Trial Outcomes & Findings for A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia (NCT NCT01808092)
NCT ID: NCT01808092
Last Updated: 2017-09-06
Results Overview
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
969 participants
Primary outcome timeframe
At the test-of-cure (TOC) visit (Day 21 to 25)
Results posted on
2017-09-06
Participant Flow
Overall, 879 patients were randomized in this study, from 4 geographic regions. The first patient was enrolled on 13 April 2013 and the last patient last visit was on 07 January 2016. Summary tables exclude 62 patients with moderate/severe renal impairment recruited prior to a protocol amendment to the dose regimen for such patients (MSRIBorig).
The first patient was enrolled on 13 April 2013 and the last patient last vist was on 07 January 2016. Overall, 969 patients were enrolled in this study, 90 of them screen failures.
Participant milestones
| Measure |
CAZ-AVI
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
Overall Study
STARTED
|
409
|
408
|
|
Overall Study
COMPLETED
|
355
|
363
|
|
Overall Study
NOT COMPLETED
|
54
|
45
|
Reasons for withdrawal
| Measure |
CAZ-AVI
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
Overall Study
Death
|
39
|
29
|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
9
|
4
|
|
Overall Study
Other Eligibility criteria
|
3
|
5
|
Baseline Characteristics
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
Baseline characteristics by cohort
| Measure |
CAZ-AVI
n=405 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=403 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
Total
n=808 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 Years
STANDARD_DEVIATION 16.76 • n=5 Participants
|
61.7 Years
STANDARD_DEVIATION 17.57 • n=7 Participants
|
61.7 Years
STANDARD_DEVIATION 17.16 • n=5 Participants
|
|
Age, Customized
18-45
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Age, Customized
46-64
|
124 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Age, Customized
65-74
|
97 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Age, Customized
75-90
|
110 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
304 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
602 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
226 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
443 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
171 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
348 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Outcome measures
| Measure |
CAZ-AVI
n=356 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=370 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)
Clinical cure
|
245 participants
|
270 participants
|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)
Clinical failure
|
79 participants
|
70 participants
|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)
Indeterminate
|
32 participants
|
30 participants
|
PRIMARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Outcome measures
| Measure |
CAZ-AVI
n=257 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=270 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)
Clinical cure
|
199 participants
|
211 participants
|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)
Clinical failure
|
58 participants
|
59 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set
Clinical cure
|
120 participants
|
138 participants
|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set
Clinical failure
|
37 participants
|
34 participants
|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set
Indeterminate
|
14 participants
|
12 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Outcome measures
| Measure |
CAZ-AVI
n=125 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=131 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set
Clinical cure
|
96 participants
|
103 participants
|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set
Clinical failure
|
29 participants
|
28 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Outcome measures
| Measure |
CAZ-AVI
n=107 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=118 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set
Clinical cure
|
85 participants
|
94 participants
|
|
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set
Clinical failure
|
22 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Clinical cure
|
143 participants
|
161 participants
|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Clinical failure
|
23 participants
|
18 participants
|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Indeterminate
|
5 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Outcome measures
| Measure |
CAZ-AVI
n=356 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=370 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set
Clinical cure
|
292 participants
|
309 participants
|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set
Clinical failure
|
50 participants
|
45 participants
|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set
Indeterminate
|
14 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Outcome measures
| Measure |
CAZ-AVI
n=291 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=306 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set
Clinical cure
|
253 participants
|
268 participants
|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set
Clinical failure
|
38 participants
|
38 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Outcome measures
| Measure |
CAZ-AVI
n=143 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=151 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set
Clinical cure
|
125 participants
|
135 participants
|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set
Clinical failure
|
18 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Outcome measures
| Measure |
CAZ-AVI
n=122 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=138 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set
Clinical cure
|
110 participants
|
126 participants
|
|
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set
Clinical failure
|
12 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Favorable
|
128 participants
|
148 participants
|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Unfavorable
|
38 participants
|
31 participants
|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Indeterminate
|
5 participants
|
5 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Favorable
|
95 participants
|
118 participants
|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Unfavorable
|
64 participants
|
54 participants
|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Indeterminate
|
12 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=143 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=151 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Favorable
|
112 participants
|
123 participants
|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Unfavorable
|
31 participants
|
28 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=125 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=131 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Favorable
