Trial Outcomes & Findings for Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens (NCT NCT02714595)

NCT ID: NCT02714595

Last Updated: 2021-01-12

Results Overview

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. Participants with missing data were considered as non-responders.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 152 participants
• Primary outcome timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21
• Results posted on: 2021-01-12

Participant Flow

This study enrolled hospitalized patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP), bloodstream infection (BSI), sepsis, or complicated urinary tract infection (cUTI) caused by carbapenem-resistant Gram-negative pathogens, and was conducted at 95 sites in 16 countries.

Participants were randomized in a 2:1 ratio to receive therapy with cefiderocol or best available therapy (BAT), stratified by primary clinical diagnosis (HAP/VAP/HCAP, BSI/sepsis, cUTI), Acute Physiology and Chronic Health Evaluation (APACHE) II score (≤ 15 or ≥ 16-≤ 30), and region (North America, South America region, Europe, Asia-Pacific).

Participant milestones

Measure	Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Best Available Therapy (BAT) Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Overall Study STARTED	101	51
Overall Study Received Treatment	101	49
Overall Study Carbapenem-resistant Microbiological Intent-to-treat	80	38
Overall Study COMPLETED	69	38
Overall Study NOT COMPLETED	32	13

Reasons for withdrawal

Measure	Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Best Available Therapy (BAT) Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	2
Overall Study Lack of Efficacy	0	1
Overall Study Death	30	9
Overall Study Other-Miscellaneous	0	1

Baseline Characteristics

Only conducted in participants with HAP/VAP/HCAP; 2 participants had missing CPIS scores at Baseline.

Baseline characteristics by cohort

Measure	Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Best Available Therapy (BAT) n=38 Participants Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Total n=118 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 18.7 • n=80 Participants	62.1 years STANDARD_DEVIATION 17.3 • n=38 Participants	62.8 years STANDARD_DEVIATION 18.2 • n=118 Participants
Age, Customized < 65 years	30 Participants n=80 Participants	21 Participants n=38 Participants	51 Participants n=118 Participants
Age, Customized ≥ 65 years	50 Participants n=80 Participants	17 Participants n=38 Participants	67 Participants n=118 Participants
Sex: Female, Male Female	25 Participants n=80 Participants	9 Participants n=38 Participants	34 Participants n=118 Participants
Sex: Female, Male Male	55 Participants n=80 Participants	29 Participants n=38 Participants	84 Participants n=118 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=80 Participants	2 Participants n=38 Participants	12 Participants n=118 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=80 Participants	35 Participants n=38 Participants	99 Participants n=118 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=80 Participants	1 Participants n=38 Participants	7 Participants n=118 Participants
Race/Ethnicity, Customized White	48 Participants n=80 Participants	27 Participants n=38 Participants	75 Participants n=118 Participants
Race/Ethnicity, Customized Asian	24 Participants n=80 Participants	9 Participants n=38 Participants	33 Participants n=118 Participants
Race/Ethnicity, Customized Other	8 Participants n=80 Participants	2 Participants n=38 Participants	10 Participants n=118 Participants
Region North America	4 Participants n=80 Participants	3 Participants n=38 Participants	7 Participants n=118 Participants
Region South America	7 Participants n=80 Participants	3 Participants n=38 Participants	10 Participants n=118 Participants
Region Europe	45 Participants n=80 Participants	23 Participants n=38 Participants	68 Participants n=118 Participants
Region Asia-Pacific	24 Participants n=80 Participants	9 Participants n=38 Participants	33 Participants n=118 Participants
Total APACHE II Score ≤ 15	41 Participants n=80 Participants	21 Participants n=38 Participants	62 Participants n=118 Participants
Total APACHE II Score ≥ 16	39 Participants n=80 Participants	17 Participants n=38 Participants	56 Participants n=118 Participants
Clinical Diagnosis HAP/VAP/HCAP	40 Participants n=80 Participants	19 Participants n=38 Participants	59 Participants n=118 Participants
Clinical Diagnosis BSI/Sepsis	23 Participants n=80 Participants	14 Participants n=38 Participants	37 Participants n=118 Participants
Clinical Diagnosis cUTI	17 Participants n=80 Participants	5 Participants n=38 Participants	22 Participants n=118 Participants
Sequential Organ Failure Assessment (SOFA) Score	5.6 units on a scale STANDARD_DEVIATION 4.1 • n=80 Participants	5.6 units on a scale STANDARD_DEVIATION 3.9 • n=38 Participants	5.6 units on a scale STANDARD_DEVIATION 4.0 • n=118 Participants
Clinical Pulmonary Infection Score (CPIS)	5.1 units on a scale STANDARD_DEVIATION 1.6 • n=39 Participants • Only conducted in participants with HAP/VAP/HCAP; 2 participants had missing CPIS scores at Baseline.	5.0 units on a scale STANDARD_DEVIATION 1.1 • n=18 Participants • Only conducted in participants with HAP/VAP/HCAP; 2 participants had missing CPIS scores at Baseline.	5.1 units on a scale STANDARD_DEVIATION 1.4 • n=57 Participants • Only conducted in participants with HAP/VAP/HCAP; 2 participants had missing CPIS scores at Baseline.

PRIMARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat (CR Micro-ITT) Population included all participants who received at least 1 dose of the study treatment, who had a baseline Gram-negative pathogen from an appropriate clinical specimen, and whose baseline Gram-negative pathogen was carbapenem-resistant as confirmed by central laboratory testing.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

HAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.

BSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.

Participants with missing data were considered as non-responders.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis	50.0 percentage of participants Interval 33.8 to 66.2	52.6 percentage of participants Interval 28.9 to 75.6	43.5 percentage of participants Interval 23.2 to 65.5	42.9 percentage of participants Interval 17.7 to 71.1	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Test of cure, defined as 7 days after the end of treatment, equivalent to Study Days 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ colony-forming units (CFU)/mL was reduced to < 10³ CFU/mL.

Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=17 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=5 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at TOC in Participants With cUTI	52.9 percentage of participants Interval 27.8 to 77.0	20.0 percentage of participants Interval 0.5 to 71.6	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were counted as non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

HAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.

BSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis	60.0 percentage of participants Interval 43.3 to 75.1	63.2 percentage of participants Interval 38.4 to 83.7	69.6 percentage of participants Interval 47.1 to 86.8	50.0 percentage of participants Interval 23.0 to 77.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.

BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Clinical Cure at Follow-up (FU) in Participants With HAP/VAP/HCAP or BSI/Sepsis	50.0 percentage of participants Interval 33.8 to 66.2	31.6 percentage of participants Interval 12.6 to 56.6	39.1 percentage of participants Interval 19.7 to 61.5	28.6 percentage of participants Interval 8.4 to 58.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=17 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=5 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Clinical Cure at Test of Cure in Participants With cUTI	70.6 percentage of participants Interval 44.0 to 89.7	60.0 percentage of participants Interval 14.7 to 94.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered as non-responders

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=17 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=5 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With cUTI	76.5 percentage of participants Interval 50.1 to 93.2	60.0 percentage of participants Interval 14.7 to 94.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population); participants with missing data were considered non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

Sustained clinical cure for cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=17 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=5 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With cUTI	52.9 percentage of participants Interval 27.8 to 77.0	60.0 percentage of participants Interval 14.7 to 94.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.

BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.

cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=80 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=38 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Clinical Cure at End of Treatment in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall	63.5 percentage of participants Interval 50.4 to 75.3	57.6 percentage of participants Interval 39.2 to 74.5	66.3 percentage of participants Interval 54.8 to 76.4	57.9 percentage of participants Interval 40.8 to 73.7	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.

BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.

cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=80 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=38 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Clinical Cure at Test of Cure in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall	47.6 percentage of participants Interval 34.9 to 60.6	48.5 percentage of participants Interval 30.8 to 66.5	52.5 percentage of participants Interval 41.0 to 63.8	50.0 percentage of participants Interval 33.4 to 66.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy is required for the treatment of pneumonia in a participant assessed as cured at TOC.

BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy is required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.

cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=80 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=38 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall	46.0 percentage of participants Interval 33.4 to 59.1	30.3 percentage of participants Interval 15.6 to 48.7	47.5 percentage of participants Interval 36.2 to 59.0	34.2 percentage of participants Interval 19.6 to 51.4	—	—	—	—	—	—

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant pathogen at Baseline; participants with missing data were considered non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis:

HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.

BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.

cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Clinical Cure at End of Treatment By Baseline Pathogen Acinetobacter baumannii	61.5 percentage of participants	70.0 percentage of participants	70.0 percentage of participants	42.9 percentage of participants	0 percentage of participants	—	63.9 percentage of participants	58.8 percentage of participants	62.2 percentage of participants	58.8 percentage of participants
Percentage of Participants With Clinical Cure at End of Treatment By Baseline Pathogen Pseudomonas aeruginosa	63.6 percentage of participants	83.3 percentage of participants	100.0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	69.2 percentage of participants	66.7 percentage of participants	64.7 percentage of participants	63.6 percentage of participants
Percentage of Participants With Clinical Cure at End of Treatment By Baseline Pathogen Klebsiella pneumoniae	70.0 percentage of participants	40.0 percentage of participants	63.6 percentage of participants	75.0 percentage of participants	90.9 percentage of participants	66.7 percentage of participants	66.7 percentage of participants	55.6 percentage of participants	75.0 percentage of participants	58.3 percentage of participants
Percentage of Participants With Clinical Cure at End of Treatment By Baseline Pathogen Stenotrophomonas maltophilia	20.0 percentage of participants	—	—	—	—	—	20.0 percentage of participants	—	20.0 percentage of participants	—
Percentage of Participants With Clinical Cure at End of Treatment By Baseline Pathogen Escherichia coli	100.0 percentage of participants	0 percentage of participants	100.0 percentage of participants	—	100.0 percentage of participants	—	100.0 percentage of participants	0 percentage of participants	100.0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant pathogen at Baseline; participants with missing data were considered non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.

BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.

cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Clinical Cure at Test of Cure By Baseline Pathogen Pseudomonas aeruginosa	45.5 percentage of participants	66.7 percentage of participants	100.0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	53.8 percentage of participants	55.6 percentage of participants	52.9 percentage of participants	54.5 percentage of participants
Percentage of Participants With Clinical Cure at Test of Cure By Baseline Pathogen Acinetobacter baumannii	50.0 percentage of participants	60.0 percentage of participants	30.0 percentage of participants	42.9 percentage of participants	0 percentage of participants	—	44.4 percentage of participants	52.9 percentage of participants	43.2 percentage of participants	52.9 percentage of participants
Percentage of Participants With Clinical Cure at Test of Cure By Baseline Pathogen Klebsiella pneumoniae	60.0 percentage of participants	40.0 percentage of participants	54.5 percentage of participants	50.0 percentage of participants	81.8 percentage of participants	66.7 percentage of participants	57.1 percentage of participants	44.4 percentage of participants	65.6 percentage of participants	50.0 percentage of participants
Percentage of Participants With Clinical Cure at Test of Cure By Baseline Pathogen Stenotrophomonas maltophilia	0.0 percentage of participants	—	—	—	—	—	5.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Participants With Clinical Cure at Test of Cure By Baseline Pathogen Escherichia coli	50.0 percentage of participants	0.0 percentage of participants	50.0 percentage of participants	—	100.0 percentage of participants	—	50.0 percentage of participants	0.0 percentage of participants	60.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant pathogen at Baseline; participants with missing data were considered non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.

BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.

cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Pathogen Klebsiella pneumoniae	60.0 percentage of participants	40.0 percentage of participants	45.5 percentage of participants	25.0 percentage of participants	63.6 percentage of participants	66.7 percentage of participants	52.4 percentage of participants	33.3 percentage of participants	56.3 percentage of participants	41.7 percentage of participants
Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Pathogen Acinetobacter baumannii	50.0 percentage of participants	60.0 percentage of participants	30.0 percentage of participants	28.6 percentage of participants	0.0 percentage of participants	—	44.4 percentage of participants	35.3 percentage of participants	43.2 percentage of participants	35.3 percentage of participants
Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Pathogen Pseudomonas aeruginosa	45.5 percentage of participants	16.7 percentage of participants	100.0 percentage of participants	33.3 percentage of participants	25.0 percentage of participants	50.0 percentage of participants	53.8 percentage of participants	55.6 percentage of participants	47.1 percentage of participants	27.3 percentage of participants
Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Pathogen Stenotrophomonas maltophilia	0.0 percentage of participants	—	—	—	—	—	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Pathogen Escherichia coli	50.0 percentage of participants	0.0 percentage of participants	50.0 percentage of participants	—	100.0 percentage of participants	—	50.0 percentage of participants	0.0 percentage of participants	60.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis:

HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.

BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.

cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Clinical Cure at EOT By Baseline Carbapenem-resistant Pathogen Acinetobacter baumannii	61.5 percentage of participants	70.0 percentage of participants	70.0 percentage of participants	42.9 percentage of participants	0.0 percentage of participants	—	63.9 percentage of participants	58.8 percentage of participants	62.2 percentage of participants	58.8 percentage of participants
Percentage of Participants With Clinical Cure at EOT By Baseline Carbapenem-resistant Pathogen Klebsiella pneumoniae	83.3 percentage of participants	40.0 percentage of participants	60.0 percentage of participants	75.0 percentage of participants	90.9 percentage of participants	66.7 percentage of participants	68.8 percentage of participants	55.6 percentage of participants	77.8 percentage of participants	58.3 percentage of participants
Percentage of Participants With Clinical Cure at EOT By Baseline Carbapenem-resistant Pathogen Pseudomonas aeruginosa	50.0 percentage of participants	80.0 percentage of participants	100.0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	62.5 percentage of participants	62.5 percentage of participants	58.3 percentage of participants	60.0 percentage of participants
Percentage of Participants With Clinical Cure at EOT By Baseline Carbapenem-resistant Pathogen Stenotrophomonas maltophilia	20.0 percentage of participants	—	—	—	—	—	20.0 percentage of participants	—	20.0 percentage of participants	—

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis:

HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.

BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.

cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Clinical Cure at TOC By Baseline Carbapenem-resistant Pathogen Acinetobacter baumannii	50.0 percentage of participants	60.0 percentage of participants	30.0 percentage of participants	42.9 percentage of participants	0.0 percentage of participants	—	44.4 percentage of participants	52.9 percentage of participants	43.2 percentage of participants	52.9 percentage of participants
Percentage of Participants With Clinical Cure at TOC By Baseline Carbapenem-resistant Pathogen Klebsiella pneumoniae	66.7 percentage of participants	40.0 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	81.8 percentage of participants	66.7 percentage of participants	56.3 percentage of participants	44.4 percentage of participants	66.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With Clinical Cure at TOC By Baseline Carbapenem-resistant Pathogen Pseudomonas aeruginosa	50.0 percentage of participants	60.0 percentage of participants	100.0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	62.5 percentage of participants	50.0 percentage of participants	58.3 percentage of participants	50.0 percentage of participants
Percentage of Participants With Clinical Cure at TOC By Baseline Carbapenem-resistant Pathogen Stenotrophomonas maltophilia	0.0 percentage of participants	—	—	—	—	—	0.0 percentage of participants	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.

Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.

Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.

BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.

cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Carbapenem-resistant Pathogen Acinetobacter baumannii	50.0 percentage of participants	40.0 percentage of participants	30.0 percentage of participants	28.6 percentage of participants	0.0 percentage of participants	—	44.4 percentage of participants	35.3 percentage of participants	43.2 percentage of participants	35.3 percentage of participants
Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Carbapenem-resistant Pathogen Klebsiella pneumoniae	66.7 percentage of participants	40.0 percentage of participants	40.0 percentage of participants	25.0 percentage of participants	63.6 percentage of participants	66.7 percentage of participants	50.0 percentage of participants	33.3 percentage of participants	55.6 percentage of participants	41.7 percentage of participants
Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Carbapenem-resistant Pathogen Pseudomonas aeruginosa	50.0 percentage of participants	20.0 percentage of participants	100.0 percentage of participants	33.3 percentage of participants	25.0 percentage of participants	50.0 percentage of participants	62.5 percentage of participants	25.0 percentage of participants	50.0 percentage of participants	30.0 percentage of participants
Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Carbapenem-resistant Pathogen Stenotrophomonas maltophilia	0.0 percentage of participants	—	—	—	—	—	0.0 percentage of participants	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria established for each infection site:

HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.

Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at EOT in Participants With HAP/VAP/HCAP or BSI/Sepsis	30.0 percentage of participants Interval 16.6 to 46.5	26.3 percentage of participants Interval 9.1 to 51.2	60.9 percentage of participants Interval 38.5 to 80.3	28.6 percentage of participants Interval 8.4 to 58.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria established for each infection site:

HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.

Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at TOC in Participants With HAP/VAP/HCAP or BSI/Sepsis	22.5 percentage of participants Interval 10.8 to 38.5	21.1 percentage of participants Interval 6.1 to 45.6	30.4 percentage of participants Interval 13.2 to 52.9	28.6 percentage of participants Interval 8.4 to 58.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:

HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. If an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For sepsis, if the participant has a successful clinical outcome after TOC and an appropriate clinical culture could not be obtained, the response was presumed sustained eradication.

Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With HAP/VAP/HCAP or BSI/Sepsis	20.0 percentage of participants Interval 9.1 to 35.6	15.8 percentage of participants Interval 3.4 to 39.6	26.1 percentage of participants Interval 10.2 to 48.4	21.4 percentage of participants Interval 4.7 to 50.8	—	—	—	—	—	—

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL.

Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=17 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=5 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at EOT in Participants With cUTI	70.6 percentage of participants Interval 44.0 to 89.7	20.0 percentage of participants Interval 0.5 to 71.6	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Microbiological outcome per Baseline pathogen at follow-up was determined by the sponsor as defined for each infection site.

For cUTI sustained eradication was defined as a culture taken any time after documented eradication at TOC and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained <10³ CFU/mL.

Overall per-participant sustained eradication was defined as sustained eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=17 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=5 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With cUTI	41.2 percentage of participants Interval 18.4 to 67.1	20.0 percentage of participants Interval 0.5 to 71.6	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:

HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.

cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL.

Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=80 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=38 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at EOT in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall	41.3 percentage of participants Interval 29.0 to 54.4	27.3 percentage of participants Interval 13.3 to 45.5	47.5 percentage of participants Interval 36.2 to 59.0	26.3 percentage of participants Interval 13.4 to 43.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders

Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:

HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.

cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL.

Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=80 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=38 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at TOC in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall	25.4 percentage of participants Interval 15.3 to 37.9	24.2 percentage of participants Interval 11.1 to 42.3	31.3 percentage of participants Interval 21.3 to 42.6	23.7 percentage of participants Interval 11.4 to 40.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:

HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable.

For HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.

cUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained < 10³ CFU/mL.

Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=80 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=38 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall	22.2 percentage of participants Interval 12.7 to 34.5	18.2 percentage of participants Interval 7.0 to 35.5	26.3 percentage of participants Interval 17.0 to 37.3	18.4 percentage of participants Interval 7.7 to 34.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant Gram-negative pathogen at Baseline; participants with missing data were considered non-responders.

Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:

HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.

cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at EOT By Baseline Pathogen Acinetobacter baumannii	34.6 percentage of participants	30.0 percentage of participants	60.0 percentage of participants	28.6 percentage of participants	0.0 percentage of participants	—	41.7 percentage of participants	29.4 percentage of participants	40.5 percentage of participants	29.4 percentage of participants
Percentage of Participants With Microbiologic Eradication at EOT By Baseline Pathogen Pseudomonas aeruginosa	36.4 percentage of participants	33.3 percentage of participants	0.0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	30.8 percentage of participants	33.3 percentage of participants	35.3 percentage of participants	36.4 percentage of participants
Percentage of Participants With Microbiologic Eradication at EOT By Baseline Pathogen Klebsiella pneumoniae	50.0 percentage of participants	20.0 percentage of participants	72.7 percentage of participants	25.0 percentage of participants	81.8 percentage of participants	0.0 percentage of participants	61.9 percentage of participants	22.2 percentage of participants	68.8 percentage of participants	16.7 percentage of participants
Percentage of Participants With Microbiologic Eradication at EOT By Baseline Pathogen Escherichia coli	100.0 percentage of participants	0.0 percentage of participants	100.0 percentage of participants	—	100.0 percentage of participants	—	100.0 percentage of participants	0.0 percentage of participants	100.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Microbiologic Eradication at EOT By Baseline Pathogen Stenotrophomonas maltophilia	20.0 percentage of participants	—	—	—	—	—	20.0 percentage of participants	—	20.0 percentage of participants	—

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant Gram-negative pathogen at Baseline; participants with missing data were considered non-responders.

Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:

HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.

cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL.

Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at TOC By Baseline Pathogen Acinetobacter baumannii	30.8 percentage of participants	30.0 percentage of participants	20.0 percentage of participants	28.6 percentage of participants	0.0 percentage of participants	—	27.8 percentage of participants	29.4 percentage of participants	27.0 percentage of participants	29.4 percentage of participants
Percentage of Participants With Microbiologic Eradication at TOC By Baseline Pathogen Pseudomonas aeruginosa	9.1 percentage of participants	16.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	25.0 percentage of participants	50.0 percentage of participants	7.7 percentage of participants	11.1 percentage of participants	11.8 percentage of participants	18.2 percentage of participants
Percentage of Participants With Microbiologic Eradication at TOC By Baseline Pathogen Klebsiella pneumoniae	50.0 percentage of participants	20.0 percentage of participants	54.5 percentage of participants	50.0 percentage of participants	72.7 percentage of participants	0.0 percentage of participants	38.1 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	25.0 percentage of participants
Percentage of Participants With Microbiologic Eradication at TOC By Baseline Pathogen Stenotrophomonas maltophilia	0.0 percentage of participants	—	—	—	—	—	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Participants With Microbiologic Eradication at TOC By Baseline Pathogen Escherichia coli	50.0 percentage of participants	0.0 percentage of participants	100.0 percentage of participants	—	0.0 percentage of participants	—	50.0 percentage of participants	0.0 percentage of participants	40.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant Gram-negative pathogen at Baseline; participants with missing data were considered non-responders.

Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:

HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable.

For HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.

cUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained < 10³ CFU/mL.

Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Pathogen Acinetobacter baumannii	26.9 percentage of participants	20.0 percentage of participants	20.0 percentage of participants	14.3 percentage of participants	0.0 percentage of participants	—	25.0 percentage of participants	17.6 percentage of participants	24.3 percentage of participants	17.6 percentage of participants
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Pathogen Pseudomonas aeruginosa	9.1 percentage of participants	16.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	50.0 percentage of participants	7.7 percentage of participants	11.1 percentage of participants	5.9 percentage of participants	18.2 percentage of participants
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Pathogen Klebsiella pneumoniae	20.0 percentage of participants	20.0 percentage of participants	45.5 percentage of participants	50.0 percentage of participants	63.6 percentage of participants	0.0 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	43.8 percentage of participants	25.0 percentage of participants
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Pathogen Stenotrophomonas maltophilia	0.0 percentage of participants	—	—	—	—	—	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Pathogen Escherichia coli	50.0 percentage of participants	0.0 percentage of participants	50.0 percentage of participants	—	0.0 percentage of participants	—	50.0 percentage of participants	0.0 percentage of participants	40.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.

