76%)
Soft tissue infection † 1	1/263 (0.38%)	1/264 (0.38%)
Staphylococcal bacteraemia † 1	1/263 (0.38%)	1/264 (0.38%)
Staphylococcal sepsis † 1	2/263 (0.76%)	1/264 (0.38%)
Streptococcal bacteraemia † 1	1/263 (0.38%)	0/264 (0.00%)
Thrombophlebitis septic † 1	0/263 (0.00%)	1/264 (0.38%)
Tooth infection † 1	0/263 (0.00%)	1/264 (0.38%)
Upper respiratory tract infection † 1	0/263 (0.00%)	1/264 (0.38%)
Urinary tract infection † 1	7/263 (2.66%)	2/264 (0.76%)
Vascular device infection † 1	3/263 (1.14%)	1/264 (0.38%)
Injury, poisoning and procedural complications
Fall † 1	3/263 (1.14%)	2/264 (0.76%)
Febrile nonhaemolytic transfusion reaction † 1	0/263 (0.00%)	1/264 (0.38%)
Infusion related reaction † 1	31/263 (11.79%)	1/264 (0.38%)
Overdose † 1	1/263 (0.38%)	0/264 (0.00%)
Post procedural haemorrhage † 1	1/263 (0.38%)	0/264 (0.00%)
Rib fracture † 1	1/263 (0.38%)	0/264 (0.00%)
Skin laceration † 1	1/263 (0.38%)	0/264 (0.00%)
Subdural haematoma † 1	1/263 (0.38%)	0/264 (0.00%)
Synovial rupture † 1	1/263 (0.38%)	0/264 (0.00%)
Transfusion reaction † 1	5/263 (1.90%)	0/264 (0.00%)
Vascular access complication † 1	1/263 (0.38%)	1/264 (0.38%)
Vascular procedure complication † 1	1/263 (0.38%)	0/264 (0.00%)
Investigations
Alanine aminotransferase increased † 1	3/263 (1.14%)	0/264 (0.00%)
Amylase increased † 1	1/263 (0.38%)	0/264 (0.00%)
Aspartate aminotransferase increased † 1	4/263 (1.52%)	0/264 (0.00%)
Blood bilirubin increased † 1	2/263 (0.76%)	2/264 (0.76%)
Blood creatinine increased † 1	1/263 (0.38%)	0/264 (0.00%)
Brain natriuretic peptide increased † 1	1/263 (0.38%)	0/264 (0.00%)
Electrocardiogram QT prolonged † 1	2/263 (0.76%)	0/264 (0.00%)
Escherichia test positive † 1	1/263 (0.38%)	0/264 (0.00%)
International normalised ratio increased † 1	1/263 (0.38%)	0/264 (0.00%)
Neutrophil count decreased † 1	0/263 (0.00%)	1/264 (0.38%)
Oxygen saturation decreased † 1	0/263 (0.00%)	1/264 (0.38%)
Platelet count decreased † 1	1/263 (0.38%)	2/264 (0.76%)
Troponin increased † 1	0/263 (0.00%)	1/264 (0.38%)
White blood cell count decreased † 1	1/263 (0.38%)	0/264 (0.00%)
Metabolism and nutrition disorders
Acidosis † 1	1/263 (0.38%)	0/264 (0.00%)
Failure to thrive † 1	1/263 (0.38%)	0/264 (0.00%)
Hyperglycaemia † 1	2/263 (0.76%)	0/264 (0.00%)
Hypoglycaemia † 1	1/263 (0.38%)	1/264 (0.38%)
Hypokalaemia † 1	1/263 (0.38%)	0/264 (0.00%)
Hyponatraemia † 1	1/263 (0.38%)	0/264 (0.00%)
Lactic acidosis † 1	1/263 (0.38%)	0/264 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/263 (0.00%)	2/264 (0.76%)
Arthritis † 1	0/263 (0.00%)	1/264 (0.38%)
Back pain † 1	1/263 (0.38%)	2/264 (0.76%)
Haemarthrosis † 1	1/263 (0.38%)	1/264 (0.38%)
Joint effusion † 1	0/263 (0.00%)	1/264 (0.38%)
Muscle mass † 1	1/263 (0.38%)	0/264 (0.00%)
Muscle necrosis † 1	0/263 (0.00%)	1/264 (0.38%)
Muscular weakness † 1	2/263 (0.76%)	0/264 (0.00%)
Musculoskeletal pain † 1	0/263 (0.00%)	1/264 (0.38%)
Osteoarthritis † 1	0/263 (0.00%)	1/264 (0.38%)
Pain in extremity † 1	1/263 (0.38%)	0/264 (0.00%)
Rhabdomyolysis † 1	1/263 (0.38%)	0/264 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma † 1	0/263 (0.00%)	1/264 (0.38%)
Squamous cell carcinoma † 1	1/263 (0.38%)	0/264 (0.00%)
Nervous system disorders
Cerebral haemorrhage † 1	1/263 (0.38%)	0/264 (0.00%)
Cerebrovascular accident † 1	0/263 (0.00%)	1/264 (0.38%)
Dizziness † 1	2/263 (0.76%)	1/264 (0.38%)
Dysarthria † 1	0/263 (0.00%)	1/264 (0.38%)
Encephalopathy † 1	2/263 (0.76%)	1/264 (0.38%)
Facial paralysis † 1	0/263 (0.00%)	1/264 (0.38%)
Haemorrhage intracranial † 1	2/263 (0.76%)	3/264 (1.14%)
Headache † 1	0/263 (0.00%)	1/264 (0.38%)
Hemiparesis † 1	1/263 (0.38%)	0/264 (0.00%)
Iiird nerve paralysis † 1	1/263 (0.38%)	0/264 (0.00%)
Ischaemic stroke † 1	1/263 (0.38%)	0/264 (0.00%)
Lethargy † 1	0/263 (0.00%)	1/264 (0.38%)
Presyncope † 1	1/263 (0.38%)	1/264 (0.38%)
Seizure † 1	3/263 (1.14%)	1/264 (0.38%)
Sigmoid sinus thrombosis † 1	0/263 (0.00%)	1/264 (0.38%)
Somnolence † 1	0/263 (0.00%)	1/264 (0.38%)
Syncope † 1	3/263 (1.14%)	3/264 (1.14%)
Psychiatric disorders
Anxiety † 1	1/263 (0.38%)	0/264 (0.00%)
Confusional state † 1	0/263 (0.00%)	2/264 (0.76%)
Delirium † 1	0/263 (0.00%)	2/264 (0.76%)
Mental status changes † 1	1/263 (0.38%)	0/264 (0.00%)
Suicidal ideation † 1	1/263 (0.38%)	0/264 (0.00%)
Renal and urinary disorders
Acute kidney injury † 1	4/263 (1.52%)	2/264 (0.76%)
Haematuria † 1	0/263 (0.00%)	2/264 (0.76%)
Nephrolithiasis † 1	1/263 (0.38%)	0/264 (0.00%)
Renal colic † 1	0/263 (0.00%)	1/264 (0.38%)
Renal failure † 1	0/263 (0.00%)	1/264 (0.38%)
Renal impairment † 1	1/263 (0.38%)	0/264 (0.00%)
Urinary bladder haemorrhage † 1	0/263 (0.00%)	1/264 (0.38%)
Urinary retention † 1	1/263 (0.38%)	0/264 (0.00%)
Reproductive system and breast disorders
Balanoposthitis † 1	0/263 (0.00%)	1/264 (0.38%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	3/263 (1.14%)	1/264 (0.38%)
Cough † 1	1/263 (0.38%)	0/264 (0.00%)
Dyspnoea † 1	5/263 (1.90%)	1/264 (0.38%)
Epistaxis † 1	1/263 (0.38%)	1/264 (0.38%)
Haemoptysis † 1	0/263 (0.00%)	2/264 (0.76%)
Hypoxia † 1	4/263 (1.52%)	1/264 (0.38%)
Laryngeal oedema † 1	0/263 (0.00%)	1/264 (0.38%)
Lung disorder † 1	1/263 (0.38%)	0/264 (0.00%)
Organising pneumonia † 1	0/263 (0.00%)	1/264 (0.38%)
Pleural effusion † 1	0/263 (0.00%)	1/264 (0.38%)
Pleuritic pain † 1	1/263 (0.38%)	0/264 (0.00%)
Pneumonitis † 1	1/263 (0.38%)	1/264 (0.38%)
Pulmonary embolism † 1	4/263 (1.52%)	3/264 (1.14%)
Pulmonary hypertension † 1	1/263 (0.38%)	0/264 (0.00%)
Pulmonary oedema † 1	2/263 (0.76%)	1/264 (0.38%)
Respiratory distress † 1	1/263 (0.38%)	0/264 (0.00%)