|
80 participants
|
89 participants
|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Unfavorable
|
45 participants
|
42 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=122 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=138 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Favorable
|
96 participants
|
112 participants
|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Unfavorable
|
26 participants
|
26 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=107 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=118 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Favorable
|
70 participants
|
83 participants
|
|
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Unfavorable
|
37 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Enterobacter aerogenes (n=8, 8)
|
6 participants with favorable responses
|
5 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Enterobacter cloacae (n=26, 22)
|
25 participants with favorable responses
|
20 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Escherichia coli (n=17, 20)
|
15 participants with favorable responses
|
18 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Klebsiella pneumoniae (n=59, 71)
|
49 participants with favorable responses
|
65 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Proteus mirabilis (n=14, 12)
|
12 participants with favorable responses
|
10 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Serratia marcescens (n=15, 13)
|
12 participants with favorable responses
|
11 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Haemophilus influenzae (n=16, 25)
|
15 participants with favorable responses
|
25 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Pseudomonas aeruginosa (n=58, 47)
|
33 participants with favorable responses
|
27 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Staphylococcus aureus (n=24, 34)
|
21 participants with favorable responses
|
32 participants with favorable responses
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=143 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=151 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacter aerogenes (n=6, 7)
|
4 participants with favorable responses
|
5 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacter cloacae (n=22, 17)
|
22 participants with favorable responses
|
17 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Escherichia coli (n=14, 18)
|
13 participants with favorable responses
|
17 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Klebsiella pneumoniae (n=46, 57)
|
39 participants with favorable responses
|
53 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Proteus mirabilis (n=9, 8)
|
8 participants with favorable responses
|
6 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Serratia marcescens (n=13, 10)
|
12 participants with favorable responses
|
8 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Haemophilus influenzae (n=14, 16)
|
14 participants with favorable responses
|
16 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Pseudomonas aeruginosa (n=50, 41)
|
30 participants with favorable responses
|
24 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Staphylococcus aureus (n=18, 26)
|
16 participants with favorable responses
|
25 participants with favorable responses
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=122 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=138 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Proteus mirabilis (n=9, 8)
|
8 participants with favorable responses
|
6 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Serratia marcescens (n=13, 10)
|
12 participants with favorable responses
|
8 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacter aerogenes (n=6, 7)
|
4 participants with favorable responses
|
5 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacter cloacae (n=22, 17)
|
22 participants with favorable responses
|
17 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Escherichia coli (n=13, 18)
|
13 participants with favorable responses
|
17 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Klebsiella pneumoniae (n=45, 55)
|
38 participants with favorable responses
|
51 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Haemophilus influenzae (n=12, 15)
|
12 participants with favorable responses
|
15 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Pseudomonas aeruginosa (n=38, 34)
|
22 participants with favorable responses
|
19 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Staphylococcus aureus (n=16, 23)
|
14 participants with favorable responses
|
22 participants with favorable responses
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Enterobacter aerogenes (n=8, 8)
|
5 participants with favorable responses
|
5 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Enterobacter cloacae (n=26, 22)
|
21 participants with favorable responses
|
13 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Escherichia coli (n=17, 20)
|
13 participants with favorable responses
|
16 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Klebsiella pneumoniae (n=59, 71)
|
37 participants with favorable responses
|
53 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Proteus mirabilis (n=14, 12)
|
11 participants with favorable responses
|
8 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Serratia marcescens (n=15, 13)
|
10 participants with favorable responses
|
8 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Haemophilus influenzae (n=16, 25)
|
14 participants with favorable responses
|
23 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Pseudomonas aeruginosa (n=58, 47)
|
22 participants with favorable responses
|
18 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Staphylococcus aureus (n=24, 34)
|
11 participants with favorable responses
|
25 participants with favorable responses
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=125 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=131 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Staphylococcus aureus (n=14, 22)
|
5 participants with favorable responses
|
17 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Enterobacter aerogenes (n=6, 5)
|
5 participants with favorable responses
|
3 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Enterobacter cloacae (n=21, 11)
|
18 participants with favorable responses
|
7 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Escherichia coli (n=11, 18)
|
10 participants with favorable responses
|
16 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Klebsiella pneumoniae (n=37, 49)
|
29 participants with favorable responses
|
39 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Proteus mirabilis (n=11, 8)
|
9 participants with favorable responses
|
6 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Serratia marcescens (n=12, 8)
|
9 participants with favorable responses
|
5 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Haemophilus influenzae (n=11, 13)
|
11 participants with favorable responses
|
12 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Pseudomonas aeruginosa (n=42, 35)
|