Microbiological outcome per Baseline carbapenem-resistant pathogen were determined according to the following criteria for each diagnosis:

HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.

cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL.

Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at EOT By Baseline Carbapenem-resistant Pathogen Acinetobacter baumannii	34.6 percentage of participants	30.0 percentage of participants	60.0 percentage of participants	28.6 percentage of participants	0.0 percentage of participants	—	41.7 percentage of participants	29.4 percentage of participants	40.5 percentage of participants	29.4 percentage of participants
Percentage of Participants With Microbiologic Eradication at EOT By Baseline Carbapenem-resistant Pathogen Klebsiella pneumoniae	33.3 percentage of participants	20.0 percentage of participants	70.0 percentage of participants	75.0 percentage of participants	81.8 percentage of participants	0.0 percentage of participants	56.3 percentage of participants	22.2 percentage of participants	66.7 percentage of participants	16.7 percentage of participants
Percentage of Participants With Microbiologic Eradication at EOT By Baseline Carbapenem-resistant Pathogen Pseudomonas aeruginosa	33.3 percentage of participants	40.0 percentage of participants	0.0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	25.0 percentage of participants	37.5 percentage of participants	33.3 percentage of participants	40.0 percentage of participants
Percentage of Participants With Microbiologic Eradication at EOT By Baseline Carbapenem-resistant Pathogen Stenotrophomonas maltophilia	20.0 percentage of participants	—	—	—	—	—	20. percentage of participants	—	20.0 percentage of participants	—

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.

Microbiological outcome per Baseline carbapenem-resistant pathogen were determined according to the following criteria for each diagnosis:

HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.

cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL.

Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at TOC By Baseline Carbapenem-resistant Pathogen Acinetobacter baumannii	30.8 percentage of participants	30.0 percentage of participants	20.0 percentage of participants	28.6 percentage of participants	0.0 percentage of participants	—	27.8 percentage of participants	29.4 percentage of participants	27.0 percentage of participants	29.4 percentage of participants
Percentage of Participants With Microbiologic Eradication at TOC By Baseline Carbapenem-resistant Pathogen Klebsiella pneumoniae	0.0 percentage of participants	20.0 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	72.7 percentage of participants	0.0 percentage of participants	31.3 percentage of participants	33.3 percentage of participants	48.1 percentage of participants	25.0 percentage of participants
Percentage of Participants With Microbiologic Eradication at TOC By Baseline Carbapenem-resistant Pathogen Pseudomonas aeruginosa	0.0 percentage of participants	20.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	25.0 percentage of participants	50.0 percentage of participants	0.0 percentage of participants	12.5 percentage of participants	8.3 percentage of participants	20.0 percentage of participants
Percentage of Participants With Microbiologic Eradication at TOC By Baseline Carbapenem-resistant Pathogen Stenotrophomonas maltophilia	0.0 percentage of participants	—	—	—	—	—	0.0 percentage of participants	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.

Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:

HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC.

BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable.

For HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.

cUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained < 10³ CFU/mL.

Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Carbapenem-resistant Pathogen Acinetobacter baumannii	26.9 percentage of participants	20.0 percentage of participants	20.0 percentage of participants	14.3 percentage of participants	0.0 percentage of participants	—	25.0 percentage of participants	17.6 percentage of participants	24.3 percentage of participants	17.6 percentage of participants
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Carbapenem-resistant Pathogen Klebsiella pneumoniae	0.0 percentage of participants	20.0 percentage of participants	40.0 percentage of participants	50.0 percentage of participants	63.6 percentage of participants	0.0 percentage of participants	25.0 percentage of participants	33.3 percentage of participants	40.7 percentage of participants	25.0 percentage of participants
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Carbapenem-resistant Pathogen Pseudomonas aeruginosa	0.0 percentage of participants	20.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	50.0 percentage of participants	0.0 percentage of participants	12.5 percentage of participants	0.0 percentage of participants	20.0 percentage of participants
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Carbapenem-resistant Pathogen Stenotrophomonas maltophilia	0.0 percentage of participants	—	—	—	—	—	0.0 percentage of participants	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with documented carbapenem-resistant Gram-negative bacteremia at Baseline (all infection sites combined); participants with missing data were considered non-responders.

The percentage of participants who experienced eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=22 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=13 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at EOT in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia	54.5 percentage of participants Interval 32.2 to 75.6	30.8 percentage of participants Interval 9.1 to 61.4	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with documented carbapenem-resistant Gram-negative bacteremia at Baseline (all infection sites combined); participants with missing data were considered non-responders.

The percentage of participants who experienced eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=22 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=13 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Microbiologic Eradication at TOC in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia	31.8 percentge of participants Interval 13.9 to 54.9	30.8 percentge of participants Interval 9.1 to 61.4	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population with documented carbapenem-resistant Gram-negative bacteremia at Baseline (all infection sites combined); participants with missing data were considered non-responders.

The percentage of participants who experienced sustained eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture after TOC.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=22 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=13 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia	27.3 percentage of participants Interval 10.7 to 50.2	23.1 percentage of participants Interval 5.0 to 53.8	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: End of treatment, Day 7 to 14

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders

The composite clinical and microbiological response rate is defined as the percentage of participants with both clinical cure and microbiologic eradication, as defined above for each site of infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With a Composite Clinical and Microbiological Response at EOT	30.0 percentage of participants Interval 16.6 to 46.5	26.3 percentage of participants Interval 9.1 to 51.2	56.5 percentage of participants Interval 34.5 to 76.8	21.4 percentage of participants Interval 4.7 to 50.8	70.6 percentage of participants Interval 44.0 to 89.7	20.0 percentage of participants Interval 0.5 to 71.6	39.7 percentage of participants Interval 27.6 to 52.8	24.2 percentage of participants Interval 11.1 to 42.3	46.3 percentage of participants Interval 35.0 to 57.8	23.7 percentage of participants Interval 11.4 to 40.2

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders

The composite clinical and microbiological response rate is defined as the percentage of participants with both clinical cure and microbiologic eradication, as defined above for each site of infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With a Composite Clinical and Microbiological Response at TOC	22.5 percentage of participants Interval 10.8 to 38.5	21.1 percentage of participants Interval 6.1 to 45.6	30.4 percentage of participants Interval 13.2 to 52.9	21.4 percentage of participants Interval 4.7 to 50.8	47.1 percentage of participants Interval 23.0 to 72.2	20.0 percentage of participants Interval 0.5 to 71.6	25.4 percentage of participants Interval 15.3 to 37.9	21.2 percentage of participants Interval 9.0 to 38.9	30.0 percentage of participants Interval 20.3 to 41.3	21.1 percentage of participants Interval 9.6 to 37.3

SECONDARY outcome

Timeframe: Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28

Population: Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.

