Trial Outcomes & Findings for Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005) (NCT NCT01728376)

NCT ID: NCT01728376

Last Updated: 2018-08-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 82 participants
• Primary outcome timeframe: Administration of first dose through the last follow-up visit (up to 77 days)
• Results posted on: 2018-08-28

Participant Flow

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

Participant milestones

Measure	Daptomycin - 1 to 6 Year Olds 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).	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.	Daptomycin - 7 to 11 Year Olds 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).	Comparator - 7 to 11 Year Olds 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.	Daptomycin - 12 to 17 Year Olds 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).	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.
Overall Study STARTED	22	11	19	9	14	7
Overall Study Treated	22	10	19	9	14	7
Overall Study COMPLETED	18	9	17	7	12	5
Overall Study NOT COMPLETED	4	2	2	2	2	2

Reasons for withdrawal

Measure	Daptomycin - 1 to 6 Year Olds 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).	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.	Daptomycin - 7 to 11 Year Olds 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).	Comparator - 7 to 11 Year Olds 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.	Daptomycin - 12 to 17 Year Olds 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).	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.
Overall Study Adverse Event	1	1	1	1	1	0
Overall Study Persistent Positive Blood Cultures	1	0	1	0	0	0
Overall Study No relevant bacteria	2	0	0	0	1	1
Overall Study Did not receive treatment	0	1	0	0	0	0
Overall Study Subject/Parent/Legal Guardian Decision	0	0	0	1	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Daptomycin - 1 to 6 Year Olds n=22 Participants 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).	Comparator- 1 to 6 Year Olds n=10 Participants 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.	Daptomycin - 7 to 11 Year Olds n=19 Participants 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).	Comparator - 7 to 11 Year Olds n=9 Participants 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.	Daptomycin - 12 to 17 Year Olds n=14 Participants 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).	Comparator - 12 to 17 Year Olds n=7 Participants 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 n=81 Participants Total of all reporting groups
Age, Continuous	3.81 Years STANDARD_DEVIATION 1.232 • n=5 Participants	4.13 Years STANDARD_DEVIATION 1.752 • n=7 Participants	10.25 Years STANDARD_DEVIATION 1.217 • n=5 Participants	9.46 Years STANDARD_DEVIATION 1.345 • n=4 Participants	14.14 Years STANDARD_DEVIATION 1.677 • n=21 Participants	14.56 Years STANDARD_DEVIATION 1.868 • n=10 Participants	8.70 Years STANDARD_DEVIATION 4.468 • n=115 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	27 Participants n=115 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants	8 Participants n=4 Participants	14 Participants n=21 Participants	6 Participants n=10 Participants	54 Participants n=115 Participants

PRIMARY outcome

Timeframe: Administration of first dose through the last follow-up visit (up to 77 days)

Population: Participants who received any dose of IV study medication

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.

Outcome measures

Measure	Daptomycin - 1 to 6 Year Olds n=22 Participants 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).	Comparator- 1 to 6 Year Olds n=10 Participants 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.	Daptomycin - 7 to 11 Year Olds n=19 Participants 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).	Comparator - 7 to 11 Year Olds n=9 Participants 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.	Daptomycin - 12 to 17 Year Olds n=14 Participants 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).	Comparator - 12 to 17 Year Olds n=7 Participants 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.
Number of Participants With One or More Adverse Events (AEs)	15 Participants	6 Participants	12 Participants	9 Participants	9 Participants	5 Participants

PRIMARY outcome

Timeframe: Administration of first dose through the last follow-up visit (up to 77 days)

Population: Participants who received any dose of IV study medication

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.

Outcome measures

Measure	Daptomycin - 1 to 6 Year Olds n=22 Participants 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).	Comparator- 1 to 6 Year Olds n=10 Participants 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.	Daptomycin - 7 to 11 Year Olds n=19 Participants 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).	Comparator - 7 to 11 Year Olds n=9 Participants 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.	Daptomycin - 12 to 17 Year Olds n=14 Participants 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).	Comparator - 12 to 17 Year Olds n=7 Participants 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.
Number of Participants With One or More Serious Adverse Events (SAEs)	6 Participants	2 Participants	4 Participants	3 Participants	3 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline up to end of therapy visit (up to 49 days)

Population: Participants who received any dose of IV study medication

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) .