Respiratory failure † 1	7/263 (2.66%)	3/264 (1.14%)
Skin and subcutaneous tissue disorders
Rash † 1	1/263 (0.38%)	1/264 (0.38%)
Rash maculo-papular † 1	1/263 (0.38%)	0/264 (0.00%)
Skin lesion † 1	1/263 (0.38%)	0/264 (0.00%)
Skin ulcer † 1	0/263 (0.00%)	1/264 (0.38%)
Vascular disorders
Blood pressure inadequately controlled † 1	0/263 (0.00%)	1/264 (0.38%)
Deep vein thrombosis † 1	2/263 (0.76%)	0/264 (0.00%)
Embolism † 1	2/263 (0.76%)	1/264 (0.38%)
Embolism arterial † 1	1/263 (0.38%)	0/264 (0.00%)
Haematoma † 1	0/263 (0.00%)	1/264 (0.38%)
Hypotension † 1	4/263 (1.52%)	6/264 (2.27%)
Orthostatic hypotension † 1	0/263 (0.00%)	1/264 (0.38%)
Peripheral arterial occlusive disease † 1	1/263 (0.38%)	0/264 (0.00%)
Peripheral artery thrombosis † 1	0/263 (0.00%)	1/264 (0.38%)
Phlebitis † 1	0/263 (0.00%)	1/264 (0.38%)
Shock haemorrhagic † 1	2/263 (0.76%)	0/264 (0.00%)
Vasculitis † 1	0/263 (0.00%)	1/264 (0.38%)
1 Term from vocabulary, MedDRA 26.0.; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Magrolimab + Azacitidine	Placebo + Azacitidine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	246/263 (93.54%)	256/264 (96.97%)
Blood and lymphatic system disorders
Anaemia † 1	124/263 (47.15%)	75/264 (28.41%)
Febrile neutropenia † 1	14/263 (5.32%)	14/264 (5.30%)
Neutropenia † 1	63/263 (23.95%)	60/264 (22.73%)
Thrombocytopenia † 1	54/263 (20.53%)	46/264 (17.42%)
Cardiac disorders
Atrial fibrillation † 1	17/263 (6.46%)	9/264 (3.41%)
Palpitations † 1	16/263 (6.08%)	7/264 (2.65%)
Sinus tachycardia † 1	12/263 (4.56%)	14/264 (5.30%)
Gastrointestinal disorders
Abdominal pain † 1	39/263 (14.83%)	25/264 (9.47%)
Constipation † 1	144/263 (54.75%)	150/264 (56.82%)
Diarrhoea † 1	102/263 (38.78%)	89/264 (33.71%)
Haemorrhoids † 1	13/263 (4.94%)	15/264 (5.68%)
Nausea † 1	133/263 (50.57%)	114/264 (43.18%)
Oral pain † 1	17/263 (6.46%)	9/264 (3.41%)
Stomatitis † 1	22/263 (8.37%)	25/264 (9.47%)
Vomiting † 1	53/263 (20.15%)	55/264 (20.83%)
General disorders
Asthenia † 1	22/263 (8.37%)	15/264 (5.68%)
Chills † 1	41/263 (15.59%)	22/264 (8.33%)
Fatigue † 1	105/263 (39.92%)	101/264 (38.26%)
Injection site reaction † 1	18/263 (6.84%)	26/264 (9.85%)
Non-cardiac chest pain † 1	14/263 (5.32%)	14/264 (5.30%)
Oedema peripheral † 1	62/263 (23.57%)	46/264 (17.42%)
Pain † 1	14/263 (5.32%)	12/264 (4.55%)
Pyrexia † 1	75/263 (28.52%)	39/264 (14.77%)
Infections and infestations
Covid-19 † 1	23/263 (8.75%)	22/264 (8.33%)
Pneumonia † 1	21/263 (7.98%)	8/264 (3.03%)
Urinary tract infection † 1	14/263 (5.32%)	13/264 (4.92%)
Injury, poisoning and procedural complications
Contusion † 1	31/263 (11.79%)	34/264 (12.88%)
Fall † 1	29/263 (11.03%)	21/264 (7.95%)
Infusion related reaction † 1	72/263 (27.38%)	40/264 (15.15%)
Investigations
Alanine aminotransferase increased † 1	19/263 (7.22%)	15/264 (5.68%)
