Trial Outcomes & Findings for Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036) (NCT NCT04223752)
NCT ID: NCT04223752
Last Updated: 2025-09-22
Results Overview
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants experiencing any AE was reported for each arm.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Up to 31 days
Results posted on
2025-09-22
Participant Flow
One participant was enrolled in error in the Group 5 arm and was excluded from the All participants as treated (APaT) population; the participant did not receive study intervention.
Participant milestones
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
8
|
10
|
8
|
|
Overall Study
Treated
|
8
|
7
|
8
|
10
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
8
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Overall Study
Participant enrolled in error
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
Baseline characteristics by cohort
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=8 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=8 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
14.345 Years
STANDARD_DEVIATION 1.6408 • n=5 Participants
|
9.709 Years
STANDARD_DEVIATION 1.9100 • n=7 Participants
|
3.185 Years
STANDARD_DEVIATION 0.7430 • n=5 Participants
|
0.806 Years
STANDARD_DEVIATION 0.2994 • n=4 Participants
|
0.102 Years
STANDARD_DEVIATION 0.0628 • n=21 Participants
|
5.294 Years
STANDARD_DEVIATION 5.6787 • n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 31 daysPopulation: The analysis population consisted of participants who received any dose (including partial doses) of ceftolozane/tazobactam.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants experiencing any AE was reported for each arm.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=8 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Any Adverse Events (AEs)
|
50.0 Percentage of participants
95% Confidence Interval 15.7 • Interval 15.7 to 84.3
|
71.4 Percentage of participants
95% Confidence Interval 29.0 • Interval 29.0 to 96.3
|
75.0 Percentage of participants
95% Confidence Interval 34.9 • Interval 34.9 to 96.8
|
90.0 Percentage of participants
95% Confidence Interval 55.5 • Interval 55.5 to 99.7
|
85.7 Percentage of participants
95% Confidence Interval 42.1 • Interval 42.1 to 99.6
|
PRIMARY outcome
Timeframe: Up to 31 daysPopulation: The analysis population consisted of participants who received any dose (including partial doses) of ceftolozane/tazobactam.
An SAE was defined as any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event. The percentage of participants with any SAE was reported for each arm.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=8 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Any Serious AEs (SAEs)
|
12.5 Percentage of participants
95% Confidence Interval 0.3 • Interval 0.3 to 52.7
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 36.9
|
30.0 Percentage of participants
95% Confidence Interval 6.7 • Interval 6.7 to 65.2
|
28.6 Percentage of participants
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
PRIMARY outcome
Timeframe: Up to 31 daysPopulation: The analysis population consisted of participants who received any dose (including partial doses) of ceftolozane/tazobactam.
A drug-related AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered related to the study intervention. The percentage of participants with any drug related AEs was reported for each arm.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=8 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Any Drug-related AEs
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 36.9
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 36.9
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 30.8
|
14.3 Percentage of participants
95% Confidence Interval 0.4 • Interval 0.4 to 57.9
|
PRIMARY outcome
Timeframe: Up to 31 daysPopulation: The analysis population consisted of participants who received any dose (including partial doses) of ceftolozane/tazobactam.
A drug-related SAE was defined any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event, that is considered related to the study intervention. The percentage of participants with any drug related SAEs was reported for each arm.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=8 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Any Drug-related SAEs
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 36.9
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 36.9
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 30.8
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
PRIMARY outcome
Timeframe: Up to 14 daysPopulation: The analysis population consisted of participants who received any dose (including partial doses) of ceftolozane/tazobactam.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with AEs leading to discontinuation of study intervention was reported for each arm.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=8 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 36.9
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 36.9
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 30.8
|
0.0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 41.0
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 1 dose of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane.
