Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)

• Sponsor: Cubist Pharmaceuticals LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01728376
• Collaborator: (none)
• Enrollment: 82
• Arms: 6
• Actual Duration (Months): 37.7

Study Details

Study Description

Brief Summary

The intent of this study is to describe the safety and efficacy of daptomycin versus standard of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by Staphylococcus aureus (S. aureus).

Condition or Disease	Intervention/Treatment	Phase
Bacteremia	Drug: Daptomycin; Drug: Comparator	Phase 4

Detailed Description

1. aureus causes a series of invasive diseases in adults and children, including bacteremia. Infections due to S. aureus in children, particularly those due to methicillin resistant S. aureus (MRSA), are a growing world-wide public health concern.

Daptomycin, a cyclic lipopeptide antibacterial agent, shows rapid in vitro bactericidal activity with concentration-dependent killing for Gram-positive organisms, including S. aureus. Surveillance studies have demonstrated a daptomycin MIC90 of 0.5µg/ml for both methicillin-susceptible S. aureus (MSSA) and MRSA with >99% of MRSA isolates being categorized as susceptible by the Food and Drug Administration (FDA), European Committee of antimicrobial susceptibility testing (EUCAST) and Clinical and Laboratory Standards Institute (CLSI) breakpoints (5). Clinical trials in adults demonstrated that daptomycin was safe and efficacious in complicated skin and skin structure infections (cSSSI) and bloodstream infections caused by S. aureus, including right-sided infective endocarditis (RIE). However, information on the safety and efficacy of daptomycin for use in children is lacking.

The intent of this study in children is to confirm the safety of daptomycin at mean steady state systemic exposures (AUC) similar to those reported for adults treated at 6 mg/kg for bacteremia.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparative Evaluation of the Safety and Efficacy of Daptomycin Versus Standard of Care in Pediatric Subjects One - Seventeen Years of Age With Bacteremia Caused by Staphylococcus Aureus.
• Actual Study Start Date: Nov 29, 2012
• Actual Primary Completion Date: Jan 20, 2016
• Actual Study Completion Date: Jan 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Daptomycin - 12 to 17 year olds Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously (IV), over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Drug: Daptomycin; Intravenous daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 1-6 years) infused once daily, intravenously, over 30 or 60 minutes. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.; Other Names: Cubicin
Active Comparator: Comparator - 12 to 17 year olds Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Drug: Comparator; Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin: administered per standard of care. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.
Experimental: Daptomycin - 7 to 11 year olds Participants ages 7 to 11 years old were administered daptomycin 9 mg/kg, infused once daily, IV over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Drug: Daptomycin; Intravenous daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 1-6 years) infused once daily, intravenously, over 30 or 60 minutes. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.; Other Names: Cubicin
Experimental: Daptomycin - 1 to 6 year olds Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, IV over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Drug: Daptomycin; Intravenous daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 1-6 years) infused once daily, intravenously, over 30 or 60 minutes. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.; Other Names: Cubicin
Active Comparator: Comparator - 7 to 11 year olds Participants ages 7-11 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Drug: Comparator; Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin: administered per standard of care. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.
Active Comparator: Comparator - 1 to 6 year olds Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Drug: Comparator; Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin: administered per standard of care. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With One or More Adverse Events (AEs) [Administration of first dose through the last follow-up visit (up to 77 days)]

   An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

2. Number of Participants With One or More Serious Adverse Events (SAEs) [Administration of first dose through the last follow-up visit (up to 77 days)]

   An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.

3. Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal [Baseline up to end of therapy visit (up to 49 days)]

   Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .

4. Percentage of Participants With Sustained CPK Elevations [Baseline up to end of therapy visit (up to 44 days)]

   Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)

5. Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) [TOC Safety Visit (up to 56 days)]

   Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers.

Secondary Outcome Measures

1. Percentage of Participants With Clinical Success at TOC/Safety Visit [7-14 days after the last dose of study medication (up to 56 days)]

   Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.

2. Percentage of Participants With Overall Success at TOC Visit [7-14 days after the last dose of study medication (up to 56 days)]

   Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.

3. Trough Plasma Concentration of Daptomycin [Days 3, 4, 5 or 6 of treatment at pre-dose]

   Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.

