Trial Outcomes & Findings for Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients (NCT NCT03459287)

NCT ID: NCT03459287

Last Updated: 2025-09-10

Results Overview

Any raised serum creatinine (sCr) level, occurring after transfusion of a study RBC, of ≥0.3 mg/dL (or 26.5 µmol/L) from the pre-surgery baseline within 48±4 hours of the end of surgery.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 581 participants
• Primary outcome timeframe: Within 48±4 hours of the end of surgery
• Results posted on: 2025-09-10

Participant Flow

636 subjects consented, 16 subjects did not meet inclusion criteria; 28 subjects met exclusion criteria; 11 other (surgery cancelled, subject chose not to be randomized), 581 subjects enrolled.

Participant milestones

Measure	INTERCEPT (Test) The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Overall Study STARTED	296	285
Overall Study COMPLETED	136	136
Overall Study NOT COMPLETED	160	149

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients

Baseline characteristics by cohort

Measure	INTERCEPT (Test) n=296 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=285 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs	Total n=581 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	128 Participants n=5 Participants	136 Participants n=7 Participants	264 Participants n=5 Participants
Age, Categorical >=65 years	168 Participants n=5 Participants	149 Participants n=7 Participants	317 Participants n=5 Participants
Age, Continuous	64.4 Years STANDARD_DEVIATION 13.1 • n=5 Participants	63.2 Years STANDARD_DEVIATION 12.7 • n=7 Participants	63.8 Years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	122 Participants n=5 Participants	112 Participants n=7 Participants	234 Participants n=5 Participants
Sex: Female, Male Male	174 Participants n=5 Participants	173 Participants n=7 Participants	347 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	282 Participants n=5 Participants	271 Participants n=7 Participants	553 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	31 Participants n=5 Participants	28 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) White	258 Participants n=5 Participants	245 Participants n=7 Participants	503 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	296 Participants n=5 Participants	285 Participants n=7 Participants	581 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 48±4 hours of the end of surgery

Population: Participants who received at least one study transfusion with available data on the outcome.

Any raised serum creatinine (sCr) level, occurring after transfusion of a study RBC, of ≥0.3 mg/dL (or 26.5 µmol/L) from the pre-surgery baseline within 48±4 hours of the end of surgery.

Outcome measures

Measure	INTERCEPT (Test) n=157 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=161 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Percentage of Patients Who Have Received at Least One Study Transfusion With a Diagnosis of Renal Impairment Defined as:	46 Participants	45 Participants

PRIMARY outcome

Timeframe: From the start of the first study transfusion to 28 days after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).

Population: Participants who received at least one study transfusion with available data on the outcome.

Percentage of patients with any treatment-emergent adverse events (TEAEs) possibly, probably or definitely related to study RBC transfusion through 28 days after the last study transfusion.

Outcome measures

Measure	INTERCEPT (Test) n=159 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=162 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Percentage of Patients With Related Adverse Events	4 Participants	1 Participants

PRIMARY outcome

Timeframe: From the start of the first study transfusion to 75 days after the last study transfusion (between 76-82 days depending on the day of the last study transfusion).

Population: Participants who received at least one study transfusion with available data on the outcome.

Percentage of patients with treatment-emergent antibodies with confirmed specificity to INTERCEPT RBCs by the end of study.

Outcome measures

Measure	INTERCEPT (Test) n=159 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=162 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Percentage of Patients With Treatment Emergent Antibodies	5 Participants	0 Participants

SECONDARY outcome

Timeframe: 7 days

The percentage of patients with a diagnosis of stage I, II, or III Acute Kidney Injury (KDIGO 2012) by day 7 post surgery, as defined by the change in serum creatinine (sCr) from baseline and the need for renal replacement therapy, i.e. clinical worsening of outcome from Stage I to Stage III. Stage I: sCr 1.5-1.9 times baseline within 7 days after surgery or > or=0.3 mg/dl (> or= 26.5 micromol/L) increase within 48 hrs of surgery; Stage II: sCr 2.0-2.9 times baseline within 7 days after surgery; Stage III: sCr 3.0 times baseline within 7 days after surgery or increase in sCr to > or=4.0 mg/dl (> or=353.6 micromol/L) or initiation of renal replacement therapy.

Outcome measures

Measure	INTERCEPT (Test) n=159 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=162 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Percentage of Patients With a Diagnosis of Stage I, II or III Acute Kidney Injury Diagnosis of KDIGO Stage II	8 Participants	9 Participants
Percentage of Patients With a Diagnosis of Stage I, II or III Acute Kidney Injury Diagnosis of KDIGO Stage III	15 Participants	7 Participants
Percentage of Patients With a Diagnosis of Stage I, II or III Acute Kidney Injury Diagnosis of KDIGO Stage I	36 Participants	39 Participants

SECONDARY outcome

Timeframe: 30 days

Mortality or the need for RRT by 30 days post surgery

Outcome measures

Measure	INTERCEPT (Test) n=159 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=162 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Mortality or the Need for RRT	16 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the start of the first study transfusion to 28 after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).

Population: Participants who received at least one study transfusion with available data on the outcome.

Treatment-emergent (TE) immunization to RBC alloantigens through 28 ± 3 days after the last study transfusion.

Outcome measures

Measure	INTERCEPT (Test) n=159 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=162 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Number of Participants With Treatment-emergent (TE) Immunization to RBC Alloantigens	1 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the start of the first study transfusion to 28 days after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).

Population: Participants who received at least one study transfusion with available data on the outcome.

Transfusion reactions (as defined by the CDC National Healthcare Safety Network) through 28 days after the last study transfusion

Outcome measures

Measure	INTERCEPT (Test) n=159 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=162 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Number of Participants With Transfusion Reactions (TR)	4 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the start of the first study transfusion to 28 days after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).

Population: Participants who received at least one study transfusion with available data on the outcome.

Treatment-emergent SAEs through 28 days after the last study transfusion

Outcome measures

Measure	INTERCEPT (Test) n=159 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=162 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Number of Participants With Serious Adverse Events (SAEs)	66 Participants	57 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).

Population: Data only available for a subset of subjects with samples collected both at baseline and Day 28, therefore only 114 INTERCEPT (Test) participants and 113 Conventional (Control) participants were available for analysis, as seen in Outcome Measure Data Table below.

Treatment emergent HLA Class 1 or Class 2 antibodies at high cutoff values

Outcome measures

Measure	INTERCEPT (Test) n=114 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=113 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Number of Participants With Treatment Emergent Immunization to HLA Alloantigens Through 28 ± 3 Days From After the Last Study Transfusion HLA Class 1	17 Participants	13 Participants
Number of Participants With Treatment Emergent Immunization to HLA Alloantigens Through 28 ± 3 Days From After the Last Study Transfusion HLA Class 2	8 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the start of the first study transfusion to 28 days after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).

Population: Participants who received at least one study transfusion with available data on the outcome.

Treatment emergent adverse events through 28 days after the last study transfusion.

Outcome measures

Measure	INTERCEPT (Test) n=159 Participants The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=162 Participants The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Number of Participants With Treatment Emergent AEs Through 28 Days After the Last Study Transfusion.	153 Participants	147 Participants

Adverse Events

INTERCEPT (Test)

Serious events: 66 serious events

Other events: 152 other events

Deaths: 13 deaths

Conventional (Control)

Serious events: 57 serious events

Other events: 145 other events

Deaths: 10 deaths

Serious adverse events

Measure	INTERCEPT (Test) n=159 participants at risk The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=162 participants at risk The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Blood and lymphatic system disorders anaemia	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Blood and lymphatic system disorders Coagulopathy	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	2.5% 4/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Blood and lymphatic system disorders Thrombocytopenia	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Arrhythmia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Arrhythmia supraventricular	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Atrial fibrillation	5.0% 8/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Atrial flutter	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Atrioventricular block	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Atrioventricular block complete	1.9% 3/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.9% 3/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Bradyarrhythmia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Bradycardia	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Cardiac arrest	2.5% 4/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	2.5% 4/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Cardiac failure	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Cardiac failure acute	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Cardiac failure congestive	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Cardiac tamponade	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.9% 3/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Cardiogenic shock	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	2.5% 4/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Cardiopulmonary failure	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Coronary artery thrombosis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Nodal rhythm	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Pericardial effusion	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Pericardial haemorrhage	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Pericarditis	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Prosthetic cardiac valve thrombosis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Right ventricular dysfunction	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Right ventricular failure	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Sinus arrest	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Sinus node dysfunction	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Supraventricular tachycardia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Tachycardia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Ventricular dysfunction	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Ventricular fibrillation	1.9% 3/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Ventricular tachycardia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Abdominal pain	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Enteritis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Gastrointestinal angiectasia	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Haematemesis	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Ileus	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Intestinal ischaemia	2.5% 4/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Pneumoperitoneum	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Volvulus	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
General disorders Effusion	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
General disorders Impaired healing	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
General disorders Medical device site haemorrhage	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
General disorders Multiple organ dysfunction syndrome	4.4% 7/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
General disorders Necrosis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
General disorders Peripheral swelling	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
General disorders Pyrexia	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Hepatobiliary disorders Hepatobiliary disorders	3.1% 5/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Hepatobiliary disorders Ischaemic hepatitis	2.5% 4/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Hepatobiliary disorders Liver injury	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Bacteraemia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Cellulitis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Corona virus infection	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Endocarditis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Klebsiella bacteraemia	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Pneumonia	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	3.1% 5/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Pneumonia klebsiella	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Sepsis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Septic shock	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Urinary tract infection	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Wound infection	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Injury, poisoning and procedural complications Postoperative ileus	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Injury, poisoning and procedural complications Procedural haemorrhage	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	2.5% 4/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Injury, poisoning and procedural complications Toxicity to various agents	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Injury, poisoning and procedural complications Transfusion-related circulatory overload	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Injury, poisoning and procedural complications Vasoplegia syndrome	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Investigations Aspartate aminotransferase increased	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Investigations Blood creatinine increased	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Dehydration	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Fluid overload	2.5% 4/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Hyperkalaemia	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Hyperphosphataemia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Hypoglycaemia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Hyponatraemia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Lactic acidosis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Malnutrition	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Metabolic acidosis	1.9% 3/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Musculoskeletal and connective tissue disorders Compartment syndrome	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Nervous system disorders Cerebral haemorrhage	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Nervous system disorders Cerebral infarction	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Nervous system disorders Cerebrovascular accident	1.9% 3/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Nervous system disorders Encephalopathy	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Nervous system disorders Ischaemic stroke	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Nervous system disorders Nervous system disorder	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Nervous system disorders Syncope	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Nervous system disorders Vocal cord paralysis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Psychiatric disorders Delirium	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Psychiatric disorders Mental status changes	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Renal and urinary disorders Acute kidney injury	9.4% 15/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.9% 3/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Renal and urinary disorders Chronic kidney disease	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Renal and urinary disorders Renal infarct	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Renal and urinary disorders Renal injury	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Renal and urinary disorders Urinary retention	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Mediastinal haematoma	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Mediastinal haemorrhage	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.1% 5/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.9% 11/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	7.4% 12/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Aortic thrombosis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Deep vein thrombosis	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Haematoma	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Haemorrhage	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Hypoperfusion	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Hypotension	3.8% 6/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	1.2% 2/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Peripheral artery thrombosis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Peripheral ischaemia	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Shock	0.00% 0/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Shock haemorrhagic	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.62% 1/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Thrombosis	0.63% 1/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	0.00% 0/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.

Other adverse events

Measure	INTERCEPT (Test) n=159 participants at risk The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. INTERCEPT: Pathogen reduced RBCs	Conventional (Control) n=162 participants at risk The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. Control: Conventional RBCs
Blood and lymphatic system disorders Anaemia	29.6% 47/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	24.1% 39/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Blood and lymphatic system disorders Haemorrhagic anaemia	13.8% 22/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	12.3% 20/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Blood and lymphatic system disorders Leukocytosis	5.7% 9/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	3.7% 6/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Blood and lymphatic system disorders Thrombocytopenia	31.4% 50/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	25.3% 41/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Atrial fibrillation	22.0% 35/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	33.3% 54/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Cardiac disorders Atrial flutter	1.3% 2/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	5.6% 9/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Gastrointestinal disorders Nausea	5.7% 9/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	4.9% 8/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
General disorders Pyrexia	3.8% 6/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	6.8% 11/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Infections and infestations Urinary tract infection	6.9% 11/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	4.9% 8/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Injury, poisoning and procedural complications Procedural pain	18.2% 29/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	15.4% 25/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Investigations Transaminases increased	3.8% 6/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	5.6% 9/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Fluid overload	4.4% 7/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	8.0% 13/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Hyperglycaemia	19.5% 31/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	17.3% 28/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Hypocalcaemia	17.6% 28/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	16.7% 27/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Hypokalaemia	13.8% 22/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	14.8% 24/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Hypomagnesaemia	6.3% 10/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	7.4% 12/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Metabolism and nutrition disorders Hypophosphataemia	13.2% 21/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	14.2% 23/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Psychiatric disorders Delirium	3.8% 6/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	5.6% 9/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Renal and urinary disorders Acute kidney injury	17.0% 27/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	21.0% 34/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Atelectasis	3.8% 6/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	6.2% 10/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.3% 18/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	15.4% 25/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.9% 3/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	7.4% 12/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	3.1% 5/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	6.2% 10/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	9.4% 15/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	8.6% 14/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Hypertension	5.7% 9/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	6.8% 11/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.
Vascular disorders Hypotension	10.1% 16/159 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.	13.0% 21/162 • Adverse Events from the first study transfusion until 28 days following the last transfusion (29-35 days after the first transfusion). All cause mortality was assessed 75 days following the last transfusion (76-82 days after the first study transfusion). The number of participants at risk for adverse events includes all randomized subjects who received at least one study transfusion, based on the actual treatment received.

Additional Information

Richard Benjamin, M.D., Ph.D.

Cerus Corp

Phone: 925 288 6000

Email: rbenjamin@cerus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place