The plasma concentrations of ceftolozane were determined in each group. Blood samples were collected at pre-specified timepoints to determine the plasma concentrations of ceftolozane in participants receiving ceftolozane/tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=6 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Plasma Concentrations of Ceftolozane
7-8 hrs post start of infusion
|
6.61 mg/L
Geometric Coefficient of Variation 27.2 • Interval 27.2 to
|
4.53 mg/L
Geometric Coefficient of Variation 53.1 • Interval 53.1 to
|
2.79 mg/L
Geometric Coefficient of Variation 59.9 • Interval 59.9 to
|
6.84 mg/L
Geometric Coefficient of Variation 172 • Interval 172.0 to
|
19.2 mg/L
Geometric Coefficient of Variation 48.9 • Interval 48.9 to
|
|
Plasma Concentrations of Ceftolozane
1 hr post start of infusion
|
93.0 mg/L
Geometric Coefficient of Variation 18.9 • Interval 18.9 to
|
70.3 mg/L
Geometric Coefficient of Variation 28.6 • Interval 28.6 to
|
67.6 mg/L
Geometric Coefficient of Variation 46.9 • Interval 46.9 to
|
54.3 mg/L
Geometric Coefficient of Variation 203 • Interval 203.0 to
|
78.5 mg/L
Geometric Coefficient of Variation 19.0 • Interval 19.0 to
|
|
Plasma Concentrations of Ceftolozane
4-5 hrs post start of infusion
|
18.8 mg/L
Geometric Coefficient of Variation 20.1 • Interval 20.1 to
|
13.4 mg/L
Geometric Coefficient of Variation 55.6 • Interval 55.6 to
|
10.5 mg/L
Geometric Coefficient of Variation 52.4 • Interval 52.4 to
|
17.6 mg/L
Geometric Coefficient of Variation 83.2 • Interval 83.2 to
|
31.8 mg/L
Geometric Coefficient of Variation 45.8 • Interval 45.8 to
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane.
AUC0-8 was defined as a measure of ceftolozane exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at pre-specified timepoints to determine the AUC0-8 of ceftolozane in participants receiving ceftolozane/tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Ceftolozane
|
260 μg*hr/mL
Geometric Coefficient of Variation 18.4 • Interval 18.4 to
|
230 μg*hr/mL
Geometric Coefficient of Variation 27.2 • Interval 27.2 to
|
202 μg*hr/mL
Geometric Coefficient of Variation 22.5 • Interval 22.5 to
|
282 μg*hr/mL
Geometric Coefficient of Variation 42.8 • Interval 42.8 to
|
360 μg*hr/mL
Geometric Coefficient of Variation 29.7 • Interval 29.7 to
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane.
Cmax was defined as the maximum concentration of ceftolozane observed in plasma. Blood samples were collected at pre-specified timepoints to determine the Cmax of ceftolozane in participants receiving ceftolozane/tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Ceftolozane
|
116 μg/mL
Geometric Coefficient of Variation 17.8 • Interval 17.8 to
|
121 μg/mL
Geometric Coefficient of Variation 22.7 • Interval 22.7 to
|
107 μg/mL
Geometric Coefficient of Variation 15.9 • Interval 15.9 to
|
113 μg/mL
Geometric Coefficient of Variation 18.9 • Interval 18.9 to
|
107 μg/mL
Geometric Coefficient of Variation 16.0 • Interval 16.0 to
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane.
Elimination half-life (t1/2) was defined as the time needed to reduce the level of ceftolozane in the blood by one-half (1/2). Blood samples collected at pre-specified timepoints were used to determine the apparent terminal half-life (t1/2) of ceftolozane in participants receiving ceftolozane/tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Elimination Half-life (t1/2) of Plasma Ceftolozane
|
1.87 Hours
Geometric Coefficient of Variation 8.60 • Interval 8.6 to
|
1.56 Hours
Geometric Coefficient of Variation 16.2 • Interval 16.2 to
|
1.33 Hours
Geometric Coefficient of Variation 15.7 • Interval 15.7 to
|
1.79 Hours
Geometric Coefficient of Variation 39.2 • Interval 39.2 to
|
2.60 Hours
Geometric Coefficient of Variation 24.6 • Interval 24.6 to
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane.
CL was defined as the total clearance of ceftolozane in plasma over time, assessed as the rate at which ceftolozane was removed from the plasma. Blood samples were collected at pre-specified timepoints to determine the CL of ceftolozane in participants receiving ceftolozane/tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Clearance (CL) of Plasma Ceftolozane
|
7.68 L/hr
Geometric Coefficient of Variation 18.4 • Interval 18.4 to
|
4.95 L/hr
Geometric Coefficient of Variation 53.3 • Interval 53.3 to
|
2.54 L/hr
Geometric Coefficient of Variation 36.1 • Interval 36.1 to
|
0.919 L/hr
Geometric Coefficient of Variation 62.1 • Interval 62.1 to
|
0.378 L/hr
Geometric Coefficient of Variation 57.5 • Interval 57.5 to
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane or tazobactam.
Vd was defined as the distributed volume of study drug in plasma at steady state. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. Blood samples were collected at pre-specified timepoints to determine the Vd of ceftolozane in participants receiving ceftolozane/tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Volume of Distribution (Vd) of Plasma Ceftolozane
|
16.2 Liters
Geometric Coefficient of Variation 18.8 • Interval 18.8 to
|
8.35 Liters
Geometric Coefficient of Variation 50.0 • Interval 50.0 to
|
3.97 Liters
Geometric Coefficient of Variation 17.0 • Interval 17.0 to
|
2.13 Liters
Geometric Coefficient of Variation 36.3 • Interval 36.3 to
|
1.36 Liters
Geometric Coefficient of Variation 34.8 • Interval 34.8 to
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 1 dose of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
The plasma concentrations of tazobactam were determined in each group. Blood samples were collected at pre-specified timepoints to determine the plasma concentrations of tazobactam in participants receiving ceftolozane/tazobactam. No data were calculated for a timepoint if \>50% of samples were below limit of quantification (BLOQ).
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=6 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Plasma Concentrations of Tazobactam
1 hr post start of infusion
|
18.6 mg/L
Geometric Coefficient of Variation 22.4
|
15.5 mg/L
Geometric Coefficient of Variation 43.0
|
15.0 mg/L
Geometric Coefficient of Variation 66.6
|
10.2 mg/L
Geometric Coefficient of Variation 747
|
22.2 mg/L
Geometric Coefficient of Variation 35.5
|
|
Plasma Concentrations of Tazobactam
4-5 hrs post start of infusion
|
0.876 mg/L
Geometric Coefficient of Variation 38.3
|
0.788 mg/L
Geometric Coefficient of Variation 157
|
0.404 mg/L
Geometric Coefficient of Variation 122
|
0.844 mg/L
Geometric Coefficient of Variation 349
|
3.38 mg/L
Geometric Coefficient of Variation 88.6
|
|
Plasma Concentrations of Tazobactam
7-8 hrs post start of infusion
|
0.152 mg/L
Geometric Coefficient of Variation 68.4
|
0.181 mg/L
Geometric Coefficient of Variation 183
|
NA mg/L
Geometric Coefficient of Variation NA
NA= Plasma concentration was not calculated because \>50% of samples were BLOQ.
|
0.261 mg/L
Geometric Coefficient of Variation 372
|
0.895 mg/L
Geometric Coefficient of Variation 122
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
AUC0-8 was defined as a measure of tazobactam exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at pre-specified timepoints to determine the AUC0-8 of tazobactam in participants receiving ceftolozane/tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Tazobactam
|
46.7 μg*hr/mL
Geometric Coefficient of Variation 25.5 • Interval 25.5 to
|
50.1 μg*hr/mL
Geometric Coefficient of Variation 42.7 • Interval 42.7 to
|
42.7 μg*hr/mL
Geometric Coefficient of Variation 33.8 • Interval 33.8 to
|
58.3 μg*hr/mL
Geometric Coefficient of Variation 50.5 • Interval 50.5 to
|
72.5 μg*hr/mL
Geometric Coefficient of Variation 35.0 • Interval 35.0 to
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionCmax was defined as the maximum concentration of tazobactam observed in plasma. Blood samples were collected at pre-specified timepoints to determine the Cmax of tazobactam in participants receiving ceftolozane/tazobactam. The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Tazobactam
|
36.7 μg/mL
Geometric Coefficient of Variation 29.6 • Interval 29.6 to
|
39.4 μg/mL
Geometric Coefficient of Variation 34.1 • Interval 34.1 to
|
34.2 μg/mL
Geometric Coefficient of Variation 24.5 • Interval 24.5 to
|
38.1 μg/mL
Geometric Coefficient of Variation 29.1 • Interval 29.1 to
|
37.9 μg/mL
Geometric Coefficient of Variation 14.5 • Interval 14.5 to
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Elimination half-life (t1/2) was defined as the time needed to reduce the level of tazobactam in the blood by one-half (1/2). Blood samples collected at pre-specified timepoints were used to determine the apparent terminal half-life (t1/2) of tazobactam in participants receiving ceftolozane/tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Elimination Half-life (t1/2) of Plasma Tazobactam
|
1.07 Hours
Geometric Coefficient of Variation 6.59 • Interval 6.59 to
|
0.932 Hours
Geometric Coefficient of Variation 27.8 • Interval 27.8 to
|
0.748 Hours
Geometric Coefficient of Variation 22.9 • Interval 22.9 to
|
0.930 Hours
Geometric Coefficient of Variation 38.9 • Interval 38.9 to
|
1.23 Hours
Geometric Coefficient of Variation 31.6 • Interval 31.6 to
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
CL was defined as the total clearance of tazobactam in plasma over time, assessed as the rate at which tazobactam was removed from the plasma. Blood samples were collected at pre-specified timepoints to determine the CL of tazobactam in participants receiving ceftolozane/tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Clearance (CL) of Plasma Tazobactam
|
21.4 L/hr
Geometric Coefficient of Variation 25.5 • Interval 25.5 to
|
11.4 L/hr
Geometric Coefficient of Variation 67.6 • Interval 67.6 to
|
6.00 L/hr
Geometric Coefficient of Variation 45.9 • Interval 45.9 to
|
2.22 L/hr
Geometric Coefficient of Variation 68.5 • Interval 68.5 to
|
0.938 L/hr
Geometric Coefficient of Variation 58.2 • Interval 58.2 to
|
SECONDARY outcome
Timeframe: Day 3: 1, between 4-5, and between 7-8 hours post start of infusionPopulation: The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Vd is defined as the distributed volume of study drug in plasma at steady state. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. Blood samples were collected at pre-specified timepoints to determine the Vd of tazobactam in participants receiving ceftolozane/tazobactam.