The composite clinical and microbiological response rate is defined as the percentage of participants with both sustained clinical cure and sustained microbiologic eradication, as defined above for each site of infection.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=63 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=33 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=80 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=38 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants With a Composite Clinical and Microbiological Response at Follow-up	20.0 percentage of participants Interval 9.1 to 35.6	15.8 percentage of participants Interval 3.4 to 39.6	26.1 percentage of participants Interval 10.2 to 48.4	14.3 percentage of participants Interval 1.8 to 42.8	41.2 percentage of participants Interval 18.4 to 67.1	20.0 percentage of participants Interval 0.5 to 71.6	22.2 percentage of participants Interval 12.7 to 34.5	15.2 percentage of participants Interval 5.1 to 31.9	26.3 percentage of participants Interval 17.0 to 37.3	15.8 percentage of participants Interval 6.0 to 31.3

SECONDARY outcome

Timeframe: Day 14 and Day 28

Population: The safety population includes randomized participants who received at least 1 dose of study drug.

The all-cause mortality rate at Day 14 and Day 28 was calculated as the percentage of participants who experienced mortality regardless of the cause at or before Day 14 and Day 28, respectively.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=45 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=22 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=30 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=17 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=26 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=10 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=75 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=39 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol n=101 Participants Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy n=49 Participants Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
All-cause Mortality at Day 14 and Day 28 Day 14	24.4 percentage of participants Interval 12.9 to 39.5	13.6 percentage of participants Interval 2.9 to 34.9	16.7 percentage of participants Interval 5.6 to 34.7	5.9 percentage of participants Interval 0.1 to 28.7	11.5 percentage of participants Interval 2.4 to 30.2	20.0 percentage of participants Interval 2.5 to 55.6	21.3 percentage of participants Interval 12.7 to 32.3	10.3 percentage of participants Interval 2.9 to 24.2	18.8 percentage of participants Interval 11.7 to 27.8	12.2 percentage of participants Interval 4.6 to 24.8
All-cause Mortality at Day 14 and Day 28 Day 28	31.1 percentage of participants Interval 18.2 to 46.6	18.2 percentage of participants Interval 5.2 to 40.3	23.3 percentage of participants Interval 9.9 to 42.3	17.6 percentage of participants Interval 3.8 to 43.4	15.4 percentage of participants Interval 4.4 to 34.9	20.0 percentage of participants Interval 2.5 to 55.6	28.0 percentage of participants Interval 18.2 to 39.6	17.9 percentage of participants Interval 7.5 to 33.5	24.8 percentage of participants Interval 16.7 to 34.3	18.4 percentage of participants Interval 8.8 to 32.0

SECONDARY outcome

Timeframe: Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21

Population: Carbapenem-resistant Microbiological Intent-to-treat Population

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=80 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=38 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Percentage of Participants Alive and With No Change in Antibiotic Treatment Due to Either Lack of Therapeutic Benefit or Drug-related Toxicity at TOC	62.5 percentage of participants Interval 51.0 to 73.1	60.5 percentage of participants Interval 43.4 to 76.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1 to 10, 11 to 20, 21 to 30, 31 to 40, 41-50, and 51 to 60.

Population: Carbapenem-resistant Microbiological Intent-to-treat Population

Survival time was analyzed by Kaplan-Meier survival curve. The table below presents deaths that occurred in10-day time intervals through the end of study

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=80 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=38 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Survival Time Days 1 to 10	12 Participants	3 Participants	—	—	—	—	—	—	—	—
Survival Time Days 11 to 20	9 Participants	3 Participants	—	—	—	—	—	—	—	—
Survival Time Days 21 to 30	1 Participants	2 Participants	—	—	—	—	—	—	—	—
Survival Time Days 31 to 40	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Survival Time Days 41 to 50	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Survival Time Days 51 to 60	0 Participants	0 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, end of treatment (Day 7-14), test of cure (7 days after end of treatment, equivalent to Study Day 14 to 21) and follow-up (14 days after end of treatment, equivalent to Study Day 21 to 28)

Population: Carbapenem-resistant microbiological intention-to-treat population; Participants with pneumonia and CPIS measurement at Baseline and at each post-baseline time point.

Clinical pulmonary infection score (CPIS) is a surrogate for diagnosis and treatment response. Points (0, 1, or 2) are assigned for observed findings for 5 variables including body temperature, white blood cell count, tracheal secretions, ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), and chest radiograph infiltrates. The total score ranges from 0 to 10, where higher scores may indicate a higher likelihood of mortality; a negative change from Baseline indicates improvement

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=39 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=18 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) in Participants With Pneumonia (HAP/VAP/HCAP) End of treatment	-2.5 scores on a scale Standard Deviation 2.2	-1.9 scores on a scale Standard Deviation 1.7	—	—	—	—	—	—	—	—
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) in Participants With Pneumonia (HAP/VAP/HCAP) Test of cure	-3.1 scores on a scale Standard Deviation 2.1	-2.7 scores on a scale Standard Deviation 2.2	—	—	—	—	—	—	—	—
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) in Participants With Pneumonia (HAP/VAP/HCAP) Follow-up	-3.4 scores on a scale Standard Deviation 1.8	-2.7 scores on a scale Standard Deviation 1.9	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, end of treatment (Day 7 to 14), test of cure (7 days after end of treatment, equivalent to Study Day 14 to 21) and follow-up (14 days after end of treatment, equivalent to Study Day 21 to 28)

Population: Carbapenem-resistant microbiological intention-to-treat population with SOFA measurement at Baseline and at each post-baseline time point.

