Study of Daptomycin Safety and Efficacy for Complicated S... | NCT01104662

ID	Type	Description	Link
DAP-RENSE-08-05	Other Identifier	Cubist Study Number

Label	Type	Description	Intervention Names
Daptomycin, Bacteremia, Severe Renal Impairment	Experimental	Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.	Drug: Daptomycin
Vancomycin or SSP, Bacteremia, Severe Renal Impairment	Active Comparator	Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously (IV) until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.	Drug: Vancomycin Drug: Semi-Synthetic Penicillin
Daptomycin, Bacteremia, Moderate Renal Impairment	Experimental	Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.

Name	Type	Description	Arm Group Labels	Other Names
Vancomycin	Drug		Vancomycin or SSP , Bacteremia, Moderate Renal Impairment Vancomycin or SSP , cSSSI, Moderate Renal Impairment Vancomycin or SSP , cSSSI, Severe Renal Impairment Vancomycin or SSP, Bacteremia, Severe Renal Impairment

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)	The number of participants with CPK elevations of >500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented.	Baseline through EOT/ET

Measure	Description	Time Frame
Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit	Participants were assigned a Sponsor-assessed clinical outcome based on the following definitions at the TOC/Safety visit: Failure: Assessed as a failure at any time by the Investigator or received non-study antimicrobial therapy for lack of efficacy or had the primary site of infection removed completely by surgery or underwent surgery to treat the infection >4 days after starting study medication. Success: Were not assessed as a failure at any time and were assessed as a cure or improvement by the Investigator at the TOC visit. Non-evaluable: Received potentially effective antimicrobial therapy during the study period for reasons other than lack of efficacy or received <4 days of study medication or were not assessed by the Investigator.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Male or female ≥18 years of age
Diagnosis of cSSSI or Staphylococcus aureus (S. aureus) bacteremia
Renal impairment of CLcr of 30 - 50 mL/min or CLcr <30 mL/min per Cockcroft-Gault equation using actual body weight
Functioning hemodialysis access and on stable regimen for those receiving dialysis
In appropriate health for the study with no acute or chronic illnesses that could adversely impact safety or ability to complete the study

Specific inclusion criteria for cSSSI:

Presence of a wound infection, major abscess, severe carbunculosis, infected ulcers, dialysis access site infection, or other type of infection in presence of complicating factor
At least 3 of the following symptoms, signs, or laboratory values of a skin infection: elevated temperature; elevated white blood cell (WBC) count; pain; tenderness; swelling; erythema greater than 1 centimeter (cm) beyond wound edge; induration; pus formation
Evidence of a Gram-positive infecting pathogen as indicated by positive Gram stain or culture obtained within 96 hours prior to study drug administration
Infection of sufficient severity to require parenteral antimicrobial therapy

Specific inclusion criteria for S. aureus bacteremia:

• Documented S. aureus bacteremia defined as at least one positive blood culture for S. aureus obtained within 96 hours prior to the first dose of study medication

Exclusion Criteria:

Pregnant or lactating females, or unwilling to practice barrier methods of birth control
Received an investigational drug (including experimental biologic agents) within 30 days of study entry
Unable to discontinue use of HMG-CoA reductase inhibitor therapy while on study
Known allergy or intolerance to daptomycin, penicillin, or vancomycin
Active intravenous (IV) drug abuse
Confirmed or suspected osteomyelitis, septic arthritis, meningitis, epidural abscess, intra-abdominal infection, pneumonia, or infective endocarditis
Required use of non-study systemic antibacterial agent with activity against target pathogen
History of muscular disease
Neurological disease except stroke >6 months prior to study entry
Intramuscular injection within 7 days of study drug administration
Moribund clinical condition (high likelihood of death during next 3 days)
Shock or hypotension (supine systolic blood pressure <80 millimeters of mercury [mmHg])
Body mass index (BMI) <18 or >40 kilograms per meter squared (kg/m^2) [BMI = weight (kg)/height (m^2)]
Known human immunodeficiency virus (HIV) infection with CD4 count ≤200 cells/millimeter (mm)^3
Neutropenic participants with an absolute neutrophil count ≤500 cells/mm^3
Anticipated to develop neutropenia absolute neutrophil count ≤500 due to prior or planned chemotherapy
Alanine aminotransferase (ALT) value >3 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) value >3 × ULN
Total bilirubin values ≥ 1.5 x ULN associated with ALT values >3 x ULN
Creatine phosphokinase (CPK) value >2 × ULN
Hemoglobin <8 grams per deciliter (gm/dL)
Unlikely to comply with study procedures or to return for evaluations
History of rhabdomyolysis
Prior enrollment into this study
Infections caused by Gram-positive pathogens known to be resistant to daptomycin or selected comparator agent

