Trial Outcomes & Findings for Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections (NCT NCT00711802)
NCT ID: NCT00711802
Last Updated: 2018-09-05
Results Overview
A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
396 participants
Primary outcome timeframe
Baseline through 14 days after last dose of study drug
Results posted on
2018-09-05
Participant Flow
Participant milestones
| Measure |
Age Group 1: Daptomycin
Daptomycin: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years
|
Age Group 1: Standard of Care (SOC)
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years
|
Age Group 2: Daptomycin
Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years
|
Age Group 2: SOC
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years
|
Age Group 3: Daptomycin
Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years
|
Age Group 3: SOC
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years
|
Age Group 4: Daptomycin
Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to \<2 years
|
Age Group 4: SOC
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to \<2 years
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
38
|
75
|
38
|
83
|
42
|
30
|
15
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
73
|
37
|
73
|
38
|
81
|
42
|
30
|
15
|
|
Overall Study
COMPLETED
|
73
|
32
|
69
|
35
|
69
|
34
|
25
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
6
|
3
|
14
|
8
|
5
|
2
|
Reasons for withdrawal
| Measure |
Age Group 1: Daptomycin
Daptomycin: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years
|
Age Group 1: Standard of Care (SOC)
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years
|
Age Group 2: Daptomycin
Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years
|
Age Group 2: SOC
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years
|
Age Group 3: Daptomycin
Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years
|
Age Group 3: SOC
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years
|
Age Group 4: Daptomycin
Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to \<2 years
|
Age Group 4: SOC
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to \<2 years
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Not treated (no further detail)
|
2
|
1
|
2
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Microbiological failure
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
1
|
10
|
6
|
4
|
2
|
|
Overall Study
Reason not reported
|
0
|
1
|
1
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
Baseline characteristics by cohort
| Measure |
Age Group 1: Daptomycin
n=73 Participants
Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years
|
Age Group 1: Standard of Care (SOC)
n=37 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years
|
Age Group 2: Daptomycin
n=73 Participants
Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years
|
Age Group 2: SOC
n=38 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years
|
Age Group 3: Daptomycin
n=81 Participants
Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years
|
Age Group 3: SOC
n=42 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years
|
Age Group 4: Daptomycin
n=30 Participants
Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to \<2 years
|
Age Group 4: SOC
n=15 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to \<2 years
|
Total
n=389 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
15.02 years
STANDARD_DEVIATION 1.584 • n=5 Participants
|
14.84 years
STANDARD_DEVIATION 1.735 • n=7 Participants
|
9.05 years
STANDARD_DEVIATION 1.443 • n=5 Participants
|
8.98 years
STANDARD_DEVIATION 1.305 • n=4 Participants
|
3.92 years
STANDARD_DEVIATION 1.556 • n=21 Participants
|
3.86 years
STANDARD_DEVIATION 1.555 • n=8 Participants
|
1.46 years
STANDARD_DEVIATION 0.299 • n=8 Participants
|
1.43 years
STANDARD_DEVIATION 0.299 • n=24 Participants
|
8.21 years
STANDARD_DEVIATION 5.134 • n=42 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
188 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
201 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
125 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
90 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
165 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline through 14 days after last dose of study drugPopulation: Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data.
A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Age Group 1: Daptomycin
n=72 Participants
Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years
|
Age Group 1: Standard of Care (SOC)
n=38 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years
|
Age Group 2: Daptomycin
n=73 Participants
Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years
|
Age Group 2: SOC
n=38 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years
|
Age Group 3: Daptomycin
n=81 Participants
Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years
|
Age Group 3: SOC
n=42 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years
|
Age Group 4: Daptomycin
n=30 Participants
Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to \<2 years
|
Age Group 4: SOC
n=15 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to \<2 years
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
At least 1 TEAE
|
36.1 percentage of participants
|
36.8 percentage of participants
|
23.3 percentage of participants
|
18.4 percentage of participants
|
50.6 percentage of participants
|
38.1 percentage of participants
|
46.7 percentage of participants
|
73.3 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
At least 1 drug-related TEAE
|
13.9 percentage of participants
|
10.5 percentage of participants
|
5.5 percentage of participants
|
10.5 percentage of participants
|
22.2 percentage of participants
|
21.4 percentage of participants
|
10.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Discontinued treatment due to a TEAE
|
2.8 percentage of participants
|
0 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
3.7 percentage of participants
|
14.3 percentage of participants
|
3.3 percentage of participants
|
6.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 14 days after last dose of study drugPopulation: Participants who received at least 1 dose of study drug with evaluable test-of-cure visit data.
The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as "Success" or "Failure" by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered "Success" by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of "Failure" was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was "Failure." If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was "Unable to evaluate."
Outcome measures
| Measure |
Age Group 1: Daptomycin
n=73 Participants
Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years
|
Age Group 1: Standard of Care (SOC)
n=37 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years
|
Age Group 2: Daptomycin
n=73 Participants
Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years
|
Age Group 2: SOC
n=38 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years
|
Age Group 3: Daptomycin
n=81 Participants
Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years
|
Age Group 3: SOC
n=42 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years
|
Age Group 4: Daptomycin
n=30 Participants
Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to \<2 years
|
Age Group 4: SOC
n=15 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to \<2 years
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit
Clinical success
|
95.9 percentage of participants
|
91.9 percentage of participants
|
90.4 percentage of participants
|
92.1 percentage of participants
|
82.7 percentage of participants
|
76.2 percentage of participants
|
80.0 percentage of participants
|
86.7 percentage of participants
|
|
Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit
Clinical failure
|
0 percentage of participants
|
2.7 percentage of participants
|
2.7 percentage of participants
|
0 percentage of participants
|
1.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit
Unable to evaluate
|
4.1 percentage of participants
|
5.4 percentage of participants
|
6.9 percentage of participants
|
7.9 percentage of participants
|
16.1 percentage of participants
|
23.8 percentage of participants
|
20.0 percentage of participants
|
13.3 percentage of participants
|
SECONDARY outcome
Timeframe: Predose and 5 timepoints according to age group (up to 12 hours postdose)Population: Participants who received at least 1 dose of study drug with evaluable daptomycin AUC(0-t) data.
Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points: Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion.
Outcome measures
| Measure |
Age Group 1: Daptomycin
n=6 Participants
Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years
|
Age Group 1: Standard of Care (SOC)
n=2 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years
|
Age Group 2: Daptomycin
n=7 Participants
Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years
|
Age Group 2: SOC
n=30 Participants
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years
|
Age Group 3: Daptomycin
Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years
|
Age Group 3: SOC
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years
|
Age Group 4: Daptomycin
Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to \<2 years
|
Age Group 4: SOC
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to \<2 years
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])
|
318 microgram*hour per milliliter (μg*hr/mL)
Standard Deviation 62.2
|
NA microgram*hour per milliliter (μg*hr/mL)
Standard Deviation NA
Due to limited pharmacokinetic (PK) samples, these measures could not be calculated.
|
318 microgram*hour per milliliter (μg*hr/mL)
Standard Deviation 68.6
|
466 microgram*hour per milliliter (μg*hr/mL)
Standard Deviation NA
Due to limited PK samples, PK parameters were computed using the mean concentration-time profile during a sampling interval. As a result, no variability could be calculated.
|
—
|
—
|
—
|
—
|
Adverse Events
Age Group 1: Daptomycin
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Age Group 1: Standard of Care (SOC)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Age Group 2: Daptomycin
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Age Group 2: SOC
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Age Group 3: Daptomycin
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Age Group 3: SOC
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Age Group 4: Daptomycin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Age Group 4: SOC
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Age Group 1: Daptomycin
n=72 participants at risk
Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years
|
Age Group 1: Standard of Care (SOC)
n=38 participants at risk
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years
|
Age Group 2: Daptomycin
n=73 participants at risk
Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years
|
Age Group 2: SOC
n=38 participants at risk
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years
|
Age Group 3: Daptomycin
n=81 participants at risk
Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years
|
Age Group 3: SOC
n=42 participants at risk
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years
|
Age Group 4: Daptomycin
n=30 participants at risk
Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to \<2 years
|
Age Group 4: SOC
n=15 participants at risk
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to \<2 years
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
1.4%
1/72 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
General disorders
Pyrexia
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.4%
1/73 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.2%
1/81 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Abscess
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.4%
1/73 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.4%
1/42 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.6%
1/38 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Subcutaneous abscess
|
1.4%
1/72 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.4%
1/72 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
1.4%
1/72 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.2%
1/81 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.4%
1/73 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Toxic shock syndrome
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.6%
1/38 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
Other adverse events
| Measure |
Age Group 1: Daptomycin
n=72 participants at risk
Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years
|
Age Group 1: Standard of Care (SOC)
n=38 participants at risk
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years
|
Age Group 2: Daptomycin
n=73 participants at risk
Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years
|
Age Group 2: SOC
n=38 participants at risk
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years
|
Age Group 3: Daptomycin
n=81 participants at risk
Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years
|
Age Group 3: SOC
n=42 participants at risk
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years
|
Age Group 4: Daptomycin
n=30 participants at risk
Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to \<2 years
|
Age Group 4: SOC
n=15 participants at risk
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to \<2 years
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.6%
1/38 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
3/72 • Number of events 3 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.6%
1/38 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
4.1%
3/73 • Number of events 3 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.6%
1/38 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
14.8%
12/81 • Number of events 13 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
9.5%
4/42 • Number of events 4 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
2/72 • Number of events 3 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.4%
1/73 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.4%
1/73 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
4.9%
4/81 • Number of events 4 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.4%
1/42 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
2/30 • Number of events 3 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
General disorders
Infusion site extravasation
|
1.4%
1/72 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.6%
1/38 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
General disorders
Infusion site pain
|
1.4%
1/72 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
5.3%
2/38 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.4%
1/73 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.2%
1/81 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
General disorders
Pyrexia
|
2.8%
2/72 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
5.5%
4/73 • Number of events 4 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.2%
1/81 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.4%
1/42 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
2/30 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
20.0%
3/15 • Number of events 3 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
3.3%
1/30 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/72 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.2%
1/81 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
2/30 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.2%
1/81 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.6%
1/38 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.4%
1/42 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
4/72 • Number of events 4 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
5.3%
2/38 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.6%
1/38 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
9.9%
8/81 • Number of events 8 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
4.8%
2/42 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
3.3%
1/30 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
13.3%
2/15 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.2%
1/81 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
3.3%
1/30 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Investigations
Lymphocyte percentage increase
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Investigations
Platelet count increased
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Investigations
Red blood cells urine
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.2%
1/81 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
2/30 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Nervous system disorders
Headache
|
6.9%
5/72 • Number of events 5 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
7.9%
3/38 • Number of events 4 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.7%
2/73 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal lesion
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.6%
1/38 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.5%
2/81 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/42 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
2/30 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.4%
1/42 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
2/30 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
13.3%
2/15 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.6%
1/38 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
1.2%
1/81 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
4.8%
2/42 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.4%
1/72 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.4%
1/42 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
2/30 • Number of events 2 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/15 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/72 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/73 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/38 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/81 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
2.4%
1/42 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
0.00%
0/30 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
6.7%
1/15 • Number of events 1 • Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
|
Additional Information
Vice President, Clinical Research
Cubist Pharmaceuticals
Phone: (781) 860-8660
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60