Trial Outcomes & Findings for Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (NCT NCT00107978)

Last Updated: 2019-01-16

Results Overview

The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs \& symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1035 participants

Primary outcome timeframe

7 to 14 days after the last antibiotic dose

Results posted on

2019-01-16

Participant Flow

Enrollment Period: 18 February 2005 to 31 May 2006

Participant milestones

Participant milestones
Measure	Telavancin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.	Vancomycin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
Overall Study STARTED	458	481
Overall Study COMPLETED	425	431
Overall Study NOT COMPLETED	33	50

Reasons for withdrawal

Reasons for withdrawal
Measure	Telavancin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.	Vancomycin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
Overall Study Adverse Event	1	5
Overall Study Death	3	3
Overall Study Lost to Follow-up	20	28
Overall Study Withdrawal by Subject	4	9
Overall Study Protocol Violation	0	1
Overall Study Other	5	4

Baseline Characteristics

Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telavancin n=458 Participants Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.	Vancomycin n=481 Participants Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.	Total n=939 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	287 participants n=5 Participants	310 participants n=7 Participants	597 participants n=5 Participants
Region of Enrollment South Africa	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Argentina	35 participants n=5 Participants	33 participants n=7 Participants	68 participants n=5 Participants
Region of Enrollment Canada	35 participants n=5 Participants	29 participants n=7 Participants	64 participants n=5 Participants
Region of Enrollment Chile	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment France	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Germany	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Italy	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Korea, Republic of	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment Lithuania	12 participants n=5 Participants	6 participants n=7 Participants	18 participants n=5 Participants
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	377 Participants n=5 Participants	379 Participants n=7 Participants	756 Participants n=5 Participants
Age, Categorical >=65 years	81 Participants n=5 Participants	102 Participants n=7 Participants	183 Participants n=5 Participants
Age, Continuous	49.2 years STANDARD_DEVIATION 16.1 • n=5 Participants	49.9 years STANDARD_DEVIATION 17.0 • n=7 Participants	49.5 years STANDARD_DEVIATION 16.6 • n=5 Participants
Sex: Female, Male Female	200 Participants n=5 Participants	187 Participants n=7 Participants	387 Participants n=5 Participants
Sex: Female, Male Male	258 Participants n=5 Participants	294 Participants n=7 Participants	552 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	79 Participants n=5 Participants	84 Participants n=7 Participants	163 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	379 Participants n=5 Participants	397 Participants n=7 Participants	776 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Asian	38 Participants n=5 Participants	44 Participants n=7 Participants	82 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Black or African American	69 Participants n=5 Participants	74 Participants n=7 Participants	143 Participants n=5 Participants
Race (NIH/OMB) White	336 Participants n=5 Participants	343 Participants n=7 Participants	679 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Peru	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Poland	38 participants n=5 Participants	43 participants n=7 Participants	81 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Taiwan	20 participants n=5 Participants	25 participants n=7 Participants	45 participants n=5 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Diabetes Status Diabetic	113 Participants n=5 Participants	118 Participants n=7 Participants	231 Participants n=5 Participants
Diabetes Status Not diabetic	345 Participants n=5 Participants	363 Participants n=7 Participants	708 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 to 14 days after the last antibiotic dose

Population: Data for the all-treated population (AT) are presented. The AT and clinically evaluable (CE) populations were considered co-primary.

Outcome measures

Outcome measures
Measure	Telavancin n=458 Participants Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.	Vancomycin n=481 Participants Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
Clinical Response Cure	358 patients	364 patients
Clinical Response Not cured	59 patients	57 patients
Clinical Response Indeterminate	17 patients	20 patients
Clinical Response Missing	24 patients	40 patients

Adverse Events

Telavancin

Serious events: 38 serious events

Other events: 377 other events

Deaths: 0 deaths

Vancomycin

Serious events: 15 serious events

Other events: 341 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=503 participants at risk Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.	Vancomycin n=509 participants at risk Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
Renal and urinary disorders Renal Failure Acute	0.60% 3/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Cardiac disorders Myocardial Infarction	0.40% 2/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.20% 1/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Blood and lymphatic system disorders Anemia	0.60% 3/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Investigations Blood creatinine increased	0.60% 3/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Immune system disorders Drug Hypersensitivity	0.40% 2/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.20% 1/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Vascular disorders Hypotension	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Psychiatric disorders Mental Status Changes	0.40% 2/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Renal and urinary disorders Renal Insufficiency	0.40% 2/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.40% 2/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Investigations Blood Urea increased	0.40% 2/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Metabolism and nutrition disorders Dehydration	0.40% 2/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Infections and infestations Osteomyelitis	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Vascular disorders Peripheral Occlusive Disease	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Infections and infestations Pneumonia	0.40% 2/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.20% 1/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Skin and subcutaneous tissue disorders Rash	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Infections and infestations Abscess Soft Tissue	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Respiratory, thoracic and mediastinal disorders Alveolitis Allergic	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Immune system disorders Anaphylactic Reaction	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Cardiac disorders Atrial fibrillation	0.00% 0/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.20% 1/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Nervous system disorders Brain Stem Infarction	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Cardiac disorders Cardiac Arrest	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.20% 1/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Cardiac disorders Cardio-Respiratory Arrest	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Hepatobiliary disorders Cholecystitis	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Gastrointestinal disorders Diarrhoea	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Skin and subcutaneous tissue disorders Erythema Multiforme	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Vascular disorders Gangrene	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Hepatobiliary disorders Hepatic Cirrhosis	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Immune system disorders Hypersensitivity	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Metabolism and nutrition disorders Hypoglycaemia	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Musculoskeletal and connective tissue disorders Intervertebral Discitis	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
General disorders Malaise	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Renal and urinary disorders Nephrolithiasis	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Injury, poisoning and procedural complications Non-Accidental Overdose	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Vascular disorders Orthostatic Hypotension	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Infections and infestations Sepsis	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.20% 1/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Infections and infestations Urinary Tract Infection	0.20% 1/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.20% 1/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Investigations Alanine Aminotransferase increased	0.00% 0/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.20% 1/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Gastrointestinal disorders Ascites	0.00% 0/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.20% 1/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.

Other adverse events
Measure	Telavancin n=503 participants at risk Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.	Vancomycin n=509 participants at risk Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
Blood and lymphatic system disorders Anemia	2.2% 11/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	2.0% 10/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Gastrointestinal disorders Abdominal Pain	1.2% 6/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.8% 9/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Gastrointestinal disorders Constipation	7.0% 35/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	4.7% 24/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Gastrointestinal disorders Diarrhoea	7.2% 36/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	6.9% 35/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Gastrointestinal disorders Dry Mouth	1.8% 9/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.4% 7/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Gastrointestinal disorders Dyspepsia	1.4% 7/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.4% 7/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Gastrointestinal disorders Loose stools	1.2% 6/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.2% 6/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Gastrointestinal disorders Nausea	24.1% 121/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	9.2% 47/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Gastrointestinal disorders Vomiting	9.7% 49/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	3.7% 19/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
General disorders Asthenia	0.99% 5/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.4% 7/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
General disorders Fatigue	4.4% 22/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	2.0% 10/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
General disorders Infusion site erythema	3.4% 17/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	2.9% 15/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
General disorders Infusion site pain	4.0% 20/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	3.7% 19/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
General disorders Infusion site phlebitis	2.4% 12/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	2.8% 14/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
General disorders Infusion site pruritis	0.80% 4/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.8% 9/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
General disorders Infusion site reaction	1.4% 7/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.4% 7/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
General disorders Pyrexia	1.2% 6/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.39% 2/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
General disorders Rigors	3.8% 19/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.4% 7/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Immune system disorders Drug Hypersensitivity	0.99% 5/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.2% 6/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Infections and infestations Urinary Tract Infection	2.6% 13/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.59% 3/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Infections and infestations Vaginal mycosis	0.80% 4/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.2% 6/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Investigations Alanine Aminotransferase increased	1.2% 6/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	2.6% 13/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Investigations Aspartate Aminotransferase increased	1.2% 6/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	2.0% 10/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Investigations Blood Creatinine Increased	1.8% 9/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.59% 3/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Metabolism and nutrition disorders Anorexia	1.4% 7/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.20% 1/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Metabolism and nutrition disorders Decreased appetite	2.4% 12/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.39% 2/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Metabolism and nutrition disorders Hypoglycaemia	1.4% 7/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.59% 3/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Metabolism and nutrition disorders Hypokalaemia	1.8% 9/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	2.4% 12/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 7/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.98% 5/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Musculoskeletal and connective tissue disorders Back pain	1.2% 6/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.8% 9/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Nervous system disorders Dizziness	5.6% 28/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	3.5% 18/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Nervous system disorders Dysgeusia	30.8% 155/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	6.1% 31/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Nervous system disorders Headache	9.5% 48/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	10.0% 51/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Nervous system disorders Hypoaesthesia	0.60% 3/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.2% 6/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Nervous system disorders Paraesthesia	0.60% 3/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.4% 7/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Nervous system disorders Somnolence	1.6% 8/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.59% 3/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Psychiatric disorders Anxiety	1.6% 8/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	1.6% 8/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Psychiatric disorders Insomnia	3.8% 19/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	6.5% 33/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Renal and urinary disorders Renal Failure Acute	1.2% 6/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	0.00% 0/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
Renal and urinary disorders Urine Abnormality	10.5% 53/503 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.	3.7% 19/509 Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.