Specific exclusion criteria for cSSSI:

Minor or superficial skin infections as the primary site of infection
Cellulitis or erysipelas not associated with complicating factor as primary site of infection
Perirectal abscess, hidradenitis suppurativa, concomitant gangrene, myositis, multiple infected ulcers at distant sites, necrotizing fasciitis, or infected third-degree burn wounds
Infections requiring emergency surgery
Infections suspected or documented to be due exclusively to gram-negative, anaerobic, or fungal organism
Confirmed or suspected disorder that could interfere with the evaluations (for example, primary skin disorders)
Use of a topical antibiotic at the site of the infection
Use of systemic antibacterial therapy for the infection for >24 hours within 48 hours prior to start of study drug unless (a) infecting Gram-positive pathogen resistant to therapy or (b) therapy administered for 3 or more days with worsening or no improvement
Planned surgical treatment that is considered curative of the infection

Specific exclusion criteria for S. aureus bacteremia:

Has intravascular foreign material at the time the positive blood culture was drawn (for example., intracardiac pacemaker wires, percutaneous or implanted venous catheters, vascular grafts) unless material removed within 4 days after first dose of study medication or approval of medical monitor (exceptions: vascular stents in place for >6 months, permanent pacemaker attached via epicardial leads, or any dialysis access device unless this material is felt to be infected)
Prosthetic heart valve
Cardiac decompensation or valve damage or both with high likelihood of valve surgery in the 3 days after randomization
Polymicrobial blood infection

Name	Affiliation	Role
Ellie Hershberger, Pharm.D.	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Study Director

ID	Title	Description
FG000	Daptomycin, Bacteremia, Severe Renal Impairment	Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.

Arm/Group Information

ID	Title	Description
BG000	Daptomycin, Bacteremia, Severe Renal Impairment	Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
BG001	Vancomycin or SSP, Bacteremia, Severe Renal Impairment	Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
BG002	Daptomycin, Bacteremia, Moderate Renal Impairment	Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
BG003	Vancomycin or SSP, Bacteremia, Moderate Renal Impairment	Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
BG004	Daptomycin, cSSSI, Severe Renal Impairment	Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
BG005	Vancomycin or SSP, cSSSI, Severe Renal Impairment	Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
BG006	Daptomycin, cSSSI, Moderate Renal Impairment	Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
BG007	Vancomycin or SSP, cSSSI, Moderate Renal Impairment	Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
BG008	Total	Total of all reporting groups

Units	Counts
Participants	BG00017 BG00117 BG0024 BG0034 BG00415 BG00515 BG0065 BG0076 BG00883

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)

The number of participants with CPK elevations of >500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented.

Participants who received at least 1 dose of study drug and had a baseline CPK value and at least 1 post-baseline CPK assessment between Day 1 post-dosing and EOT visit.

Posted

Number

participants

Baseline through EOT/ET

ID	Title	Description
OG000	Daptomycin, Bacteremia, Severe Renal Impairment	Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
OG001	Vancomycin or SSP, Bacteremia, Severe Renal Impairment	Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
OG002	Daptomycin, Bacteremia, Moderate Renal Impairment	Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
OG003	Vancomycin or SSP, Bacteremia, Moderate Renal Impairment	Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
OG004	Daptomycin, cSSSI, Severe Renal Impairment	Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
OG005	Vancomycin or SSP, cSSSI, Severe Renal Impairment	Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
OG006	Daptomycin, cSSSI, Moderate Renal Impairment	Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
OG007	Vancomycin or SSP, cSSSI, Moderate Renal Impairment	Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.

Units	Counts
Participants	OG00016 OG00114 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Secondary

Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit

Participants were assigned a Sponsor-assessed clinical outcome based on the following definitions at the TOC/Safety visit:

Failure: Assessed as a failure at any time by the Investigator or received non-study antimicrobial therapy for lack of efficacy or had the primary site of infection removed completely by surgery or underwent surgery to treat the infection >4 days after starting study medication.

Success: Were not assessed as a failure at any time and were assessed as a cure or improvement by the Investigator at the TOC visit.