Outcome measures

Measure	Daptomycin - 1 to 6 Year Olds n=22 Participants 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).	Comparator- 1 to 6 Year Olds n=10 Participants 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.	Daptomycin - 7 to 11 Year Olds n=19 Participants 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).	Comparator - 7 to 11 Year Olds n=9 Participants 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.	Daptomycin - 12 to 17 Year Olds n=14 Participants 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).	Comparator - 12 to 17 Year Olds n=7 Participants 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.
Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal	40.9 Percentage of Participants	40.0 Percentage of Participants	10.5 Percentage of Participants	0.0 Percentage of Participants	28.6 Percentage of Participants	14.3 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline up to end of therapy visit (up to 44 days)

Population: Participants who received any dose of IV study medication

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)

Outcome measures

Measure	Daptomycin - 1 to 6 Year Olds n=22 Participants 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).	Comparator- 1 to 6 Year Olds n=10 Participants 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.	Daptomycin - 7 to 11 Year Olds n=19 Participants 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).	Comparator - 7 to 11 Year Olds n=9 Participants 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.	Daptomycin - 12 to 17 Year Olds n=14 Participants 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).	Comparator - 12 to 17 Year Olds n=7 Participants 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.
Percentage of Participants With Sustained CPK Elevations	18.2 Percentage of Participants	20.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants	28.6 Percentage of Participants	14.3 Percentage of Participants

PRIMARY outcome

Timeframe: TOC Safety Visit (up to 56 days)

Population: Participants who received any dose of IV study medication.

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.

Outcome measures

Measure	Daptomycin - 1 to 6 Year Olds n=22 Participants 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).	Comparator- 1 to 6 Year Olds n=10 Participants 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.	Daptomycin - 7 to 11 Year Olds n=19 Participants 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).	Comparator - 7 to 11 Year Olds n=9 Participants 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.	Daptomycin - 12 to 17 Year Olds n=14 Participants 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).	Comparator - 12 to 17 Year Olds n=7 Participants 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.
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Alertness	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Pupillary Reflex and Tracking	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Peripheral Reflex - Biceps	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Peripheral Reflex - Patellar Tendon	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Peripheral Reflex - Ankle Jerk	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Peripheral Reflex - Plantar Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Muscle Tone - Lower/Upper Limbs	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Muscle Strength - Lower/Upper Limbs	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Coordination - (Finger to Nose)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Tremor of the hands/fingers	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) Sensation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 7-14 days after the last dose of study medication (up to 56 days)

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

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.

Outcome measures

Measure	Daptomycin - 1 to 6 Year Olds n=20 Participants 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).	Comparator- 1 to 6 Year Olds n=8 Participants 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.	Daptomycin - 7 to 11 Year Olds n=17 Participants 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).	Comparator - 7 to 11 Year Olds n=9 Participants 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.	Daptomycin - 12 to 17 Year Olds n=14 Participants 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).	Comparator - 12 to 17 Year Olds n=5 Participants 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.
Percentage of Participants With Clinical Success at TOC/Safety Visit Cured	80.0 Percentage of participants	87.5 Percentage of participants	94.1 Percentage of participants	77.8 Percentage of participants	78.6 Percentage of participants	60.0 Percentage of participants
Percentage of Participants With Clinical Success at TOC/Safety Visit Improved	5.0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	7.1 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 7-14 days after the last dose of study medication (up to 56 days)

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

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.

Outcome measures

Measure	Daptomycin - 1 to 6 Year Olds n=20 Participants 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).	Comparator- 1 to 6 Year Olds n=8 Participants 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.	Daptomycin - 7 to 11 Year Olds n=17 Participants 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).	Comparator - 7 to 11 Year Olds n=9 Participants 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.	Daptomycin - 12 to 17 Year Olds n=14 Participants 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).	Comparator - 12 to 17 Year Olds n=5 Participants 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.
Percentage of Participants With Overall Success at TOC Visit	80.0 Percentage of participants	75.0 Percentage of participants	82.4 Percentage of participants	44.4 Percentage of participants	50.0 Percentage of participants	60.0 Percentage of participants

SECONDARY outcome

Timeframe: Days 3, 4, 5 or 6 of treatment at pre-dose

Population: 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.

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.

Outcome measures

Measure	Daptomycin - 1 to 6 Year Olds n=3 Participants 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).	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.	Daptomycin - 7 to 11 Year Olds n=10 Participants 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).	Comparator - 7 to 11 Year Olds 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.	Daptomycin - 12 to 17 Year Olds n=7 Participants 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).	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.
Trough Plasma Concentration of Daptomycin	4.72 µg/mL Standard Deviation 1.643	—	6.39 µg/mL Standard Deviation 3.035	—	14.69 µg/mL Standard Deviation 19.109	—

SECONDARY outcome

Timeframe: Days 3, 4, 5 or 6 of treatment at end of infusion

Population: 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.

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.

Outcome measures

Measure	Daptomycin - 1 to 6 Year Olds n=15 Participants 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).	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.	Daptomycin - 7 to 11 Year Olds n=18 Participants 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).	Comparator - 7 to 11 Year Olds 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.	Daptomycin - 12 to 17 Year Olds n=8 Participants 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).	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.
Maximum Plasma Concentration (Cmax) of Daptomycin	96.69 µg/mL Standard Deviation 32.946	—	87.66 µg/mL Standard Deviation 34.992	—	74.70 µg/mL Standard Deviation 34.909	—

Adverse Events

Daptomycin - 1 to 6 Year Olds

Serious events: 6 serious events

Other events: 9 other events

Deaths: 0 deaths

Comparator - 1 to 6 Year Olds

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Daptomycin - 7 to 11 Year Olds

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Comparator - 7 to 11 Year Olds

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Daptomycin - 12 to 17 Year Olds