4. Maximum Plasma Concentration (Cmax) of Daptomycin [Days 3, 4, 5 or 6 of treatment at end of infusion]

   Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

To be included in this study, participants must:

• Sign a parental consent form; if appropriate, sign an assent form

• Be between 1 and 17 years of age

• Have proven or probable bacteremia caused by S. aureus based on the traditional culture result, rapid diagnostic test or Gram stain

• If female of childbearing potential, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study

• If male, must take appropriate measures to not get partner pregnant

• Able to comply with the protocol requirements

Exclusion Criteria:

Participants will not be allowed into the study if they:

• Have received a certain amount of antibacterial therapy specific for current bacteremia unless it is demonstrated that the organism is resistant to the given antibacterial;

• Anticipate to require other antibiotics that may be potentially effective against S. aureus;

• Have shock or hypotension unresponsive to standard therapy;

• Have received an investigational product or have participated in an experimental procedure within 30 days;

• Have an intolerance or hypersensitivity to daptomycin;

• Have renal insufficiency;

• Have prior history or current evidence of muscle damage (rhabdomyolysis; significant CPK elevation);

• Have history of clinically significant muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;

• Have S. aureus pneumonia, empyema, meningitis, or endocarditis

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cubist Pharmaceuticals LLC

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cubist Pharmaceuticals LLC
• ClinicalTrials.gov Identifier: NCT01728376
• Other Study ID Numbers: 3009-005; DAP-PEDBAC-11-02
• First Posted: Nov 19, 2012
• Last Update Posted: Aug 28, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Bacteremia; Daptomycin

Study Results

Participant Flow

Recruitment Details	Participants aged 1-17 with bacteremia caused by Staphylococcus aureus (S. aureus) were enrolled in this study.

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
Period Title: Overall Study
STARTED	22	11	19	9	14	7
Treated	22	10	19	9	14	7
COMPLETED	18	9	17	7	12	5
NOT COMPLETED	4	2	2	2	2	2

Baseline Characteristics

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds	Total
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Total of all reporting groups
Overall Participants	22	10	19	9	14	7	81
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	3.81 (1.232)	4.13 (1.752)	10.25 (1.217)	9.46 (1.345)	14.14 (1.677)	14.56 (1.868)	8.70 (4.468)
Sex: Female, Male (Count of Participants)
Female	10 45.5%	8 80%	7 36.8%	1 11.1%	0 0%	1 14.3%	27 33.3%
Male	12 54.5%	2 20%	12 63.2%	8 88.9%	14 100%	6 85.7%	54 66.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With One or More Adverse Events (AEs)
Description	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Time Frame	Administration of first dose through the last follow-up visit (up to 77 days)

Outcome Measure Data

Analysis Population Description

Participants who received any dose of IV study medication

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
Measure Participants	22	10	19	9	14	7
Number [Participants]	15 68.2%	6 60%	12 63.2%	9 100%	9 64.3%	5 71.4%

2. Primary Outcome

Title	Number of Participants With One or More Serious Adverse Events (SAEs)
Description	An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.
Time Frame	Administration of first dose through the last follow-up visit (up to 77 days)

Outcome Measure Data

Analysis Population Description

Participants who received any dose of IV study medication

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
Measure Participants	22	10	19	9	14	7
Number [Participants]	6 27.3%	2 20%	4 21.1%	3 33.3%	3 21.4%	2 28.6%

3. Primary Outcome

Title	Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal
Description	Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .
Time Frame	Baseline up to end of therapy visit (up to 49 days)

Outcome Measure Data

Analysis Population Description

Participants who received any dose of IV study medication

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
Measure Participants	22	10	19	9	14	7
Number [Percentage of Participants]	40.9 185.9%	40.0 400%	10.5 55.3%	0.0 0%	28.6 204.3%	14.3 204.3%

4. Primary Outcome

Title	Percentage of Participants With Sustained CPK Elevations
Description	Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)
Time Frame	Baseline up to end of therapy visit (up to 44 days)

Outcome Measure Data

Analysis Population Description

Participants who received any dose of IV study medication

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
Measure Participants	22	10	19	9	14	7
Number [Percentage of Participants]	18.2 82.7%	20.0 200%	0.0 0%	0.0 0%	28.6 204.3%	14.3 204.3%

5. Primary Outcome

Title	Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)
Description	Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers.
Time Frame	TOC Safety Visit (up to 56 days)

Outcome Measure Data

Analysis Population Description

Participants who received any dose of IV study medication.

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
Measure Participants	22	10	19	9	14	7
Alertness	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pupillary Reflex and Tracking	0 0%	0 0%	1 5.3%	0 0%	0 0%	0 0%
Peripheral Reflex - Biceps	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Peripheral Reflex - Patellar Tendon	0 0%	0 0%	1 5.3%	0 0%	0 0%	0 0%
Peripheral Reflex - Ankle Jerk	0 0%	0 0%	1 5.3%	0 0%	0 0%	0 0%
Peripheral Reflex - Plantar Response	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Muscle Tone - Lower/Upper Limbs	0 0%	0 0%	0 0%	0 0%	2 14.3%	0 0%
Muscle Strength - Lower/Upper Limbs	0 0%	0 0%	0 0%	0 0%	2 14.3%	0 0%
Coordination - (Finger to Nose)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Tremor of the hands/fingers	0 0%	0 0%	1 5.3%	0 0%	0 0%	0 0%
Sensation	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Percentage of Participants With Clinical Success at TOC/Safety Visit
Description	Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.
Time Frame	7-14 days after the last dose of study medication (up to 56 days)

Outcome Measure Data

Analysis Population Description

All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
Measure Participants	20	8	17	9	14	5
Cured	80.0 363.6%	87.5 875%	94.1 495.3%	77.8 864.4%	78.6 561.4%	60.0 857.1%
Improved	5.0 22.7%	0 0%	0 0%	0 0%	7.1 50.7%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Daptomycin - 1 to 6 Year Olds, Comparator- 1 to 6 Year Olds
	Comments	Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference (%)
	Estimated Value	-2.5
	Confidence Interval	(2-Sided) 95%; -30.3 to 25.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Daptomycin minus Comparator 95% Confidence Interval (CI) by Wilson score method

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Daptomycin - 7 to 11 Year Olds, Comparator - 7 to 11 Year Olds
	Comments	Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference (%)
	Estimated Value	16.3
	Confidence Interval	(2-Sided) 95%; -13.0 to 45.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Daptomycin minus Comparator 95% CI by Wilson score method

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Daptomycin - 12 to 17 Year Olds, Comparator - 12 to 17 Year Olds
	Comments	Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference (%)
	Estimated Value	25.7
	Confidence Interval	(2-Sided) 95%; -21.0 to 72.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Daptomycin minus Comparator 95% CI by Wilson score method

7. Secondary Outcome

Title	Percentage of Participants With Overall Success at TOC Visit
Description	Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.
Time Frame	7-14 days after the last dose of study medication (up to 56 days)

Outcome Measure Data

Analysis Population Description

All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
Measure Participants	20	8	17	9	14	5
Number [Percentage of participants]	80.0 363.6%	75.0 750%	82.4 433.7%	44.4 493.3%	50.0 357.1%	60.0 857.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Daptomycin - 1 to 6 Year Olds, Comparator- 1 to 6 Year Olds
	Comments	Difference in success response between treatment arms
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference (%)
	Estimated Value	5.0
	Confidence Interval	(2-Sided) 95%; -29.8 to 39.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Daptomycin minus Comparator 95% CI by Wilson score method

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Daptomycin - 7 to 11 Year Olds, Comparator - 7 to 11 Year Olds
	Comments	Difference in success response between treatment arms
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference (%)
	Estimated Value	37.9
	Confidence Interval	(2-Sided) 95%; 0.7 to 75.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Daptomycin minus Comparator 95% CI by Wilson score method

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Daptomycin - 12 to 17 Year Olds, Comparator - 12 to 17 Year Olds
	Comments	Difference in success response between treatment arms
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference (%)
	Estimated Value	-10.0
	Confidence Interval	() 95%; -60.3 to 40.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Daptomycin minus Comparator 95% CI by Wilson score method

8. Secondary Outcome

Title	Trough Plasma Concentration of Daptomycin
Description	Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.
Time Frame	Days 3, 4, 5 or 6 of treatment at pre-dose

Outcome Measure Data

Analysis Population Description

Participants treated with daptomycin with at least one trough sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
Measure Participants	3	0	10	0	7	0
Mean (Standard Deviation) [µg/mL]	4.72 (1.643)	6.39 (3.035)	14.69 (19.109)

9. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of Daptomycin
Description	Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.
Time Frame	Days 3, 4, 5 or 6 of treatment at end of infusion

Outcome Measure Data

Analysis Population Description

Participants treated with daptomycin with at least one peak sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.

Arm/Group Title	Daptomycin - 1 to 6 Year Olds	Comparator- 1 to 6 Year Olds	Daptomycin - 7 to 11 Year Olds	Comparator - 7 to 11 Year Olds	Daptomycin - 12 to 17 Year Olds	Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.	Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).	Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
Measure Participants	15	0	18	0	8	0
Mean (Standard Deviation) [µg/mL]	96.69 (32.946)	87.66 (34.992)	74.70 (34.909)

Adverse Events

Time Frame	Administration of first dose through the last follow-up visit (up to 77 days).
Adverse Event Reporting Description	Participants who received any dose of IV study medication
Arm/Group Title	Daptomycin - 1 to 6 Year Olds		Comparator - 1 to 6 Year Olds		Daptomycin - 7 to 11 Year Olds		Comparator - 7 to 11 Year Olds		Daptomycin - 12 to 17 Year Olds		Comparator - 12 to 17 Year Olds
Arm/Group Description	Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).		Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.		Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).		Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.		Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).		Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
All Cause Mortality
	Daptomycin - 1 to 6 Year Olds		Comparator - 1 to 6 Year Olds		Daptomycin - 7 to 11 Year Olds		Comparator - 7 to 11 Year Olds		Daptomycin - 12 to 17 Year Olds		Comparator - 12 to 17 Year Olds
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Daptomycin - 1 to 6 Year Olds		Comparator - 1 to 6 Year Olds		Daptomycin - 7 to 11 Year Olds		Comparator - 7 to 11 Year Olds		Daptomycin - 12 to 17 Year Olds		Comparator - 12 to 17 Year Olds
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/22 (27.3%)		2/10 (20%)		4/19 (21.1%)		3/9 (33.3%)		3/14 (21.4%)		2/7 (28.6%)
Cardiac disorders
Cardiac failure congestive	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
General disorders
Device breakage	1/22 (4.5%)	1	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Immune system disorders
Intestine transplant rejection	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Infections and infestations
Arthritis bacterial	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1
Bacteraemia	2/22 (9.1%)	2	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	1/14 (7.1%)	1	0/7 (0%)	0
Bone abscess	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Muscle abscess	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	1/14 (7.1%)	1	0/7 (0%)	0
Osteomyelitis	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	1/9 (11.1%)	2	0/14 (0%)	0	0/7 (0%)	0
Pneumonia	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	1/14 (7.1%)	1	0/7 (0%)	0
Staphylococcal bacteraemia	1/22 (4.5%)	1	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Investigations
Hepatic enzyme increased	1/22 (4.5%)	1	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Metabolism and nutrition disorders
Malnutrition	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Musculoskeletal and connective tissue disorders
Bone fistula	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Synovitis	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	1/14 (7.1%)	1	0/7 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1
Pneumothorax	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Pulmonary oedema	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Respiratory failure	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Vascular disorders
Venous thrombosis limb	1/22 (4.5%)	1	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Other (Not Including Serious) Adverse Events
	Daptomycin - 1 to 6 Year Olds		Comparator - 1 to 6 Year Olds		Daptomycin - 7 to 11 Year Olds		Comparator - 7 to 11 Year Olds		Daptomycin - 12 to 17 Year Olds		Comparator - 12 to 17 Year Olds
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/22 (40.9%)		6/10 (60%)		11/19 (57.9%)		9/9 (100%)		8/14 (57.1%)		5/7 (71.4%)
Blood and lymphatic system disorders
Abdominal lymphadenopathy	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Anaemia	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Lymphadenopathy	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	2
Thrombocytosis	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Cardiac disorders
Ventricular extrasystoles	1/22 (4.5%)	1	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Eye disorders
Vision blurred	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Diarrhoea	4/22 (18.2%)	4	1/10 (10%)	1	1/19 (5.3%)	1	3/9 (33.3%)	3	1/14 (7.1%)	1	1/7 (14.3%)	1
Nausea	0/22 (0%)	0	1/10 (10%)	1	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Vomiting	2/22 (9.1%)	2	2/10 (20%)	4	2/19 (10.5%)	4	0/9 (0%)	0	2/14 (14.3%)	2	0/7 (0%)	0
General disorders
Catheter site discharge	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Catheter site oedema	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Catheter site pain	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Device breakage	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Infusion site pain	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Pyrexia	2/22 (9.1%)	3	1/10 (10%)	1	1/19 (5.3%)	1	2/9 (22.2%)	3	2/14 (14.3%)	2	0/7 (0%)	0
Immune system disorders
Drug hypersensitivity	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	1/7 (14.3%)	1
Infections and infestations
Abdominal abscess	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Abscess	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	1/14 (7.1%)	1	0/7 (0%)	0
Arthritis bacterial	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Candida infection	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Cellulitis	0/22 (0%)	0	1/10 (10%)	1	1/19 (5.3%)	1	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Infected skin ulcer	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Lung abscess	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Nasopharyngitis	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Osteomyelitis	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	2/7 (28.6%)	2
Osteomyelitis acute	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1
Postoperative wound infection	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Rash pustular	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1
Rhinovirus infection	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Systemic candida	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1
Varicella	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Viral infection	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Pneumonia	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Injury, poisoning and procedural complications
Arthropod bite	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	1/14 (7.1%)	1	0/7 (0%)	0
Contusion	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Excoriation	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Wound	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Wound dehiscence	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Investigations
Alanine aminotransferase increased	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1
Blood creatine phosphokinase increased	1/22 (4.5%)	1	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	2/14 (14.3%)	2	0/7 (0%)	0
Blood potassium decreased	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Blood sodium decreased	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Hepatic enzyme increased	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Transaminases increased	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Body temperature increased	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Metabolism and nutrition disorders
Fluid overload	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1
Hypernatraemia	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Hyperphosphataemia	1/22 (4.5%)	1	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	2	0/14 (0%)	0	0/7 (0%)	0
Haemarthrosis	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Muscle spasms	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	1/14 (7.1%)	1	0/7 (0%)	0
Myositis	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Neck pain	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Pain in extremity	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	1/14 (7.1%)	1	1/7 (14.3%)	1
Nervous system disorders
Headache	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1
Lethargy	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Psychiatric disorders
Abnormal behaviour	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Renal and urinary disorders
Dysuria	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Pollakiuria	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Renal failure acute	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Renal necrosis	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1
Reproductive system and breast disorders
Epididymal cyst	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1
Respiratory, thoracic and mediastinal disorders
Atelectasis	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Cough	1/22 (4.5%)	1	0/10 (0%)	0	1/19 (5.3%)	1	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Hypoxia	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Pharyngeal ulceration	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	1/14 (7.1%)	1	0/7 (0%)	0
Pulmonary mass	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Wheezing	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Skin and subcutaneous tissue disorders
Acne	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Decubitus ulcer	0/22 (0%)	0	1/10 (10%)	1	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Dermatitis contact	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	1/14 (7.1%)	1	0/7 (0%)	0
Erythema	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	2/9 (22.2%)	2	0/14 (0%)	0	0/7 (0%)	0
Pruritus	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Rash	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Rash erythematous	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Rash macular	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Rash maculo-papular	0/22 (0%)	0	1/10 (10%)	1	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Skin exfoliation	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Vascular disorders
Hypotension	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	1/9 (11.1%)	1	0/14 (0%)	0	0/7 (0%)	0
Phlebitis	0/22 (0%)	0	0/10 (0%)	0	1/19 (5.3%)	1	0/9 (0%)	0	0/14 (0%)	0	0/7 (0%)	0
Thrombophlebitis	0/22 (0%)	0	0/10 (0%)	0	0/19 (0%)	0	0/9 (0%)	0	0/14 (0%)	0	1/7 (14.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.