Non-evaluable: Received potentially effective antimicrobial therapy during the study period for reasons other than lack of efficacy or received <4 days of study medication or were not assessed by the Investigator.

Participants who received at least 1 dose of study drug and had at least 1 Gram-positive baseline infecting pathogen for cSSSI participants or S. aureus bacteremia for bacteremia participants.

Posted

Number

participants

Baseline through TOC/Safety Visit

ID	Title	Description
OG000	Daptomycin, Bacteremia, Severe Renal Impairment	Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Daptomycin, Bacteremia, Severe Renal Impairment	Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.)	2	17	9	17
EG001	Vancomycin or SSP, Bacteremia, Severe Renal Impairment	Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.	6	17	15	17
EG002	Daptomycin, Bacteremia, Moderate Renal Impairment	Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.	2	4	4	4
EG003	Vancomycin or SSP, Bacteremia, Moderate Renal Impairment	Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.	1	4	4	4
EG004	Daptomycin, cSSSI, Severe Renal Impairment	Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.	1	15	4	15
EG005	Vancomycin or SSP, cSSSI, Severe Renal Impairment	Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.	5	15	5	15
EG006	Daptomycin, cSSSI, Moderate Renal Impairment	Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.	0	5	2	5
EG007	Vancomycin or SSP, cSSSI, Moderate Renal Impairment	Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.	2	6	4	6

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG0030 events0 affected4 at risk EG0040 events0 affected15 at risk EG0051 events1 affected15 at risk EG0060 events0 affected5 at risk EG0070 events0 affected6 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 12.1	Systematic Assessment	Resulted in one participant death.	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 12.1	Systematic Assessment		EG0002 events2 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	Resulted in one participant death.	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Cellulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Endocarditis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0002 events1 affected17 at risk EG0012 events2 affected17 at risk EG0020 events0 affected4 at risk EG003
Graft infection	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Klebsiella bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Septic shock	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Graft complication	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
White blood cell count increased	Investigations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Thrombolysis	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Haematoma	Vascular disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG0030 events0 affected4 at risk EG0040 events0 affected15 at risk EG0050 events0 affected15 at risk EG0060 events0 affected5 at risk EG0070 events0 affected6 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0021 events1 affected4 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Eye inflammation	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Eye pain	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Vision blurred	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected17 at risk EG0021 events1 affected4 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0013 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0021 events1 affected4 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0015 events4 affected17 at risk EG0021 events1 affected4 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0015 events4 affected17 at risk EG0021 events1 affected4 at risk EG003
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0015 events3 affected17 at risk EG0021 events1 affected4 at risk EG003
Catheter site oedema	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Chest discomfort	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Chills	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0022 events1 affected4 at risk EG003
Device leakage	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0022 events2 affected4 at risk EG003
Infusion site haemorrhage	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Infusion site pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Malaise	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0021 events1 affected4 at risk EG003
Medical device complication	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Oedema	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0016 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected17 at risk EG0013 events3 affected17 at risk EG0020 events0 affected4 at risk EG003
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Tenderness	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Thrombosis in device	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Cellulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Chest wall abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Endocarditis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Fungal infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Localised infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0022 events2 affected4 at risk EG003
Osteomyelitis acute	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Septic shock	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Blood glucose decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Blood glucose increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Cardiac murmur	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Heart sounds abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
International normalised ratio increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Urine output decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
White blood cell count increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 events2 affected17 at risk EG0014 events3 affected17 at risk EG0020 events0 affected4 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0013 events3 affected17 at risk EG0020 events0 affected4 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected17 at risk EG0021 events1 affected4 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0014 events2 affected17 at risk EG0022 events1 affected4 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Agitation	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Depression	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected17 at risk EG0020 events0 affected4 at risk EG003
Renal pain	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected17 at risk EG0021 events1 affected4 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0012 events2 affected17 at risk EG0020 events0 affected4 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0021 events1 affected4 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0020 events0 affected4 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected17 at risk EG0020 events0 affected4 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0022 events1 affected4 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0013 events3 affected17 at risk EG0020 events0 affected4 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Skin chapped	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected17 at risk EG0021 events1 affected4 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected17 at risk EG0020 events0 affected4 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Azusa	California		United States

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D014640	Vancomycin
D017576	Daptomycin
D009254	Nafcillin
D010068	Oxacillin
D003023	Cloxacillin

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D055666	Lipopeptides
D008055	Lipids
D010406	Penicillins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds