Trial Outcomes & Findings for A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013) (NCT NCT02750761)

Last Updated: 2019-12-20

Results Overview

Cmax of tedizolid phosphate in participants ages 6 to \<12 years (Group 1) and 2 to \<6 years (Group 2). Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.

Results posted on

2019-12-20

Participant Flow

Prior to enrollment, participants were receiving prophylaxis for or with a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram-positive antibacterial activity.

Participant milestones

Participant milestones
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Overall Study STARTED	5	5	5	5	6	6
Overall Study COMPLETED	5	5	4	5	6	6
Overall Study NOT COMPLETED	0	0	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Overall Study Lost to Follow-up	0	0	1	0	0	0

Baseline Characteristics

A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=6 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Total n=32 Participants Total of all reporting groups
Age, Continuous	8.2 years STANDARD_DEVIATION 1.3 • n=5 Participants	7.4 years STANDARD_DEVIATION 1.1 • n=7 Participants	3.4 years STANDARD_DEVIATION 0.5 • n=5 Participants	4.0 years STANDARD_DEVIATION 1.4 • n=4 Participants	8.5 years STANDARD_DEVIATION 1.8 • n=21 Participants	3.2 years STANDARD_DEVIATION 1.0 • n=10 Participants	5.8 years STANDARD_DEVIATION 2.6 • n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	13 Participants n=115 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=10 Participants	19 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	11 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	21 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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=10 Participants	0 Participants n=115 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=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	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=10 Participants	0 Participants n=115 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=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=10 Participants	26 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	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=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.

Population: All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid phosphate.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=4 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=4 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=1 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug)	76.3 ng/mL Interval 8.38 to 695.0	82.4 ng/mL Interval 11.4 to 595.0	710 ng/mL Interval 98.4 to 5130.0	234 ng/mL Interval 25.7 to 2140.0	NA ng/mL All participants' results in this group were below the lower limit of quantification, so no data exist to report for this group.	9.4 ng/mL 95% CI cannot be calculated for a population containing only a single participant.

PRIMARY outcome

Time to reach peak plasma concentration (Tmax) of tedizolid phosphate in participants ages 6 to \<12 years (Group 1) and 2 to \<6 years (Group 2). Tedizolid phosphate concentrations were below the lower limit of quantification in Group 3 and Group 4. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=4 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=4 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=1 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid Phosphate (Prodrug)	1.18 Hours Interval 1.07 to 2.07	1.10 Hours Interval 1.0 to 1.33	1.12 Hours Interval 1.07 to 1.17	1.02 Hours Interval 1.0 to 1.05	NA Hours All participants' results in this group were below the lower limit of quantification, so no data exist to report for this group.	6.0 Hours Interval 6.0 to 6.0

PRIMARY outcome

Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=4 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=4 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=1 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Last Detectable Measurement	64.8 hr*ng/mL Interval 6.42 to 654.0	63.6 hr*ng/mL Interval 8.04 to 503.0	433 hr*ng/mL Interval 54.8 to 3430.0	182 hr*ng/mL Interval 18.1 to 1840.0	NA hr*ng/mL All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	14.1 hr*ng/mL 95% CI cannot be calculated for a population containing only a single participant.

PRIMARY outcome

Population: All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the AUC. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure.

Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=1 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=6 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Infinity	NA hr*ng/mL All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	NA hr*ng/mL All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	NA hr*ng/mL All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	2000 hr*ng/mL Interval 2000.0 to 2000.0	NA hr*ng/mL All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	NA hr*ng/mL All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.

PRIMARY outcome

Population: All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the T1/2. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure.

Terminal elimination half-life (T1/2) of tedizolid phosphate following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=1 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=6 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Terminal Elimination Half-life (T1/2) of Tedizolid Phosphate (Prodrug)	NA Hours Geometric Coefficient of Variation NA All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	NA Hours Geometric Coefficient of Variation NA All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	NA Hours Geometric Coefficient of Variation NA All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	2.77 Hours Geometric Coefficient of Variation NA Geometric coefficient of variation cannot be calculated for a population containing only a single participant.	NA Hours Geometric Coefficient of Variation NA All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	NA Hours Geometric Coefficient of Variation NA All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.

PRIMARY outcome

Timeframe: Group 1 (6 to <12 years): Day 1 immediately after infusion and at 1.5, 2, 3, 4, 6, 12, and 24 hours. Group 2 (2 to <6 years): Day 1 immediately after infusion and at 3, 6, 12, 24 and 48 hours.

Population: All participants who received an IV infusion of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the CL. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure.

CL of IV tedizolid phosphate in participants ages 6 to \<12 years (Group 1) and 2 to \<6 years (Group 2).

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=1 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Clearance (CL) of Tedizolid Phosphate (Prodrug) in Participants Who Received Tedizolid Phosphate Intravenously (IV)	NA mL/hr Geometric Coefficient of Variation NA All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	NA mL/hr Geometric Coefficient of Variation NA All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	NA mL/hr Geometric Coefficient of Variation NA All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	24400 mL/hr Geometric Coefficient of Variation NA Geometric coefficient of variation cannot be calculated for a population containing only a single participant.	—	—

PRIMARY outcome

Timeframe: Group 3 (6 to <12 years): at 1, 2, 3, 4, 6, 8, 12, and 24 hours after the dose; Group 4 (2 to <6 years): at 3, 6, 9, 12, 24 and 48 hours after the dose

Population: All participants who received an oral dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the CL/F. All orally dosed participants' data were below the lower limit of quantification, resulting in no reportable data.

