Trial Outcomes & Findings for Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections (NCT NCT01499290)
NCT ID: NCT01499290
Last Updated: 2017-09-06
Results Overview
The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention is necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, death where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
493 participants
Primary outcome timeframe
TOC: 28 to 35 days after start of study drug
Results posted on
2017-09-06
Participant Flow
Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA. First patient enrolled 22 March 2012 and last patient's last visit was 07 April 2014. Patients were adults hospitalised with complicated intra-abdominal infection (cIAI) that required surgery and IV antibiotics.
After obtaining written informed consent patients underwent a preliminary evaluation for eligibility within the 24-hour period prior to initiation of IV study therapy. eligible patients were randomized to 1 of 2 treatment groups in a 1:1 ratio according to the central randomization schedule.
Participant milestones
| Measure |
CAZ-AVI + Metronidazole
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
1000 mg: IV treatment
|
|---|---|---|
|
Overall Study
STARTED
|
529
|
529
|
|
Overall Study
COMPLETED
|
474
|
494
|
|
Overall Study
NOT COMPLETED
|
55
|
35
|
Reasons for withdrawal
| Measure |
CAZ-AVI + Metronidazole
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
1000 mg: IV treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
22
|
15
|
|
Overall Study
Not specified in study report
|
11
|
5
|
|
Overall Study
Condition improved/subject recovered
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
7
|
8
|
|
Overall Study
Adverse Event
|
14
|
7
|
Baseline Characteristics
Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
Baseline characteristics by cohort
| Measure |
CAZ-AVI + Metronidazole
n=520 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=523 Participants
1000 mg: IV treatment
|
Total
n=1043 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 Years
STANDARD_DEVIATION 17.48 • n=99 Participants
|
50.3 Years
STANDARD_DEVIATION 18.29 • n=107 Participants
|
50.0 Years
STANDARD_DEVIATION 17.88 • n=206 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=99 Participants
|
191 Participants
n=107 Participants
|
385 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
326 Participants
n=99 Participants
|
332 Participants
n=107 Participants
|
658 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: TOC: 28 to 35 days after start of study drugPopulation: The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention is necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, death where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA.
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=413 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=410 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA).
Clinical failure
|
37 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA).
Indeterminate
|
39 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA).
Clinical cure
|
337 Participants
|
349 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: TOC: 28 to 35 days after start of study drugPopulation: The MITT analysis set included all randomized patients who met the disease definition of cIAI and who received any amount of study drug.
The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=520 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=523 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]).
Clinical cure
|
429 Participants
|
444 Participants
|
—
|
—
|
—
|
—
|
|
Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]).
Clinical failure
|
47 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]).
Indeterminate
|
44 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: TOC: 28 to 35 days after start of study drugPopulation: The CE analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.
The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=410 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=416 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]).
Clinical cure
|
376 Participants
|
385 Participants
|
—
|
—
|
—
|
—
|
|
Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]).
Clinical failure
|
34 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: TOC: 28 to 35 days after start of study drugPopulation: ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, susceptible pathogen in the initial/prestudy culture.
The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=265 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=287 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set
Clinical failure
|
21 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set
Clinical cure
|
244 Participants
|
272 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: TOC: 28 to 35 days after start of study drugPopulation: Extended ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, pathogen in the initial/prestudy culture, regardless of susceptibility.
The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=270 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=294 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Clinical Cure at TOC in the Extended Microbiologically Evaluable Analysis Set
Clinical cure
|
248 Participants
|
278 Participants
|
—
|
—
|
—
|
—
|
|
Clinical Cure at TOC in the Extended Microbiologically Evaluable Analysis Set
Clinical failure
|
22 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU: 42 to 49 days after start of study drugPopulation: The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=413 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=410 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
n=413 Participants
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
n=410 Participants
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
n=413 Participants
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
n=410 Participants
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT)
Clinical cure
|
361 Participants
|
379 Participants
|
337 Participants
|
349 Participants
|
340 Participants
|
347 Participants
|
|
Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT)
Indeterminate
|
22 Participants
|
12 Participants
|
39 Participants
|
31 Participants
|
35 Participants
|
32 Participants
|
|
Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT)
Clinical failure
|
30 Participants
|
19 Participants
|
37 Participants
|
30 Participants
|
38 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU 42 to 49 days after start of study drugPopulation: The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
Microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to a surgical review panel (SRP) assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=413 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=410 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
n=413 Participants
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
n=410 Participants
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
n=413 Participants
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
n=410 Participants
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set
Favourable response
|
362 Participants
|
379 Participants
|
337 Participants
|
349 Participants
|
340 Participants
|
347 Participants
|
|
Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set
Unfavourable response
|
30 Participants
|
19 Participants
|
37 Participants
|
31 Participants
|
38 Participants
|
32 Participants
|
|
Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set
Indeterminate
|
21 Participants
|
12 Participants
|
39 Participants
|
30 Participants
|
35 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: TOC: 28 to 35 days after start of study drug.Population: The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=413 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=410 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
n=413 Participants
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
n=410 Participants
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Enterobacter cloacae
|
11 Participants
|
16 Participants
|
13 Participants
|
19 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Escherichia coli
|
218 Participants
|
249 Participants
|
271 Participants
|
285 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Klebsiella oxytoca
|
14 Participants
|
12 Participants
|
18 Participants
|
15 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Klebsiella pneumoniae
|
40 Participants
|
37 Participants
|
51 Participants
|
49 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Proteus mirabilis
|
5 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Pseudomonas aeruginosa
|
30 Participants
|
34 Participants
|
35 Participants
|
36 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Enterococcus faecium
|
13 Participants
|
18 Participants
|
16 Participants
|
22 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Staphylococcus aureus
|
17 Participants
|
14 Participants
|
18 Participants
|
14 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Bacteroides vulgatus
|
6 Participants
|
6 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Eggerthella lenta
|
5 Participants
|
7 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Parabacteroides distasonis
|
13 Participants
|
12 Participants
|
16 Participants
|
13 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Parvimonas micra
|
7 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Citrobacter freundii complex
|
14 Participants
|
9 Participants
|
18 Participants
|
12 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Enterobacter aerogenes
|
4 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Enterococcus avium
|
8 Participants
|
10 Participants
|
8 Participants
|
15 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Enterococcus faecalis
|
22 Participants
|
23 Participants
|
31 Participants
|
28 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Streptococcus anginosus group
|
59 Participants
|
50 Participants
|
72 Participants
|
61 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Streptococcus bovis group
|
2 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Streptococcus mitis group
|
10 Participants
|
9 Participants
|
15 Participants
|
11 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Bacteroides fragilis
|
45 Participants
|
38 Participants
|
52 Participants
|
47 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Bacteroides ovatus
|
17 Participants
|
17 Participants
|
22 Participants
|
20 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Bacteroides stercoris
|
9 Participants
|
1 Participants
|
10 Participants
|
1 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Bacteroides thetaiotaomicron
|
18 Participants
|
21 Participants
|
22 Participants
|
25 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Bacteroides uniformis
|
4 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
|
Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.
Clostridium perfringens
|
7 Participants
|
4 Participants
|
10 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Test of Cure: 28 to 35 days after start of study drugPopulation: The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=413 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=410 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
n=413 Participants
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
n=410 Participants
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Citrobacter freundii complex
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Comamonas testosteroni
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Pseudomonas aeruginosa
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
All
|
39 Participants
|
55 Participants
|
47 Participants
|
64 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Enterobacter aerogenes
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Enterobacter cloacae
|
2 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Escherichia coli
|
19 Participants
|
31 Participants
|
24 Participants
|
37 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Klebsiella pneumoniae
|
10 Participants
|
9 Participants
|
13 Participants
|
13 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Morganella morganii
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Proteus mirabilis
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Serratia marcescens
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set
Alcaligenes faecalis
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: TOC: 28 to 35 days after start of study drugPopulation: The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=48 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=64 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
n=48 Participants
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
n=64 Participants
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Enterobacter aerogenes
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Enterobacter cloacae
|
2 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Escherichia coli
|
19 Participants
|
31 Participants
|
24 Participants
|
37 Participants
|
—
|
—
|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Klebsiella pneumoniae
|
10 Participants
|
9 Participants
|
13 Participants
|
13 Participants
|
—
|
—
|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Morganella morganii
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Proteus mirabilis
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Serratia marcescens
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Alcaligenes faecalis
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Comamonas testosteroni
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Pseudomonas aeruginosa
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Citrobacter freundii complex
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Test of Cure: 28 to 35 days after start of study drugPopulation: The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
Microbiological responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=48 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=64 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Per-patient Microbiological Response at TOC for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Favourable
|
39 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
|
Per-patient Microbiological Response at TOC for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
indeterminate
|
2 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Per-patient Microbiological Response at TOC for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set
Unfavourable
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Test of Cure: 1 to 14 days after start of study drugPopulation: Clinically evaluable (CE) with fever, defined as \>38ºC at study entry.
Time to first defervescence was calculated for patients with a fever (\>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day.
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=84 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=78 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Number of Patients Afebrile at Last Observation in the Clinically Evaluable Analysis Set for Patients Who Have Fever at Study Entry
|
84 Participants
|
72 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drugPopulation: PK analysis set
Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations
Outcome measures
| Measure |
CAZ-AVI + Metronidazole
n=486 Participants
CAZ (2000mg)/AVI (500mg): IV treatment
|
Meropenem
n=493 Participants
1000 mg: IV treatment
|
CAZ-AVI + Metronidazole (TOC)
n=484 Participants
TOC - 28 to 35 days after start of study drug
|
Meropenem (TOC)
n=489 Participants
TOC - 28 to 35 days after start of study drug
|
CAZ-AVI + Metronidazole (LFU)
n=481 Participants
LFU - 42 to 49 days after start of study drug
|
Meropenem (LFU)
n=484 Participants
LFU - 42 to 49 days after start of study drug
|
|---|---|---|---|---|---|---|
|
Plasma Concentrations for Ceftazidime and Avibactam
|
50823.0 (NG/ML)
Interval 171.0 to 3110000.0
|
9229.4 (NG/ML)
Interval 13.0 to 693000.0
|
40053.1 (NG/ML)
Interval 155.0 to 235000.0
|
7163.9 (NG/ML)
Interval 15.0 to 46800.0
|
10967.6 (NG/ML)
Interval 159.0 to 151000.0
|
1690.7 (NG/ML)
Interval 14.0 to 30800.0
|
Adverse Events
CAZ-AVI + Metronidazole
Serious events: 17 serious events
Other events: 184 other events
Deaths: 0 deaths
Meropenem
Serious events: 15 serious events
Other events: 152 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAZ-AVI + Metronidazole
n=529 participants at risk
CAZ (2000mg)/AVI (500mg): IV treatment.
|
Meropenem
n=529 participants at risk
1000 mg: IV treatment
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.38%
2/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.57%
3/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.57%
3/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Renal and urinary disorders
Renal failure acute
|
0.95%
5/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Investigations
Transaminases increased
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.38%
2/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma necrosis
|
0.38%
2/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.38%
2/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Bronchopneumonia
|
0.38%
2/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.38%
2/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Candida sepsis
|
0.38%
2/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Cardiac disorders
Cardiac failure
|
0.38%
2/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.57%
3/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.38%
2/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.38%
2/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Diverticulitis
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Empyema
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Pneumonia
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Sepsis
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Septic enceohalopathy
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Septic shock
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Infections and infestations
Systematic candida
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Immune system disorders
Hypersensitivity
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Psychiatric disorders
Delirium tremens
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Cardiac disorders
Left ventricular failure
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Cardiac disorders
Right ventricular failure
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Vascular disorders
Shock
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Ileus
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Small intestine perforation
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Hepatobiliary disorders
Biloma
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Musculoskeletal and connective tissue disorders
Critical illness myopathy
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Renal and urinary disorders
Renal failure
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
General disorders
Multi-organ failure
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
General disorders
Sudden death
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.00%
0/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
0.19%
1/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
Other adverse events
| Measure |
CAZ-AVI + Metronidazole
n=529 participants at risk
CAZ (2000mg)/AVI (500mg): IV treatment.
|
Meropenem
n=529 participants at risk
1000 mg: IV treatment
|
|---|---|---|
|
Infections and infestations
Wound infection
|
2.5%
13/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
2.1%
11/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Nervous system disorders
Headache
|
2.8%
15/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
1.7%
9/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Vascular disorders
Hypertension
|
2.8%
15/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
4.5%
24/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Vascular disorders
Hypotension
|
2.3%
12/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
2.3%
12/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
11/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
2.5%
13/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.6%
40/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
3.2%
17/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Nausea
|
6.8%
36/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
4.5%
24/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
24/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
1.9%
10/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
8/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
3.8%
20/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
General disorders
Pyrexia
|
4.5%
24/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
4.5%
24/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
General disorders
Asthenia
|
1.9%
10/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
2.3%
12/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.9%
10/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
2.1%
11/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Vascular disorders
Phlebitis
|
1.9%
10/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
2.1%
11/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
11/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
1.7%
9/529 • Adverse event data were collected from the screening/consent visit until the late follow-up visit (ie Day -1/0 to Day 42).
AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI shall not publish results until the earliest of (i) date of the 1st study publication (joint between PI, sponsor and study sites) (ii) 18 months after study completion, or (iii) sponsor notification that no multi-center publication is to be made. The PI submits the publication for review 60 days before submission. Sponsor may embargo for a further 90 days to protect IP rights. Sponsor may request removal of confidential and/or proprietry information.
- Publication restrictions are in place
Restriction type: OTHER