18 participants with favorable responses
|
14 participants with favorable responses
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=107 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=118 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Enterobacter cloacae (n=21, 11)
|
18 participants with favorable responses
|
7 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Enterobacter aerogenes (n=6, 5)
|
5 participants with favorable responses
|
3 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Escherichia coli (n=10, 18)
|
10 participants with favorable responses
|
16 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Klebsiella pneumoniae (n=37, 47)
|
29 participants with favorable responses
|
38 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Proteus mirabilis (n=11, 8)
|
9 participants with favorable responses
|
6 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Serratia marcescens (n=12, 8)
|
9 participants with favorable responses
|
5 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Haemophilus influenzae (n=9, 12)
|
9 participants with favorable responses
|
11 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Pseudomonas aeruginosa (n=31, 28)
|
13 participants with favorable responses
|
12 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Staphylococcus aureus (n=13, 19)
|
4 participants with favorable responses
|
15 participants with favorable responses
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Klebsiella pneumoniae (n=20, 30)
|
20 participants
|
26 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Gram- pathogens not Enterobacteriaceae (n=11,16)
|
8 participants
|
14 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Pseudomonas aeruginosa (n=11, 15)
|
8 participants
|
13 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Escherichia coli (n=6, 5)
|
5 participants
|
3 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
All (n=45, 54)
|
40 participants
|
45 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Enterobacteriaceae (n=34, 41)
|
32 participants
|
33 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Enterobacter aerogenes (n=4, 2)
|
3 participants
|
2 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Enterobacter cloacae (n=6, 6)
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Outcome measures
| Measure |
CAZ-AVI
n=291 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=306 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
Escherichia coli (n=6, 4)
|
5 participants
|
3 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
Enterobacter aerogenes (n=4, 2)
|
3 participants
|
2 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
All (n=39, 49)
|
35 participants
|
42 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
Enterobacteriaceae (n=29, 37)
|
27 participants
|
31 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
Enterobacter cloacae (n=6, 5)
|
6 participants
|
3 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
Klebsiella pneumoniae (n=16, 28)
|
16 participants
|
25 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
Gram- pathogens not Enterobacteriaceae (n=10,14)
|
8 participants
|
13 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
Pseudomonas aeruginosa (n=10, 13)
|
8 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Outcome measures
| Measure |
CAZ-AVI
n=122 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=138 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
All (n=32, 40)
|
31 participants
|
36 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacteriaceae (n=28, 35)
|
27 participants
|
31 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacter aerogenes (n=4, 2)
|
3 participants
|
2 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacter cloacae (n=6, 5)
|
6 participants
|
3 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Escherichia coli (n=5, 4)
|
5 participants
|
3 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Klebsiella pneumoniae (n=16, 26)
|
16 participants
|
25 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Gram- pathogens not Enterobacteriaceae (n=4,7)
|
4 participants
|
7 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Pseudomonas aeruginosa (n=4, 6)
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Pseudomonas aeruginosa (n=11, 15)
|
7 participants
|
13 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Gram- pathogens not Enterobacteriaceae (n=11,16)
|
7 participants
|
13 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
All (n=45, 54)
|
35 participants
|
40 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Enterobacteriaceae (n=34, 41)
|
28 participants
|
29 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Enterobacter aerogenes (n=4, 2)
|
3 participants
|
2 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Enterobacter cloacae (n=6, 6)
|
6 participants
|
4 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Escherichia coli (n=6, 5)
|
4 participants
|
3 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Klebsiella pneumoniae (n=20, 30)
|
16 participants
|
22 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Outcome measures
| Measure |
CAZ-AVI
n=257 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=270 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set
Pseudomonas aeruginosa (n=9, 13)
|
6 participants
|
12 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set
All (n=36, 41)
|
29 participants
|
32 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set
Enterobacteriaceae (n=27, 30)
|
23 participants
|
22 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set
Enterobacter cloacae (n=5, 5)
|
5 participants
|
3 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set
Escherichia coli (n=5, 4)
|
4 participants
|
3 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set
Klebsiella pneumoniae (n=14, 22)
|
12 participants
|
17 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set
Gram- pathogens not Enterobacteriaceae (n=9,13)
|
6 participants
|
12 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Outcome measures
| Measure |
CAZ-AVI
n=107 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=118 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Pseudomonas aeruginosa (n=3, 6)
|
2 participants
|
6 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
All (n=29, 32)
|
25 participants
|
26 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Enterobacteriaceae (n=26, 28)
|
23 participants
|
22 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Enterobacter cloacae (n=5, 5)
|
5 participants
|
3 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Escherichia coli (n=4, 4)
|
4 participants
|
3 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Klebsiella pneumoniae (n=14, 20)
|
12 participants
|
17 participants
|
|
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Gram- pathogens not Enterobacteriaceae (n=3,6)
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=46 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=54 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Favorable
|
35 participants
|
39 participants
|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Unfavorable
|
10 participants
|
13 participants
|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Indeterminate
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=40 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=49 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Favorable
|
31 participants
|
36 participants
|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Unfavorable
|
9 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=33 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=40 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Favorable
|
26 participants
|
29 participants
|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Unfavorable
|
7 participants
|
11 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=46 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=54 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Favorable
|
27 participants
|
27 participants
|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Unfavorable
|
16 participants
|
23 participants
|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Indeterminate
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=37 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=41 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Favorable
|
23 participants
|
21 participants
|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Unfavorable
|
14 participants
|
20 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC
Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=30 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=32 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Favorable
|
21 participants
|
18 participants
|
|
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Unfavorable
|
9 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=46 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=54 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Enterobacter aerogenes (n=4, 2)
|
3 participants with favorable responses
|
2 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Enterobacter cloacae (n=6, 6)
|
6 participants with favorable responses
|
6 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Escherichia coli (n=6, 5)
|
5 participants with favorable responses
|
4 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Klebsiella pneumoniae (n=20, 30)
|
18 participants with favorable responses
|
26 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Pseudomonas aeruginosa (n=11, 15)
|
8 participants with favorable responses
|
7 participants with favorable responses
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=40 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=49 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacter aerogenes (n=4, 2)
|
3 participants with favorable responses
|
2 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacter cloacae (n=6, 5)
|
6 participants with favorable responses
|
5 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Escherichia coli (n=6, 4)
|
5 participants with favorable responses
|
4 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Klebsiella pneumoniae (n=16, 28)
|
14 participants with favorable responses
|
25 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Pseudomonas aeruginosa (n=10, 13)
|
8 participants with favorable responses
|
6 participants with favorable responses
|
SECONDARY outcome
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.Population: Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=33 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=40 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Escherichia coli (n=5, 4)
|
5 participants with favorable responses
|
4 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Klebsiella pneumoniae (n=16, 26)
|
14 participants with favorable responses
|
23 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Pseudomonas aeruginosa (n=4, 6)
|
3 participants with favorable responses
|
1 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacter aerogenes (n=4, 2)
|
3 participants with favorable responses
|
2 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Enterobacter cloacae (n=6, 5)
|
6 participants with favorable responses
|
5 participants with favorable responses
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=46 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=54 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Enterobacter aerogenes (n=4, 2)
|
3 participants with favorable responses
|
2 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Enterobacter cloacae (n=6, 6)
|
5 participants with favorable responses
|
5 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Escherichia coli (n=6, 5)
|
4 participants with favorable responses
|
4 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Klebsiella pneumoniae (n=20, 30)
|
15 participants with favorable responses
|
18 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Pseudomonas aeruginosa (n=11, 15)
|
4 participants with favorable responses
|
4 participants with favorable responses
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=37 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=41 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Enterobacter cloacae (n=5, 5)
|
4 participants with favorable responses
|
4 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Escherichia coli (n=5, 4)
|
4 participants with favorable responses
|
4 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Klebsiella pneumoniae (n=14, 22)
|
11 participants with favorable responses
|
14 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Pseudomonas aeruginosa (n=9, 13)
|
3 participants with favorable responses
|
3 participants with favorable responses
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Outcome measures
| Measure |
CAZ-AVI
n=30 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=32 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Enterobacter cloacae (n=5, 5)
|
4 participants with favorable responses
|
4 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Escherichia coli (n=4, 4)
|
4 participants with favorable responses
|
4 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Klebsiella pneumoniae (n=14, 20)
|
11 participants with favorable responses
|
13 participants with favorable responses
|
|
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Pseudomonas aeruginosa (n=3, 6)
|
1 participants with favorable responses
|
1 participants with favorable responses
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at test-of-cure visit.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Number of patients who died (all cause mortality)
|
16 participants
|
14 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Deaths due to disease progression
|
6 participants
|
5 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Number of patients with any AE with outcome=death
|
10 participants
|
9 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Number of patients alive
|
153 participants
|
170 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Number of patients with unknown survival status
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at test-of-cure visit.
Outcome measures
| Measure |
CAZ-AVI
n=356 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=370 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Number of patients who died (all cause mortality)
|
29 participants
|
25 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Deaths due to disease progression
|
10 participants
|
6 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Number of patients with any AE with outcome=death
|
19 participants
|
19 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Number of patients alive
|
316 participants
|
341 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Number of patients with unknown survival status
|
11 participants
|
4 participants
|
SECONDARY outcome
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.
The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set.
Outcome measures
| Measure |
CAZ-AVI
n=257 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=270 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
Number of patients who died (all cause mortality)
|
11 participants
|
8 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
Deaths due to disease progression
|
5 participants
|
4 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
Number of patients with any AE with outcome=death
|
6 participants
|
4 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
Number of patients alive
|
245 participants
|
262 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
Number of patients with unknown survival status
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at Day 28 from randomizationPopulation: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28
Number of patients who died (all cause mortality)
|
17 participants
|
16 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28
Deaths due to disease progression
|
6 participants
|
5 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28
Number of patients with any AE with outcome=death
|
11 participants
|
11 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28
Number of patients alive
|
152 participants
|
168 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28
Number of patients with unknown survival status
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at Day 28 from randomizationPopulation: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28.
Outcome measures
| Measure |
CAZ-AVI
n=356 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=370 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28
Number of patients who died (all cause mortality)
|
30 participants
|
27 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28
Deaths due to disease progression
|
10 participants
|
6 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28
Number of patients with any AE with outcome=death
|
20 participants
|
21 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28
Number of patients alive
|
315 participants
|
339 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28
Number of patients with unknown survival status
|
11 participants
|
4 participants
|
SECONDARY outcome
Timeframe: at Day 28 from randomizationPopulation: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.
The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set at day 28.
Outcome measures
| Measure |
CAZ-AVI
n=257 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=270 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28
Number of patients who died (all cause mortality)
|
12 participants
|
9 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28
Deaths due to disease progression
|
5 participants
|
4 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28
Number of patients with any AE with outcome=death
|
7 participants
|
5 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28
Number of patients alive
|
244 participants
|
261 participants
|
|
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28
Number of patients with unknown survival status
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to 25 days from randomizationPopulation: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
The number of patients discharged from hospital in microbiologically modified intent-to-treat analysis set.
Outcome measures
| Measure |
CAZ-AVI
n=171 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=184 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Number of patients with admission date
|
170 participants
|
182 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Number of patients with at least one discharge
|
71 participants
|
75 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
1 discharge
|
71 participants
|
74 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
2 discharges
|
0 participants
|
1 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
>2 discharges
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to 25 days from randomizationPopulation: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
The number of patients discharged from hospital in the clinically modified intent-to-treat analysis set.
Outcome measures
| Measure |
CAZ-AVI
n=356 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=370 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set
Number of patients with admission date
|
355 participants
|
366 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set
Number of patients with at least one discharge
|
206 participants
|
206 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set
1 discharge
|
201 participants
|
200 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set
2 discharges
|
5 participants
|
4 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set
>2 discharges
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: up to 25 days from randomizationPopulation: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.
The number of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set.
Outcome measures
| Measure |
CAZ-AVI
n=257 Participants
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=270 Participants
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
Number of patients with admission date
|
256 participants
|
266 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
Number of patients with at least one discharge
|
148 participants
|
155 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
1 discharge
|
144 participants
|
151 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
2 discharges
|
4 participants
|
3 participants
|
|
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
>2 discharges
|
0 participants
|
1 participants
|
Adverse Events
CAZ-AVI
Serious events: 75 serious events
Other events: 198 other events
Deaths: 0 deaths
Meropenem
Serious events: 54 serious events
Other events: 195 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAZ-AVI
n=405 participants at risk
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=403 participants at risk
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Cardiac arrest
|
0.49%
2/405 • Number of events 3 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.74%
3/403 • Number of events 4 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Cardiac failure
|
0.99%
4/405 • Number of events 4 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.74%
3/403 • Number of events 3 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Cardiac failure acute
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.50%
2/403 • Number of events 2 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.49%
2/405 • Number of events 2 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.50%
2/403 • Number of events 2 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Cyanosis
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Left ventricular failure
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
General disorders
Death
|
0.74%
3/405 • Number of events 3 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
General disorders
Intentional medical device removal by patient
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
General disorders
Multi-organ failure
|
0.74%
3/405 • Number of events 3 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
General disorders
Pyrexia
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
General disorders
Sudden death
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Hepatobiliary disorders
Subacute hepatic failure
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
CNS ventriculitis
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.50%
2/403 • Number of events 2 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Diabetic foot infection
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Enterobacter pneumonia
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
HIV infection
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Influenza
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Lung infection
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Meningitis
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Pneumonia
|
1.7%
7/405 • Number of events 7 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
1.5%
6/403 • Number of events 6 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Pneumonia fungal
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Postoperative wound infection
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Sepsis
|
1.2%
5/405 • Number of events 5 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.99%
4/403 • Number of events 5 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Septic shock
|
0.74%
3/405 • Number of events 3 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.74%
3/403 • Number of events 3 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Tracheitis
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Tuberculosis
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Urosepsis
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Injury, poisoning and procedural complications
Weaning failure
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Investigations
Alanine aminotransferase increased
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Investigations
Aspartate aminotransferase increased
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Investigations
Liver function test abnormal
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Investigations
Platelet count decreased
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Nervous system disorders
Brachial plexopathy
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.50%
2/403 • Number of events 2 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Nervous system disorders
Ischaemic stroke
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.49%
2/405 • Number of events 2 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Renal and urinary disorders
Renal failure
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.49%
2/405 • Number of events 2 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchoplegia
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.49%
2/405 • Number of events 2 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.74%
3/403 • Number of events 3 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.99%
4/405 • Number of events 4 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.74%
3/403 • Number of events 3 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.49%
2/405 • Number of events 2 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
5/405 • Number of events 5 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.99%
4/403 • Number of events 4 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/405 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.25%
1/403 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.25%
1/405 • Number of events 1 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
0.00%
0/403 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
Other adverse events
| Measure |
CAZ-AVI
n=405 participants at risk
2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
|
Meropenem
n=403 participants at risk
meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
24/405 • Number of events 25 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
4.5%
18/403 • Number of events 21 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
10/405 • Number of events 11 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
2.0%
8/403 • Number of events 8 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
25/405 • Number of events 25 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
7.7%
31/403 • Number of events 38 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
60/405 • Number of events 65 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
15.4%
62/403 • Number of events 68 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
13/405 • Number of events 13 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
1.7%
7/403 • Number of events 7 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
23/405 • Number of events 28 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
5.5%
22/403 • Number of events 24 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
General disorders
Oedema peripheral
|
4.2%
17/405 • Number of events 18 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
3.7%
15/403 • Number of events 15 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
General disorders
Pyrexia
|
2.5%
10/405 • Number of events 11 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
3.2%
13/403 • Number of events 20 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
11/405 • Number of events 11 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
3.5%
14/403 • Number of events 14 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
16/405 • Number of events 16 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
4.7%
19/403 • Number of events 20 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
16/405 • Number of events 16 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
4.2%
17/403 • Number of events 18 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.6%
43/405 • Number of events 47 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
8.2%
33/403 • Number of events 40 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
10/405 • Number of events 10 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
1.5%
6/403 • Number of events 6 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Psychiatric disorders
Insomnia
|
0.99%
4/405 • Number of events 4 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
2.7%
11/403 • Number of events 11 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
9/405 • Number of events 10 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
1.7%
7/403 • Number of events 7 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.2%
9/405 • Number of events 13 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
1.5%
6/403 • Number of events 6 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
8/405 • Number of events 8 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
3.2%
13/403 • Number of events 13 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Vascular disorders
Hypertension
|
3.5%
14/405 • Number of events 14 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
3.7%
15/403 • Number of events 16 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
|
Vascular disorders
Hypotension
|
2.5%
10/405 • Number of events 10 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
2.0%
8/403 • Number of events 13 • Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
|
Additional Information
David Wilson, Statistical Team Leader - Infection
AstraZeneca
Phone: +44 1625 517830
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place