CL/F of oral suspension tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to \<12 years (Group 3) and 2 to \<6 years (Groups 4).

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Clearance (CL/F) of Tedizolid Phosphate in Participants Who Received Oral Tedizolid Phosphate (Prodrug)	NA mL/hr/kg Geometric Coefficient of Variation NA All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	NA mL/hr/kg Geometric Coefficient of Variation NA All participants' results in this group were below the lower limit of quantification, so no data exist to present for this group.	—	—	—	—

PRIMARY outcome

Population: All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid.

Maximum observed drug concentration in plasma (Cmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=6 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid (the Active Metabolite)	4960 ng/mL 95% Confidence Interval 3440 • Interval 3440.0 to 7140.0	4140 ng/mL 95% Confidence Interval 2880 • Interval 2880.0 to 5970.0	7460 ng/mL 95% Confidence Interval 5180 • Interval 5180.0 to 10800.0	4190 ng/mL 95% Confidence Interval 2910 • Interval 2910.0 to 6030.0	2590 ng/mL 95% Confidence Interval 1860 • Interval 1860.0 to 3620.0	1820 ng/mL 95% Confidence Interval 1310 • Interval 1310.0 to 2550.0

PRIMARY outcome

Population: All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid.

Time to reach peak plasma concentration (Tmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=6 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid (the Active Metabolite)	1.18 Hours Full Range 1.07 • Interval 1.07 to 1.5	1.10 Hours Full Range 1.00 • Interval 1.0 to 1.33	1.12 Hours Full Range 1.07 • Interval 1.07 to 1.17	1.00 Hours Full Range 1.00 • Interval 1.0 to 1.05	2.53 Hours Full Range 1.20 • Interval 1.2 to 6.02	3.08 Hours Full Range 3.00 • Interval 3.0 to 12.0

PRIMARY outcome

Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=6 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Last Detectable Measurement	28200 hr*ng/mL 95% Confidence Interval 21200 • Interval 21200.0 to 37600.0	19700 hr*ng/mL 95% Confidence Interval 14800 • Interval 14800.0 to 26200.0	26800 hr*ng/mL 95% Confidence Interval 20200 • Interval 20200.0 to 35800.0	17100 hr*ng/mL 95% Confidence Interval 12800 • Interval 12800.0 to 22700.0	22700 hr*ng/mL 95% Confidence Interval 17500 • Interval 17500.0 to 29500.0	14600 hr*ng/mL 95% Confidence Interval 11200 • Interval 11200.0 to 18900.0

PRIMARY outcome

Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity	29600 hr*ng/mL Interval 22500.0 to 38900.0	21000 hr*ng/mL Interval 16000.0 to 27600.0	27300 hr*ng/mL Interval 20800.0 to 35900.0	17300 hr*ng/mL Interval 13200.0 to 22700.0	24900 hr*ng/mL Interval 19400.0 to 32000.0	17200 hr*ng/mL Interval 13100.0 to 22600.0

PRIMARY outcome

Terminal elimination half-life (T1/2) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Terminal Elimination Half-life (T1/2) of Tedizolid (Active Metabolite)	5.18 Hours Geometric Coefficient of Variation 21.54 • Interval 21.54 to	4.93 Hours Geometric Coefficient of Variation 13.82 • Interval 13.82 to	5.51 Hours Geometric Coefficient of Variation 30.16 • Interval 30.16 to	5.76 Hours Geometric Coefficient of Variation 29.20 • Interval 29.2 to	6.15 Hours Geometric Coefficient of Variation 24.41 • Interval 24.41 to	6.79 Hours Geometric Coefficient of Variation 10.85 • Interval 10.85 to

PRIMARY outcome

CL of IV tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to \<12 years (Group 1) and 2 to \<6 years (Group 2).

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Clearance (CL) of Tedizolid (Active Metabolite) in Participants Who Received Tedizolid Phosphate Intravenously (IV)	4164.60 mL/hr Geometric Coefficient of Variation 36.39	4145.73 mL/hr Geometric Coefficient of Variation 73.21	2582.66 mL/hr Geometric Coefficient of Variation 20.64	2461.08 mL/hr Geometric Coefficient of Variation 11.99	—	—

PRIMARY outcome

Timeframe: Group 3 (6 to <12 years): at 1, 2, 3, 4, 6, 8, 12, and 24 hours after the dose; Group 4 (2 to <6 years): at 3, 6, 9, 12, 24 and 48 hours after the dose

CL/F of tedizolid, in participants ages 6 to \<12 years (Group 3) and 2 to \<6 years (Groups 4).

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Clearance (CL/F) of Tedizolid (Active Metabolite) in Participants Who Received Oral Tedizolid Phosphate	4073.32 mL/hr/kg Geometric Coefficient of Variation 21.14	2090.77 mL/hr/kg Geometric Coefficient of Variation 50.27	—	—	—	—

PRIMARY outcome

Population: All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the AUC. Per protocol, participant arms were pooled based on route of administration (IV or Oral) and outcome was normalized to the dose received.

The area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose, normalized to dosage, was calculated. Per protocol, this outcome used pooled groups as follows: The IV Group pooled Groups 1 and 2, who received tedizolid phosphate via intravenous (IV) administration; the Oral Group pooled groups 3 and 4, who received tedizolid phosphate via oral administration. Pharmacokinetic sampling occurred at the following time points: Group 1 (part of the IV Group): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (part of the IV Group): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (part of the Oral Group): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (part of the Oral Group): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=20 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=11 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Dose Normalized Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity	5340 hr*ng/mL/mg/kg Interval 4680.0 to 6100.0	6000 hr*ng/mL/mg/kg Interval 5020.0 to 7180.0	—	—	—	—

SECONDARY outcome

Timeframe: Up to 9 days

Population: All participants who received any study drug.

An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=6 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Number of Participants Who Experienced at Least One Adverse Event	2 Participants	1 Participants	2 Participants	0 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 day

Population: All participants who received any study drug.

An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 Participants Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) n=6 Participants Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Following single oral dose on Day 1

Population: All participants who received an oral dose of tedizolid phosphate suspension.

Palatability of oral tedizolid phosphate suspension in participants ages 6 to \<12 years (Group 3) and 2 to \<6 years (Group 4). Palatability was assessed using a 5-point hedonic scale and spontaneous verbal judgment. This hedonic scale consists of 5 pictures of line drawn faces corresponding to very bad, bad, neither good nor bad, good and very good. The participant was asked to mark or point to the face to show how they felt about the taste of the study drug. For preverbal children, the score was assessed by the parent/caregiver, or study staff administering or witnessing administration of the study drug.

Outcome measures

Outcome measures
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=6 Participants Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate Very good	0 Participants	0 Participants	—	—	—	—
Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate Good	0 Participants	1 Participants	—	—	—	—
Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate Neither good nor bad	3 Participants	2 Participants	—	—	—	—
Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate Bad	1 Participants	3 Participants	—	—	—	—
Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate Very bad	2 Participants	0 Participants	—	—	—	—

Adverse Events

Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 4: Tedizolid Oral 3 mg/kg (6 to <12 Years)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 participants at risk Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 participants at risk Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 participants at risk Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 participants at risk Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 participants at risk Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (6 to <12 Years) n=6 participants at risk Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Infections and infestations Appendicitis	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days

Other adverse events

Other adverse events
Measure	Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) n=5 participants at risk Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) n=5 participants at risk Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) n=5 participants at risk Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) n=5 participants at risk Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) n=6 participants at risk Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.	Group 4: Tedizolid Oral 3 mg/kg (6 to <12 Years) n=6 participants at risk Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days
Cardiac disorders Tachycardia	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	0.00% 0/6 • Up to 9 days
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days
Gastrointestinal disorders Faeces discoloured	0.00% 0/5 • Up to 9 days	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days
Gastrointestinal disorders Nausea	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days
Gastrointestinal disorders Vomiting	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	33.3% 2/6 • Number of events 2 • Up to 9 days	0.00% 0/6 • Up to 9 days
General disorders Asthenia	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	0.00% 0/6 • Up to 9 days
General disorders Chest pain	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	0.00% 0/6 • Up to 9 days
General disorders Pyrexia	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	33.3% 2/6 • Number of events 2 • Up to 9 days	0.00% 0/6 • Up to 9 days
Infections and infestations Gastroenteritis	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days
Injury, poisoning and procedural complications Incision site swelling	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	0.00% 0/6 • Up to 9 days
Investigations Blood pressure systolic decreased	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days
Investigations Blood pressure systolic increased	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days
Investigations Haemoglobin decreased	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	0.00% 0/6 • Up to 9 days
Investigations Heart rate decreased	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days
Investigations Respiratory rate increased	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days
Investigations Weight decreased	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	0.00% 0/6 • Up to 9 days
Nervous system disorders Dystonia	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	0.00% 0/6 • Up to 9 days
Nervous system disorders Headache	0.00% 0/5 • Up to 9 days	20.0% 1/5 • Number of events 2 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	0.00% 0/6 • Up to 9 days
Renal and urinary disorders Polyuria	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	0.00% 0/6 • Up to 9 days
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	20.0% 1/5 • Number of events 1 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/6 • Up to 9 days	0.00% 0/6 • Up to 9 days
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	0.00% 0/5 • Up to 9 days	16.7% 1/6 • Number of events 1 • Up to 9 days	0.00% 0/6 • Up to 9 days

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor intends to pursue publication of the results of the study in cooperation with a lead Investigator. Sponsor written approval is required for publication of any data subsets. Final authorship will be determined in accordance with the International Committee of Medical Journal Editors definition of authorship. Participant names and other personal data may not be disclosed in any publication without prior written authorization from Sponsor and the participant.
Publication restrictions are in place

Restriction type: OTHER