Trial Outcomes & Findings for Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection (NCT NCT00600483)

NCT ID: NCT00600483

Last Updated: 2022-05-05

Results Overview

Efficacy will be evaluated by a comparison between the 2 study groups of the incidence of surgical wound infections that occur within the period from surgery through postop day 90.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1502 participants
• Primary outcome timeframe: 90 days post cardiac surgery
• Results posted on: 2022-05-05

Participant Flow

Participant milestones

Measure	Gentamicin Group Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group Standard of care, ie, insertion of no gentamicin-collagen sponge.
Overall Study STARTED	753	749
Overall Study COMPLETED	717	702
Overall Study NOT COMPLETED	36	47

Reasons for withdrawal

Measure	Gentamicin Group Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group Standard of care, ie, insertion of no gentamicin-collagen sponge.
Overall Study Lost to Follow-up	26	47
Overall Study Randomized but not treated	10	0

Baseline Characteristics

Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection

Baseline characteristics by cohort

Measure	Gentamicin Group n=753 Participants Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group n=749 Participants Standard of care, ie, insertion of no gentamicin-collagen sponge.	Total n=1502 Participants Total of all reporting groups
Age, Continuous	64.3 Years STANDARD_DEVIATION 9.88 • n=5 Participants	64.3 Years STANDARD_DEVIATION 10.50 • n=7 Participants	64.3 Years STANDARD_DEVIATION 10.19 • n=5 Participants
Sex: Female, Male Female	223 Participants n=5 Participants	219 Participants n=7 Participants	442 Participants n=5 Participants
Sex: Female, Male Male	530 Participants n=5 Participants	530 Participants n=7 Participants	1060 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	56 Participants n=5 Participants	59 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) White	688 Participants n=5 Participants	683 Participants n=7 Participants	1371 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days post cardiac surgery

Population: ITT population

Efficacy will be evaluated by a comparison between the 2 study groups of the incidence of surgical wound infections that occur within the period from surgery through postop day 90.

Outcome measures

Measure	Gentamicin Group n=753 Participants Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group n=749 Participants Standard of care, ie, insertion of no gentamicin-collagen sponge.
Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90	63 Participants	65 Participants

SECONDARY outcome

Timeframe: 90 days post cardiac surgery

Population: ITT Population

Proportion of patients with surgically treated surgical wound infection adjudicated by an independent blinded committee.

Outcome measures

Measure	Gentamicin Group n=753 Participants Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group n=749 Participants Standard of care, ie, insertion of no gentamicin-collagen sponge.
Surgically Treated Surgical Wound Infection Postoperative Day 90	25 Participants	37 Participants

SECONDARY outcome

Timeframe: 90 days post cardiac surgery

Outcome measures

Measure	Gentamicin Group n=753 Participants Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group n=749 Participants Standard of care, ie, insertion of no gentamicin-collagen sponge.
Proportion of Patients With Deep Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee.	14 Participants	19 Participants

SECONDARY outcome

Timeframe: 90 days post cardiac surgery

Outcome measures

Measure	Gentamicin Group n=753 Participants Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group n=749 Participants Standard of care, ie, insertion of no gentamicin-collagen sponge.
Proportion of Patients With Superficial Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee.	49 Participants	46 Participants

SECONDARY outcome

Timeframe: 90 days post cardiac surgery

Population: PP Population: INN-SWI-001)

Analysis associated with Microbial Pathogens in Adjudicated 90 Day SWI Subjects ME within Per Protocol Population. Any Microbial Pathogens Detected in SWI (ME)

Outcome measures

Measure	Gentamicin Group n=27 Participants Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group n=32 Participants Standard of care, ie, insertion of no gentamicin-collagen sponge.
Number of Participants Positive for Each Pathogen Culture Staphylococcus xylosus	0 participants	1 participants
Number of Participants Positive for Each Pathogen Culture Acinetobacter calcoaceticus	1 participants	0 participants
Number of Participants Positive for Each Pathogen Culture Coagulase-neg staphylococci	0 participants	2 participants
Number of Participants Positive for Each Pathogen Culture Enterobacter cloacae	2 participants	1 participants
Number of Participants Positive for Each Pathogen Culture Enterococcus faecalis	1 participants	1 participants
Number of Participants Positive for Each Pathogen Culture Escherichia coli	3 participants	3 participants
Number of Participants Positive for Each Pathogen Culture Group B species streptococcus	1 participants	0 participants
Number of Participants Positive for Each Pathogen Culture Klebsiella pneumoniae	0 participants	2 participants
Number of Participants Positive for Each Pathogen Culture Klebsiella spp	1 participants	2 participants
Number of Participants Positive for Each Pathogen Culture Methicillin-resistant SA	2 participants	1 participants
Number of Participants Positive for Each Pathogen Culture Methicillin-sensitive SA	6 participants	2 participants
Number of Participants Positive for Each Pathogen Culture Other Specify 1	3 participants	3 participants
Number of Participants Positive for Each Pathogen Culture Proteus mirabilis	4 participants	5 participants
Number of Participants Positive for Each Pathogen Culture Providencia stuartii	1 participants	0 participants
Number of Participants Positive for Each Pathogen Culture Pseudomonas aeruginosa	3 participants	3 participants
Number of Participants Positive for Each Pathogen Culture Serratia marcescens	2 participants	4 participants
Number of Participants Positive for Each Pathogen Culture Staphylococcus aureus	5 participants	6 participants
Number of Participants Positive for Each Pathogen Culture Staphylococcus capitis	1 participants	0 participants
Number of Participants Positive for Each Pathogen Culture Staphylococcus epidermidis	2 participants	7 participants
Number of Participants Positive for Each Pathogen Culture Staphylococcus hominis	0 participants	1 participants
Number of Participants Positive for Each Pathogen Culture Staphylococcus lugdunensis	0 participants	1 participants
Number of Participants Positive for Each Pathogen Culture Streptococcus agalactiae	1 participants	0 participants

SECONDARY outcome

Timeframe: 90 days post cardiac surgery

Population: ITT population

ASEPSIS Score through 90 days postoperative - To compare antibiotic regimens for their effectiveness in preventing or treating wound sepsis, well-defined criteria for outcome are needed. A method of assessing wound healing has been devised that defines carefully the characteristics to be considered and how they are to be awarded points. Objective criteria are also included in the assessment. Points are given for the need for Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay (ASEPSIS). The higher the points the worse outcome. Maximum Points would be 60. Minimum points would be 0

Outcome measures

Measure	Gentamicin Group n=753 Participants Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group n=749 Participants Standard of care, ie, insertion of no gentamicin-collagen sponge.
ASEPSIS Score	1.9 score on a scale Standard Deviation 6.32	2.0 score on a scale Standard Deviation 7.18

SECONDARY outcome

Timeframe: 90 days post cardiac surgery

Rehospitalization for Sternal Wound Infection - within 90 days postoperatively.

Outcome measures

Measure	Gentamicin Group n=753 Participants Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group n=749 Participants Standard of care, ie, insertion of no gentamicin-collagen sponge.
Rehospitalization for Sternal Wound Infection	23 Participants	24 Participants

Adverse Events

Gentamicin Group

Serious events: 269 serious events

Other events: 741 other events

Deaths: 19 deaths

Control Group

Serious events: 290 serious events

Other events: 757 other events

Deaths: 27 deaths

Serious adverse events

Measure	Gentamicin Group n=743 participants at risk Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group n=759 participants at risk Standard of care, ie, insertion of no gentamicin-collagen sponge. Includes patients randomized to Gentamicin but where not treated in the Gentamicin group
Blood and lymphatic system disorders Anaemia	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Coagulopathy	0.67% 5/743 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Thrombocytopenia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Acute coronary syndrome	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Acute myocardial infarction	0.54% 4/743 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • Number of events 6 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Angina pectoris	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Angina unstable	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Arrhythmia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrial fibrillation	2.6% 19/743 • Number of events 19 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.0% 23/759 • Number of events 23 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrial flutter	1.6% 12/743 • Number of events 12 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrial tachycardia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrioventricular block	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrioventricular block complete	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Bradycardia	1.3% 10/743 • Number of events 10 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardiac arrest	0.81% 6/743 • Number of events 6 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • Number of events 6 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardiac failure	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardiac failure congestive	3.8% 28/743 • Number of events 28 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.8% 29/759 • Number of events 29 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardiac tamponade	0.40% 3/743 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardio-respiratory arrest	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardiogenic shock	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Coronary artery disease	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Dressler's syndrome	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Intracardiac thrombus	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Low cardiac output syndrome	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Myocardial infarction	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Nodal rhythm	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Pericardial effusion	0.67% 5/743 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • Number of events 7 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Pericarditis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Sick sinus syndrome	0.67% 5/743 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • Number of events 8 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Sinus arrest	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Stress cardiomyopathy	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Supraventricular tachycardia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Tachycardia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ventricular dysfunction	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ventricular failure	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ventricular fibrillation	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ventricular tachycardia	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Congenital, familial and genetic disorders Atrial septal defect	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Abdominal pain	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Abdominal pain upper	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Colitis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Constipation	0.40% 3/743 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Diabetic gastroparesis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Diarrhoea	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Dysphagia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Erosive oesophagitis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Gastrointestinal haemorrhage	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Gastrointestinal ischaemia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Haematochezia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Ileus	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Inguinal hernia, obstructive	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Intestinal ischaemia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Nausea	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Pancreatitis	0.54% 4/743 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Pancreatitis acute	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Peptic ulcer haemorrhage	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Small intestinal obstruction	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Volvulus	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Vomiting	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Asthenia	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Catheter site haemorrhage	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Generalised oedema	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Impaired healing	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Malaise	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Mechanical complication of implant	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Multi-organ failure	0.54% 4/743 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Non-cardiac chest pain	1.2% 9/743 • Number of events 9 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • Number of events 7 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Pyrexia	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Systemic inflammatory response syndrome	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Cholecystitis	0.40% 3/743 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Cholecystitis acute	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Cholelithiasis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Bacteraemia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Bronchitis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Cellulitis	1.2% 9/743 • Number of events 9 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Cholecystitis infective	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Clostridium difficile colitis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Diabetic foot infection	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Enterococcal infection	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Gangrene	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Gastroenteritis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Gastroenteritis viral	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Incision site cellulitis	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Incision site infection	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Lobar pneumonia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Lung infection pseudomonal	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Mediastinitis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Osteomyelitis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pneumonia	0.67% 5/743 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.6% 20/759 • Number of events 20 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pneumonia bacterial	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pneumonia escherichia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pneumonia klebsiella	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Postoperative abscess	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Postoperative wound infection	2.3% 17/743 • Number of events 17 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.2% 24/759 • Number of events 24 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pyelonephritis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Sepsis	0.67% 5/743 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • Number of events 8 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Septic shock	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Small intestine gangrene	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Staphylococcal