Trial Outcomes & Findings for Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults (NCT NCT02168946)
NCT ID: NCT02168946
Last Updated: 2019-03-04
Results Overview
Overall success is defined as clinical cure \& microbiological eradication. Eradication defined by FDA as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 colony forming unit (CFU)/mL urine. Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
77 participants
Primary outcome timeframe
at Test of Cure (TOC) visit (Day 12-23)
Results posted on
2019-03-04
Participant Flow
The first patient enrolled November 2014 and last patient in June 2017. The patients were enrolled at 27 study sites in 8 countries. 77 patients (28 with bacteremia, 34 with cUTI, 8 with HABP/VABP and 7 with cIAI) were enrolled and 47 had confirmed Carbapenem-Resistant Enterobacteriaceae and therefore were included in the mCRE population.
Randomization was stratified by presenting indication (cUTI or AP, cIAI, HABP, VABP, or bacteremia) and by region (North America, Europe, Asia Pacific, and Rest of World).
Participant milestones
| Measure |
Vabomere
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Vabomere: Vabomere for IV injection, administered as a 2 g/2 g dose
|
Best Available Therapy
Subjects will receive Best Available Therapy (IV antibiotics)
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
25
|
|
Overall Study
COMPLETED
|
38
|
20
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
| Measure |
Vabomere
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Vabomere: Vabomere for IV injection, administered as a 2 g/2 g dose
|
Best Available Therapy
Subjects will receive Best Available Therapy (IV antibiotics)
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Subject unable to come back for visits
|
1
|
0
|
Baseline Characteristics
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
Baseline characteristics by cohort
| Measure |
Vabomere
n=50 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=25 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 15.30 • n=93 Participants
|
63.2 years
STANDARD_DEVIATION 13.10 • n=4 Participants
|
63.5 years
STANDARD_DEVIATION 14.51 • n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Body Mass Index
|
27.90 kg/m^2
STANDARD_DEVIATION 8.340 • n=93 Participants
|
27.14 kg/m^2
STANDARD_DEVIATION 7.522 • n=4 Participants
|
27.64 kg/m^2
STANDARD_DEVIATION 8.029 • n=27 Participants
|
|
Systemic Inflammatory Response Syndrome (SIRS) present
|
22 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Creatinine Clearance <50 mL/min
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Baseline Pathogen - Klebsiella pneumoniae
|
30 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at Test of Cure (TOC) visit (Day 12-23)Population: The mCRE-MITT population includes all patients who had confirmed Carbapenem-Resistant Enterobacteriaceae at Baseline. (cUTI/AP patients only)
Overall success is defined as clinical cure \& microbiological eradication. Eradication defined by FDA as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 colony forming unit (CFU)/mL urine. Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
Outcome measures
| Measure |
Vabomere
n=12 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=4 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the Microbiological Carbapenem-resistant Enterobacteriaceae Modified Intent-to-Treat (mCRE-MITT) Population With a Response of Overall Success [Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Subjects]
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: mCRE-MITT Population (HABP/VABP and Bacteremia subjects only)
The All-cause mortality rate at Day 28 in the mCRE-MITT population (HABP/VABP and Bacteremia)
Outcome measures
| Measure |
Vabomere
n=18 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=9 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects)
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: at TOC visit (Day 12-23)Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.
Outcome measures
| Measure |
Vabomere
n=2 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=2 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only]
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at Day 28Population: mCRE-MITT population (all indications)
All Cause Mortality at Day 28 in the mCRE-MITT population (all indications)
Outcome measures
| Measure |
Vabomere
n=32 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=15 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
The All-cause Mortality Rate in the mCRE-MITT Population (All Indications)
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at Day 28Population: The m-MITT population includes all patients who receive at least one dose of study drug and have a baseline gram negative bacterial pathogen.
The All Cause Mortality rate at Day 28 in the m-MITT population (all indications)
Outcome measures
| Measure |
Vabomere
n=35 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=19 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
The All-cause Mortality Rate in the m-MITT Population (All Indications)
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at Day 28Population: mCRE-MITT (cUTI/AP subjects only)
All Cause Mortality at Day 28 in the mCRE-MITT population (cUTI/AP subjects only)
Outcome measures
| Measure |
Vabomere
n=12 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=4 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at End of Therapy (EOT) visit (7-14 days) and TOC visit (12-23 days)Population: mCRE-MITT population (all indications)
Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
Outcome measures
| Measure |
Vabomere
n=32 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=15 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications)
EOT
|
21 Participants
|
5 Participants
|
|
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications)
TOC
|
19 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: at EOT visit (7-14) and TOC visit (day 12-23)Population: mCRE-MITT population (cUTI/AP subjects only)
Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
Outcome measures
| Measure |
Vabomere
n=12 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=4 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only)
TOC
|
5 Participants
|
2 Participants
|
|
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only)
EOT
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at EOT visit (7-14) and TOC visit (day 12-23)Population: mCRE-MITT (HABP/VABP or Bacteremia Subjects only)
Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
Outcome measures
| Measure |
Vabomere
n=18 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=9 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)
EOT
|
10 Participants
|
3 Participants
|
|
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)
TOC
|
12 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at EOT visit (7-14) and TOC visit (day 12-23)Population: m-MITT Population (all indications)
Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.
Outcome measures
| Measure |
Vabomere
n=35 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=19 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications)
EOT
|
24 Participants
|
7 Participants
|
|
Proportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications)
TOC
|
21 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: at EOT visit (7-14) and TOC visit (day 12-23)Population: m-MITT Population (cUTI/AP subjects only)
Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
Outcome measures
| Measure |
Vabomere
n=13 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=8 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (cUTI/AP)
EOT
|
10 Participants
|
4 Participants
|
|
Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (cUTI/AP)
TOC
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: at EOT visit (7-14) and TOC visit (day 12-23)Population: m-MITT Population (HABP/VABP or Bacteremia Subjects only)
Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
Outcome measures
| Measure |
Vabomere
n=20 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=9 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)
EOT
|
12 Participants
|
3 Participants
|
|
Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)
TOC
|
13 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at EOT visit (7-14) and TOC visit (day 12-23)Population: mCRE-MITT Population (all indications)
Includes subjects with microbiologic eradication or presumed eradication as defined: microbiologic eradication of the baseline pathogen or absence of culture result (microbiologic outcome of indeterminate or not assesses) where subject is deemed as clinical cure at that visit. For cUTI/AP subjects, demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA).
Outcome measures
| Measure |
Vabomere
n=32 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=15 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the mCRE-MITT Population With a Microbiological Outcome of Eradication (All Indications)
TOC
|
17 Participants
|
5 Participants
|
|
Proportion of Subjects in the mCRE-MITT Population With a Microbiological Outcome of Eradication (All Indications)
EOT
|
21 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: at EOT visit (7-14) and TOC visit (day 12-23)Population: m-MITT Population (all indications)
Microbiological eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA).
Outcome measures
| Measure |
Vabomere
n=35 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=19 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the m-MITT Population With a Microbiological Outcome of Eradication (All Indications)
EOT
|
23 Participants
|
8 Participants
|
|
Proportion of Subjects in the m-MITT Population With a Microbiological Outcome of Eradication (All Indications)
TOC
|
17 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: at EOT visit (7-14) and TOC visit (day 12-23)Population: m-MITT Population (cUTI/AP Subjects Only)
Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA). Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
Outcome measures
| Measure |
Vabomere
n=13 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=8 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (cUTI/AP)
EOT
|
10 Participants
|
4 Participants
|
|
Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (cUTI/AP)
TOC
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: at EOT visit (7-14) and TOC visit (day 12-23)Population: m-MITT Population (Bacteremia Subjects Only)
Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
Outcome measures
| Measure |
Vabomere
n=15 Participants
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=8 Participants
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (Bacteremia Only)
EOT
|
8 Participants
|
3 Participants
|
|
Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (Bacteremia Only)
TOC
|
8 Participants
|
2 Participants
|
Adverse Events
Vabomere
Serious events: 17 serious events
Other events: 28 other events
Deaths: 10 deaths
Best Available Therapy
Serious events: 11 serious events
Other events: 20 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Vabomere
n=50 participants at risk
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=25 participants at risk
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Cardiac disorders
Cardiac Arrest
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
General disorders
General Physical Health Deterioration
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
General disorders
Multi-organ Failure
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Enterococcal bacteremia
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Gangrene
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Klebsiella Bacteremia
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Peritonitis
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Sepsis
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
16.0%
4/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Septic Shock
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
16.0%
4/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Superinfection Bacterial
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Urosepsis
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Nervous system disorders
Cerebral Hemorrhage
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Nervous system disorders
Convulsion
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Vascular disorders
Arterial Hemorrhage
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Vascular disorders
Shock Hemorrhagic
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
Other adverse events
| Measure |
Vabomere
n=50 participants at risk
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
|
Best Available Therapy
n=25 participants at risk
Best Available Therapy: Antibiotic(s) chosen by Investigator
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
6/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
16.0%
4/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
4/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Constipation
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Melaena
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
5/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Blood and lymphatic system disorders
Sickle Cell Anemia with Crisis
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Oral Candidiasis
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Systemic Candida
|
6.0%
3/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Candiduria
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Clostridium Difficile Colitis
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Bacteremia
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Perinephric Abscess
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Pseudomonal Bacteremia
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
5/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.0%
4/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.0%
3/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Metabolism and nutrition disorders
Vitamin B Complex Deficiency
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Vascular disorders
Hypotension
|
8.0%
4/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
12.0%
3/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Vascular disorders
Hypertension
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Vascular disorders
Embolism
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Vascular disorders
Extremity Necrosis
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
General disorders
Asthenia
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
General disorders
Generalized Edema
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
General disorders
Hypothermia
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
General disorders
Infusion Site Phlebitis
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
General disorders
Edema Peripheral
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
General disorders
Pain
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
General disorders
Malaise
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Investigations
Transaminases Increased
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Investigations
Urine Output Decreased
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Investigations
Blood Fibrinogen Decreased
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Investigations
Blood Urea Increased
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Nervous system disorders
Tremor
|
6.0%
3/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Nervous system disorders
Parasthesia
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
12.0%
3/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Renal and urinary disorders
Renal Impairment
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Cardiac disorders
Extrasystoles
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
8.0%
2/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Injury, poisoning and procedural complications
Wound
|
2.0%
1/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.0%
2/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
0.00%
0/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
|
Reproductive system and breast disorders
Penile Hemorrhage
|
0.00%
0/50 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
4.0%
1/25 • Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
|
Additional Information
Global Health Science Center
Rempex Pharmaceuticals, A Wholly Owned Subsidiary of Melinta Therapeutics, Inc.
Phone: 1-844-633-6568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place