Trial Outcomes & Findings for A Trial to Evaluate the Pharmacokinetics and Safety of AVYCAZ(R) in Combination With Aztreonam (NCT NCT03978091)
NCT ID: NCT03978091
Last Updated: 2022-06-07
Results Overview
Adverse events include local and systemic reactions. All Grade 2 (moderate) adverse events were reported, regardless of relationship to study product. Number of participants with an AE are summarized by MedDRA system organ class (SOC). Each participant is only counted once per SOC.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Day 1 through Day 11
Results posted on
2022-06-07
Participant Flow
Participants were healthy adult male and female subjects age 18-45, inclusively. Participants were enrolled between 09JUL2019 and 06NOV2020 and were recruited from the community around the clinical site.
Participant milestones
| Measure |
AVYCAZ IV
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam
|
AVYCAZ CI
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam
|
ATM IV
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
AZACTAM (aztreonam): A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
AZACTAM: A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum
|
AVYCAZ + ATM 1.5
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
AZACTAM: A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum
Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam
|
AVYCAZ + ATM 2.0
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
AZACTAM: A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum
Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
7
|
7
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
AVYCAZ IV
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam
|
AVYCAZ CI
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam
|
ATM IV
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
AZACTAM (aztreonam): A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
AZACTAM: A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum
|
AVYCAZ + ATM 1.5
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
AZACTAM: A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum
Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam
|
AVYCAZ + ATM 2.0
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
AZACTAM: A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum
Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Trial to Evaluate the Pharmacokinetics and Safety of AVYCAZ(R) in Combination With Aztreonam
Baseline characteristics by cohort
| Measure |
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
n=8 Participants
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
48 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
36.4 years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
34.5 years
STANDARD_DEVIATION 5.9 • n=206 Participants
|
30.8 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
28.5 years
STANDARD_DEVIATION 3.8 • n=31 Participants
|
33.8 years
STANDARD_DEVIATION 4.6 • n=30 Participants
|
33.5 years
STANDARD_DEVIATION 6.2 • n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
40 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
29 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
8 participants
n=7 Participants
|
8 participants
n=31 Participants
|
8 participants
n=30 Participants
|
48 participants
n=3 Participants
|
|
BMI
|
25.74 kg/m^2
STANDARD_DEVIATION 2.92 • n=99 Participants
|
27.65 kg/m^2
STANDARD_DEVIATION 3.44 • n=107 Participants
|
26.16 kg/m^2
STANDARD_DEVIATION 3.52 • n=206 Participants
|
25.38 kg/m^2
STANDARD_DEVIATION 4.09 • n=7 Participants
|
25.55 kg/m^2
STANDARD_DEVIATION 3.33 • n=31 Participants
|
28.31 kg/m^2
STANDARD_DEVIATION 4.58 • n=30 Participants
|
26.46 kg/m^2
STANDARD_DEVIATION 3.66 • n=3 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 11Population: The safety population includes all participants who received any amount of study product (started first infusion).
Adverse events include local and systemic reactions. All Grade 2 (moderate) adverse events were reported, regardless of relationship to study product. Number of participants with an AE are summarized by MedDRA system organ class (SOC). Each participant is only counted once per SOC.
Outcome measures
| Measure |
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
n=8 Participants
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Grade 2 (Moderate) or Higher Treatment-emergent Adverse Event
Cardiac Disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With at Least One Grade 2 (Moderate) or Higher Treatment-emergent Adverse Event
Eye disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Grade 2 (Moderate) or Higher Treatment-emergent Adverse Event
General disorders and administration site conditions
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Grade 2 (Moderate) or Higher Treatment-emergent Adverse Event
Infections and infestations
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Grade 2 (Moderate) or Higher Treatment-emergent Adverse Event
Injury, poisoning and procedural complications
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least One Grade 2 (Moderate) or Higher Treatment-emergent Adverse Event
Investigations
|
1 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With at Least One Grade 2 (Moderate) or Higher Treatment-emergent Adverse Event
Nervous system disorders
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Grade 2 (Moderate) or Higher Treatment-emergent Adverse Event
Respiratory, thoracic and mediastinal disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. The AVYCAZ + ATM 1.5 arm consists of 4 participants as 4 participants missed aztreonam doses on day 7. The AVYCAZ CI and ATM CI arms consist of 0 participants as AUC(0-Tau) was not collected on Day 1 due to the study drug being administered as a continuous infusion.
Mean and standard deviation (SD) of the RAUC PK parameter were estimated for ceftazidime, avibactam, and/or aztreonam by dividing the AUC(0-8) (avibactam and ceftazidime) or AUC(0-6) (aztreonam) on Day 7 by the AUC(0-Tau) on Day 1. AUC(0-8) and AUC(0-6) (µg\*hr/mL) on Day 7 and AUC(0-Tau) (µg\*hr/mL) on Day 1 were estimated from plasma concentration-time data using Non-compartmental analysis with the linear trapezoidal linear interpolation method for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0.
Outcome measures
| Measure |
AVYCAZ CI
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=4 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Accumulation Ratio for AUC (Area Under the Plasma Concentration-time Curve of Study Drug) [RAUC]
Avibactam
|
—
|
—
|
—
|
0.80 Accumulation ratio
Standard Deviation 0.03
|
0.82 Accumulation ratio
Standard Deviation 0.06
|
0.87 Accumulation ratio
Standard Deviation 0.12
|
|
Accumulation Ratio for AUC (Area Under the Plasma Concentration-time Curve of Study Drug) [RAUC]
Ceftazidime
|
—
|
—
|
—
|
0.95 Accumulation ratio
Standard Deviation 0.04
|
0.95 Accumulation ratio
Standard Deviation 0.05
|
0.98 Accumulation ratio
Standard Deviation 0.12
|
|
Accumulation Ratio for AUC (Area Under the Plasma Concentration-time Curve of Study Drug) [RAUC]
Aztreonam
|
—
|
0.90 Accumulation ratio
Standard Deviation 0.07
|
—
|
0.91 Accumulation ratio
Standard Deviation 0.04
|
0.94 Accumulation ratio
Standard Deviation 0.05
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. The AVYCAZ + ATM 1.5 arm consists of 4 participants as 4 participants missed aztreonam doses on day 7. The AVYCAZ CI and ATM CI arms consist of 0 participants as this data was not collected in arms where the study drug was administered as a continuous infusion.
Mean and standard deviation (SD) of the RCmax PK parameter were estimated for ceftazidime, avibactam, and/or aztreonam by dividing the Cmax on Day 7 by the Cmax on Day 1. Cmax (ug/mL) was estimated from plasma concentration-time data using Non-compartmental analysis for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0.
Outcome measures
| Measure |
AVYCAZ CI
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=4 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Accumulation Ratio for Cmax (Maximum Plasma Concentration) (RCmax)
Avibactam
|
—
|
—
|
—
|
0.83 Accumulation ratio
Standard Deviation 0.05
|
0.91 Accumulation ratio
Standard Deviation 0.08
|
0.88 Accumulation ratio
Standard Deviation 0.18
|
|
Accumulation Ratio for Cmax (Maximum Plasma Concentration) (RCmax)
Ceftazidime
|
—
|
—
|
—
|
0.96 Accumulation ratio
Standard Deviation 0.06
|
1.01 Accumulation ratio
Standard Deviation 0.11
|
0.96 Accumulation ratio
Standard Deviation 0.20
|
|
Accumulation Ratio for Cmax (Maximum Plasma Concentration) (RCmax)
Aztreonam
|
—
|
0.88 Accumulation ratio
Standard Deviation 0.07
|
—
|
0.95 Accumulation ratio
Standard Deviation 0.05
|
0.97 Accumulation ratio
Standard Deviation 0.11
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. Participants in the ATM CI arm do not have data because dosing for all participants was stopped prior to Day 7, so their PK data was excluded from the analysis.
Mean and standard deviation (SD) of the AUC(0-inf) (µg\*hr/mL) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis.
Outcome measures
| Measure |
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=4 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve of Study Drug From Time of Dosing Extrapolated to Infinity [AUC(0-Inf)]
Avibactam
|
42.40 µg*hr/mL
Standard Deviation 7.17
|
—
|
—
|
39.10 µg*hr/mL
Standard Deviation 4.57
|
36.10 µg*hr/mL
Standard Deviation 6.17
|
32.10 µg*hr/mL
Standard Deviation 3.73
|
|
Area Under the Plasma Concentration-time Curve of Study Drug From Time of Dosing Extrapolated to Infinity [AUC(0-Inf)]
Ceftazidime
|
308.00 µg*hr/mL
Standard Deviation 63.30
|
—
|
—
|
277.00 µg*hr/mL
Standard Deviation 27.50
|
249.00 µg*hr/mL
Standard Deviation 26.40
|
235.00 µg*hr/mL
Standard Deviation 25.80
|
|
Area Under the Plasma Concentration-time Curve of Study Drug From Time of Dosing Extrapolated to Infinity [AUC(0-Inf)]
Aztreonam
|
—
|
263.00 µg*hr/mL
Standard Deviation 38.80
|
—
|
245.00 µg*hr/mL
Standard Deviation 23.50
|
317.00 µg*hr/mL
Standard Deviation 47.70
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. The AVYCAZ CI and ATM CI arms consist of 0 participants as AUC(0-Tau) was not collected on Day 1 due to the study drug being administered as a continuous infusion.
Mean and standard deviation (SD) of the AUC(0-Tau) (µg\*hr/mL) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis using linear trapezoidal linear interpolation method for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. AVYCAZ CI and ATM CI were not reported.
Outcome measures
| Measure |
AVYCAZ CI
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve Data of Study Drug During the Dosing Interval on Day 1 [AUC(0-Tau)]
Avibactam
|
—
|
—
|
—
|
44.00 µg*hr/mL
Standard Deviation 7.10
|
42.40 µg*hr/mL
Standard Deviation 7.16
|
35.80 µg*hr/mL
Standard Deviation 5.96
|
|
Area Under the Plasma Concentration-time Curve Data of Study Drug During the Dosing Interval on Day 1 [AUC(0-Tau)]
Ceftazidime
|
—
|
—
|
—
|
255.00 µg*hr/mL
Standard Deviation 34.30
|
241.00 µg*hr/mL
Standard Deviation 33.10
|
223.00 µg*hr/mL
Standard Deviation 33.90
|
|
Area Under the Plasma Concentration-time Curve Data of Study Drug During the Dosing Interval on Day 1 [AUC(0-Tau)]
Aztreonam
|
—
|
266.00 µg*hr/mL
Standard Deviation 36.10
|
—
|
221.00 µg*hr/mL
Standard Deviation 32.70
|
295.00 µg*hr/mL
Standard Deviation 41.30
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 14Population: The safety population includes all participants who received any amount of study product (started first infusion).
Number of participants with an AE are summarized by MedDRA system organ class (SOC) and severity. Each participant is only counted once at the highest severity recorded. For clinical laboratory tests, mild abnormal laboratory values that were not, in the investigator's opinion, medically significant were not reported as adverse events.
Outcome measures
| Measure |
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
n=8 Participants
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Eye disorders · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Cardiac Disorders · Mild
|
2 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Cardiac Disorders · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Cardiac Disorders · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Cardiac Disorders · None
|
6 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Eye disorders · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Eye disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Eye disorders · None
|
8 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Gastrointestinal Disorders · Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Gastrointestinal Disorders · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Gastrointestinal Disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Gastrointestinal Disorders · None
|
7 Participants
|
6 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
General disorders and administration site conditions · Mild
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
General disorders and administration site conditions · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
General disorders and administration site conditions · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
General disorders and administration site conditions · None
|
6 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Infections and infestations · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Infections and infestations · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Infections and infestations · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Infections and infestations · None
|
8 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Injury, poisoning and procedural complications · Mild
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Injury, poisoning and procedural complications · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Injury, poisoning and procedural complications · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Injury, poisoning and procedural complications · None
|
8 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Investigations · Mild
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Investigations · Moderate
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Investigations · Severe
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Investigations · None
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Musculoskeletal and connective tissue disorders · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Musculoskeletal and connective tissue disorders · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Musculoskeletal and connective tissue disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Musculoskeletal and connective tissue disorders · None
|
7 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Nervous system disorders · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Nervous system disorders · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Nervous system disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Nervous system disorders · None
|
7 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Renal and urinary disorders · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Renal and urinary disorders · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Renal and urinary disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Renal and urinary disorders · None
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Respiratory, thoracic and mediastinal disorders · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Respiratory, thoracic and mediastinal disorders · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Respiratory, thoracic and mediastinal disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Respiratory, thoracic and mediastinal disorders · None
|
8 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Skin and subcutaneous tissue disorders · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Skin and subcutaneous tissue disorders · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Skin and subcutaneous tissue disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Skin and subcutaneous tissue disorders · None
|
7 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Vascular disorders · Mild
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Vascular disorders · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Vascular disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Vascular disorders · None
|
7 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam.
Mean and standard deviation (SD) of the Cmax (ug/mL) PK parameter after the first dose were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis.
Outcome measures
| Measure |
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
n=8 Participants
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Study Drug After the First Dose (Cmax)
Avibactam
|
13.10 ug/mL
Standard Deviation 2.20
|
—
|
—
|
15.80 ug/mL
Standard Deviation 3.04
|
14.30 ug/mL
Standard Deviation 2.69
|
12.40 ug/mL
Standard Deviation 2.38
|
|
Maximum Plasma Concentration of Study Drug After the First Dose (Cmax)
Ceftazidime
|
71.20 ug/mL
Standard Deviation 11.80
|
—
|
—
|
82.70 ug/mL
Standard Deviation 18.50
|
70.30 ug/mL
Standard Deviation 12.70
|
67.90 ug/mL
Standard Deviation 14.00
|
|
Maximum Plasma Concentration of Study Drug After the First Dose (Cmax)
Aztreonam
|
—
|
89.10 ug/mL
Standard Deviation 10.40
|
93.80 ug/mL
Standard Deviation 4.98
|
71.20 ug/mL
Standard Deviation 12.80
|
93.20 ug/mL
Standard Deviation 15.80
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. Participants in the ATM CI arm do not have data because dosing for all participants was stopped prior to Day 7, so their PK data was excluded from the analysis
Mean and standard deviation (SD) of the Cmax (ug/mL) PK parameter following multiple daily dosing were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis.
Outcome measures
| Measure |
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=4 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Study Drug Following Multiple Daily Dosing (Cmax)
Ceftazidime
|
31.80 ug/mL
Standard Deviation 6.31
|
—
|
—
|
88.20 ug/mL
Standard Deviation 12.40
|
69.80 ug/mL
Standard Deviation 8.31
|
63.60 ug/mL
Standard Deviation 12.60
|
|
Maximum Plasma Concentration of Study Drug Following Multiple Daily Dosing (Cmax)
Avibactam
|
4.58 ug/mL
Standard Deviation 0.74
|
—
|
—
|
14.20 ug/mL
Standard Deviation 1.75
|
12.80 ug/mL
Standard Deviation 2.03
|
10.70 ug/mL
Standard Deviation 2.52
|
|
Maximum Plasma Concentration of Study Drug Following Multiple Daily Dosing (Cmax)
Aztreonam
|
—
|
78.40 ug/mL
Standard Deviation 9.38
|
—
|
74.40 ug/mL
Standard Deviation 9.14
|
90.30 ug/mL
Standard Deviation 16.70
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. Zero participants have data because this analysis was not performed.
Mean and standard deviation (SD) of the Cmin (ug/mL) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. Cmin was not provided on day 7 because it was the last dosage of the study product administered; Cmin was therefore not calculated for this terminal elimination profile since the minimum concentration after a final dose would only reflect the last time point after Cmax that a blood sample is obtained, or the assay's limit of quantitation. It is therefore not comparable to Cmin calculated on prior days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. The AVYCAZ CI and ATM CI arms consist of 0 participants as this data was not collected in arms where the study drug was administered as a continuous infusion.
Mean and standard deviation (SD) of the Cmin (ug/mL) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0.
Outcome measures
| Measure |
AVYCAZ CI
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Minimum Plasma Concentration of Study Drug Following Multiple Daily Dosing on Day 1 (Cmin)
Avibactam
|
—
|
—
|
—
|
0.74 ug/mL
Standard Deviation 0.40
|
0.72 ug/mL
Standard Deviation 0.29
|
0.52 ug/mL
Standard Deviation 0.20
|
|
Minimum Plasma Concentration of Study Drug Following Multiple Daily Dosing on Day 1 (Cmin)
Ceftazidime
|
—
|
—
|
—
|
6.29 ug/mL
Standard Deviation 2.58
|
6.28 ug/mL
Standard Deviation 1.54
|
5.52 ug/mL
Standard Deviation 1.20
|
|
Minimum Plasma Concentration of Study Drug Following Multiple Daily Dosing on Day 1 (Cmin)
Aztreonam
|
—
|
13.90 ug/mL
Standard Deviation 2.84
|
—
|
13.30 ug/mL
Standard Deviation 1.91
|
18.90 ug/mL
Standard Deviation 3.99
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. The AVYCAZ CI and AVYCAZ + ATM 2.0 arms consist of 7 participants due to participants missing the urine collection interval.
Mean and standard deviation (SD) of the CLR (L/h) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma and urine concentration-time data using Non-compartmental analysis. Renal clearance was calculated as Ae(0-8)/AUC(0-8) for ceftazidime and avibactam and as AE(0-4)/AUC(0-4) for aztreonam where Ae(0-8) and Ae(0-4) are the amounts of study drug excreted into the urine from time of dosing to 8 or 4 h post-dose, respectively, and AUC(0-8) and AUC(0-4) are the areas under the plasma concentration-time curve from time of dosing to 8 or 4 h post-dose, respectively.
Outcome measures
| Measure |
AVYCAZ CI
n=7 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
n=8 Participants
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=7 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Renal Clearance of Study Drug (CLR)
Aztreonam
|
—
|
4.25 L/h
Standard Deviation 0.91
|
3.90 L/h
Standard Deviation 0.97
|
4.61 L/h
Standard Deviation 1.66
|
4.50 L/h
Standard Deviation 1.08
|
—
|
|
Renal Clearance of Study Drug (CLR)
Avibactam
|
11.70 L/h
Standard Deviation 2.61
|
—
|
—
|
11.40 L/h
Standard Deviation 2.36
|
14.70 L/h
Standard Deviation 5.35
|
11.10 L/h
Standard Deviation 2.58
|
|
Renal Clearance of Study Drug (CLR)
Ceftazidime
|
6.92 L/h
Standard Deviation 1.71
|
—
|
—
|
7.10 L/h
Standard Deviation 1.09
|
9.42 L/h
Standard Deviation 3.00
|
5.70 L/h
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Day 1Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam.
Mean and standard deviation (SD) of the Css (ug/mL) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data for AVYCAZ CI and ATM CI.
Outcome measures
| Measure |
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
n=8 Participants
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Concentration of Study Drug at Steady State After Continuous Infusion (Css)
Avibactam
|
4.34 ug/mL
Standard Deviation 1.80
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of Study Drug at Steady State After Continuous Infusion (Css)
Ceftazidime
|
27.60 ug/mL
Standard Deviation 11.40
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of Study Drug at Steady State After Continuous Infusion (Css)
Aztreonam
|
—
|
—
|
58.80 ug/mL
Standard Deviation 6.05
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. The ATM CI arm consists of 0 participants as dosing for all was stopped prior to Day 7. The AVYCAZ + ATM 1.5 arm consists of 4 participants as they missed doses on day 7. One participant in AVYCAZ CI for avibactam had an elimination parameter that did not meet acceptance criteria and was excluded.
Mean and standard deviation (SD) of the CL (L/h) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis.
Outcome measures
| Measure |
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=4 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Total Body Plasma Clearance of Study Drug (CL)
Ceftazidime
|
6.80 L/h
Standard Deviation 1.59
|
—
|
—
|
7.26 L/h
Standard Deviation 0.68
|
8.13 L/h
Standard Deviation 1.01
|
8.59 L/h
Standard Deviation 0.95
|
|
Total Body Plasma Clearance of Study Drug (CL)
Aztreonam
|
—
|
7.74 L/h
Standard Deviation 1.07
|
—
|
6.18 L/h
Standard Deviation 0.57
|
6.47 L/h
Standard Deviation 1.20
|
—
|
|
Total Body Plasma Clearance of Study Drug (CL)
Avibactam
|
12.20 L/h
Standard Deviation 2.38
|
—
|
—
|
12.90 L/h
Standard Deviation 1.59
|
14.30 L/h
Standard Deviation 2.85
|
15.80 L/h
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: Day 1Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam.
Mean and standard deviation (SD) of the Tmax (h) PK parameter after the first dose were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis.
Outcome measures
| Measure |
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
n=8 Participants
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Time of Cmax (Maximum Plasma Concentration) of Study Drug After the First Dose (Tmax)
Avibactam
|
2.00 h
Standard Deviation 0.00
|
—
|
—
|
1.81 h
Standard Deviation 0.27
|
1.99 h
Standard Deviation 0.01
|
1.89 h
Standard Deviation 0.35
|
|
Time of Cmax (Maximum Plasma Concentration) of Study Drug After the First Dose (Tmax)
Ceftazidime
|
2.06 h
Standard Deviation 0.18
|
—
|
—
|
1.93 h
Standard Deviation 0.33
|
1.93 h
Standard Deviation 0.18
|
2.06 h
Standard Deviation 0.42
|
|
Time of Cmax (Maximum Plasma Concentration) of Study Drug After the First Dose (Tmax)
Aztreonam
|
—
|
1.94 h
Standard Deviation 0.18
|
2.00 h
Standard Deviation 0.01
|
1.99 h
Standard Deviation 0.02
|
2.06 h
Standard Deviation 0.18
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. Participants in the ATM CI arm do not have data because dosing for all participants was stopped prior to Day 7, so their PK data was excluded from the analysis. The AVYCAZ + ATM 1.5 arm consists of 4 participants as 4 participants missed aztreonam doses on day 7.
Mean and standard deviation (SD) of the Tmax (h) PK parameter following multiple daily dosing were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis.
Outcome measures
| Measure |
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=4 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Time to Cmax (Maximum Plasma Concentration) of Study Drug Following Multiple Daily Dosing (Tmax)
Avibactam
|
2.85 h
Standard Deviation 2.59
|
—
|
—
|
1.99 h
Standard Deviation 0.02
|
1.88 h
Standard Deviation 0.23
|
1.82 h
Standard Deviation 0.27
|
|
Time to Cmax (Maximum Plasma Concentration) of Study Drug Following Multiple Daily Dosing (Tmax)
Ceftazidime
|
2.25 h
Standard Deviation 2.06
|
—
|
—
|
1.86 h
Standard Deviation 0.25
|
1.88 h
Standard Deviation 0.23
|
2.14 h
Standard Deviation 0.35
|
|
Time to Cmax (Maximum Plasma Concentration) of Study Drug Following Multiple Daily Dosing (Tmax)
Aztreonam
|
—
|
2.00 h
Standard Deviation 0.00
|
—
|
1.99 h
Standard Deviation 0.02
|
2.00 h
Standard Deviation 0.04
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: The PK population includes all participants who received at least one dose of study drug and had at least one quantifiable plasma or urine concentration of ceftazidime, avibactam, or aztreonam. The ATM CI arm consists of 0 participants as dosing for all was stopped prior to Day 7. The AVYCAZ + ATM 1.5 arm consists of 4 participants as they missed doses on day 7. One participant in AVYCAZ CI for avibactam had an elimination parameter that did not meet acceptance criteria and was excluded.
Mean and standard deviation (SD) of the Vss (L) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis.
Outcome measures
| Measure |
AVYCAZ CI
n=8 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 Participants
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=4 Participants
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 Participants
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
AVYCAZ IV
n=8 Participants
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Volume of Distribution of Study Drug at Steady-state Based on the Last Observed Concentration (Vss)
Avibactam
|
17.40 L
Standard Deviation 4.91
|
—
|
—
|
18.50 L
Standard Deviation 4.48
|
24.30 L
Standard Deviation 6.65
|
25.90 L
Standard Deviation 5.26
|
|
Volume of Distribution of Study Drug at Steady-state Based on the Last Observed Concentration (Vss)
Ceftazidime
|
12.60 L
Standard Deviation 3.17
|
—
|
—
|
14.50 L
Standard Deviation 2.86
|
19.20 L
Standard Deviation 4.27
|
19.90 L
Standard Deviation 3.86
|
|
Volume of Distribution of Study Drug at Steady-state Based on the Last Observed Concentration (Vss)
Aztreonam
|
—
|
14.30 L
Standard Deviation 1.86
|
—
|
11.50 L
Standard Deviation 2.14
|
13.80 L
Standard Deviation 3.17
|
—
|
Adverse Events
AVYCAZ IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AVYCAZ CI
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ATM IV
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
ATM CI
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
AVYCAZ + ATM 1.5
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
AVYCAZ + ATM 2.0
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AVYCAZ IV
n=8 participants at risk
2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
|
AVYCAZ CI
n=8 participants at risk
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
|
ATM IV
n=8 participants at risk
2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
ATM CI
n=8 participants at risk
2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
|
AVYCAZ + ATM 1.5
n=8 participants at risk
2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
|
AVYCAZ + ATM 2.0
n=8 participants at risk
2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
|
|---|---|---|---|---|---|---|
|
Investigations
Blood glucose increased
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Blood pressure systolic decreased
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Culture urine positive
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Cardiac disorders
Bradycardia
|
25.0%
2/8 • Number of events 4 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
50.0%
4/8 • Number of events 4 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Cardiac disorders
Sinus bradycardia
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
37.5%
3/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Cardiac disorders
Ventricular extrasystoles
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
General disorders
Application site irritation
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
General disorders
Chest pain
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
General disorders
Infusion site extravasation
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
General disorders
Infusion site irritation
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
General disorders
Infusion site pain
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
37.5%
3/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
General disorders
Infusion site phlebitis
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Injury, poisoning and procedural complications
Vascular access site swelling
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Abdominal bruit
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
62.5%
5/8 • Number of events 5 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
37.5%
3/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
37.5%
3/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
62.5%
5/8 • Number of events 5 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
62.5%
5/8 • Number of events 5 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
50.0%
4/8 • Number of events 4 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
62.5%
5/8 • Number of events 5 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Electrocardiogram QT prolonged
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Haemoglobin decreased
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
37.5%
3/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
37.5%
3/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
37.5%
3/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
37.5%
3/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
37.5%
3/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
37.5%
3/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Protein total decreased
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
50.0%
4/8 • Number of events 4 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
87.5%
7/8 • Number of events 7 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Vascular disorders
Phlebitis
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
12.5%
1/8 • Number of events 1 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 3 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
25.0%
2/8 • Number of events 2 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
0.00%
0/8 • Local and systemic adverse events (AEs) and serious adverse events (SAEs) were recorded occurring from first dose of study product day 1 through the final visit, up to 14 days following the first dose.
|
Additional Information
Thomas Lodise, PharmD, PhD
ARLG - Albany College of Pharmacy and Health Sciences
Phone: 1 (518) 694-7292
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60