Aspartate aminotransferase increased † 1	14/263 (5.32%)	13/264 (4.92%)
Blood bilirubin increased † 1	27/263 (10.27%)	8/264 (3.03%)
Blood creatinine increased † 1	13/263 (4.94%)	16/264 (6.06%)
Lymphocyte count decreased † 1	18/263 (6.84%)	13/264 (4.92%)
Neutrophil count decreased † 1	67/263 (25.48%)	59/264 (22.35%)
Platelet count decreased † 1	71/263 (27.00%)	64/264 (24.24%)
Weight decreased † 1	18/263 (6.84%)	11/264 (4.17%)
White blood cell count decreased † 1	47/263 (17.87%)	41/264 (15.53%)
Metabolism and nutrition disorders
Decreased appetite † 1	72/263 (27.38%)	47/264 (17.80%)
Hyperglycaemia † 1	19/263 (7.22%)	15/264 (5.68%)
Hypoalbuminaemia † 1	20/263 (7.60%)	14/264 (5.30%)
Hypokalaemia † 1	50/263 (19.01%)	31/264 (11.74%)
Hypomagnesaemia † 1	17/263 (6.46%)	21/264 (7.95%)
Hyponatraemia † 1	18/263 (6.84%)	18/264 (6.82%)
Hypophosphataemia † 1	23/263 (8.75%)	20/264 (7.58%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	41/263 (15.59%)	47/264 (17.80%)
Back pain † 1	24/263 (9.13%)	21/264 (7.95%)
Muscle spasms † 1	13/263 (4.94%)	14/264 (5.30%)
Muscular weakness † 1	26/263 (9.89%)	24/264 (9.09%)
Neck pain † 1	6/263 (2.28%)	17/264 (6.44%)
Pain in extremity † 1	20/263 (7.60%)	28/264 (10.61%)
Nervous system disorders
Dizziness † 1	46/263 (17.49%)	46/264 (17.42%)
Dysgeusia † 1	19/263 (7.22%)	13/264 (4.92%)
Headache † 1	49/263 (18.63%)	60/264 (22.73%)
Psychiatric disorders
Anxiety † 1	24/263 (9.13%)	19/264 (7.20%)
Insomnia † 1	35/263 (13.31%)	30/264 (11.36%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	55/263 (20.91%)	38/264 (14.39%)
Dyspnoea † 1	57/263 (21.67%)	42/264 (15.91%)
Epistaxis † 1	27/263 (10.27%)	34/264 (12.88%)
Hypoxia † 1	14/263 (5.32%)	11/264 (4.17%)
Nasal congestion † 1	7/263 (2.66%)	16/264 (6.06%)
Oropharyngeal pain † 1	21/263 (7.98%)	15/264 (5.68%)
Pleural effusion † 1	20/263 (7.60%)	10/264 (3.79%)
Skin and subcutaneous tissue disorders
Pruritus † 1	31/263 (11.79%)	25/264 (9.47%)
Rash † 1	19/263 (7.22%)	21/264 (7.95%)
Rash maculo-papular † 1	18/263 (6.84%)	16/264 (6.06%)
Vascular disorders
Hypertension † 1	16/263 (6.08%)	15/264 (5.68%)
Hypotension † 1	42/263 (15.97%)	22/264 (8.33%)
1 Term from vocabulary, MedDRA 26.0.; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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

Results Point of Contact

• Name/Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences
• Phone: 1-833-445-3230 (GILEAD-0)
• EMail: GileadClinicalTrials@gilead.com

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT04313881
• Other Study ID Numbers: 5F9009; 2020-004287-26 ( EudraCT Number )
• First Submitted: March 11, 2020
• First Posted: March 18, 2020
• Results First Submitted: February 15, 2024
• Results First Posted: March 21, 2024
• Last Update Posted: March 21, 2024