Outcome measures
| Measure |
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
n=8 Participants
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
n=7 Participants
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
n=7 Participants
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
n=10 Participants
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
n=7 Participants
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Volume of Distribution (Vd) of Plasma Tazobactam
|
15.2 Liters
Geometric Coefficient of Variation 37.9 • Interval 37.9 to
|
7.71 Liters
Geometric Coefficient of Variation 74.6 • Interval 74.6 to
|
3.34 Liters
Geometric Coefficient of Variation 17.3 • Interval 17.3 to
|
2.07 Liters
Geometric Coefficient of Variation 32.5 • Interval 32.5 to
|
1.38 Liters
Geometric Coefficient of Variation 23.7 • Interval 23.7 to
|
Adverse Events
Group 1: 12 to <18 Years
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2: 7 to <12 Years
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3: 2 to <7 Years
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 4: 3 Months to <2 Years
Serious events: 3 serious events
Other events: 9 other events
Deaths: 2 deaths
Group 5: Birth to <3 Months
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1: 12 to <18 Years
n=8 participants at risk
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: 7 to <12 Years
n=7 participants at risk
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: 2 to <7 Years
n=8 participants at risk
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: 3 Months to <2 Years
n=10 participants at risk
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Birth to <3 Months
n=7 participants at risk
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Cardiac disorders
Myocardial depression
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Gastrointestinal disorders
Omentitis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Candida infection
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Septic shock
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign mediastinal neoplasm
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Product Issues
Device dislocation
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
Other adverse events
| Measure |
Group 1: 12 to <18 Years
n=8 participants at risk
Participants 12 to \<18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
|
Group 2: 7 to <12 Years
n=7 participants at risk
Participants 7 to \<12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 3: 2 to <7 Years
n=8 participants at risk
Participants 2 to \<7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 4: 3 Months to <2 Years
n=10 participants at risk
Participants 3 months to \<2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
|
Group 5: Birth to <3 Months
n=7 participants at risk
Participants from birth to \<3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
30.0%
3/10 • Number of events 3 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
20.0%
2/10 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Cardiac disorders
Cardiac dysfunction
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Gastrointestinal disorders
Anal erythema
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 3 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
28.6%
2/7 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
20.0%
2/10 • Number of events 3 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
General disorders
Chest pain
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
General disorders
Face oedema
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
General disorders
Hyperthermia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
28.6%
2/7 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
20.0%
2/10 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
General disorders
Withdrawal syndrome
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Candida infection
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Device related infection
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Systemic mycosis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Alanine aminotransferase increased
|
37.5%
3/8 • Number of events 3 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Amylase increased
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Base excess decreased
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
1/8 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Lipase increased
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Myelocyte count increased
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Investigations
Platelet count increased
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
25.0%
2/8 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal lipoma
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Nervous system disorders
Seizure
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Product Issues
Device breakage
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Renal and urinary disorders
Urinary retention
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
12.5%
1/8 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 2 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
10.0%
1/10 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/7 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/8 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
0.00%
0/10 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 days
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER