Trial Outcomes & Findings for Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (NCT NCT00124020)

Last Updated: 2019-01-16

Results Overview

Clinical Response: Categorical (Cured, Failed or Indeterminate) * Failure - at least one of the following: * Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy * Termination of study med due to "lack of efficacy" * Death on or after Day 3 attributable to primary infection * Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress. * Indeterminate: Inability to determine outcome

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

771 participants

Primary outcome timeframe

7-14 days following end of antibiotic treatment

Results posted on

2019-01-16

Participant Flow

Enrollment Period: 23 January 2005 to 02 May 2007

14 patients (9 telavancin and 5 vancomycin) enrolled in the study but never started study treatment

Participant milestones

Participant milestones
Measure	Telavancin Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs	Vancomycin Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
Overall Study STARTED	377	380
Overall Study COMPLETED	289	289
Overall Study NOT COMPLETED	88	91

Reasons for withdrawal

Reasons for withdrawal
Measure	Telavancin Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs	Vancomycin Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
Overall Study Death	67	71
Overall Study Withdrawal by Subject	13	11
Overall Study Lost to Follow-up	5	8
Overall Study Other	1	1
Overall Study Transfer to another hospital	2	0

Baseline Characteristics

Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telavancin n=377 Participants Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs	Vancomycin n=380 Participants Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.	Total n=757 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	182 Participants n=5 Participants	184 Participants n=7 Participants	366 Participants n=5 Participants
Age, Categorical >=65 years	195 Participants n=5 Participants	196 Participants n=7 Participants	391 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION 17.8 • n=5 Participants	62 years STANDARD_DEVIATION 18.0 • n=7 Participants	62 years STANDARD_DEVIATION 17.9 • n=5 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	124 Participants n=7 Participants	249 Participants n=5 Participants
Sex: Female, Male Male	252 Participants n=5 Participants	256 Participants n=7 Participants	508 Participants n=5 Participants
Region of Enrollment Argentina	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants
Region of Enrollment Australia	9 participants n=5 Participants	14 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Brazil	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants
Region of Enrollment Bulgaria	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	10 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Chile	0 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment China	27 participants n=5 Participants	37 participants n=7 Participants	64 participants n=5 Participants
Region of Enrollment Croatia	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Czech Republic	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Estonia	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment France	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Georgia	17 participants n=5 Participants	13 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment Greece	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Israel	38 participants n=5 Participants	38 participants n=7 Participants	76 participants n=5 Participants
Region of Enrollment Korea, Republic of	23 participants n=5 Participants	30 participants n=7 Participants	53 participants n=5 Participants
Region of Enrollment Lebanon	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Lithuania	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Mexico	31 participants n=5 Participants	29 participants n=7 Participants	60 participants n=5 Participants
Region of Enrollment Philippines	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Poland	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Romania	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Russian Federation	21 participants n=5 Participants	29 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment Serbia	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Slovakia	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment South Africa	7 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Spain	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Thailand	22 participants n=5 Participants	11 participants n=7 Participants	33 participants n=5 Participants
Region of Enrollment Ukraine	12 participants n=5 Participants	6 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	46 participants n=7 Participants	106 participants n=5 Participants
Diabetes Status Diabetic	69 participants n=5 Participants	65 participants n=7 Participants	134 participants n=5 Participants
Diabetes Status Non-Diabetic	308 participants n=5 Participants	315 participants n=7 Participants	623 participants n=5 Participants
History of Pneumonia Prior history of pneumonia	37 participants n=5 Participants	45 participants n=7 Participants	82 participants n=5 Participants
History of Pneumonia No prior history of pneumonia	340 participants n=5 Participants	335 participants n=7 Participants	675 participants n=5 Participants
Ventilator Status Ventilated	175 participants n=5 Participants	175 participants n=7 Participants	350 participants n=5 Participants
Ventilator Status Non-ventilated	202 participants n=5 Participants	205 participants n=7 Participants	407 participants n=5 Participants

PRIMARY outcome

Timeframe: 7-14 days following end of antibiotic treatment

Outcome measures

Outcome measures
Measure	Telavancin n=377 Participants Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs	Vancomycin n=380 Participants Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
Clinical Response Cured	227 participants	228 participants
Clinical Response Failure	53 participants	52 participants
Clinical Response Indeterminate	39 participants	38 participants
Clinical Response Missing	58 participants	62 participants

Adverse Events

Telavancin

Serious events: 107 serious events

Other events: 295 other events

Deaths: 0 deaths

Vancomycin

Serious events: 109 serious events

Other events: 296 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs

Theravance, Inc

Phone: 650-808-6132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Telavancin n=379 participants at risk Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs	Vancomycin n=378 participants at risk Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
Blood and lymphatic system disorders Anemia	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.79% 3/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Acute Coronary Syndrome	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.53% 2/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Atrial fibrillation	0.53% 2/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.53% 2/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Bradycardia	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.53% 2/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Cardiac Arrest	1.3% 5/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Cardiac failure	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.79% 3/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Cardiac failure acute	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Cardiac failure congestive	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.9% 7/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Cardiogenic Shock	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.53% 2/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Cardiopulmonary Failure	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Cardiovascular disorder	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Ischaemic cardiomyopathy	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Myocardial Infarction	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Pericardial Effusion	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Ventricular fibrillation	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Cardiac disorders Wandering pacemaker	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Gastrointestinal disorders Gastric haemorrhage	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.53% 2/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.79% 3/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Gastrointestinal disorders Gastrointestinal Necrosis	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Gastrointestinal disorders Mesenteric Occlusion	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Gastrointestinal disorders Peritonitis	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.53% 2/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
General disorders Multi-organ Failure	3.4% 13/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.6% 6/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Hepatobiliary disorders Cholecystitis	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Hepatobiliary disorders Hepatic Failure	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Hepatobiliary disorders Hepatocellular damage	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Abdominal Abscess	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Abdominal Sepsis	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Bacteraemia	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Bacterial Sepsis	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Candida Sepsis	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Chronic sinusitis	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Escherichia sepsis	0.26% 1/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Lung Infection pseudomonal	0.53% 2/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.00% 0/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Meningitis	0.79% 3/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.53% 2/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Meningitis Candida	0.00% 0/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.26% 1/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.

Other adverse events
Measure	Telavancin n=379 participants at risk Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs	Vancomycin n=378 participants at risk Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
Gastrointestinal disorders Nausea	3.4% 13/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	3.2% 12/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.79% 3/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.9% 7/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Gastrointestinal disorders Vomiting	4.0% 15/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	3.2% 12/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
General disorders Anasarca	1.8% 7/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	2.1% 8/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
General disorders Multi-organ Failure	3.4% 13/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.6% 6/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
General disorders Oedema Peripheral	3.7% 14/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	3.2% 12/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
General disorders Pain	0.79% 3/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.6% 6/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Bacteraemia	1.6% 6/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.53% 2/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Oral Candidiasis	1.3% 5/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.6% 6/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Pneumonia	2.1% 8/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.9% 7/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Sepsis	4.5% 17/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.9% 7/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Septic Shock	4.5% 17/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	4.2% 16/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Infections and infestations Urinary Tract Infection	3.7% 14/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	2.4% 9/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Injury, poisoning and procedural complications Post-Procedural Haemorrhage	1.1% 4/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.6% 6/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Injury, poisoning and procedural complications Post-Procedural Pain	1.1% 4/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.6% 6/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Investigations Alanine Aminotransferase increased	2.6% 10/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	4.5% 17/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Investigations Aspartate Aminotransferase increased	2.6% 10/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	3.4% 13/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Investigations Blood Creatinine Increased	1.8% 7/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.6% 6/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Hyperglycemia	4.2% 16/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	4.5% 17/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Hyperkalaemia	3.4% 13/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	2.6% 10/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Hypernatremia	1.6% 6/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.1% 4/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Hypoalbuminaemia	2.9% 11/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.79% 3/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Hypocalcemia	1.8% 7/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.1% 4/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Hypoglycaemia	3.7% 14/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	2.4% 9/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Hypokalemia	8.2% 31/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	10.3% 39/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Hypomagnesaemia	2.6% 10/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.9% 7/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Hyponatremia	2.1% 8/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	2.9% 11/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Malnutrition	1.6% 6/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.79% 3/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Metabolism and nutrition disorders Metabolic acidosis	1.8% 7/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.1% 4/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Nervous system disorders Convulsion	1.3% 5/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	2.4% 9/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Nervous system disorders Headache	3.4% 13/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	2.6% 10/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Psychiatric disorders Agitation	2.1% 8/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	2.9% 11/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Psychiatric disorders Anxiety	3.2% 12/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	3.2% 12/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Psychiatric disorders Confusional State	0.79% 3/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.9% 7/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Psychiatric disorders Depression	2.4% 9/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.79% 3/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Psychiatric disorders Insomnia	4.7% 18/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	4.0% 15/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Renal and urinary disorders Renal Failure Acute	4.2% 16/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	4.8% 18/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Renal and urinary disorders Renal Impairment	1.6% 6/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.1% 4/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Renal and urinary disorders Renal Insufficiency	1.8% 7/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	0.79% 3/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	1.8% 7/379 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.	1.9% 7/378 Two patients were randomized to vancomycin, yet were treated with telavancin. For analyses of efficacy, results were analyzed according to the treatment group assigned by randomization. For safety analyses, results were analyzed according to treatment received; 379 patients received telavancin and 378 patients received vancomycin.