abscess	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Staphylococcal bacteraemia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Staphylococcal infection	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Staphylococcal mediastinitis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Staphylococcal sepsis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Tracheobronchitis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Urinary tract infection	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Wound infection	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Wound infection staphylococcal	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Anaemia postoperative	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Cardiac pacemaker malfunction	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Cardiac procedure complication	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Complication of device removal	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Concussion	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Confusion postoperative	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Contusion	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Delayed recovery from anaesthesia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Device breakage	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Device leakage	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Excoriation	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Fall	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Graft thrombosis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Incision site haematoma	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Incision site pain	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Operative haemorrhage	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural discharge	0.54% 4/743 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural haemorrhage	1.2% 9/743 • Number of events 9 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • Number of events 10 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Postoperative ileus	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Postoperative renal failure	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.67% 5/743 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Postoperative wound complication	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Procedural hypotension	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Procedural pain	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Vascular graft complication	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Vascular graft occlusion	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Weaning failure	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Wound dehiscence	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Anticoagulation drug level below therapeutic	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood glucose fluctuation	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood pressure decreased	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Clostridium difficile toxin test positive	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations International normalised ratio increased	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Platelet count decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Troponin increased	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Dehydration	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Fluid overload	0.54% 4/743 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hyperkalaemia	0.40% 3/743 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypoglycaemia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hyponatraemia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypovolaemia	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Lactic acidosis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Metabolic acidosis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Aphasia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Carotid artery stenosis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Cerebral infarction	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Cerebrovascular accident	0.94% 7/743 • Number of events 7 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • Number of events 8 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Cognitive disorder	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Convulsion	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Depressed level of consciousness	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Dizziness	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Dysarthria	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Embolic stroke	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Encephalopathy	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Facial paresis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Hepatic encephalopathy	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Ischaemic stroke	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Metabolic encephalopathy	0.40% 3/743 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Paraesthesia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Presyncope	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Somnolence	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Syncope	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Transient ischaemic attack	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Unresponsive to stimuli	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Agitation	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Anxiety	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Confusional state	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Depression	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Disorientation	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Major depression	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Mental status changes	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Psychotic disorder	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Azotaemia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Dysuria	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Nephropathy toxic	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal failure	0.40% 3/743 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • Number of events 6 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal failure acute	2.4% 18/743 • Number of events 18 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.0% 23/759 • Number of events 23 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal failure chronic	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal tubular necrosis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Urinary retention	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Prostatitis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.6% 12/743 • Number of events 12 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • Number of events 10 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Atelectasis	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.54% 4/743 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Haemothorax	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Hypoxia	0.54% 4/743 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Laryngeal keratotic plaque	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Lung hernia	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Mediastinal haematoma	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Mediastinal haemorrhage	0.54% 4/743 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • Number of events 8 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Mediastinal mass	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 28/743 • Number of events 28 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.3% 25/759 • Number of events 25 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.40% 3/743 • Number of events 3 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.2% 9/759 • Number of events 9 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.54% 4/743 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.67% 5/743 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.2% 9/759 • Number of events 9 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.81% 6/743 • Number of events 6 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.3% 25/759 • Number of events 25 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.1% 23/743 • Number of events 23 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.8% 21/759 • Number of events 21 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Aortic dissection	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Aortic rupture	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Aortic stenosis	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Arterial haemorrhage	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Arterial thrombosis limb	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Deep vein thrombosis	0.67% 5/743 • Number of events 5 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • Number of events 4 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Femoral artery occlusion	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Haematoma	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Hypertension	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Hypertensive crisis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Hypotension	1.1% 8/743 • Number of events 8 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • Number of events 10 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Hypovolaemic shock	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Labile blood pressure	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Orthostatic hypotension	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Peripheral vascular disorder	0.27% 2/743 • Number of events 2 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Phlebitis superficial	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Shock	0.13% 1/743 • Number of events 1 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control

Other adverse events

Measure	Gentamicin Group n=743 participants at risk Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge	Control Group n=759 participants at risk Standard of care, ie, insertion of no gentamicin-collagen sponge. Includes patients randomized to Gentamicin but where not treated in the Gentamicin group
Cardiac disorders Atrial tachycardia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrioventricular block	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrioventricular block complete	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrioventricular block first degree	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.6% 12/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrioventricular block second degree	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Bifascicular block	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Bradyarrhythmia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Bradycardia	3.0% 22/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	4.0% 30/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Bundle branch block	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Bundle branch block left	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Bundle branch block right	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Aspiration bronchial	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Bacteria sputum identified	2.3% 17/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Bacterial culture positive	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.7% 13/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Base excess increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Basophil count increased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood albumin decreased	1.6% 12/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.2% 9/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood alkaline phosphatase decreased	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood alkaline phosphatase increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood bicarbonate decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood bicarbonate increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood bilirubin increased	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood calcium decreased	2.8% 21/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.5% 19/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood calcium increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood chloride decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood chloride increased	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood cortisol decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood creatine increased	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood sodium decreased	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Haemodynamic instability	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Hypertension	8.2% 61/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	9.0% 68/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Hypotension	24.5% 182/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	24.4% 185/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Hypovolaemic shock	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood creatine phosphokinase increased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood creatine phosphokinase mb increased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood creatinine decreased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood creatinine increased	5.9% 44/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	5.0% 38/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood fibrinogen decreased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood glucose fluctuation	1.5% 11/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.8% 14/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Coccydynia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Costochondritis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Flank pain	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Joint crepitation	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood glucose increased	3.1% 23/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.4% 26/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Joint swelling	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Lower extremity mass	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Mobility decreased	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Muscle spasms	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Muscular weakness	1.9% 14/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.8% 14/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood lactic acid increased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.8% 28/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.6% 27/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood magnesium decreased	1.7% 13/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood magnesium increased	1.3% 10/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood ph decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood phosphorus decreased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood phosphorus increased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.6% 27/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	4.3% 33/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Myalgia	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Neck pain	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Osteoarthritis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 24/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	4.3% 33/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Pain in jaw	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Soft tissue disorder	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Synovial cyst	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Genital rash	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Anaemia	43.1% 320/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	43.0% 326/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Blood disorder	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Aphasia	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Balance disorder	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Burning sensation	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Carotid arteriosclerosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Carotid artery stenosis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Cerebellar infarction	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Cerebral cyst	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Cerebral infarction	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Coagulopathy	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Convulsion	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Haemoconcentration	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Depressed level of consciousness	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Dizziness	3.2% 24/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	5.0% 38/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Dizziness exertional	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Haemorrhagic anaemia	5.4% 40/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	6.7% 51/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Dysarthria	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Dysgeusia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Dysphasia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood potassium decreased	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Encephalopathy	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Hypercoagulation	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Facial palsy	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Headache	5.1% 38/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.9% 22/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Iron deficiency anaemia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Hemiparesis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Leukocytosis	22.1% 164/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	20.3% 154/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Hepatic encephalopathy	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Hyperaesthesia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Hypoaesthesia	2.6% 19/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.6% 20/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Hypotonia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Lethargy	2.2% 16/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.1% 16/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Loss of consciousness	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Memory impairment	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Metabolic encephalopathy	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Migraine	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Nerve compression	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Neuralgia	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Neuropathy peripheral	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Paraesthesia	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Presyncope	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Restless legs syndrome	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Sedation	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Somnolence	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Syncope	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Thalamic infarction	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Leukopenia	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Transient ischaemic attack	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Tremor	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Unresponsive to stimuli	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Nervous system disorders Upper motor neurone lesion	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Abnormal dreams	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Aggression	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Lymphadenopathy	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Agitation	3.6% 27/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.2% 24/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Anxiety	8.1% 60/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	5.3% 40/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Claustrophobia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Confusional state	7.7% 57/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	8.0% 61/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Delirium	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Depressed mood	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Depression	1.6% 12/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.4% 11/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Disorientation	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Hallucination	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Hallucination, visual	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Insomnia	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	6.9% 52/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Lymphopenia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Mania	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Mental status changes	1.6% 12/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.4% 11/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Neutropenia	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Mood altered	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Neutrophilia	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Nervousness	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Paranoia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Psychotic disorder	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Restlessness	2.2% 16/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.2% 17/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Splenomegaly	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Sleep disorder	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Thrombocythaemia	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Psychiatric disorders Stress	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Acute prerenal failure	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Blood and lymphatic system disorders Thrombocytopenia	20.2% 150/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	21.2% 161/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Anuria	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Acute left ventricular failure	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Azotaemia	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Bladder fibrosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Bladder spasm	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Chromaturia	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Dysuria	1.5% 11/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Acute myocardial infarction	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Angina pectoris	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Haematuria	2.0% 15/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.6% 12/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Micturition urgency	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Nephrolithiasis	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Neurogenic bladder	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Nocturia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Aortic valve incompetence	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Oliguria	1.6% 12/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.4% 11/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Pollakiuria	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Polyuria	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Proteinuria	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal cyst	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal disorder	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal failure	8.1% 60/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	6.3% 48/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal failure acute	3.5% 26/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	4.5% 34/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal failure chronic	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal impairment	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal mass	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Renal tubular necrosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Aortic valve sclerosis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Urinary incontinence	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.7% 13/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Arrhythmia	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.4% 11/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Urinary retention	2.0% 15/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.0% 15/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Urinary tract obstruction	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Arrhythmia supraventricular	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Renal and urinary disorders Urine abnormality	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrial fibrillation	25.0% 186/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	25.3% 192/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrial flutter	1.6% 12/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.2% 24/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Benign prostatic hyperplasia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Atrial hypertrophy	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Breast pain	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Genital erythema	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardiac arrest	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardiac failure	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardiac failure congestive	4.8% 36/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	5.1% 39/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardiogenic shock	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cardiomegaly	10.8% 80/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	8.2% 62/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Cyanosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Dilatation atrial	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Dressler's syndrome	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Extrasystoles	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Intracardiac thrombus	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ischaemic cardiomyopathy	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Left atrial dilatation	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Left ventricular dysfunction	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Left ventricular hypertrophy	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Mitral valve calcification	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Mitral valve incompetence	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Myocardial infarction	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Myocardial ischaemia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Nodal arrhythmia	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Nodal rhythm	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.0% 15/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Palpitations	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Pericardial effusion	2.0% 15/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.2% 9/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Pericardial rub	4.8% 36/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	4.2% 32/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Pericarditis	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Pulmonary valve incompetence	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Right atrial dilatation	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Sick sinus syndrome	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Sinus arrest	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Sinus arrhythmia	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Sinus bradycardia	2.4% 18/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.0% 15/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Sinus tachycardia	9.4% 70/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	7.9% 60/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Supraventricular extrasystoles	2.0% 15/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.6% 12/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Supraventricular tachycardia	1.3% 10/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.1% 16/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Tachycardia	4.4% 33/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.2% 24/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood potassium increased	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.4% 11/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Tachycardia paroxysmal	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.4% 11/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Tricuspid valve incompetence	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Tricuspid valve prolapse	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ventricular arrhythmia	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ventricular dysfunction	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ventricular extrasystoles	5.2% 39/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	4.0% 30/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ventricular fibrillation	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ventricular hypokinesia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Ventricular tachycardia	3.8% 28/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.8% 29/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Cardiac disorders Wolff-parkinson-white syndrome	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Deafness	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Hypoacusis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Vertigo	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Vertigo positional	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Endocrine disorders	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Adrenal mass	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Hypothyroidism	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Eye disorders	2.6% 19/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.2% 9/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Diplopia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Dry eye	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Eye haemorrhage	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Eye pruritus	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Eye swelling	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Lacrimation increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Myodesopsia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Ocular hyperaemia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Pupils unequal	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Retinal artery embolism	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Vision blurred	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Visual acuity reduced	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Ear and labyrinth disorders Visual impairment	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Abdominal discomfort	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Abdominal distension	1.5% 11/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.6% 20/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Abdominal pain	1.3% 10/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Abdominal pain lower	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Abdominal pain upper	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Abdominal tenderness	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Ascites	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Barrett's oesophagus	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Chapped lips	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Colitis ischaemic	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Constipation	18.0% 134/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	18.2% 138/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Diarrhoea	4.4% 33/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.6% 27/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Dry mouth	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Duodenal ulcer	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Dyspepsia	1.3% 10/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.4% 11/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Dysphagia	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Faecal incontinence	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Faecaloma	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Flatulence	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Gastric disorder	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Gastritis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Gastritis erosive	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Gastrointestinal haemorrhage	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Gastrointestinal sounds abnormal	1.5% 11/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Gastrooesophageal reflux disease	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Gingival bleeding	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Haematemesis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Haematochezia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood pressure decreased	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Haemorrhoids	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Ileus	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Impaired gastric emptying	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Intestinal dilatation	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Lip swelling	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood pressure increased	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Melaena	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Nausea	34.2% 254/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	33.6% 255/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Odynophagia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Oesophageal ulcer	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Oral