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Comparator - 12 to 17 Year Olds

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Daptomycin - 1 to 6 Year Olds n=22 participants at risk 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).	Comparator - 1 to 6 Year Olds n=10 participants at risk 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.	Daptomycin - 7 to 11 Year Olds n=19 participants at risk 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).	Comparator - 7 to 11 Year Olds n=9 participants at risk 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.	Daptomycin - 12 to 17 Year Olds n=14 participants at risk 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).	Comparator - 12 to 17 Year Olds n=7 participants at risk 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.
Cardiac disorders Cardiac failure congestive	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
General disorders Device breakage	4.5% 1/22 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Immune system disorders Intestine transplant rejection	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Arthritis bacterial	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Bacteraemia	9.1% 2/22 • Number of events 2 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Bone abscess	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Muscle abscess	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Osteomyelitis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 2 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Pneumonia	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Staphylococcal bacteraemia	4.5% 1/22 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Investigations Hepatic enzyme increased	4.5% 1/22 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Metabolism and nutrition disorders Malnutrition	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Musculoskeletal and connective tissue disorders Bone fistula	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Vascular disorders Venous thrombosis limb	4.5% 1/22 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication

Other adverse events

Measure	Daptomycin - 1 to 6 Year Olds n=22 participants at risk 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).	Comparator - 1 to 6 Year Olds n=10 participants at risk 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.	Daptomycin - 7 to 11 Year Olds n=19 participants at risk 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).	Comparator - 7 to 11 Year Olds n=9 participants at risk 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.	Daptomycin - 12 to 17 Year Olds n=14 participants at risk 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).	Comparator - 12 to 17 Year Olds n=7 participants at risk 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.
Blood and lymphatic system disorders Abdominal lymphadenopathy	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Blood and lymphatic system disorders Anaemia	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 2 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Cardiac disorders Ventricular extrasystoles	4.5% 1/22 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Eye disorders Vision blurred	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Gastrointestinal disorders Abdominal pain	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Gastrointestinal disorders Diarrhoea	18.2% 4/22 • Number of events 4 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	33.3% 3/9 • Number of events 3 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Gastrointestinal disorders Nausea	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Gastrointestinal disorders Vomiting	9.1% 2/22 • Number of events 2 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	20.0% 2/10 • Number of events 4 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.5% 2/19 • Number of events 4 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 2/14 • Number of events 2 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
General disorders Catheter site discharge	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
General disorders Catheter site oedema	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
General disorders Catheter site pain	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
General disorders Device breakage	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
General disorders Infusion site pain	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
General disorders Pyrexia	9.1% 2/22 • Number of events 3 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	22.2% 2/9 • Number of events 3 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 2/14 • Number of events 2 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Immune system disorders Drug hypersensitivity	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Abdominal abscess	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Abscess	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Arthritis bacterial	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Candida infection	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Cellulitis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Infected skin ulcer	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Lung abscess	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Nasopharyngitis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Osteomyelitis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	28.6% 2/7 • Number of events 2 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Osteomyelitis acute	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Postoperative wound infection	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Rash pustular	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Rhinovirus infection	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Systemic candida	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Varicella	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Viral infection	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Injury, poisoning and procedural complications Contusion	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Injury, poisoning and procedural complications Excoriation	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Injury, poisoning and procedural complications Wound	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Investigations Alanine aminotransferase increased	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Investigations Blood creatine phosphokinase increased	4.5% 1/22 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 2/14 • Number of events 2 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Investigations Blood potassium decreased	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Investigations Blood sodium decreased	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Investigations Hepatic enzyme increased	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Investigations Transaminases increased	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Metabolism and nutrition disorders Fluid overload	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Metabolism and nutrition disorders Hyperphosphataemia	4.5% 1/22 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 2 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Nervous system disorders Headache	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Nervous system disorders Lethargy	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Psychiatric disorders Abnormal behaviour	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Renal and urinary disorders Dysuria	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Renal and urinary disorders Pollakiuria	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Renal and urinary disorders Renal failure acute	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Renal and urinary disorders Renal necrosis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Reproductive system and breast disorders Epididymal cyst	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Respiratory, thoracic and mediastinal disorders Cough	4.5% 1/22 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Respiratory, thoracic and mediastinal disorders Pharyngeal ulceration	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Skin and subcutaneous tissue disorders Acne	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	7.1% 1/14 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Skin and subcutaneous tissue disorders Erythema	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	22.2% 2/9 • Number of events 2 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Skin and subcutaneous tissue disorders Rash	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Vascular disorders Hypotension	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	11.1% 1/9 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Vascular disorders Phlebitis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	5.3% 1/19 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Vascular disorders Thrombophlebitis	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/10 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	14.3% 1/7 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Infections and infestations Pneumonia	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication
Investigations Body temperature increased	0.00% 0/22 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	10.0% 1/10 • Number of events 1 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/19 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/9 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/14 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication	0.00% 0/7 • Administration of first dose through the last follow-up visit (up to 77 days). Participants who received any dose of IV study medication

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

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