Trial Outcomes & Findings for Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002) (NCT NCT02019420)
NCT ID: NCT02019420
Last Updated: 2019-06-27
Results Overview
The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
726 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2019-06-27
Participant Flow
Ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) were enrolled at study sites located in 34 countries.
Participant milestones
| Measure |
Tedizolid
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Overall Study
STARTED
|
366
|
360
|
|
Overall Study
Treated
|
361
|
357
|
|
Overall Study
COMPLETED
|
258
|
254
|
|
Overall Study
NOT COMPLETED
|
108
|
106
|
Reasons for withdrawal
| Measure |
Tedizolid
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Overall Study
Did not receive study drug
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
At request of sponsor or investigator
|
0
|
1
|
|
Overall Study
Death
|
104
|
99
|
|
Overall Study
Transferred to other care facility
|
1
|
1
|
Baseline Characteristics
Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)
Baseline characteristics by cohort
| Measure |
Tedizolid
n=366 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=360 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
Total
n=726 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 Years
STANDARD_DEVIATION 18.41 • n=99 Participants
|
58.7 Years
STANDARD_DEVIATION 17.44 • n=107 Participants
|
58.4 Years
STANDARD_DEVIATION 17.93 • n=206 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
223 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
249 Participants
n=99 Participants
|
254 Participants
n=107 Participants
|
503 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
65 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
290 Participants
n=99 Participants
|
289 Participants
n=107 Participants
|
579 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
68 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
269 Participants
n=99 Participants
|
258 Participants
n=107 Participants
|
527 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: The ITT set is all randomized participants.
The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.
Outcome measures
| Measure |
Tedizolid
n=366 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=360 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population
|
103 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if methicillin-resistant S. aureus \[MRSA\]) before first study drug dose, and bacterial pathogen against which the investigational drug has antibacterial activity.
The numbers of participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.
Outcome measures
| Measure |
Tedizolid
n=178 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=202 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
|
46 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 7-14 days after end of therapy - TOCPopulation: The ITT set includes all randomized participants.
The clinical response in the ITT population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP.
Outcome measures
| Measure |
Tedizolid
n=366 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=360 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population
Clinical Success
|
206 Participants
|
230 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population
Clinical Failure
|
144 Participants
|
110 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population
Indeterminate
|
16 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 7-14 days after end of therapy - TOCPopulation: The CE set is all randomized and treated participants who had assessment data available and did not have confounding events.
The clinical response in the CE population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP.
Outcome measures
| Measure |
Tedizolid
n=267 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=243 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population
Clinical Success
|
143 Participants
|
146 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population
Clinical Failure
|
124 Participants
|
97 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population
Indeterminate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: The MSSA-infected mITT set is all randomized, treated participants who have MSSA confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.
The number of MSSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MSSA culture results from respiratory tract or pleural fluid specimens obtained within 36 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.
Outcome measures
| Measure |
Tedizolid
n=117 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=128 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
|
31 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: The MRSA-infected mITT set is all randomized, treated participants who have MRSA confirmed by respiratory tract/pleural fluid culture results obtained within 72 hours before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.
The number of MRSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MRSA culture results from respiratory tract or pleural fluid specimens obtained within 72 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.
Outcome measures
| Measure |
Tedizolid
n=54 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=69 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 1-3 days after completing study therapy (Days 8-10 or Days 15-17)Population: The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if MRSA) before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.
The number of patients in the mITT population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).
Outcome measures
| Measure |
Tedizolid
n=178 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=202 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population
|
123 Participants
|
166 Participants
|
SECONDARY outcome
Timeframe: 1-3 days after completing study therapy (Days 8-10 or Days 15-17)Population: The ME-1 set is all mITT participants who did not receive an antibiotic (other than study drug) with activity against the baseline pathogen up to 28 days after randomization.
The number of patients in the ME-1 population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).
Outcome measures
| Measure |
Tedizolid
n=178 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=202 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population
|
123 Participants
|
166 Participants
|
SECONDARY outcome
Timeframe: 7-14 days after end of therapy - TOCPopulation: The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if MRSA) before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.
The number of patients in the mITT population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).
Outcome measures
| Measure |
Tedizolid
n=178 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=202 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population
|
117 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: 7-14 days after end of therapy - TOCPopulation: The ME-2 set is all mITT participants who did not receive an antibiotic (other than study drug) with activity against the baseline pathogen up to the TOC visit and is also in the clinically-evaluable (CE) set.
The number of patients in the ME-2 population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).
Outcome measures
| Measure |
Tedizolid
n=120 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=109 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population
|
65 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: Up to 32 daysPopulation: The safety set is all randomized participants who received any amount of study drug. A total of 4 participants were randomized to tedizolid but received linezolid.
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis is based on actual treatment received instead of randomization.
Outcome measures
| Measure |
Tedizolid
n=357 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=361 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Number of Participants With ≥1 Adverse Events (AEs)
|
327 Participants
|
325 Participants
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: The safety set is all randomized participants who received any amount of study drug. A total of 4 participants were randomized to tedizolid but received linezolid.
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis was based on actual treatment received and not randomization.
Outcome measures
| Measure |
Tedizolid
n=357 Participants
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=361 Participants
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE)
|
4 Participants
|
3 Participants
|
Adverse Events
Tedizolid
Serious events: 129 serious events
Other events: 176 other events
Deaths: 101 deaths
Linezolid
Serious events: 149 serious events
Other events: 175 other events
Deaths: 103 deaths
Serious adverse events
| Measure |
Tedizolid
n=357 participants at risk
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=361 participants at risk
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Infections and infestations
Empyema
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Endotoxaemia
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Endotoxic shock
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Enterobacter pneumonia
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
1.4%
5/361 • Number of events 5 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Cardiac arrest
|
5.9%
21/357 • Number of events 24 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
4.4%
16/361 • Number of events 16 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.84%
3/357 • Number of events 3 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.83%
3/361 • Number of events 3 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.0%
7/357 • Number of events 8 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
1.7%
6/361 • Number of events 6 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.83%
3/361 • Number of events 3 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Glossoptosis
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
General disorders
Brain death
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.2%
8/357 • Number of events 8 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
3.3%
12/361 • Number of events 12 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Bacteraemia
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Bacterial infection
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Bacterial sepsis
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
CNS ventriculitis
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Meningitis
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
1.1%
4/361 • Number of events 4 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Meningitis bacterial
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Peritonitis
|
1.1%
4/357 • Number of events 4 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Pneumonia
|
1.1%
4/357 • Number of events 4 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
1.7%
6/361 • Number of events 6 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Pneumonia acinetobacter
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.84%
3/357 • Number of events 3 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Pulmonary sepsis
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Sepsis
|
1.7%
6/357 • Number of events 6 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
1.4%
5/361 • Number of events 5 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Septic shock
|
4.5%
16/357 • Number of events 16 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
5.0%
18/361 • Number of events 18 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Toxic shock syndrome
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
1.1%
4/357 • Number of events 4 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.83%
3/361 • Number of events 3 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Metabolism and nutrition disorders
Propofol infusion syndrome
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellopontine angle tumour
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Benign enlargement of the subarachnoid spaces
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Brain hypoxia
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Brain injury
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Brain oedema
|
3.6%
13/357 • Number of events 13 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
1.9%
7/361 • Number of events 7 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Cerebral vasoconstriction
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Cholinergic syndrome
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Coma
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Hydrocephalus
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Myasthenia gravis crisis
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Stroke in evolution
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
5/357 • Number of events 5 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
1.9%
7/361 • Number of events 7 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.56%
2/357 • Number of events 3 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
1.7%
6/361 • Number of events 6 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haematoma
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural thickening
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
1.4%
5/361 • Number of events 5 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.83%
3/361 • Number of events 3 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.28%
1/357 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.00%
0/361 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.55%
2/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Vascular disorders
Hypotension
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.83%
3/361 • Number of events 3 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Vascular disorders
Neurogenic shock
|
0.00%
0/357 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 1 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.56%
2/357 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
0.28%
1/361 • Number of events 2 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
Other adverse events
| Measure |
Tedizolid
n=357 participants at risk
Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
|
Linezolid
n=361 participants at risk
Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.7%
56/357 • Number of events 66 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
14.1%
51/361 • Number of events 52 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Constipation
|
8.7%
31/357 • Number of events 33 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
7.8%
28/361 • Number of events 31 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
34/357 • Number of events 36 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
13.6%
49/361 • Number of events 52 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
19/357 • Number of events 19 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
4.2%
15/361 • Number of events 16 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Infections and infestations
Urinary tract infection
|
7.3%
26/357 • Number of events 26 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
5.5%
20/361 • Number of events 20 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.6%
38/357 • Number of events 49 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
9.4%
34/361 • Number of events 38 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.2%
22/357 • Number of events 26 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
7.2%
26/361 • Number of events 31 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Vascular disorders
Hypertension
|
5.3%
19/357 • Number of events 20 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
3.9%
14/361 • Number of events 14 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
|
Vascular disorders
Hypotension
|
7.6%
27/357 • Number of events 28 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
6.9%
25/361 • Number of events 26 • Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Cubist intends to pursue publication of the results of the study in cooperation with a lead Investigator, subject to the terms and conditions of the clinical study agreement between Cubist and Investigators. Cubist approval in writing is required for publication of any data subsets.
- Publication restrictions are in place
Restriction type: OTHER