The SOFA score is a scoring system to determine the extent of a patient's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each score is from 0 to 4, and the total score ranges from 0 to 24, where higher scores indicate a higher likelihood of mortality. A negative change from Baseline score indicates improvement.

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=40 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=19 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol n=23 Participants Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy n=14 Participants Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol n=17 Participants Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy n=5 Participants Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol n=80 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy n=38 Participants Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Change From Baseline in Sequential Organ Failure Assessment (SOFA) End of treatment	-0.7 scores on a scale Standard Deviation 3.6	-1.6 scores on a scale Standard Deviation 2.6	-2.1 scores on a scale Standard Deviation 3.7	-0.2 scores on a scale Standard Deviation 2.8	-0.6 scores on a scale Standard Deviation 1.3	-1.3 scores on a scale Standard Deviation 2.3	-1.1 scores on a scale Standard Deviation 3.3	-1.0 scores on a scale Standard Deviation 2.7	—	—
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Test of cure	-1.3 scores on a scale Standard Deviation 5.0	-1.7 scores on a scale Standard Deviation 2.9	-2.1 scores on a scale Standard Deviation 2.5	0.2 scores on a scale Standard Deviation 4.1	-0.6 scores on a scale Standard Deviation 2.0	-1.3 scores on a scale Standard Deviation 2.3	-1.3 scores on a scale Standard Deviation 3.8	-0.9 scores on a scale Standard Deviation 3.4	—	—
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Follow-up	-2.1 scores on a scale Standard Deviation 4.4	-2.0 scores on a scale Standard Deviation 2.9	-3.1 scores on a scale Standard Deviation 3.1	-0.2 scores on a scale Standard Deviation 4.4	-0.1 scores on a scale Standard Deviation 2.5	-2.0 scores on a scale Standard Deviation 3.5	-1.9 scores on a scale Standard Deviation 3.8	-1.4 scores on a scale Standard Deviation 3.5	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to 28 days after last dose; maximum treatment duration was 29 days in the cefiderocol group and 22 days in the BAT group.

Population: Safety population

The severity of each adverse event (AE) was graded by the investigator according to the following definitions:

• Mild: Symptom or finding is minor and does not interfere with usual daily activities
• Moderate: The event causes discomfort and interferes with usual daily activity or affects clinical status
• Severe: The event causes interruption of usual daily activities or has a clinically significant effect

The relationship of AEs to study treatment was determined by the investigator according to the following definition:

● Related: An AE which can be reasonably explained as having been caused by the study treatment.

A serious AE is defined as any AE that resulted in any of the following outcomes:

• Death
• Life-threatening condition
• Hospitalization or prolongation of existing hospitalization
• Persistent or significant disability/incapacity
• Congenital anomaly/birth defect
• Other medically important condition

Outcome measures

Measure	HAP/VAP/HCAP: Cefiderocol n=101 Participants Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP: Best Available Therapy n=49 Participants Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	BSI/Sepsis: Cefiderocol Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	BSI/Sepsis: Best Available Therapy Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	cUTI: Cefiderocol Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	cUTI: Best Available Therapy Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.	Overall: Cefiderocol Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Overall: Best Available Therapy Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Number of Participants With Adverse Events Any adverse event (AE)	92 Participants	47 Participants	—	—	—	—	—	—	—	—
Number of Participants With Adverse Events Mild adverse events	23 Participants	9 Participants	—	—	—	—	—	—	—	—
Number of Participants With Adverse Events Moderate adverse events	26 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Participants With Adverse Events Severe adverse events	43 Participants	22 Participants	—	—	—	—	—	—	—	—
Number of Participants With Adverse Events Drug-related adverse events	15 Participants	11 Participants	—	—	—	—	—	—	—	—
Number of Participants With Adverse Events Discontinuations due to adverse events	10 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Participants With Adverse Events Discontinuations due to drug-related AEs	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Participants With Adverse Events Serious adverse events (SAE)	50 Participants	23 Participants	—	—	—	—	—	—	—	—
Number of Participants With Adverse Events Drug-related serious adverse events	1 Participants	5 Participants	—	—	—	—	—	—	—	—
Number of Participants With Adverse Events Death due to serious adverse events	34 Participants	9 Participants	—	—	—	—	—	—	—	—

Adverse Events

Cefiderocol

Serious events: 50 serious events

Other events: 88 other events

Deaths: 34 deaths

Best Available Therapy (BAT)

Serious events: 23 serious events

Other events: 43 other events

Deaths: 9 deaths

Serious adverse events

Measure	Cefiderocol n=101 participants at risk Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Best Available Therapy (BAT) n=49 participants at risk Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Blood and lymphatic system disorders Febrile neutropenia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Bradycardia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Cardiac arrest	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Cardiac failure congestive	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Myocardial infarction	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Pulseless electrical activity	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Abdominal pain	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Abdominal pain upper	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Intestinal ischaemia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Pancreatitis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Small intestinal obstruction	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Chills	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders General physical health deterioration	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Multi-organ failure	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Pyrexia	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Sudden death	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Hepatobiliary disorders Chronic hepatic failure	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Hepatobiliary disorders Hepatic failure	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Hepatobiliary disorders Hepatitis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Immune system disorders Anaphylactic reaction	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Bacteraemia	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Bacterial infection	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Device related infection	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Empyema	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Endocarditis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Enterococcal bacteraemia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Enterococcal infection	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Meningitis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Necrotising fasciitis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Osteomyelitis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Osteomyelitis acute	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Pneumonia	5.0% 5/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Pneumonia bacterial	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Renal abscess	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Sepsis	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Septic shock	11.9% 12/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	12.2% 6/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Systemic candida	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Urinary tract infection	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Urosepsis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Liver function test abnormal	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	6.1% 3/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Transaminases increased	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hyponatraemia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Metabolic acidosis	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Dizziness	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Hypoaesthesia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Neurological decompensation	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Paraesthesia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Quadriplegia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Status epilepticus	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Acute kidney injury	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Anuria	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Nephrolithiasis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Oliguria	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Vascular disorders Hypotension	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Vascular disorders Shock	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).

Other adverse events

Measure	Cefiderocol n=101 participants at risk Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.	Best Available Therapy (BAT) n=49 participants at risk Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
Infections and infestations Bacterial infection	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Candida infection	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Candiduria	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Catheter site infection	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Cellulitis	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Conjunctivitis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Corynebacterium infection	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Cytomegalovirus viraemia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Enterobacter infection	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Enterococcal infection	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Influenza	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Klebsiella infection	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Oral herpes	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Oropharyngeal candidiasis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Osteomyelitis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Otitis externa	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Pneumonia bacterial	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Pseudomembranous colitis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Blood and lymphatic system disorders Anaemia	7.9% 8/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Blood and lymphatic system disorders Anaemia of chronic disease	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Blood and lymphatic system disorders Leukopenia	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Blood and lymphatic system disorders Splenic infarction	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Blood and lymphatic system disorders Thrombocytopenia	5.9% 6/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	8.2% 4/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Blood and lymphatic system disorders Thrombocytosis	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Atrial fibrillation	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Atrial flutter	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Bradycardia	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Cyanosis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Myocardial ischaemia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Sinus tachycardia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Cardiac disorders Tachycardia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Endocrine disorders Hypothyroidism	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Eye disorders Ocular hyperaemia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Eye disorders Pupils unequal	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Abdominal distension	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Abdominal pain	5.0% 5/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	8.2% 4/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Abdominal pain upper	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Constipation	7.9% 8/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	6.1% 3/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Diarrhoea	18.8% 19/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	12.2% 6/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Dysphagia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Haematemesis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Impaired gastric emptying	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Melaena	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Nausea	6.9% 7/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Gastrointestinal disorders Vomiting	12.9% 13/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	14.3% 7/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Asthenia	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Catheter site inflammation	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Chest pain	5.9% 6/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Fatigue	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Hypothermia	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Localised oedema	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Malaise	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Oedema	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Oedema peripheral	5.0% 5/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Pain	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
General disorders Pyrexia	11.9% 12/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	12.2% 6/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Hepatobiliary disorders Biliary dilatation	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Hepatobiliary disorders Cholangitis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Hepatobiliary disorders Gallbladder necrosis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Abdominal abscess	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Acinetobacter infection	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Bacteraemia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Bacterial disease carrier	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Pseudomonas infection	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Sepsis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	6.1% 3/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Septic shock	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Staphylococcal infection	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Staphylococcal sepsis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Streptococcal bacteraemia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Systemic candida	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Tracheobronchitis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Urinary tract infection	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Urinary tract infection enterococcal	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Infections and infestations Wound infection pseudomonas	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Injury, poisoning and procedural complications Procedural pain	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Injury, poisoning and procedural complications Wound	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Activated partial thromboplastin time prolonged	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Alanine aminotransferase increased	6.9% 7/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Aspartate aminotransferase increased	7.9% 8/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Blood bilirubin increased	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Blood creatine increased	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Blood creatinine increased	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Blood lactate dehydrogenase increased	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Blood lactic acid increased	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Blood magnesium decreased	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Blood phosphorus decreased	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Blood urea increased	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Gastrointestinal stoma output increased	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Hepatic enzyme increased	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations International normalised ratio increased	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Lipase increased	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Liver function test abnormal	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations Platelet count decreased	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations White blood cell count abnormal	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Investigations White blood cell count increased	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Acidosis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Fluid overload	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hyperglycaemia	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hyperkalaemia	5.0% 5/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	12.2% 6/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hypernatraemia	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hyperphosphataemia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hypocalcaemia	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hypoglycaemia	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hypokalaemia	8.9% 9/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	14.3% 7/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hypomagnesaemia	5.9% 6/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	8.2% 4/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hyponatraemia	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Metabolic acidosis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Metabolic alkalosis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Metabolism and nutrition disorders Vitamin D deficiency	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Musculoskeletal and connective tissue disorders Back pain	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Cerebral small vessel ischaemic disease	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Dizziness	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Dizziness postural	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Headache	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Nervous system disorders Polyneuropathy	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Psychiatric disorders Agitation	5.0% 5/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Psychiatric disorders Anxiety	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Psychiatric disorders Confusional state	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Psychiatric disorders Delirium	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Psychiatric disorders Depression	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	6.1% 3/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Psychiatric disorders Insomnia	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	6.1% 3/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Psychiatric disorders Restlessness	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Acute kidney injury	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	8.2% 4/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Bladder disorder	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Oliguria	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Renal disorder	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Renal impairment	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Renal tubular acidosis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Renal and urinary disorders Urinary retention	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Reproductive system and breast disorders Genital erythema	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Reproductive system and breast disorders Oedema genital	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Cough	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.9% 7/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Haemoptysis	4.0% 4/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Hiccups	2.0% 2/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.9% 8/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	0.00% 0/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Skin and subcutaneous tissue disorders Blister	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Skin and subcutaneous tissue disorders Decubitus ulcer	9.9% 10/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	8.2% 4/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Skin and subcutaneous tissue disorders Erythema	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Skin and subcutaneous tissue disorders Pruritus	0.99% 1/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Skin and subcutaneous tissue disorders Rash	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	8.2% 4/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Vascular disorders Haemorrhage	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Vascular disorders Hypertension	3.0% 3/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Vascular disorders Hypotension	5.9% 6/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	4.1% 2/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Vascular disorders Shock	0.00% 0/101 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).	2.0% 1/49 • From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).

Additional Information

Shionogi Clinical Trials Administrator

Shionogi Inc.

Phone: 800-849-9707

Email: shionogiclintrials-admin@shionogi.co.jp

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER