Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex (NCT NCT03894046)

NCT ID: NCT03894046

Last Updated: 2023-02-01

Results Overview

The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

207 participants

Primary outcome timeframe

28 Days

Results posted on

2023-02-01

Participant Flow

The total number of participants enrolled in the study was 207. However, two (2) patients were transferred from Part A to part B. These participants were analyzed at each arm until/ from the time point of transfer.

Participant milestones

Participant milestones
Measure	Part A - Group 1 Experimental. 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h;	Part A - Group 2 Control group. 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.	Part B - Group 3 Experimental. Group 3: 1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.
Overall Study STARTED	92	89	26
Overall Study COMPLETED	69	61	20
Overall Study NOT COMPLETED	23	28	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A - Group 1 Experimental. 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h;	Part A - Group 2 Control group. 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.	Part B - Group 3 Experimental. Group 3: 1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.
Overall Study Protocol Violation	1	0	0
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	2	3	1
Overall Study Death	15	21	4
Overall Study No growth of ABC	2	1	0
Overall Study Physician Decision	1	1	1
Overall Study Prohibited concomitant medication	1	0	0
Overall Study Transferred to other arm/group	1	1	0

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A- Group 1 n=92 Participants Experimental. Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h;	Part A - Group 2 n=89 Participants Control Group (active comparator). Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.	Part B - Group 3 n=26 Participants Experimental. Group 3: 1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.	Total n=207 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	37 Participants n=7 Participants	18 Participants n=5 Participants	98 Participants n=4 Participants
Age, Categorical >=65 years	49 Participants n=5 Participants	52 Participants n=7 Participants	8 Participants n=5 Participants	109 Participants n=4 Participants
Age, Continuous	63.4 years STANDARD_DEVIATION 15.42 • n=5 Participants	66.9 years STANDARD_DEVIATION 17.13 • n=7 Participants	56.2 years STANDARD_DEVIATION 16.33 • n=5 Participants	59.8 years STANDARD_DEVIATION 16.45 • n=4 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	23 Participants n=7 Participants	5 Participants n=5 Participants	52 Participants n=4 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	66 Participants n=7 Participants	21 Participants n=5 Participants	155 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Asian	33 Participants n=5 Participants	44 Participants n=7 Participants	3 Participants n=5 Participants	80 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	41 Participants n=7 Participants	23 Participants n=5 Participants	112 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: 28 Days

Population: CRABC m-MITT (Carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex Microbiologically Modified Intent-to-Treat Population). The CRABC m-MITT Population included patients who met m-MITT criteria and had a baseline ABC organism that was confirmed to be carbapenem-resistant (MIC of imipenem/meropenem ≥8 ug/mL) by the central laboratory or by the local laboratory.

The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A.

Outcome measures

Outcome measures
Measure	Part A - Group 1 n=63 Participants Experimental. Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h;	Part A - Group 2 n=62 Participants Control group (active comparator). Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.
Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population	12 Participants	20 Participants

PRIMARY outcome

Timeframe: 28 days

Population: MITT (Modified Intent To Treat population containing all patients who received any amount of study drug). Analysis of patients with nephrotoxicity as measured by RIFLE criteria at any post-baseline visit based on the Investigator's opinion for the Safety Population for Part A, excluding patients with chronic hemodialysis at baseline.

The primary safety endpoint for the study is nephrotoxicity, as measured by the Risk-Injury-Failure-Loss-End-stage renal disease (RIFLE) criteria, in the MITT population in Part A.

Outcome measures

Outcome measures
Measure	Part A - Group 1 n=91 Participants Experimental. Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h;	Part A - Group 2 n=85 Participants Control group (active comparator). Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.
Proportion of Patients With Nephrotoxicity	12 Participants	32 Participants

Adverse Events

Part A - Group 1

Serious events: 36 serious events

Other events: 48 other events

Deaths: 25 deaths

Part A - Group 2

Serious events: 42 serious events

Other events: 53 other events

Deaths: 31 deaths

Part B - Group 3

Serious events: 9 serious events

Other events: 14 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. David Altarac - Chief Medical Officer

Entasis Therapeutics

Phone: +1 781 810 0120

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Part A - Group 1 n=91 participants at risk Experimental. Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h; In total, 91 patients received any amount of study drug treatment in Part A - Group 1 and were considered the Safety Population for this group.	Part A - Group 2 n=86 participants at risk Control group (active comparator). Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. In total, 86 patients received any amount of study drug treatment in Part A - Group 2 - control group and were considered the Safety Population for this group.	Part B - Group 3 n=28 participants at risk Experimental. Group 3: 1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. There were 28 patients who received any amount of study drug in Part B and were included in the Safety Population for Part B.
Vascular disorders Deep vein thrombosis	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Vascular disorders Peripheral artery thrombosis	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Vascular disorders Shock	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Vascular disorders Shock haemorrhagic	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.6% 1/28 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
General disorders Multiple organ dysfunction syndrome	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	4.7% 4/86 • Number of events 4 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	7.1% 2/28 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
General disorders Disease progression	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Injury, poisoning and procedural complications Alcohol poisoning	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Injury, poisoning and procedural complications Chemical peritonitis	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Injury, poisoning and procedural complications Craniocerebral injury	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Injury, poisoning and procedural complications Tracheostomy malfunction	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Injury, poisoning and procedural complications Weaning failure	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Investigations Liver function test abnormal	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Cardiac disorders Cardiac arrest	2.2% 2/91 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	4.7% 4/86 • Number of events 4 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.6% 1/28 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Cardiac disorders Acute myocardial infarction	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Cardiac disorders Arteriosclerosis coronary artery	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Cardiac disorders Atrial fibrillation	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Cardiac disorders Bradycardia	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Cardiac disorders Ventricular tachycardia	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.6% 1/28 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	2.2% 2/91 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	2.2% 2/91 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	2.3% 2/86 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	2.3% 2/86 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.2% 2/91 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.6% 1/28 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Respiratory, thoracic and mediastinal disorders Hypercapnia	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.6% 1/28 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Respiratory, thoracic and mediastinal disorders Tracheomalacia	1.1% 1/91 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Blood and lymphatic system disorders Anaemia	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	2.3% 2/86 • Number of events 3 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Blood and lymphatic system disorders Neutropenia	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.6% 1/28 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Nervous system disorders Brain oedema	2.2% 2/91 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Nervous system disorders Seizure	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.5% 3/86 • Number of events 3 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Nervous system disorders Cerebral haemorrhage	1.1% 1/91 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Nervous system disorders Cerebrovascular accident	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.

Other adverse events
Measure	Part A - Group 1 n=91 participants at risk Experimental. Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h; In total, 91 patients received any amount of study drug treatment in Part A - Group 1 and were considered the Safety Population for this group.	Part A - Group 2 n=86 participants at risk Control group (active comparator). Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. In total, 86 patients received any amount of study drug treatment in Part A - Group 2 - control group and were considered the Safety Population for this group.	Part B - Group 3 n=28 participants at risk Experimental. Group 3: 1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. There were 28 patients who received any amount of study drug in Part B and were included in the Safety Population for Part B.
Vascular disorders Hypotension	5.5% 5/91 • Number of events 5 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	5.8% 5/86 • Number of events 5 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.6% 1/28 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
General disorders Pyrexia	9.9% 9/91 • Number of events 14 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	9.3% 8/86 • Number of events 11 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.6% 1/28 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Investigations Blood creatinine increased	2.2% 2/91 • Number of events 6 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	8.1% 7/86 • Number of events 10 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	10.7% 3/28 • Number of events 3 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Investigations Blood alkaline phosphatase increased	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	7.1% 2/28 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Investigations Enterococcus test positive	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/86 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	10.7% 3/28 • Number of events 3 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Blood and lymphatic system disorders Anaemia	13.2% 12/91 • Number of events 18 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	12.8% 11/86 • Number of events 13 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	14.3% 4/28 • Number of events 4 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Gastrointestinal disorders Diarrhoea	16.5% 15/91 • Number of events 16 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	10.5% 9/86 • Number of events 11 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	7.1% 2/28 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Gastrointestinal disorders Constipation	5.5% 5/91 • Number of events 7 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	5.8% 5/86 • Number of events 6 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Gastrointestinal disorders Nausea	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	2.3% 2/86 • Number of events 3 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	7.1% 2/28 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Renal and urinary disorders Acute kidney injury	3.3% 3/91 • Number of events 3 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	10.5% 9/86 • Number of events 12 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Skin and subcutaneous tissue disorders Decubitus ulcer	5.5% 5/91 • Number of events 5 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.5% 3/86 • Number of events 3 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	14.3% 4/28 • Number of events 4 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Metabolism and nutrition disorders Hypokalaemia	14.3% 13/91 • Number of events 21 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	10.5% 9/86 • Number of events 19 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Infections and infestations Urinary tract infection	7.7% 7/91 • Number of events 11 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	9.3% 8/86 • Number of events 9 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.6% 1/28 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Infections and infestations Tracheobronchitis	5.5% 5/91 • Number of events 5 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Investigations Gamma-glutamyltransferase increased	1.1% 1/91 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	2.3% 2/86 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	7.1% 2/28 • Number of events 2 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Blood and lymphatic system disorders Thrombocytopenia	5.5% 5/91 • Number of events 5 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	1.2% 1/86 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	0.00% 0/28 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
Renal and urinary disorders Renal impairment	0.00% 0/91 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	7.0% 6/86 • Number of events 9 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.	3.6% 1/28 • Number of events 1 • Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment. A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug. NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.