Trial Outcomes & Findings for Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase (NCT NCT04160468)

NCT ID: NCT04160468

Last Updated: 2023-11-02

Results Overview

Clinical outcome of responder was defined as survival with resolution or 2-grade improvement of attributable signs and symptoms and negative blood cultures by Day 14, and without new signs or symptoms, new metastatic foci or septic emboli, or change in antibiotics due to lack of response.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 259 participants
• Primary outcome timeframe: Day 14
• Results posted on: 2023-11-02

Participant Flow

Approximately 348 patients were planned, and 259 patients were randomized at the time the study was stopped for futility.

Participant milestones

Measure	Exebacase + SoCA Participants received a single IV infusion of exebacase in addition to standard-of-care antibiotics (SoCA) selected by the investigator.	SoCA Alone Participants received a single IV infusion of placebo in addition to standard-of-care antibiotics (SoCA) selected by the investigator.
Overall Study STARTED	173	86
Overall Study COMPLETED	142	81
Overall Study NOT COMPLETED	31	5

Reasons for withdrawal

Measure	Exebacase + SoCA Participants received a single IV infusion of exebacase in addition to standard-of-care antibiotics (SoCA) selected by the investigator.	SoCA Alone Participants received a single IV infusion of placebo in addition to standard-of-care antibiotics (SoCA) selected by the investigator.
Overall Study Lost to Follow-up	19	4
Overall Study Randomized but not dosed	6	0
Overall Study Withdrawal by Subject	4	1
Overall Study Participant unable/unwilling to adhere to protocol	1	0
Overall Study Participant incarcerated	1	0

Baseline Characteristics

Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase

Baseline characteristics by cohort

Measure	Exebacase + SoCA n=165 Participants Participants received a single IV infusion of exebacase in addition to standard-of-care antibiotics (SoCA) selected by the investigator.	SoCA Alone n=85 Participants Participants received a single IV infusion of placebo in addition to standard-of-care antibiotics (SoCA) selected by the investigator.	Total n=250 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	119 Participants n=5 Participants	63 Participants n=7 Participants	182 Participants n=5 Participants
Age, Categorical >=65 years	44 Participants n=5 Participants	22 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	48 Participants n=7 Participants	158 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	37 Participants n=7 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	10 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=5 Participants	75 Participants n=7 Participants	213 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	16 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) White	118 Participants n=5 Participants	65 Participants n=7 Participants	183 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	165 participants n=5 Participants	85 participants n=7 Participants	250 participants n=5 Participants
Final Adjudicated Diagnosis Complicated bloodstream infection	127 Participants n=5 Participants	63 Participants n=7 Participants	190 Participants n=5 Participants
Final Adjudicated Diagnosis Uncomplicated bloodstream infection	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Final Adjudicated Diagnosis Right-sided infective endocarditis	22 Participants n=5 Participants	10 Participants n=7 Participants	32 Participants n=5 Participants
Final Adjudicated Diagnosis Left-sided infective endocarditis	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Final Adjudicated Diagnosis Right- and left-sided infective endocarditis	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA) MRSA	64 Participants n=5 Participants	33 Participants n=7 Participants	97 Participants n=5 Participants
Methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA) MSSA	101 Participants n=5 Participants	52 Participants n=7 Participants	153 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14

Population: MRSA population in the mITT analysis set

Clinical outcome of responder was defined as survival with resolution or 2-grade improvement of attributable signs and symptoms and negative blood cultures by Day 14, and without new signs or symptoms, new metastatic foci or septic emboli, or change in antibiotics due to lack of response.

Outcome measures

Measure	Exebacase + SoCA n=64 Participants Participants received a single IV infusion of exebacase in addition to standard-of-care antibiotics (SoCA) selected by the investigator.	SoCA Alone n=33 Participants Participants received a single IV infusion of placebo in addition to standard-of-care antibiotics (SoCA) selected by the investigator.
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set Responder	32 Participants	20 Participants
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set Failure	30 Participants	13 Participants
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set Indeterminate	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Through Day 60

Population: Safety analysis set

Number and percentage of patients with treatment-emergent adverse events (TEAEs)

Outcome measures

Measure	Exebacase + SoCA n=165 Participants Participants received a single IV infusion of exebacase in addition to standard-of-care antibiotics (SoCA) selected by the investigator.	SoCA Alone n=85 Participants Participants received a single IV infusion of placebo in addition to standard-of-care antibiotics (SoCA) selected by the investigator.
Treatment-emergent Adverse Events (TEAEs) Through Day 60	142 Participants	72 Participants