disorder	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Pancreatitis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Peptic ulcer	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Peritoneal haematoma	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Proctalgia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Reflux oesophagitis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Retching	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Retroperitoneal haematoma	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Salivary gland cyst	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Salivary hypersecretion	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Small intestinal obstruction	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Stomatitis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Swollen tongue	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Tongue oedema	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Toothache	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Umbilical hernia, obstructive	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Gastrointestinal disorders Vomiting	7.0% 52/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	7.2% 55/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Adverse drug reaction	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Asthenia	6.6% 49/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	5.7% 43/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Axillary pain	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Breakthrough pain	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Catheter site discharge	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Catheter site haematoma	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Catheter site haemorrhage	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood pressure systolic decreased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Catheter site pain	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Catheter site related reaction	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Catheter thrombosis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Chest discomfort	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Chest pain	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Chills	1.5% 11/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Discomfort	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Face oedema	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Fatigue	2.0% 15/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Feeling cold	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Feeling hot	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Gait disturbance	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders General symptom	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Generalised oedema	28.0% 208/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	29.5% 224/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Granuloma	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Hyperthermia	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Hypothermia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood pressure systolic increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Impaired healing	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Implant site pain	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Inflammation	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Infusion site erythema	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Infusion site extravasation	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Infusion site haemorrhage	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Infusion site inflammation	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Infusion site pain	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Infusion site swelling	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Infusion site ulcer	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Infusion site warmth	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Irritability	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Local swelling	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Localised oedema	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Malaise	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Non-cardiac chest pain	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.8% 14/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Oedema peripheral	18.3% 136/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	18.6% 141/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Pain	1.9% 14/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.2% 24/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Pitting oedema	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Pyrexia	16.6% 123/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	15.2% 115/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Submandibular mass	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
General disorders Wound necrosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Biliary dyskinesia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Cholecystitis	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Cholecystitis acute	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Cholelithiasis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Hepatic failure	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Hepatic ischaemia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Hepatic steatosis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Hepatitis acute	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Hepatomegaly	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Hyperbilirubinaemia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Ischaemic hepatitis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Jaundice	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Portal hypertension	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Immune system disorders	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Allergic oedema	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Allergy to chemicals	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Drug hypersensitivity	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Hypersensitivity	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Hepatobiliary disorders Seasonal allergy	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Abdominal abscess	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Abscess limb	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Acarodermatitis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Acute sinusitis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Bacteraemia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Bacterial disease carrier	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Bacteriuria	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Balanitis candida	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Breast abscess	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Bronchitis	1.9% 14/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.8% 14/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Candidiasis	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Candiduria	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Catheter site infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Cellulitis	2.0% 15/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.1% 16/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Clostridial infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Clostridium difficile colitis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Cystitis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Cystitis klebsiella	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Device related infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Escherichia bacteraemia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Escherichia urinary tract infection	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Fungal infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Fungal skin infection	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Gastroenteritis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Haemophilus infection	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Helicobacter infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Hepatitis b	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Herpes zoster	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Incision site cellulitis	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Incision site infection	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Influenza	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Infusion site infection	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Kidney infection	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Liver abscess	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Lobar pneumonia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Localised infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Lower respiratory tract infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Lung infection	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Lung infection pseudomonal	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Mastoiditis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Nail infection	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Nasopharyngitis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Oral candidiasis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Oral fungal infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Oral herpes	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pharyngitis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pharyngitis streptococcal	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pneumonia	3.2% 24/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.1% 16/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pneumonia bacterial	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pneumonia staphylococcal	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pneumonia streptococcal	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Post procedural cellulitis	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Postoperative wound infection	1.6% 12/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.9% 22/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Pseudomonas bronchitis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Purulent discharge	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Respiratory tract infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Rhinitis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Sepsis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Sinusitis	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Skin candida	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Skin infection	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Sputum purulent	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Staphylococcal bacteraemia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Staphylococcal mediastinitis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Stitch abscess	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Subcutaneous abscess	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Tinea cruris	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Tooth abscess	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Tracheobronchitis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Upper respiratory tract infection	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Urinary tract infection	4.4% 33/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	6.3% 48/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Urinary tract infection bacterial	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Urinary tract infection pseudomonal	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Vulvovaginal candidiasis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Vulvovaginal mycotic infection	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Wound infection	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Infections and infestations Wound infection pseudomonas	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Agitation postoperative	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Anaemia postoperative	5.8% 43/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	6.5% 49/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Arthropod bite	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Arthropod sting	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Brachial plexus injury	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Cartilage injury	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Collapse of lung	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Confusion postoperative	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Contusion	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Device breakage	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Device dislocation	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Device leakage	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Endotracheal intubation complication	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Excoriation	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Fall	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Incision site blister	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Incision site complication	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Incision site erythema	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Incision site haematoma	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Incision site haemorrhage	1.6% 12/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.0% 15/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Incision site oedema	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Incision site pain	54.5% 405/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	55.2% 419/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Incision site pruritus	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Medical device pain	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Mental status changes postoperative	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Muscle strain	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Open wound	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Operative haemorrhage	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural complication	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural discharge	7.4% 55/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	7.6% 58/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural haematoma	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural haemorrhage	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.5% 19/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Post procedural oedema	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Postoperative ileus	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Postoperative wound complication	1.5% 11/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.6% 20/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Postpericardiotomy syndrome	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Procedural complication	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Procedural hypertension	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Procedural hypotension	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Procedural nausea	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Procedural pain	24.5% 182/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	22.3% 169/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Rib fracture	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Seroma	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Skin laceration	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Surgical skin tear	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Suture rupture	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Synovial rupture	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Thermal burn	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Thrombosis in device	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Transfusion reaction	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Upper limb fracture	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Urethral injury	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Vascular graft occlusion	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Vasoplegia syndrome	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Wound	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Wound complication	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Injury, poisoning and procedural complications Wound dehiscence	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.4% 11/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Acid base balance abnormal	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Activated partial thromboplastin time prolonged	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Alanine aminotransferase decreased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Alanine aminotransferase increased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Ammonia increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Anticoagulation drug level below therapeutic	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Aspartate aminotransferase increased	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood sodium increased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood thyroid stimulating hormone increased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood urea increased	5.1% 38/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	4.6% 35/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood urea nitrogen/creatinine ratio increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Blood urine present	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Body temperature decreased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Body temperature increased	7.4% 55/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	7.0% 53/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Brain natriuretic peptide increased	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Breath sounds abnormal	7.5% 56/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	7.4% 56/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations C-reactive protein increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Calcium ionised decreased	2.8% 21/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.2% 24/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Carbon dioxide decreased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Carbon dioxide increased	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Cardiac enzymes increased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Cardiac index decreased	2.4% 18/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.4% 18/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Cardiac murmur	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Cardiac output decreased	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Cardioactive drug level decreased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Central venous pressure decreased	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Chest x-ray abnormal	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Clostridium difficile toxin test positive	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Computerised tomogram abdomen abnormal	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Ejection fraction decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Electrocardiogram abnormal	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Electrocardiogram st segment depression	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Electrocardiogram st segment elevation	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Fibrin d dimer increased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Fungus sputum test positive	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Glycosylated haemoglobin increased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Grip strength decreased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Haematocrit decreased	3.8% 28/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	5.0% 38/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Haemoglobin decreased	2.7% 20/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	3.4% 26/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Heart rate decreased	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Heart rate increased	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Heart rate irregular	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Heart sounds abnormal	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Peripheral arterial occlusive disease	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Hepatic enzyme increased	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations International normalised ratio decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations International normalised ratio increased	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Lipase increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Liver function test abnormal	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Lymphocyte count decreased	1.6% 12/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Mean arterial pressure decreased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Methicillin-resistant staphylococcal aureus test positive	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Monocyte count increased	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Myoglobin blood increased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Neutrophil count increased	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Occult blood	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Occult blood positive	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Oxygen saturation decreased	1.6% 12/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Platelet count decreased	1.7% 13/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.7% 13/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Platelet count increased	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Protein total decreased	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Prothrombin time prolonged	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Prothrombin time ratio increased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Pulmonary arterial pressure decreased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Pulmonary arterial pressure increased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Pulmonary arterial wedge pressure increased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Pulse absent	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Pulse pressure decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Red blood cell count decreased	1.5% 11/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Serum ferritin increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Sputum abnormal	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Staphylococcal identification test positive	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Streptococcal identification test positive	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Total lung capacity decreased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Transaminases increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Troponin i increased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Troponin increased	1.3% 10/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Urinary sediment present	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Urine analysis abnormal	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Urine colour abnormal	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Urine output decreased	6.9% 51/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	8.6% 65/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Vascular resistance systemic decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Vascular resistance systemic increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Venous oxygen saturation decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Venous pressure increased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Weight decreased	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations Weight increased	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations White blood cell count decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Investigations White blood cell count increased	15.1% 112/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	13.8% 105/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Acidosis	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Anorexia	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Decreased appetite	3.8% 28/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.9% 22/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Dehydration	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Diabetes mellitus	2.3% 17/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.8% 14/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Fluid overload	7.7% 57/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	7.8% 59/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Fluid retention	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Glucose tolerance impaired	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Gout	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hyperchloraemia	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hyperglycaemia	20.5% 152/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	18.7% 142/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hyperkalaemia	9.8% 73/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	7.8% 59/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Jugular vein thrombosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Labile blood pressure	2.8% 21/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.8% 14/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypermagnesaemia	1.3% 10/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.0% 15/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypernatraemia	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.2% 9/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hyperphosphataemia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Labile hypertension	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypervolaemia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypoalbuminaemia	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypocalcaemia	13.7% 102/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	12.9% 98/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypochloraemia	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypoglycaemia	7.8% 58/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	6.6% 50/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Lymphocele	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypokalaemia	15.1% 112/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	17.1% 130/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypomagnesaemia	2.4% 18/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.5% 19/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Peripheral coldness	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hyponatraemia	6.3% 47/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	6.2% 47/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypophosphataemia	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Peripheral embolism	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Hypovolaemia	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Peripheral ischaemia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Peripheral vascular disorder	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Iron deficiency	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Lactic acidosis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Phlebitis	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Malnutrition	1.3% 10/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Shock haemorrhagic	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Subclavian artery stenosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Subclavian vein thrombosis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Thrombophlebitis superficial	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Thrombosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Vasospasm	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Venous insufficiency	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Metabolic acidosis	1.5% 11/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Metabolic alkalosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Metabolic syndrome	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Metabolism and nutrition disorders Vitamin d deficiency	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Arthralgia	0.94% 7/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Arthritis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Musculoskeletal and connective tissue disorders Back pain	6.3% 47/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	4.6% 35/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Orthostatic hypotension	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Pallor	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Penile oedema	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Perineal pain	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Prostatomegaly	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Scrotal erythema	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Scrotal haematocoele	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Scrotal oedema	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Scrotal swelling	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Testicular pain	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Uterine haemorrhage	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Reproductive system and breast disorders Vaginal discharge	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Acquired diaphragmatic eventration	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Aspiration	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Atelectasis	36.3% 270/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	37.3% 283/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Bronchial oedema	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Bullous lung disease	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.1% 8/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Chylothorax	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Cough	8.5% 63/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	7.6% 58/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Cough decreased	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Dysphonia	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 65/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	7.9% 60/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.9% 14/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Epistaxis	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Haemothorax	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Hiccups	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Hypoxia	6.5% 48/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	5.5% 42/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Lung hyperinflation	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Lung infiltration	2.4% 18/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.8% 14/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Mediastinal disorder	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Mediastinal haematoma	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Mediastinal haemorrhage	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Oropharyngeal blistering	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.6% 12/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pharyngeal haematoma	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pleural effusion	37.8% 281/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	36.5% 277/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pleural rub	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.4% 55/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	6.1% 46/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Productive cough	7.5% 56/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	5.4% 41/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	8.7% 65/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	7.0% 53/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	9.0% 67/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	9.6% 73/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Pulmonary vascular disorder	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Rales	4.3% 32/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.5% 19/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	1.3% 10/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.1% 45/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	4.2% 32/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Rhonchi	1.9% 14/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.4% 18/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.40% 3/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Stridor	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Respiratory, thoracic and mediastinal disorders Wheezing	3.6% 27/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.0% 15/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Blister	0.81% 6/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Cold sweat	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Decubitus ulcer	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Dermatitis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Dermatitis contact	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Diabetic bullosis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Ecchymosis	1.3% 10/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.1% 16/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Erythema	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.6% 12/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Heat rash	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Hyperhidrosis	2.0% 15/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.3% 10/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Hypoaesthesia facial	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Livedo reticularis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Penile ulceration	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Periorbital oedema	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Pruritus	1.2% 9/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.92% 7/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Pruritus allergic	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Pruritus generalised	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Rash	1.7% 13/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	2.0% 15/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Rash erythematous	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Rash generalised	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.26% 2/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Rash maculo-papular	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Skin burning sensation	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Skin discolouration	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Skin disorder	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	1.1% 8/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Skin ulcer	0.54% 4/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.53% 4/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Skin and subcutaneous tissue disorders Urticaria	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Vascular disorders	34.1% 253/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	34.9% 265/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Aortic aneurysm	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Aortic arteriosclerosis	0.13% 1/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Blood pressure fluctuation	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.00% 0/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Deep vein thrombosis	0.27% 2/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.79% 6/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Femoral artery aneurysm	0.00% 0/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Flushing	0.40% 3/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.13% 1/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control
Vascular disorders Haematoma	0.67% 5/743 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control	0.66% 5/759 • 90 days from Randomization. 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control

Additional Information

Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management

Innocoll

Phone: 484-406-5211

Email: ctucker@innocoll.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place