Adverse Events

Exebacase + SoCA

Serious events: 71 serious events

Other events: 72 other events

Deaths: 27 deaths

SoCA Alone

Serious events: 34 serious events

Other events: 41 other events

Deaths: 14 deaths

Serious adverse events

Measure	Exebacase + SoCA n=165 participants at risk Participants received a single IV infusion of exebacase in addition to standard-of-care antibiotics (SoCA) selected by the investigator.	SoCA Alone n=85 participants at risk Participants received a single IV infusion of placebo in addition to standard-of-care antibiotics (SoCA) selected by the investigator.
Infections and infestations Staphylococcal bacteremia	1.8% 3/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Osteomyelitis	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	2.4% 2/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Septic shock	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	2.4% 2/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Pneumonia	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	3.5% 3/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Endocarditis	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	2.4% 2/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Clostridium difficile infection	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Abscess limb	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Bacteremia	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Bone abscess	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Cavernous sinus thrombosis	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Intervertebral discitis	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Klebsiella infection	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Neutropenic sepsis	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Pharyngeal abscess	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Staphylococcal infection	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Systemic candida	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Vascular device infection	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Urosepsis	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	2.4% 2/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations COVID-19 pneumonia	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Candida sepsis	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Cellulitis	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Sepsis	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	3.0% 5/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.8% 3/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Acute pulmonary edema	1.8% 3/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.8% 3/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	2.4% 2/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Cardiac arrest	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Cardiac failure	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Atrial flutter	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Cardiac tamponade	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Acute left ventricular failure	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Acute myocardial infarction	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Atrial fibrillation	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Cardiac failure congestive	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Angina pectoris	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Bradycardia	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Cardiogenic shock	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Cardiac disorders Myocardial infarction	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Renal and urinary disorders Renal failure	1.8% 3/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Renal and urinary disorders Acute kidney injury	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	2.4% 2/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Renal and urinary disorders End stage renal disease	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Renal and urinary disorders Hydronephrosis	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Renal and urinary disorders Renal impairment	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Renal and urinary disorders Urinary retention	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Gastrointestinal disorders Gastrointestinal hemorrage	1.8% 3/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Gastrointestinal disorders Intestinal angioedema	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Gastrointestinal disorders Mesenteric artery thrombosis	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Gastrointestinal disorders Pancreatitis	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Gastrointestinal disorders Small intestinal obstruction	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Gastrointestinal disorders Constipation	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Gastrointestinal disorders Peritoneal hematoma	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Vascular disorders Deep vein thrombosis	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Vascular disorders Hypotension	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Vascular disorders Shock	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Vascular disorders Hypertensive emergency	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Nervous system disorders Acute disseminated encephalomyelitis	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Nervous system disorders Cerebrospinal fluid leakage	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Nervous system disorders Encephalopathy	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Nervous system disorders Metabolic encephalopathy	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Nervous system disorders Seizure	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Nervous system disorders Subarachnoid hemorrhage	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Nervous system disorders Ischemic stroke	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	2.4% 2/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Nervous system disorders Syncope	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
General disorders Death NOS (not otherwise specified)	1.8% 3/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	3.5% 3/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
General disorders Death	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
General disorders Multiple organ dysfunction syndrome	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
General disorders Asthenia	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
General disorders Pyrexia	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Hepatobiliary disorders Ischemic hepatitis	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Hepatobiliary disorders Cirrhosis alcoholic	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Hepatobiliary disorders Hepatic cirrhosis	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Hepatobiliary disorders Hepatic failure	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Hepatobiliary disorders Chronic hepatic failure	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Injury, poisoning and procedural complications Wound dehiscense	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Injury, poisoning and procedural complications Heart injury	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Injury, poisoning and procedural complications Tracheal obstruction	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Injury, poisoning and procedural complications Fall	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Blood and lymphatic system disorders Anemia	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	2.4% 2/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Musculoskeletal and connective tissue disorders Pain in extremity	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Psychiatric disorders Confusional state	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Psychiatric disorders Drug abuse	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Skin and subcutaneous tissue disorders Rash	1.2% 2/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Social circumstances Patient dissatisfaction with treatment	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Social circumstances Social stay hospitalization	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Ear and labyrinth disorders Mixed deafness	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Metabolism and nutrition disorders Malnutrition	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Metabolism and nutrition disorders Fluid overload	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	0.00% 0/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Product Issues Device dislocation	0.00% 0/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	1.2% 1/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.

Other adverse events

Measure	Exebacase + SoCA n=165 participants at risk Participants received a single IV infusion of exebacase in addition to standard-of-care antibiotics (SoCA) selected by the investigator.	SoCA Alone n=85 participants at risk Participants received a single IV infusion of placebo in addition to standard-of-care antibiotics (SoCA) selected by the investigator.
Infections and infestations Pneumonia	3.0% 5/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	7.1% 6/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Infections and infestations Urinary tract infection	1.8% 3/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	5.9% 5/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Gastrointestinal disorders Constipation	7.9% 13/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	12.9% 11/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Gastrointestinal disorders Diarrhea	7.3% 12/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	3.5% 3/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.1% 10/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	10.6% 9/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	1.8% 3/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	5.9% 5/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Blood and lymphatic system disorders Anemia	7.3% 12/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	9.4% 8/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Vascular disorders Hypotension	7.9% 13/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	10.6% 9/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Vascular disorders Deep vein thrombosis	3.0% 5/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	5.9% 5/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Renal and urinary disorders Acute kidney injury	9.7% 16/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	9.4% 8/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Renal and urinary disorders Urinary retention	4.2% 7/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	7.1% 6/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Skin and subcutaneous tissue disorders Rash	6.1% 10/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	3.5% 3/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Metabolism and nutrition disorders Hypomagnesemia	0.61% 1/165 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.	5.9% 5/85 • Through the Day 60 visit All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.

Additional Information

Medical Director

ContraFect

Phone: 914-207-2300

Email: clinicalstudies@contrafect.com

Results disclosure agreements

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